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129 results on '"Gordon, Ingelise J"'

1. Phase 1 dose-escalation trial evaluating a group 2 influenza hemagglutinin stabilized stem nanoparticle vaccine

Author

Casazza, Joseph P., Hofstetter, Amelia R., Costner, Pamela J. M., Holman, LaSonji A., Hendel, Cynthia S., Widge, Alicia T., Wu, Richard L., Whalen, William R., Cunningham, Jennifer, Arthur, Anita, Wang, Xiaolin, Ola, Abidemi, Saunders, Jamie, Mendoza, Floreliz, Novik, Laura, Burgos Florez, Maria C., Ortega-Villa, Ana M., Apte, Preeti J., Strom, Larisa, Wang, Lu, Imam, Marjaan, Basappa, Manjula, Naisan, Mursal, Castro, Mike, Trost, Jessica F., Narpala, Sandeep R., Vanderven, Hillary A., Yamshchikov, Galina V., Berkowitz, Nina M., Gordon, Ingelise J., Plummer, Sarah H., Wycuff, Diane L., Vazquez, Sandra, Gillespie, Rebecca A., Creanga, Adrian, Adams, William C., Carlton, Kevin, Gall, Jason G., McDermott, Adrian B., Serebryannyy, Leonid A., Houser, Katherine V., Koup, Richard A., Graham, Barney S., Ledgerwood, Julie E., Mascola, John R., Pierson, Theodore C., Andrews, Sarah F., Kanekiyo, Masaru, and Dropulic, Lesia K.

Published
2024
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2. Heterologous cAd3-Ebola and MVA-EbolaZ vaccines are safe and immunogenic in US and Uganda phase 1/1b trials

Author

Happe, Myra, Hofstetter, Amelia R., Wang, Jing, Yamshchikov, Galina V., Holman, LaSonji A., Novik, Laura, Strom, Larisa, Kiweewa, Francis, Wakabi, Salim, Millard, Monica, Kelley, Colleen F., Kabbani, Sarah, Edupuganti, Srilatha, Beck, Allison, Kaltovich, Florence, Murray, Tamar, Tsukerman, Susanna, Carr, Derick, Ashman, Carl, Stanley, Daphne A., Ploquin, Aurélie, Bailer, Robert T., Schwartz, Richard, Cham, Fatim, Tindikahwa, Allan, Hu, Zonghui, Gordon, Ingelise J., Rouphael, Nadine, Houser, Katherine V., Coates, Emily E., Graham, Barney S., Koup, Richard A., Mascola, John R., Sullivan, Nancy J., Robb, Merlin L., Ake, Julie A., Lyke, Kirsten E., Mulligan, Mark J., Ledgerwood, Julie E., and Kibuuka, Hannah

Published
2024
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3. Safety, tolerability, and immunogenicity of the Ebola Sudan chimpanzee adenovirus vector vaccine (cAd3-EBO S) in healthy Ugandan adults: a phase 1, open-label, dose-escalation clinical trial

Author

Namugabo, Jaqueline, Beingana, Claire, Mukyala, Maureen G., Wandege, Joseph, Nanteza, Christine, Atwijuka, Brenda, Kizanye, Juliet, Nassanga, Gertrude, Namuli, Joanita, Kityo, Herbert, Ssekitoleko, Mathias, Nassaka, Roy, Mutebe, Hilda, Kabahubya, Mable, Widge, Alicia T., O'Connell, Sarah E., Amoa-Awua, Obrimpong, Narpala, Sandeep R., Flach, Britta, Cox, Josephine, Beck, Allison, Guech, Mercy, Seo, Ellie, Stein, Judy A., Mwesigwa, Betty, Houser, Katherine V, Hofstetter, Amelia R, Ortega-Villa, Ana M, Naluyima, Prossy, Kiweewa, Francis, Nakabuye, Immaculate, Yamshchikov, Galina V, Andrews, Charla, O'Callahan, Mark, Strom, Larisa, Schech, Steven, Anne Eller, Leigh, Sondergaard, Erica L, Scott, Paul T, Amare, Mihret F, Modjarrad, Kayvon, Wamala, Amir, Tindikahwa, Allan, Musingye, Ezra, Nanyondo, Jauhara, Gaudinski, Martin R, Gordon, Ingelise J, Holman, LaSonji A, Saunders, Jamie G, Costner, Pamela J M, Mendoza, Floreliz H, Happe, Myra, Morgan, Patricia, Plummer, Sarah H, Hickman, Somia P, Vazquez, Sandra, Murray, Tamar, Cordon, Jamilet, Dulan, Caitlyn N M, Hunegnaw, Ruth, Basappa, Manjula, Padilla, Marcelino, Gajjala, Suprabhath R, Swanson, Phillip A, II, Lin, Bob C, Coates, Emily E, Gall, Jason G, McDermott, Adrian B, Koup, Richard A, Mascola, John R, Ploquin, Aurélie, Sullivan, Nancy J, Kibuuka, Hannah, Ake, Julie A, and Ledgerwood, Julie E

Published
2023
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4. Low-dose intravenous and subcutaneous CIS43LS monoclonal antibody for protection against malaria (VRC 612 Part C): a phase 1, adaptive trial

Author

Young, Cheryl, Boyce, Colleen, Winkler, Jennifer, Holian, Susan, Greenberg, Nancy, George, Shirley, Kwon, Alyson, Dorsey, Brenda, Da Costa, Ana Raquel, Witt, William, Grays, Daryl, Gapasin, Arren, Bernal, Paula, Floyd, Jeffrey, Goldstein, Eric, Howe, Leslie, Lee, Myounghee, Marron, Jennifer, Brooks, Kelly, Turek, Lisa, Farley, Patricia, Frels, Shantel, Booth, Delores, Gall, Jason, Carlton, Kevin, Albright, Gabriela, Amharref, Nadia, Atallah, Kandace, Banappagari, Sashikanth, Bastani, Niutish, Blackstock, Daniel, Boonyaratanakornkit, Bobby, Carey, Elizabeth, Charlton, Adam, Chaudhuri, Rajoshi, Caringal, Alegria M., Chen, Mingzhong, Chen, Peifeng, Cheng, Wei, Gowetski, Daniel, Gulla, Krishana, Hastings, Erica, Horwitz, Joe, Ivleva, Vera, Kordella, Dan, Kueltzo, Lisa A., Lagler, Sara, Le, Matt, Lee, James, Lei, Paula, Li, Yile, Nagy, Attila, Patel, Aakash, Runsewe, Peyi, Shadrick, Will, Shetty, Shamitha, Wang, Hairong, Webber, Calvin, Vejzagic, Farah, Yang, Yoo-Jung, Lyke, Kirsten E, Berry, Andrea A, Mason, Kaitlin, Idris, Azza H, O'Callahan, Mark, Happe, Myra, Strom, Larisa, Berkowitz, Nina M, Guech, Mercy, Hu, Zonghui, Castro, Mike, Basappa, Manjula, Wang, Lu, Low, Kwang, Holman, LaSonji A, Mendoza, Floreliz, Gordon, Ingelise J, Plummer, Sarah H, Trofymenko, Olga, Strauss, Kathleen S, Joshi, Sudhaunshu, Shrestha, Biraj, Adams, Matthew, Chagas, Andrezza Campos, Murphy, Jittawadee R, Stein, Judy, Hickman, Somia, McDougal, Andrew, Lin, Bob, Narpala, Sandeep R, Vazquez, Sandra, Serebryannyy, Leonid, McDermott, Adrian, Gaudinski, Martin R, Capparelli, Edmund V, Coates, Emily E, Wu, Richard L, Ledgerwood, Julie E, Dropulic, Lesia K, and Seder, Robert A

Published
2023
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5. Safety, tolerability, and immunogenicity of the chimpanzee adenovirus type 3-vectored Marburg virus (cAd3-Marburg) vaccine in healthy adults in the USA: a first-in-human, phase 1, open-label, dose-escalation trial

Author

Lampley, Rebecca, Larkin, Brenda, Costner, Pamela, Wilson, Hope, Read, Mike, Hamer, Melinda J, Houser, Katherine V, Hofstetter, Amelia R, Ortega-Villa, Ana M, Lee, Christine, Preston, Anne, Augustine, Brooke, Andrews, Charla, Yamshchikov, Galina V, Hickman, Somia, Schech, Steven, Hutter, Jack N, Scott, Paul T, Waterman, Paige E, Amare, Mihret F, Kioko, Victoria, Storme, Casey, Modjarrad, Kayvon, McCauley, Melanie D, Robb, Merlin L, Gaudinski, Martin R, Gordon, Ingelise J, Holman, LaSonji A, Widge, Alicia T, Strom, Larisa, Happe, Myra, Cox, Josephine H, Vazquez, Sandra, Stanley, Daphne A, Murray, Tamar, Dulan, Caitlyn N M, Hunegnaw, Ruth, Narpala, Sandeep R, Swanson, Phillip A, II, Basappa, Manjula, Thillainathan, Jagada, Padilla, Marcelino, Flach, Britta, O’Connell, Sarah, Trofymenko, Olga, Morgan, Patricia, Coates, Emily E, Gall, Jason G, McDermott, Adrian B, Koup, Richard A, Mascola, John R, Ploquin, Aurélie, Sullivan, Nancy J, Ake, Julie A, and Ledgerwood, Julie E

Published
2023
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6. Safety and immunogenicity of an HIV-1 prefusion-stabilized envelope trimer (Trimer 4571) vaccine in healthy adults: A first-in-human open-label, randomized, dose-escalation, phase 1 clinical trial

Author

Houser, Katherine V., Gaudinski, Martin R., Happe, Myra, Narpala, Sandeep, Verardi, Raffaello, Sarfo, Edward K., Corrigan, Angela R., Wu, Richard, Rothwell, Ro Shauna, Novik, Laura, Hendel, Cynthia S., Gordon, Ingelise J., Berkowitz, Nina M., Cartagena, Cora Trelles, Widge, Alicia T., Coates, Emily E., Strom, Larisa, Hickman, Somia, Conan-Cibotti, Michelle, Vazquez, Sandra, Trofymenko, Olga, Plummer, Sarah, Stein, Judy, Case, Christopher L., Nason, Martha, Biju, Andrea, Parchment, Danealle K., Changela, Anita, Cheng, Cheng, Duan, Hongying, Geng, Hui, Teng, I-Ting, Zhou, Tongqing, O'Connell, Sarah, Barry, Chris, Carlton, Kevin, Gall, Jason G., Flach, Britta, Doria-Rose, Nicole A., Graham, Barney S., Koup, Richard A., McDermott, Adrian B., Mascola, John R., Kwong, Peter D., and Ledgerwood, Julie E.

Published
2022
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7. Safety and immunogenicity of a ferritin nanoparticle H2 influenza vaccine in healthy adults: a phase 1 trial

Author

Houser, Katherine V., Chen, Grace L., Carter, Cristina, Crank, Michelle C., Nguyen, Thuy A., Burgos Florez, Maria Claudia, Berkowitz, Nina M., Mendoza, Floreliz, Hendel, Cynthia Starr, Gordon, Ingelise J., Coates, Emily E., Vazquez, Sandra, Stein, Judy, Case, Christopher L., Lawlor, Heather, Carlton, Kevin, Gaudinski, Martin R., Strom, Larisa, Hofstetter, Amelia R., Liang, C. Jason, Narpala, Sandeep, Hatcher, Christian, Gillespie, Rebecca A., Creanga, Adrian, Kanekiyo, Masaru, Raab, Julie E., Andrews, Sarah F., Zhang, Yi, Yang, Eun Sung, Wang, Lingshu, Leung, Kwanyee, Kong, Wing-Pui, Freyn, Alec W., Nachbagauer, Raffael, Palese, Peter, Bailer, Robert T., McDermott, Adrian B., Koup, Richard A., Gall, Jason G., Arnold, Frank, Mascola, John R., Graham, Barney S., and Ledgerwood, Julie E.

Published
2022
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8. Safety, tolerability, and immunogenicity of the respiratory syncytial virus prefusion F subunit vaccine DS-Cav1: a phase 1, randomised, open-label, dose-escalation clinical trial

Author

Arthur, Anita, Cunningham, Jennifer, Eshun, Aba, Larkin, Brenda, Mendoza, Floreliz, Novik, Laura, Saunders, Jamie, Wang, Xiaolin, Whalen, William, Carter, Cristina, Hendel, Cynthia Starr, Plummer, Sarah, Ola, Abidemi, Widge, Alicia, Burgos Florez, Maria C, Le, Lam, Pittman, Iris, Rothwell, Ro Shauna S, Trofymenko, Olga, Vasilenko, Olga, Apte, Preeti, Hicks, Renunda, Cartagena, Cora Trelles, Williams, Pernell, Requilman, LaShawn, Tran, Colin, Bai, Shufeng, Carey, Elizabeth, Chamberlain, Amy L, Chang, Ya-chen, Chen, Mingzhong, Chen, Peifeng, Cooper, Jon, Fridley, Colleen, Ghosh, Mridul, Gollapudi, Deepika, Holland-Linn, Janel, Horwitz, Joe, Hussain, Althaf, Ivleva, Vera, Kaltovich, Florence, Leach, Kristin, Lee, Christopher, Liu, Amy, Liu, Xun, Manceva, Slobodanka, Menon, Amritha, Nagy, Attila, O'Connell, Sarah, Ragunathan, Rahul, Walters, Jennifer, Zhao, Zhong, Ruckwardt, Tracy J, Morabito, Kaitlyn M, Phung, Emily, Crank, Michelle C, Costner, Pamela J, Holman, LaSonji A, Chang, Lauren A, Hickman, Somia P, Berkowitz, Nina M, Gordon, Ingelise J, Yamshchikov, Galina V, Gaudinski, Martin R, Lin, Bob, Bailer, Robert, Chen, Man, Ortega-Villa, Ana M, Nguyen, Thuy, Kumar, Azad, Schwartz, Richard M, Kueltzo, Lisa A, Stein, Judith A, Carlton, Kevin, Gall, Jason G, Nason, Martha C, Mascola, John R, Chen, Grace, and Graham, Barney S

Published
2021
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9. Safety and pharmacokinetics of broadly neutralising human monoclonal antibody VRC07-523LS in healthy adults: a phase 1 dose-escalation clinical trial

Author

Mendoza, Floreliz, Novik, Laura, Zephir, Kathy, Whalen, William, Larkin, Brenda, Saunders, Jamie, Cunningham, Jennifer, Levinson, Carol, Wang, Xiaolin, Plummer, Sarah, Victorino, Milalynn, Ola, Abidemi, Boyd, Catina, Jayasinghe, Nilusha, Apte, Preeti, Cartagena, Cora Trelles, Hicks, Renunda, Williams, Pernell, Vasilenko, Olga, Yamshchikov, Galina, Florez, Maria Burgos, Pittman, Iris, Gama, Lucio, Casazza, Joseph, DeCederfelt, Hope, Cheng, KC, Stein, Judy, Gaudinski, Martin R, Houser, Katherine V, Doria-Rose, Nicole A, Chen, Grace L, Rothwell, Ro Shauna S, Berkowitz, Nina, Costner, Pamela, Holman, LaSonji A, Gordon, Ingelise J, Hendel, Cynthia S, Kaltovich, Florence, Conan-Cibotti, Michelle, Gomez Lorenzo, Margarita, Carter, Cristina, Sitar, Sandra, Carlton, Kevin, Gall, Jason, Laurencot, Carolyn, Lin, Bob C, Bailer, Robert T, McDermott, Adrian B, Ko, Sung-Youl, Pegu, Amarendra, Kwon, Young D, Kwong, Peter D, Namboodiri, Aryan M, Pandey, Janardan P, Schwartz, Richard, Arnold, Frank, Hu, Zonghui, Zhang, Lily, Huang, Yunda, Koup, Richard A, Capparelli, Edmund V, Graham, Barney S, Mascola, John R, and Ledgerwood, Julie E

Published
2019
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10. Safety, tolerability, and immunogenicity of two Zika virus DNA vaccine candidates in healthy adults: randomised, open-label, phase 1 clinical trials

Author

Plummer, Sarah, Costner, Pamela, Zephir, Kathryn, Casazza, Joseph, Ola, Abidemi, Victorino, Milalynn, Levinson, Carol, Whalen, William, Wang, Xiaolin, Cunningham, Jennifer, Vasilenko, Olga, Burgos Florez, Maria, Hickman, Somia, Pittman, Iris, Le, Lam, Larkin, Brenda, Andrews, Charla, Apte, Preeti, Hicks, Renunda, Trelles Cartagena, Cora, Williams, Pernell, Boyd, Catina R, Conan-Cibotti, Michelle, Stein, Judy, Kaltovich, Florence, DeCederfelt, Hope, McAdams, Stacey, Renehan, Phyllis, Chen, Wilbur, Greenberg, Nancy, Wymer, Nancy, Wadsworth, Linda, Billington, Melissa, Robinson, Toni, Boyce, Colleen, Pa'ahana Brown, Faith, Chrisley, Lisa, Kwon, Alyson, Patel, Prashant, Kominou, Panagoita, Dorsey, Brenda, Eddington, Staci, Telscher, Shinyi, Lee, Myoughee, Mosely, Regina, Ross, April, Ford, Geoffrey, Domjahn, Briyana, Xu, Jianguo, Beck, Allison, Fineman, Rebecca, Heeke, Shiela, Winter, Jean, Nagar, Shashi, Kelley, Colleen, Mulligan, Mark, Gaudinski, Martin R, Houser, Katherine V, Morabito, Kaitlyn M, Hu, Zonghui, Yamshchikov, Galina, Rothwell, Ro Shauna, Berkowitz, Nina, Mendoza, Floreliz, Saunders, Jamie G, Novik, Laura, Hendel, Cynthia S, Holman, LaSonji A, Gordon, Ingelise J, Cox, Josephine H, Edupuganti, Srilatha, McArthur, Monica A, Rouphael, Nadine G, Lyke, Kirsten E, Cummings, Ginny E, Sitar, Sandra, Bailer, Robert T, Foreman, Bryant M, Burgomaster, Katherine, Pelc, Rebecca S, Gordon, David N, DeMaso, Christina R, Dowd, Kimberly A, Laurencot, Carolyn, Schwartz, Richard M, Mascola, John R, Graham, Barney S, Pierson, Theodore C, Ledgerwood, Julie E, and Chen, Grace L

Published
2018
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11. Attenuated PfSPZ Vaccine induces strain-transcending T cells and durable protection against heterologous controlled human malaria infection

Author

Lyke, Kirsten E., Ishizuka, Andrew S., Berry, Andrea A., Chakravarty, Sumana, DeZure, Adam, Enama, Mary E., James, Eric R., Billingsley, Peter F., Gunasekera, Anusha, Manoj, Anita, Li, Minglin, Ruben, Adam J., Li, Tao, Eappen, Abraham G., Stafford, Richard E., KC, Natasha, Murshedkar, Tooba, Mendoza, Floreliz H., Gordon, Ingelise J., Zephir, Kathryn L., Holman, LaSonji A., Plummer, Sarah H., Hendel, Cynthia S., Novik, Laura, Costner, Pamela J. M., Saunders, Jamie G., Berkowitz, Nina M., Flynn, Barbara J., Nason, Martha C., Garver, Lindsay S., Laurens, Matthew B., Plowe, Christopher V., Richie, Thomas L., Graham, Barney S., Roederer, Mario, Sim, B. Kim Lee, Ledgerwood, Julie E., Hoffman, Stephen L., and Seder, Robert A.

Published
2017

12. Safety, tolerability, and immunogenicity of the Ebola Sudan chimpanzee adenovirus vector vaccine (cAd3-EBO S) in healthy Ugandan adults: a phase 1, open-label, dose-escalation clinical trial

Author

Mwesigwa, Betty, primary, Houser, Katherine V, additional, Hofstetter, Amelia R, additional, Ortega-Villa, Ana M, additional, Naluyima, Prossy, additional, Kiweewa, Francis, additional, Nakabuye, Immaculate, additional, Yamshchikov, Galina V, additional, Andrews, Charla, additional, O'Callahan, Mark, additional, Strom, Larisa, additional, Schech, Steven, additional, Anne Eller, Leigh, additional, Sondergaard, Erica L, additional, Scott, Paul T, additional, Amare, Mihret F, additional, Modjarrad, Kayvon, additional, Wamala, Amir, additional, Tindikahwa, Allan, additional, Musingye, Ezra, additional, Nanyondo, Jauhara, additional, Gaudinski, Martin R, additional, Gordon, Ingelise J, additional, Holman, LaSonji A, additional, Saunders, Jamie G, additional, Costner, Pamela J M, additional, Mendoza, Floreliz H, additional, Happe, Myra, additional, Morgan, Patricia, additional, Plummer, Sarah H, additional, Hickman, Somia P, additional, Vazquez, Sandra, additional, Murray, Tamar, additional, Cordon, Jamilet, additional, Dulan, Caitlyn N M, additional, Hunegnaw, Ruth, additional, Basappa, Manjula, additional, Padilla, Marcelino, additional, Gajjala, Suprabhath R, additional, Swanson, Phillip A, additional, Lin, Bob C, additional, Coates, Emily E, additional, Gall, Jason G, additional, McDermott, Adrian B, additional, Koup, Richard A, additional, Mascola, John R, additional, Ploquin, Aurélie, additional, Sullivan, Nancy J, additional, Kibuuka, Hannah, additional, Ake, Julie A, additional, Ledgerwood, Julie E, additional, Namugabo, Jaqueline, additional, Beingana, Claire, additional, Mukyala, Maureen G., additional, Wandege, Joseph, additional, Nanteza, Christine, additional, Atwijuka, Brenda, additional, Kizanye, Juliet, additional, Nassanga, Gertrude, additional, Namuli, Joanita, additional, Kityo, Herbert, additional, Ssekitoleko, Mathias, additional, Nassaka, Roy, additional, Mutebe, Hilda, additional, Kabahubya, Mable, additional, Widge, Alicia T., additional, O'Connell, Sarah E., additional, Amoa-Awua, Obrimpong, additional, Narpala, Sandeep R., additional, Flach, Britta, additional, Cox, Josephine, additional, Beck, Allison, additional, Guech, Mercy, additional, Seo, Ellie, additional, and Stein, Judy A., additional

Published
2023
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13. Safety, tolerability, and immunogenicity of the chimpanzee adenovirus type 3-vectored Marburg virus (cAd3-Marburg) vaccine in healthy adults in the USA: a first-in-human, phase 1, open-label, dose-escalation trial

Author

Hamer, Melinda J, primary, Houser, Katherine V, additional, Hofstetter, Amelia R, additional, Ortega-Villa, Ana M, additional, Lee, Christine, additional, Preston, Anne, additional, Augustine, Brooke, additional, Andrews, Charla, additional, Yamshchikov, Galina V, additional, Hickman, Somia, additional, Schech, Steven, additional, Hutter, Jack N, additional, Scott, Paul T, additional, Waterman, Paige E, additional, Amare, Mihret F, additional, Kioko, Victoria, additional, Storme, Casey, additional, Modjarrad, Kayvon, additional, McCauley, Melanie D, additional, Robb, Merlin L, additional, Gaudinski, Martin R, additional, Gordon, Ingelise J, additional, Holman, LaSonji A, additional, Widge, Alicia T, additional, Strom, Larisa, additional, Happe, Myra, additional, Cox, Josephine H, additional, Vazquez, Sandra, additional, Stanley, Daphne A, additional, Murray, Tamar, additional, Dulan, Caitlyn N M, additional, Hunegnaw, Ruth, additional, Narpala, Sandeep R, additional, Swanson, Phillip A, additional, Basappa, Manjula, additional, Thillainathan, Jagada, additional, Padilla, Marcelino, additional, Flach, Britta, additional, O’Connell, Sarah, additional, Trofymenko, Olga, additional, Morgan, Patricia, additional, Coates, Emily E, additional, Gall, Jason G, additional, McDermott, Adrian B, additional, Koup, Richard A, additional, Mascola, John R, additional, Ploquin, Aurélie, additional, Sullivan, Nancy J, additional, Ake, Julie A, additional, Ledgerwood, Julie E, additional, Lampley, Rebecca, additional, Larkin, Brenda, additional, Costner, Pamela, additional, Wilson, Hope, additional, and Read, Mike, additional

Published
2023
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14. Low-dose intravenous and subcutaneous CIS43LS monoclonal antibody for protection against malaria (VRC 612 Part C): a phase 1, adaptive trial

Author

Lyke, Kirsten E, primary, Berry, Andrea A, additional, Mason, Kaitlin, additional, Idris, Azza H, additional, O'Callahan, Mark, additional, Happe, Myra, additional, Strom, Larisa, additional, Berkowitz, Nina M, additional, Guech, Mercy, additional, Hu, Zonghui, additional, Castro, Mike, additional, Basappa, Manjula, additional, Wang, Lu, additional, Low, Kwang, additional, Holman, LaSonji A, additional, Mendoza, Floreliz, additional, Gordon, Ingelise J, additional, Plummer, Sarah H, additional, Trofymenko, Olga, additional, Strauss, Kathleen S, additional, Joshi, Sudhaunshu, additional, Shrestha, Biraj, additional, Adams, Matthew, additional, Chagas, Andrezza Campos, additional, Murphy, Jittawadee R, additional, Stein, Judy, additional, Hickman, Somia, additional, McDougal, Andrew, additional, Lin, Bob, additional, Narpala, Sandeep R, additional, Vazquez, Sandra, additional, Serebryannyy, Leonid, additional, McDermott, Adrian, additional, Gaudinski, Martin R, additional, Capparelli, Edmund V, additional, Coates, Emily E, additional, Wu, Richard L, additional, Ledgerwood, Julie E, additional, Dropulic, Lesia K, additional, Seder, Robert A, additional, Young, Cheryl, additional, Boyce, Colleen, additional, Winkler, Jennifer, additional, Holian, Susan, additional, Greenberg, Nancy, additional, George, Shirley, additional, Kwon, Alyson, additional, Dorsey, Brenda, additional, Da Costa, Ana Raquel, additional, Witt, William, additional, Grays, Daryl, additional, Gapasin, Arren, additional, Bernal, Paula, additional, Floyd, Jeffrey, additional, Goldstein, Eric, additional, Howe, Leslie, additional, Lee, Myounghee, additional, Marron, Jennifer, additional, Brooks, Kelly, additional, Turek, Lisa, additional, Farley, Patricia, additional, Frels, Shantel, additional, Booth, Delores, additional, Gall, Jason, additional, Carlton, Kevin, additional, Albright, Gabriela, additional, Amharref, Nadia, additional, Atallah, Kandace, additional, Banappagari, Sashikanth, additional, Bastani, Niutish, additional, Blackstock, Daniel, additional, Boonyaratanakornkit, Bobby, additional, Carey, Elizabeth, additional, Charlton, Adam, additional, Chaudhuri, Rajoshi, additional, Caringal, Alegria M., additional, Chen, Mingzhong, additional, Chen, Peifeng, additional, Cheng, Wei, additional, Gowetski, Daniel, additional, Gulla, Krishana, additional, Hastings, Erica, additional, Horwitz, Joe, additional, Ivleva, Vera, additional, Kordella, Dan, additional, Kueltzo, Lisa A., additional, Lagler, Sara, additional, Le, Matt, additional, Lee, James, additional, Lei, Paula, additional, Li, Yile, additional, Nagy, Attila, additional, Patel, Aakash, additional, Runsewe, Peyi, additional, Shadrick, Will, additional, Shetty, Shamitha, additional, Wang, Hairong, additional, Webber, Calvin, additional, Vejzagic, Farah, additional, and Yang, Yoo-Jung, additional

Published
2023
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15. Clonal hematopoiesis is not significantly associated with COVID-19 disease severity

Author

Zhou, Yifan, primary, Shalhoub, Ruba, additional, Rogers, Stephanie N., additional, Yu, Shiqin, additional, Gu, Muxin, additional, Fabre, Margarete A., additional, Quiros, Pedro M., additional, Shin, Tae-Hoon, additional, Diangson, Arch, additional, Deng, Wenhan, additional, Anand, Shubha, additional, Lu, Wenhua, additional, Cullen, Matthew, additional, Godfrey, Anna L., additional, Preller, Jacobus, additional, Hadjadj, Jerome, additional, Jouanguy, Emmanuelle, additional, Cobat, Aurélie, additional, Abel, Laurent, additional, Rieux-Laucat, Frederic, additional, Terrier, Benjamin, additional, Fischer, Alain, additional, Novik, Lara, additional, Gordon, Ingelise J., additional, Strom, Larisa, additional, Gaudinski, Martin R., additional, Lisco, Andrea, additional, Sereti, Irini, additional, Gniadek, Thomas J., additional, Biondi, Andrea, additional, Bonfanti, Paolo, additional, Imberti, Luisa, additional, Dalgard, Clifton L., additional, Zhang, Yu, additional, Dobbs, Kerry, additional, Su, Helen C., additional, Notarangelo, Luigi D., additional, Wu, Colin O., additional, Openshaw, Peter J.M., additional, Semple, Malcolm G., additional, Mallat, Ziad, additional, Baillie, Kenneth, additional, Dunbar, Cynthia E., additional, and Vassiliou, George S., additional

Published
2022
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16. Supplemental Materials for Safety and Immunogenicity of Chimpanzee Adenovirus Vector Ebola Vaccine

Author

Ledgerwood, Julie E., DeZure, Adam D., Stanley, Daphne A., Novik, Laura, Enama, Mary E., Berkowitz, Nina M., Hu, Zonghui, Joshi, Gyan, Ploquin, Aurélie, Sitar, Sandra, Gordon, Ingelise J., Plummer, Sarah A., Holman, LaSonji A., Hendel, Cynthia S., Yamshchikov, Galina, Roman, Francois, Nicosia, Alfredo, Colloca, Stefano, Cortese, Riccardo, Bailer, Robert T., Schwartz, Richard M., Roederer, Mario, Mascola, John R., Koup, Richard A., Sullivan, Nancy J., and Graham, Barney S.

Published
2017

17. Protection against malaria at 1 year and immune correlates following PfSPZ vaccination

Author

Ishizuka, Andrew S, Lyke, Kirsten E, DeZure, Adam, Berry, Andrea A, Richie, Thomas L, Mendoza, Floreliz H, Enama, Mary E, Gordon, Ingelise J, Chang, Lee-Jah, Sarwar, Uzma N, Zephir, Kathryn L, Holman, LaSonji A, James, Eric R, Billingsley, Peter F, Gunasekera, Anusha, Chakravarty, Sumana, Manoj, Anita, Li, MingLin, Ruben, Adam J, Li, Tao, Eappen, Abraham G, Stafford, Richard E, K C, Natasha, Murshedkar, Tooba, DeCederfelt, Hope, Plummer, Sarah H, Hendel, Cynthia S, Novik, Laura, Costner, Pamela J M, Saunders, Jamie G, Laurens, Matthew B, Plowe, Christopher V, Flynn, Barbara, Whalen, William R, Todd, J P, Noor, Jay, Rao, Srinivas, Sierra-Davidson, Kailan, Lynn, Geoffrey M, Epstein, Judith E, Kemp, Margaret A, Fahle, Gary A, Mikolajczak, Sebastian A, Fishbaugher, Matthew, Sack, Brandon K, Kappe, Stefan H I, Davidson, Silas A, Garver, Lindsey S, Björkström, Niklas K, Nason, Martha C, Graham, Barney S, Roederer, Mario, Sim, B Kim Lee, Hoffman, Stephen L, Ledgerwood, Julie E, and Seder, Robert A

Published
2016
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18. Low-Dose Subcutaneous or Intravenous Monoclonal Antibody to Prevent Malaria

Author

Wu, Richard L., primary, Idris, Azza H., additional, Berkowitz, Nina M., additional, Happe, Myra, additional, Gaudinski, Martin R., additional, Buettner, Christian, additional, Strom, Larisa, additional, Awan, Seemal F., additional, Holman, LaSonji A., additional, Mendoza, Floreliz, additional, Gordon, Ingelise J., additional, Hu, Zonghui, additional, Campos Chagas, Andrezza, additional, Wang, Lawrence T., additional, Da Silva Pereira, Lais, additional, Francica, Joseph R., additional, Kisalu, Neville K., additional, Flynn, Barbara J., additional, Shi, Wei, additional, Kong, Wing-Pui, additional, O’Connell, Sarah, additional, Plummer, Sarah H., additional, Beck, Allison, additional, McDermott, Adrian, additional, Narpala, Sandeep R., additional, Serebryannyy, Leonid, additional, Castro, Mike, additional, Silva, Rosa, additional, Imam, Marjaan, additional, Pittman, Iris, additional, Hickman, Somia P., additional, McDougal, Andrew J., additional, Lukoskie, Ashly E., additional, Murphy, Jittawadee R., additional, Gall, Jason G., additional, Carlton, Kevin, additional, Morgan, Patricia, additional, Seo, Ellie, additional, Stein, Judy A., additional, Vazquez, Sandra, additional, Telscher, Shinyi, additional, Capparelli, Edmund V., additional, Coates, Emily E., additional, Mascola, John R., additional, Ledgerwood, Julie E., additional, Dropulic, Lesia K., additional, and Seder, Robert A., additional

Published
2022
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19. Protection Against Malaria by Intravenous Immunization with a Nonreplicating Sporozoite Vaccine

Author

Seder, Robert A., Chang, Lee-Jah, Enama, Mary E., Zephir, Kathryn L., Sarwar, Uzma N., Gordon, Ingelise J., Holman, LaSonji A., James, Eric R., Billingsley, Peter F., Gunasekera, Anusha, Richman, Adam, Chakravarty, Sumana, Manoj, Anita, Velmurugan, Soundarapandian, Li, MingLin, Ruben, Adam J., Li, Tao, Eappen, Abraham G., Stafford, Richard E., Plummer, Sarah H., Hendel, Cynthia S., Novik, Laura, Costner, Pamela J. M., Mendoza, Floreliz H., Saunders, Jamie G., Nason, Martha C., Richardson, Jason H., Murphy, Jittawadee, Davidson, Silas A., Richie, Thomas L., Sedegah, Martha, Sutamihardja, Awalludin, Fahle, Gary A., Lyke, Kirsten E., Laurens, Matthew B., Roederer, Mario, Tewari, Kavita, Epstein, Judith E., Sim, B. Kim Lee, Ledgerwood, Julie E., Graham, Barney S., and Hoffman, Stephen L.

Published
2013
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20. Therapeutic Vaccination Expands and Improves the Function of the HIV-Specific Memory T-Cell Repertoire

Author

VRC 101 Study Team, Casazza, Joseph P., Bowman, Kathryn A., Adzaku, Selorm, Smith, Emily C., Enama, Mary E., Bailer, Robert T., Price, David A., Gostick, Emma, Gordon, Ingelise J., Ambrozak, David R., Nason, Martha C., Roederer, Mario, Andrews, Charla A., Maldarelli, Frank M., Wiegand, Ann, Kearney, Mary F., Persaud, Deborah, Ziemniak, Carrie, Gottardo, Raphael, Ledgerwood, Julie E., Graham, Barney S., and Koup, Richard A.

Published
2013
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21. Clonal Hematopoiesis Is Not Significantly Associated with Covid-19 Disease Severity

Author

Zhou, Y, Shalhoub, R, Rogers, S, Yu, S, Gu, M, Fabre, M, Quiros, P, Diangson, A, Deng, W, Anand, S, Lu, W, Cullen, M, Godfrey, A, Preller, J, Hadjadj, J, Jouanguy, E, Cobat, A, Abel, L, Rieux-Laucat, F, Terrier, B, Fischer, A, Novik, L, Gordon, I, Strom, L, Gaudinski, M, Lisco, A, Sereti, I, Gniadek, T, Biondi, A, Bonfanti, P, Imberti, L, Zhang, Y, Dalgard, C, Dobbs, K, Su, H, Notarangelo, L, Wu, C, Openshaw, P, Semple, M, Mallat, Z, Baillie, K, Dunbar, C, Vassiliou, G, Zhou, Yifan, Shalhoub, Ruba N, Rogers, Stephanie N, Yu, Shiqin, Gu, Muxin, Fabre, Margarete Alice, Quiros, Pedro M, Diangson, Arch, Deng, Wenhan, Anand, Shubha, Lu, Wanhua, Cullen, Matthew, Godfrey, Anna L, Preller, Jacobus, Hadjadj, Jérôme, Jouanguy, Emmanuelle, Cobat, Aurélie, Abel, Laurent, Rieux-Laucat, Frédéric, Terrier, Benjamin, Fischer, Alain, Novik, Laura, Gordon, Ingelise J, Strom, Larisa, Gaudinski, Martin, Lisco, Andrea, Sereti, Irini, Gniadek, Thomas J, Biondi, Andrea, Bonfanti, Paolo, Imberti, Luisa, Zhang, Yu, Dalgard, Clifton L, Dobbs, Kerry, Su, Helen C, Notarangelo, Luigi D, Wu, Colin O, Openshaw, Peter J M, Semple, Malcolm Gracie, Mallat, Ziad, Baillie, Kenneth, Dunbar, Cynthia E, Vassiliou, George S, Zhou, Y, Shalhoub, R, Rogers, S, Yu, S, Gu, M, Fabre, M, Quiros, P, Diangson, A, Deng, W, Anand, S, Lu, W, Cullen, M, Godfrey, A, Preller, J, Hadjadj, J, Jouanguy, E, Cobat, A, Abel, L, Rieux-Laucat, F, Terrier, B, Fischer, A, Novik, L, Gordon, I, Strom, L, Gaudinski, M, Lisco, A, Sereti, I, Gniadek, T, Biondi, A, Bonfanti, P, Imberti, L, Zhang, Y, Dalgard, C, Dobbs, K, Su, H, Notarangelo, L, Wu, C, Openshaw, P, Semple, M, Mallat, Z, Baillie, K, Dunbar, C, Vassiliou, G, Zhou, Yifan, Shalhoub, Ruba N, Rogers, Stephanie N, Yu, Shiqin, Gu, Muxin, Fabre, Margarete Alice, Quiros, Pedro M, Diangson, Arch, Deng, Wenhan, Anand, Shubha, Lu, Wanhua, Cullen, Matthew, Godfrey, Anna L, Preller, Jacobus, Hadjadj, Jérôme, Jouanguy, Emmanuelle, Cobat, Aurélie, Abel, Laurent, Rieux-Laucat, Frédéric, Terrier, Benjamin, Fischer, Alain, Novik, Laura, Gordon, Ingelise J, Strom, Larisa, Gaudinski, Martin, Lisco, Andrea, Sereti, Irini, Gniadek, Thomas J, Biondi, Andrea, Bonfanti, Paolo, Imberti, Luisa, Zhang, Yu, Dalgard, Clifton L, Dobbs, Kerry, Su, Helen C, Notarangelo, Luigi D, Wu, Colin O, Openshaw, Peter J M, Semple, Malcolm Gracie, Mallat, Ziad, Baillie, Kenneth, Dunbar, Cynthia E, and Vassiliou, George S

Published
2022

22. Chimpanzee Adenovirus Vector Ebola Vaccine

Author

Ledgerwood, Julie E., DeZure, Adam D., Stanley, Daphne A., Coates, Emily E., Novik, Laura, Enama, Mary E., Berkowitz, Nina M., Hu, Zonghui, Joshi, Gyan, Ploquin, Aurélie, Sitar, Sandra, Gordon, Ingelise J., Plummer, Sarah A., Holman, LaSonji A., Hendel, Cynthia S., Yamshchikov, Galina, Roman, Francois, Nicosia, Alfredo, Colloca, Stefano, Cortese, Riccardo, Bailer, Robert T., Schwartz, Richard M., Roederer, Mario, Mascola, John R., Koup, Richard A., Sullivan, Nancy J., and Graham, Barney S.

Published
2017
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23. An influenza hemagglutinin stem nanoparticle vaccine induces cross-group 1 neutralizing antibodies in healthy adults.

Author

Widge, Alicia T., Hofstetter, Amelia R., Houser, Katherine V., Awan, Seemal F., Chen, Grace L., Burgos Florez, Maria C., Berkowitz, Nina M., Mendoza, Floreliz, Hendel, Cynthia S., Holman, LaSonji A., Gordon, Ingelise J., Apte, Preeti, Liang, C. Jason, Gaudinski, Martin R., Coates, Emily E., Strom, Larisa, Wycuff, Diane, Vazquez, Sandra, Stein, Judy A., and Gall, Jason G.

Subjects
IMMUNOGLOBULINS, NANOPARTICLES, IMMUNOLOGIC memory, HEMAGGLUTININ, VACCINE trials, SUMATRIPTAN, INFLUENZA vaccines
Abstract

Influenza vaccines could be improved by platforms inducing cross-reactive immunity. Immunodominance of the influenza hemagglutinin (HA) head in currently licensed vaccines impedes induction of cross-reactive neutralizing stem-directed antibodies. A vaccine without the variable HA head domain has the potential to focus the immune response on the conserved HA stem. This first-in-human dose-escalation open-label phase 1 clinical trial (NCT03814720) tested an HA stabilized stem ferritin nanoparticle vaccine (H1ssF) based on the H1 HA stem of A/New Caledonia/20/1999. Fifty-two healthy adults aged 18 to 70 years old enrolled to receive either 20 μg of H1ssF once (n = 5) or 60 μg of H1ssF twice (n = 47) with a prime-boost interval of 16 weeks. Thirty-five (74%) 60-μg dose participants received the boost, whereas 11 (23%) boost vaccinations were missed because of public health restrictions in the early stages of the COVID-19 pandemic. The primary objective of this trial was to evaluate the safety and tolerability of H1ssF, and the secondary objective was to evaluate antibody responses after vaccination. H1ssF was safe and well tolerated, with mild solicited local and systemic reactogenicity. The most common symptoms included pain or tenderness at the injection site (n = 10, 19%), headache (n = 10, 19%), and malaise (n = 6, 12%). We found that H1ssF elicited cross-reactive neutralizing antibodies against the conserved HA stem of group 1 influenza viruses, despite previous H1 subtype head-specific immunity. These responses were durable, with neutralizing antibodies observed more than 1 year after vaccination. Our results support this platform as a step forward in the development of a universal influenza vaccine. Fighting flu: A major goal for influenza vaccines is to elicit broadly reactive immune responses that can protect against many strains of the virus. Widge et al. and Andrews et al. report results of a phase 1 clinical trial testing a vaccine that may get closer to this goal. Widge et al. demonstrated that immunization with one or two doses of an H1 hemagglutinin stabilized stem nanoparticle (H1ssF) vaccine was safe in recipients and elicited durable neutralizing antibody responses. Andrews et al. found that memory B cell responses elicited by H1ssF vaccination were broadly cross-reactive and targeted two conserved epitopes on the H1 stem. Together, these studies highlight the potential of H1ssF and similar stem-only immunogens as influenza vaccines. —CM [ABSTRACT FROM AUTHOR]

Published
2023
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25. An avian influenza H7 DNA priming vaccine is safe and immunogenic in a randomized phase I clinical trial

Author

DeZure, Adam D., Coates, Emily E., Hu, Zonghui, Yamshchikov, Galina V., Zephir, Kathryn L., Enama, Mary E., Plummer, Sarah H., Gordon, Ingelise J., Kaltovich, Florence, Andrews, Sarah, McDermott, Adrian, Crank, Michelle C., Koup, Richard A, Schwartz, Richard M., Bailer, Robert T., Sun, Xiangjie, Mascola, John R., Tumpey, Terrence M., Graham, Barney S., and Ledgerwood, Julie E.

Published
2017
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27. A West Nile Virus DNA Vaccine Induces Neutralizing Antibody in Healthy Adults during a Phase 1 Clinical Trial

Author

Vaccine Research Center 302 Study Team, Martin, Julie E., Pierson, Theodore C., Hubka, Sarah, Rucker, Steve, Gordon, Ingelise J., Enama, Mary E., Andrews, Charla A., Xu, Qing, Davis, Brent S., Nason, Martha C., Fay, Michael P., Koup, Richard A., Roederer, Mario, Bailer, Robert T., Gomez, Phillip L., Mascola, John R., Chang, Gwong-Jen J., Nabel, Gary J., and Graham, Barney S.

Published
2007
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28. Safety, tolerability, and immunogenicity of the respiratory syncytial virus prefusion F subunit vaccine DS-Cav1: a phase 1, randomised, open-label, dose-escalation clinical trial

Author

Ruckwardt, Tracy J, primary, Morabito, Kaitlyn M, additional, Phung, Emily, additional, Crank, Michelle C, additional, Costner, Pamela J, additional, Holman, LaSonji A, additional, Chang, Lauren A, additional, Hickman, Somia P, additional, Berkowitz, Nina M, additional, Gordon, Ingelise J, additional, Yamshchikov, Galina V, additional, Gaudinski, Martin R, additional, Lin, Bob, additional, Bailer, Robert, additional, Chen, Man, additional, Ortega-Villa, Ana M, additional, Nguyen, Thuy, additional, Kumar, Azad, additional, Schwartz, Richard M, additional, Kueltzo, Lisa A, additional, Stein, Judith A, additional, Carlton, Kevin, additional, Gall, Jason G, additional, Nason, Martha C, additional, Mascola, John R, additional, Chen, Grace, additional, Graham, Barney S, additional, Arthur, Anita, additional, Cunningham, Jennifer, additional, Eshun, Aba, additional, Larkin, Brenda, additional, Mendoza, Floreliz, additional, Novik, Laura, additional, Saunders, Jamie, additional, Wang, Xiaolin, additional, Whalen, William, additional, Carter, Cristina, additional, Hendel, Cynthia Starr, additional, Plummer, Sarah, additional, Ola, Abidemi, additional, Widge, Alicia, additional, Burgos Florez, Maria C, additional, Le, Lam, additional, Pittman, Iris, additional, Rothwell, Ro Shauna S, additional, Trofymenko, Olga, additional, Vasilenko, Olga, additional, Apte, Preeti, additional, Hicks, Renunda, additional, Cartagena, Cora Trelles, additional, Williams, Pernell, additional, Requilman, LaShawn, additional, Tran, Colin, additional, Bai, Shufeng, additional, Carey, Elizabeth, additional, Chamberlain, Amy L, additional, Chang, Ya-chen, additional, Chen, Mingzhong, additional, Chen, Peifeng, additional, Cooper, Jon, additional, Fridley, Colleen, additional, Ghosh, Mridul, additional, Gollapudi, Deepika, additional, Holland-Linn, Janel, additional, Horwitz, Joe, additional, Hussain, Althaf, additional, Ivleva, Vera, additional, Kaltovich, Florence, additional, Leach, Kristin, additional, Lee, Christopher, additional, Liu, Amy, additional, Liu, Xun, additional, Manceva, Slobodanka, additional, Menon, Amritha, additional, Nagy, Attila, additional, O'Connell, Sarah, additional, Ragunathan, Rahul, additional, Walters, Jennifer, additional, and Zhao, Zhong, additional

Published
2021
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29. A Monoclonal Antibody for Malaria Prevention

Author

Gaudinski, Martin R., primary, Berkowitz, Nina M., additional, Idris, Azza H., additional, Coates, Emily E., additional, Holman, LaSonji A., additional, Mendoza, Floreliz, additional, Gordon, Ingelise J., additional, Plummer, Sarah H., additional, Trofymenko, Olga, additional, Hu, Zonghui, additional, Campos Chagas, Andrezza, additional, O’Connell, Sarah, additional, Basappa, Manjula, additional, Douek, Naomi, additional, Narpala, Sandeep R., additional, Barry, Christopher R., additional, Widge, Alicia T., additional, Hicks, Renunda, additional, Awan, Seemal F., additional, Wu, Richard L., additional, Hickman, Somia, additional, Wycuff, Diane, additional, Stein, Judy A., additional, Case, Christopher, additional, Evans, Brian P., additional, Carlton, Kevin, additional, Gall, Jason G., additional, Vazquez, Sandra, additional, Flach, Britta, additional, Chen, Grace L., additional, Francica, Joseph R., additional, Flynn, Barbara J., additional, Kisalu, Neville K., additional, Capparelli, Edmund V., additional, McDermott, Adrian, additional, Mascola, John R., additional, Ledgerwood, Julie E., additional, and Seder, Robert A., additional

Published
2021
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30. Ultrapotent antibodies against diverse and highly transmissible SARS-CoV-2 variants

Author

Wang, Lingshu, primary, Zhou, Tongqing, additional, Zhang, Yi, additional, Yang, Eun Sung, additional, Schramm, Chaim A., additional, Shi, Wei, additional, Pegu, Amarendra, additional, Oloniniyi, Olamide K., additional, Henry, Amy R., additional, Darko, Samuel, additional, Narpala, Sandeep R., additional, Hatcher, Christian, additional, Martinez, David R., additional, Tsybovsky, Yaroslav, additional, Phung, Emily, additional, Abiona, Olubukola M., additional, Antia, Avan, additional, Cale, Evan M., additional, Chang, Lauren A., additional, Choe, Misook, additional, Corbett, Kizzmekia S., additional, Davis, Rachel L., additional, DiPiazza, Anthony T., additional, Gordon, Ingelise J., additional, Hait, Sabrina Helmold, additional, Hermanus, Tandile, additional, Kgagudi, Prudence, additional, Laboune, Farida, additional, Leung, Kwanyee, additional, Liu, Tracy, additional, Mason, Rosemarie D., additional, Nazzari, Alexandra F., additional, Novik, Laura, additional, O’Connell, Sarah, additional, O’Dell, Sijy, additional, Olia, Adam S., additional, Schmidt, Stephen D., additional, Stephens, Tyler, additional, Stringham, Christopher D., additional, Talana, Chloe Adrienna, additional, Teng, I-Ting, additional, Wagner, Danielle A., additional, Widge, Alicia T., additional, Zhang, Baoshan, additional, Roederer, Mario, additional, Ledgerwood, Julie E., additional, Ruckwardt, Tracy J., additional, Gaudinski, Martin R., additional, Moore, Penny L., additional, Doria-Rose, Nicole A., additional, Baric, Ralph S., additional, Graham, Barney S., additional, McDermott, Adrian B., additional, Douek, Daniel C., additional, Kwong, Peter D., additional, Mascola, John R., additional, Sullivan, Nancy J., additional, and Misasi, John, additional

Published
2021
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33. Antibodies with potent and broad neutralizing activity against antigenically diverse and highly transmissible SARS-CoV-2 variants

Author

Wang, Lingshu, primary, Zhou, Tongqing, additional, Zhang, Yi, additional, Yang, Eun Sung, additional, Schramm, Chaim A., additional, Shi, Wei, additional, Pegu, Amarendra, additional, Oloninyi, Olamide K., additional, Ransier, Amy, additional, Darko, Samuel, additional, Narpala, Sandeep R., additional, Hatcher, Christian, additional, Martinez, David R., additional, Tsybovsky, Yaroslav, additional, Phung, Emily, additional, Abiona, Olubukola M., additional, Cale, Evan M., additional, Chang, Lauren A., additional, Corbett, Kizzmekia S., additional, DiPiazza, Anthony T., additional, Gordon, Ingelise J., additional, Leung, Kwanyee, additional, Liu, Tracy, additional, Mason, Rosemarie D., additional, Nazzari, Alexandra, additional, Novik, Laura, additional, Olia, Adam S., additional, Doria-Rose, Nicole A., additional, Stephens, Tyler, additional, Stringham, Christopher D., additional, Talana, Chloe Adrienna, additional, Teng, I-Ting, additional, Wagner, Danielle, additional, Widge, Alicia T., additional, Zhang, Baoshan, additional, Roederer, Mario, additional, Ledgerwood, Julie E., additional, Ruckwardt, Tracy J., additional, Gaudinski, Martin R., additional, Baric, Ralph S., additional, Graham, Barney S., additional, McDermott, Adrian B., additional, Douek, Daniel C., additional, Kwong, Peter D., additional, Mascola, John R, additional, Sullivan, Nancy J., additional, and Misasi, John, additional

Published
2021
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34. Functional Profiling of Antibody Immune Repertoires in Convalescent Zika Virus Disease Patients

Author

Fahad, Ahmed S., primary, Timm, Morgan R., additional, Madan, Bharat, additional, Burgomaster, Katherine E., additional, Dowd, Kimberly A., additional, Normandin, Erica, additional, Gutiérrez-González, Matías F., additional, Pennington, Joseph M., additional, De Souza, Matheus Oliveira, additional, Henry, Amy R., additional, Laboune, Farida, additional, Wang, Lingshu, additional, Ambrozak, David R., additional, Gordon, Ingelise J., additional, Douek, Daniel C., additional, Ledgerwood, Julie E., additional, Graham, Barney S., additional, Castilho, Leda R., additional, Pierson, Theodore C., additional, Mascola, John R., additional, and DeKosky, Brandon J., additional

Published
2021
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35. A West Nile virus dna vaccine induces neutralizing antibody in healthy adults during a phase 1 clinical trial

Author

Martin, Julie E., Pierson, Theodore C., Hubka, Sarah, Rucker, Steve, Gordon, Ingelise J., Enama, Mary E., Andrews, Charla A., Xu, Qing, Davis, Brent S., Nason, Martha C., Fay, Michael P., Koup, Richard A., Roederer, Mario, Bailer, Robert T., Gomez, Phillip L., Mascola, John R., Chang, Gwong-Jen J., Nabel, Gary J., and Graham, Barney S.

Subjects
West Nile virus -- Physiological aspects, West Nile virus -- Research, DNA vaccines -- Dosage and administration, DNA vaccines -- Physiological aspects, DNA vaccines -- Research, Human immunogenetics -- Research, Clinical trials -- Reports, Health
Published
2007

36. Safety and pharmacokinetics of broadly neutralising human monoclonal antibody VRC07-523LS in healthy adults: a phase 1 dose-escalation clinical trial

Author

Gaudinski, Martin R, primary, Houser, Katherine V, additional, Doria-Rose, Nicole A, additional, Chen, Grace L, additional, Rothwell, Ro Shauna S, additional, Berkowitz, Nina, additional, Costner, Pamela, additional, Holman, LaSonji A, additional, Gordon, Ingelise J, additional, Hendel, Cynthia S, additional, Kaltovich, Florence, additional, Conan-Cibotti, Michelle, additional, Gomez Lorenzo, Margarita, additional, Carter, Cristina, additional, Sitar, Sandra, additional, Carlton, Kevin, additional, Gall, Jason, additional, Laurencot, Carolyn, additional, Lin, Bob C, additional, Bailer, Robert T, additional, McDermott, Adrian B, additional, Ko, Sung-Youl, additional, Pegu, Amarendra, additional, Kwon, Young D, additional, Kwong, Peter D, additional, Namboodiri, Aryan M, additional, Pandey, Janardan P, additional, Schwartz, Richard, additional, Arnold, Frank, additional, Hu, Zonghui, additional, Zhang, Lily, additional, Huang, Yunda, additional, Koup, Richard A, additional, Capparelli, Edmund V, additional, Graham, Barney S, additional, Mascola, John R, additional, Ledgerwood, Julie E, additional, Mendoza, Floreliz, additional, Novik, Laura, additional, Zephir, Kathy, additional, Whalen, William, additional, Larkin, Brenda, additional, Saunders, Jamie, additional, Cunningham, Jennifer, additional, Levinson, Carol, additional, Wang, Xiaolin, additional, Plummer, Sarah, additional, Victorino, Milalynn, additional, Ola, Abidemi, additional, Boyd, Catina, additional, Jayasinghe, Nilusha, additional, Apte, Preeti, additional, Cartagena, Cora Trelles, additional, Hicks, Renunda, additional, Williams, Pernell, additional, Vasilenko, Olga, additional, Yamshchikov, Galina, additional, Florez, Maria Burgos, additional, Pittman, Iris, additional, Gama, Lucio, additional, Casazza, Joseph, additional, DeCederfelt, Hope, additional, Cheng, KC, additional, and Stein, Judy, additional

Published
2019
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37. Safety, tolerability, pharmacokinetics, and immunogenicity of the therapeutic monoclonal antibody mAb114 targeting Ebola virus glycoprotein (VRC 608): an open-label phase 1 study

Author

Gaudinski, Martin R, primary, Coates, Emily E, additional, Novik, Laura, additional, Widge, Alicia, additional, Houser, Katherine V, additional, Burch, Eugeania, additional, Holman, LaSonji A, additional, Gordon, Ingelise J, additional, Chen, Grace L, additional, Carter, Cristina, additional, Nason, Martha, additional, Sitar, Sandra, additional, Yamshchikov, Galina, additional, Berkowitz, Nina, additional, Andrews, Charla, additional, Vazquez, Sandra, additional, Laurencot, Carolyn, additional, Misasi, John, additional, Arnold, Frank, additional, Carlton, Kevin, additional, Lawlor, Heather, additional, Gall, Jason, additional, Bailer, Robert T, additional, McDermott, Adrian, additional, Capparelli, Edmund, additional, Koup, Richard A, additional, Mascola, John R, additional, Graham, Barney S, additional, Sullivan, Nancy J, additional, Ledgerwood, Julie E, additional, Hendel, Cynthia Starr, additional, Plummer, Sarah H., additional, Costner, Pamela, additional, Saunders, Jamie, additional, Mendoza, Floreliz, additional, Eshun, Aba Mensima, additional, Casazza, Joseph, additional, Ola, Abidemi, additional, Whalen, William, additional, Wang, Xiaolin, additional, Cunningham, Jennifer, additional, Vasilenko, Olga, additional, Boyd, Catina R., additional, Trofymenko, Olga, additional, Burgos Florez, Maria Claudia, additional, Hickman, Somia, additional, Rothwell, Ro Shauna, additional, Pittman, Iris R, additional, Le, Lam Ngan, additional, Larkin, Brenda D, additional, Cox, Josephine H, additional, Apte, Preeti J, additional, Hicks, Renunda T, additional, Trelles Cartagena, Cora, additional, Williams, Pernell V, additional, Requilman, LaShawn, additional, Nguyen, Thuy, additional, Tran, Colin, additional, Conan-Cibotti, Michelle, additional, Stein, Judy, additional, and Beresnev, Tatiana, additional

Published
2019
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38. Effect of a Chikungunya Virus-Like Particle Vaccine on Safety and Tolerability Outcomes: A Randomized Clinical Trial.

Author

Chen, Grace L., Coates, Emily E., Plummer, Sarah H., Carter, Cristina A., Berkowitz, Nina, Conan-Cibotti, Michelle, Cox, Josephine H., Beck, Allison, O'Callahan, Mark, Andrews, Charla, Gordon, Ingelise J., Larkin, Brenda, Lampley, Rebecca, Kaltovich, Florence, Gall, Jason, Carlton, Kevin, Mendy, Jason, Haney, Doug, May, Jeanine, and Bray, Amy

Subjects
VIRAL vaccines, CHIKUNGUNYA, IMMUNOGLOBULINS, INTRAMUSCULAR injections, RANDOMIZED controlled trials, BLIND experiment, NEUTRALIZATION tests, STATISTICAL sampling, CHIKUNGUNYA virus
Abstract

Importance: Chikungunya virus (CHIKV) is a mosquito-borne Alphavirus prevalent worldwide. There are currently no licensed vaccines or therapies.Objective: To evaluate the safety and tolerability of an investigational CHIKV virus-like particle (VLP) vaccine in endemic regions.Design, Setting, and Participants: This was a randomized, placebo-controlled, double-blind, phase 2 clinical trial to assess the vaccine VRC-CHKVLP059-00-VP (CHIKV VLP). The trial was conducted at 6 outpatient clinical research sites located in Haiti, Dominican Republic, Martinique, Guadeloupe, and Puerto Rico. A total of 400 healthy adults aged 18 through 60 years were enrolled after meeting eligibility criteria. The first study enrollment occurred on November 18, 2015; the final study visit, March 6, 2018.Interventions: Participants were randomized 1:1 to receive 2 intramuscular injections 28 days apart (20 µg, n = 201) or placebo (n = 199) and were followed up for 72 weeks.Main Outcomes and Measures: The primary outcome was the safety (laboratory parameters, adverse events, and CHIKV infection) and tolerability (local and systemic reactogenicity) of the vaccine, and the secondary outcome was immune response by neutralization assay 4 weeks after second vaccination.Results: Of the 400 randomized participants (mean age, 35 years; 199 [50%] women), 393 (98%) completed the primary safety analysis. All injections were well tolerated. Of the 16 serious adverse events unrelated to the study drugs, 4 (25%) occurred among 4 patients in the vaccine group and 12 (75%) occurred among 11 patients in the placebo group. Of the 16 mild to moderate unsolicited adverse events that were potentially related to the drug, 12 (75%) occurred among 8 patients in the vaccine group and 4 (25%) occurred among 3 patients in the placebo group. All potentially related adverse events resolved without clinical sequelae. At baseline, there was no significant difference between the effective concentration (EC50)-which is the dilution of sera that inhibits 50% infection in viral neutralization assay-geometric mean titers (GMTs) of neutralizing antibodies of the vaccine group (46; 95% CI, 34-63) and the placebo group (43; 95% CI, 32-57). Eight weeks following the first administration, the EC50 GMT in the vaccine group was 2005 (95% CI, 1680-2392) vs 43 (95% CI, 32-58; P < .001) in the placebo group. Durability of the immune response was demonstrated through 72 weeks after vaccination.Conclusions and Relevance: Among healthy adults in a chikungunya endemic population, a virus-like particle vaccine compared with placebo demonstrated safety and tolerability. Phase 3 trials are needed to assess clinical efficacy.Trial Registration: ClinicalTrials.gov Identifier: NCT02562482. [ABSTRACT FROM AUTHOR]

Published
2020
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39. Safety, tolerability, and immunogenicity of two Zika virus DNA vaccine candidates in healthy adults: randomised, open-label, phase 1 clinical trials

Author

Gaudinski, Martin R, primary, Houser, Katherine V, additional, Morabito, Kaitlyn M, additional, Hu, Zonghui, additional, Yamshchikov, Galina, additional, Rothwell, Ro Shauna, additional, Berkowitz, Nina, additional, Mendoza, Floreliz, additional, Saunders, Jamie G, additional, Novik, Laura, additional, Hendel, Cynthia S, additional, Holman, LaSonji A, additional, Gordon, Ingelise J, additional, Cox, Josephine H, additional, Edupuganti, Srilatha, additional, McArthur, Monica A, additional, Rouphael, Nadine G, additional, Lyke, Kirsten E, additional, Cummings, Ginny E, additional, Sitar, Sandra, additional, Bailer, Robert T, additional, Foreman, Bryant M, additional, Burgomaster, Katherine, additional, Pelc, Rebecca S, additional, Gordon, David N, additional, DeMaso, Christina R, additional, Dowd, Kimberly A, additional, Laurencot, Carolyn, additional, Schwartz, Richard M, additional, Mascola, John R, additional, Graham, Barney S, additional, Pierson, Theodore C, additional, Ledgerwood, Julie E, additional, Chen, Grace L, additional, Plummer, Sarah, additional, Costner, Pamela, additional, Zephir, Kathryn, additional, Casazza, Joseph, additional, Ola, Abidemi, additional, Victorino, Milalynn, additional, Levinson, Carol, additional, Whalen, William, additional, Wang, Xiaolin, additional, Cunningham, Jennifer, additional, Vasilenko, Olga, additional, Burgos Florez, Maria, additional, Hickman, Somia, additional, Pittman, Iris, additional, Le, Lam, additional, Larkin, Brenda, additional, Andrews, Charla, additional, Apte, Preeti, additional, Hicks, Renunda, additional, Trelles Cartagena, Cora, additional, Williams, Pernell, additional, Boyd, Catina R, additional, Conan-Cibotti, Michelle, additional, Stein, Judy, additional, Kaltovich, Florence, additional, DeCederfelt, Hope, additional, McAdams, Stacey, additional, Renehan, Phyllis, additional, Chen, Wilbur, additional, Greenberg, Nancy, additional, Wymer, Nancy, additional, Wadsworth, Linda, additional, Billington, Melissa, additional, Robinson, Toni, additional, Boyce, Colleen, additional, Pa'ahana Brown, Faith, additional, Chrisley, Lisa, additional, Kwon, Alyson, additional, Patel, Prashant, additional, Kominou, Panagoita, additional, Dorsey, Brenda, additional, Eddington, Staci, additional, Telscher, Shinyi, additional, Lee, Myoughee, additional, Mosely, Regina, additional, Ross, April, additional, Ford, Geoffrey, additional, Domjahn, Briyana, additional, Xu, Jianguo, additional, Beck, Allison, additional, Fineman, Rebecca, additional, Heeke, Shiela, additional, Winter, Jean, additional, Nagar, Shashi, additional, Kelley, Colleen, additional, and Mulligan, Mark, additional

Published
2018
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40. Chimpanzee Adenovirus Vector Ebola Vaccine - Preliminary Report

Author

Ledgerwood, Julie E, Dezure, Adam D, Stanley, Daphne A, Novik, Laura, Enama, Mary E, Berkowitz, Nina M, Hu, Zonghui, Joshi, Gyan, Ploquin, Aurélie, Sitar, Sandra, Gordon, Ingelise J, Plummer, Sarah A, Holman, LaSonji A, Hendel, Cynthia S, Yamshchikov, Galina, Roman, Francois, Colloca, Stefano, Cortese, Riccardo, Bailer, Robert T, Schwartz, Richard M, Roederer, Mario, Mascola, John R, Koup, Richard A, Sullivan, Nancy J, Graham, Barney S., NICOSIA, Alfredo, Ledgerwood, Julie E, Dezure, Adam D, Stanley, Daphne A, Novik, Laura, Enama, Mary E, Berkowitz, Nina M, Hu, Zonghui, Joshi, Gyan, Ploquin, Aurélie, Sitar, Sandra, Gordon, Ingelise J, Plummer, Sarah A, Holman, LaSonji A, Hendel, Cynthia S, Yamshchikov, Galina, Roman, Francoi, Nicosia, Alfredo, Colloca, Stefano, Cortese, Riccardo, Bailer, Robert T, Schwartz, Richard M, Roederer, Mario, Mascola, John R, Koup, Richard A, Sullivan, Nancy J, and Graham, Barney S.

Abstract

Background The unprecedented 2014 epidemic of Ebola virus disease (EVD) has prompted an international response to accelerate the availability of a preventive vaccine. A replication-defective recombinant chimpanzee adenovirus type 3-vectored ebolavirus vaccine (cAd3-EBO), encoding the glycoprotein from Zaire and Sudan species that offers protection in the nonhuman primate model, was rapidly advanced into phase 1 clinical evaluation. Methods We conducted a phase 1, dose-escalation, open-label trial of cAd3-EBO. Twenty healthy adults, in sequentially enrolled groups of 10 each, received vaccination intramuscularly in doses of 2×10(10) particle units or 2×10(11) particle units. Primary and secondary end points related to safety and immunogenicity were assessed throughout the first 4 weeks after vaccination. Results In this small study, no safety concerns were identified; however, transient fever developed within 1 day after vaccination in two participants who had received the 2×10(11) particle-unit dose. Glycoprotein-specific antibodies were induced in all 20 participants; the titers were of greater magnitude in the group that received the 2×10(11) particle-unit dose than in the group that received the 2×10(10) particle-unit dose (geometric mean titer against the Zaire antigen, 2037 vs. 331; P=0.001). Glycoprotein-specific T-cell responses were more frequent among those who received the 2x10(11) particle-unit dose than among those who received the 2×10(10) particle-unit dose, with a CD4 response in 10 of 10 participants versus 3 of 10 participants (P=0.004) and a CD8 response in 7 of 10 participants versus 2 of 10 participants (P=0.07). Conclusions Reactogenicity and immune responses to cAd3-EBO vaccine were dose-dependent. At the 2×10(11) particle-unit dose, glycoprotein Zaire-specific antibody responses were in the range reported to be associated with vaccine-induced protective immunity in challenge studies involving nonhuman primates. Clinical trials assessing cAd3-EBO are ongoing. (Funded by the Intramural Research Program of the National Institutes of Health; VRC 207 ClinicalTrials.gov number, NCT02231866 .).

Published
2014

41. A proof of concept for structure-based vaccine design targeting RSV in humans.

Author

Crank, Michelle C., Ruckwardt, Tracy J., Chen, Man, Morabito, Kaitlyn M., Phung, Emily, Costner, Pamela J., Holman, LaSonji A., Hickman, Somia P., Berkowitz, Nina M., Gordon, Ingelise J., Yamshchikov, Galina V., Gaudinski, Martin R., Kumar, Azad, Chang, Lauren A., Moin, Syed M., Hill, Juliane P., DiPiazza, Anthony T., Schwartz, Richard M., Kueltzo, Lisa, and Cooper, Jonathan W.

Published
2019
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42. Corrigendum: Protection against malaria at 1 year and immune correlates following PfSPZ vaccination

Author

Ishizuka, Andrew S, Lyke, Kirsten E, DeZure, Adam, Berry, Andrea A, Richie, Thomas L, Mendoza, Floreliz H, Enama, Mary E, Gordon, Ingelise J, Chang, Lee-Jah, Sarwar, Uzma N, Zephir, Kathryn L, Holman, LaSonji A, James, Eric R, Billingsley, Peter F, Gunasekera, Anusha, Chakravarty, Sumana, Manoj, Anita, Li, MingLin, Ruben, Adam J, Li, Tao, Eappen, Abraham G, Stafford, Richard E, K C, Natasha, Murshedkar, Tooba, DeCederfelt, Hope, Plummer, Sarah H, Hendel, Cynthia S, Novik, Laura, Costner, Pamela J M, Saunders, Jamie G, Laurens, Matthew B, Plowe, Christopher V, Flynn, Barbara, Whalen, William R, Todd, J P, Noor, Jay, Rao, Srinivas, Sierra-Davidson, Kailan, Lynn, Geoffrey M, Epstein, Judith E, Kemp, Margaret A, Fahle, Gary A, Mikolajczak, Sebastian A, Fishbaugher, Matthew, Sack, Brandon K, Kappe, Stefan H I, Davidson, Silas A, Garver, Lindsey S, Björkström, Niklas K, Nason, Martha C, Graham, Barney S, Roederer, Mario, Sim, B Kim Lee, Hoffman, Stephen L, Ledgerwood, Julie E, and Seder, Robert A

Subjects
Biological sciences, Health
Abstract

Author(s): Andrew S Ishizuka; Kirsten E Lyke; Adam DeZure; Andrea A Berry; Thomas L Richie; Floreliz H Mendoza; Mary E Enama; Ingelise J Gordon; Lee-Jah Chang; Uzma N Sarwar; Kathryn [...]

Published
2016
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43. Safety, immunogenicity and efficacy of modified vaccinia Ankara (MVA) against Dryvax® challenge in vaccinia-naïve and vaccinia-immune individuals

Author

Parrino, Janie, primary, McCurdy, Lewis H., additional, Larkin, Brenda D., additional, Gordon, Ingelise J., additional, Rucker, Steven E., additional, Enama, Mary E., additional, Koup, Richard A., additional, Roederer, Mario, additional, Bailer, Robert T., additional, Moodie, Zoe, additional, Gu, Lin, additional, Yan, Lihan, additional, and Graham, Barney S., additional

Published
2007
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44. Phase 1 Study of Pandemic H1 DNA Vaccine in Healthy Adults.

Author

Crank, Michelle C., Gordon, Ingelise J., Yamshchikov, Galina V., Sitar, Sandra, Hu, Zonghui, Enama, Mary E., Holman, LaSonji A., Bailer, Robert T., Pearce, Melissa B., Koup, Richard A., Mascola, John R., Nabel, Gary J., Tumpey, Terrence M., Schwartz, Richard M., Graham, Barney S., Ledgerwood, Julie E., and null, null

Subjects
*INFLUENZA A virus, H1N1 subtype, *PANDEMICS, *DNA vaccines, *CLINICAL trials
Abstract

Background: A novel, swine-origin influenza A (H1N1) virus was detected worldwide in April 2009, and the World Health Organization (WHO) declared a global pandemic that June. DNA vaccine priming improves responses to inactivated influenza vaccines. We describe the rapid production and clinical evaluation of a DNA vaccine encoding the hemagglutinin protein of the 2009 pandemic A/California/04/2009(H1N1) influenza virus, accomplished nearly two months faster than production of A/California/07/2009(H1N1) licensed monovalent inactivated vaccine (MIV). Methods: 20 subjects received three H1 DNA vaccinations (4 mg intramuscularly with Biojector) at 4-week intervals. Eighteen subjects received an optional boost when the licensed H1N1 MIV became available. The interval between the third H1 DNA injection and MIV boost was 3–17 weeks. Vaccine safety was assessed by clinical observation, laboratory parameters, and 7-day solicited reactogenicity. Antibody responses were assessed by ELISA, HAI and neutralization assays, and T cell responses by ELISpot and flow cytometry. Results: Vaccinations were safe and well-tolerated. As evaluated by HAI, 6/20 developed positive responses at 4 weeks after third DNA injection and 13/18 at 4 weeks after MIV boost. Similar results were detected in neutralization assays. T cell responses were detected after DNA and MIV. The antibody responses were significantly amplified by the MIV boost, however, the boost did not increased T cell responses induced by DNA vaccine. Conclusions: H1 DNA vaccine was produced quickly, was well-tolerated, and had modest immunogenicity as a single agent. Other HA DNA prime-MIV boost regimens utilizing one DNA prime vaccination and longer boost intervals have shown significant immunogenicity. Rapid and large-scale production of HA DNA vaccines has the potential to contribute to an efficient response against future influenza pandemics. Trial Registration: Clinicaltrials.gov [ABSTRACT FROM AUTHOR]

Published
2015
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45. Phase I Randomized Clinical Trial of VRC DNA and rAd5 HIV-1 Vaccine Delivery by Intramuscular (IM), Subcutaneous (SC) and Intradermal (ID) Administration (VRC 011).

Author

Enama, Mary E., Ledgerwood, Julie E., Novik, Laura, Nason, Martha C., Gordon, Ingelise J., Holman, LaSonji, Bailer, Robert T., Roederer, Mario, Koup, Richard A., Mascola, John R., Nabel, Gary J., and Graham, Barney S.

Subjects
CLINICAL trials, VIRAL vaccines, DRUG administration, DNA viruses, DNA primers
Abstract

Background: Phase 1 evaluation of the VRC HIV DNA and rAd5 vaccines delivered intramuscularly (IM) supported proceeding to a Phase 2 b efficacy study. Here we report comparison of the IM, subcutaneous (SC) and intradermal (ID) routes of administration. Methods: Sixty subjects were randomized to 6 schedules to evaluate the IM, SC or ID route for prime injections. Three schedules included DNA primes (Wks 0,4,8) and 3 schedules included rAd5 prime (Wk0); all included rAd5 IM boost (Wk24). DNA vaccine dosage was 4 mg IM or SC, but 0.4 mg ID, while all rAd5 vaccinations were 1010 PU. All injections were administered by needle and syringe. Results: Overall, 27/30 subjects completed 3 DNA primes; 30/30 subjects completed rAd5 primes. Mild local pruritus (itchiness), superficial skin lesions and injection site nodules were associated with ID and SC, but not IM injections. All routes induced T-cell and antibody immune responses after rAd5 boosting. Overall, >95% had Env antibody and >80% had Env T-cell responses. Conclusions: The pattern of local reactogenicity following ID and SC injections differed from IM injections but all routes were well-tolerated. There was no evidence of an immunogenicity advantage following SC or ID delivery, supporting IM delivery as the preferred route of administration. Trial Registration: Clinicaltrials.gov NCT00321061 [ABSTRACT FROM AUTHOR]

Published
2014
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46. Therapeutic Vaccination Expands and Improves the Function of the HIV-Specific Memory T-Cell Repertoire.

Author

Casazza, Joseph P., Bowman, Kathryn A., Adzaku, Selorm, Smith, Emily C., Enama, Mary E., Bailer, Robert T., Price, David A., Gostick, Emma, Gordon, Ingelise J., Ambrozak, David R., Nason, Martha C., Roederer, Mario, Andrews, Charla A., Maldarelli, Frank M., Wiegand, Ann, Kearney, Mary F., Persaud, Deborah, Ziemniak, Carrie, Gottardo, Raphael, and Ledgerwood, Julie E.

Subjects
AIDS vaccines, IMMUNOLOGIC memory, T cells, IMMUNE response, HERPES zoster vaccines, VIRUS diseases, INTRAMUSCULAR injections
Abstract

Background. The licensing of herpes zoster vaccine has demonstrated that therapeutic vaccination can help control chronic viral infection. Unfortunately, human trials of immunodeficiency virus (HIV) vaccine have shown only marginal efficacy.Methods. In this double-blind study, 17 HIV-infected individuals with viral loads of <50 copies/mL and CD4+ T-cell counts of >350 cells/µL were randomly assigned to the vaccine or placebo arm. Vaccine recipients received 3 intramuscular injections of HIV DNA (4 mg) coding for clade B Gag, Pol, and Nef and clade A, B, and C Env, followed by a replication-deficient adenovirus type 5 boost (1010 particle units) encoding all DNA vaccine antigens except Nef. Humoral, total T-cell, and CD8+ cytotoxic T-lymphocyte (CTL) responses were studied before and after vaccination. Single-copy viral loads and frequencies of latently infected CD4+ T cells were determined.Results. Vaccination was safe and well tolerated. Significantly stronger HIV-specific T-cell responses against Gag, Pol, and Env, with increased polyfunctionality and a broadened epitope-specific CTL repertoire, were observed after vaccination. No changes in single-copy viral load or the frequency of latent infection were observed.Conclusions. Vaccination of individuals with existing HIV-specific immunity improved the magnitude, breadth, and polyfunctionality of HIV-specific memory T-cell responses but did not impact markers of viral control.Clinical Trials Registration. NCT00270465 [ABSTRACT FROM PUBLISHER]

Published
2013
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47. DNA Vaccine Delivered by a Needle-Free Injection Device Improves Potency of Priming for Antibody and CD8+ T-Cell Responses after rAd5 Boost in a Randomized Clinical Trial.

Author

Graham, Barney S., Enama, Mary E., Nason, Martha C., Gordon, Ingelise J., Peel, Sheila A., Ledgerwood, Julie E., Plummer, Sarah A., Mascola, John R., Bailer, Robert T., Roederer, Mario, Koup, Richard A., and Nabel, Gary J.

Subjects
DNA vaccines, DRUG synergism, IMMUNOGLOBULINS, T cells, CLINICAL trials, DRUG delivery systems, SYRINGES, HYPODERMIC needles, FOLLOW-up studies (Medicine)
Abstract

Background: DNA vaccine immunogenicity has been limited by inefficient delivery. Needle-free delivery of DNA using a CO2-powered Biojector® device was compared to delivery by needle and syringe and evaluated for safety and immunogenicity. Methods: Forty adults, 18–50 years, were randomly assigned to intramuscular (IM) vaccinations with DNA vaccine, VRC-HIVDNA016-00-VP, (weeks 0, 4, 8) by Biojector® 2000™ or needle and syringe (N/S) and boosted IM at week 24 with VRC-HIVADV014-00-VP (rAd5) with N/S at 1010 or 1011 particle units (PU). Equal numbers per assigned schedule had low (≤500) or high (>500) reciprocal titers of preexisting Ad5 neutralizing antibody. Results: 120 DNA and 39 rAd5 injections were given; 36 subjects completed follow-up research sample collections. IFN-γ ELISpot response rates were 17/19 (89%) for Biojector® and 13/17 (76%) for N/S delivery at Week 28 (4 weeks post rAd5 boost). The magnitude of ELISpot response was about 3-fold higher in Biojector® compared to N/S groups. Similar effects on response rates and magnitude were observed for CD8+, but not CD4+ T-cell responses by ICS. Env-specific antibody responses were about 10-fold higher in Biojector-primed subjects. Conclusions: DNA vaccination by Biojector® was well-tolerated and compared to needle injection, primed for greater IFN-γ ELISpot, CD8+ T-cell, and antibody responses after rAd5 boosting. Trial Registration: ClinicalTrials.gov NCT00109629 [ABSTRACT FROM AUTHOR]

Published
2013
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48. A DNA Vaccine for Ebola Virus Is Safe and Immunogenic in a Phase I Clinical Trial

Author

Martin, Julie E., Sullivan, Nancy J., Enama, Mary E., Gordon, Ingelise J., Roederer, Mario, Koup, Richard A., Bailer, Robert T., Chakrabarti, Bimal K., Bailey, Michael A., Gomez, Phillip L., Andrews, Charla A., Moodie, Zoe, Gu, Lin, Stein, Judith A., Nabel, Gary J., and Graham, Barney S.

Abstract

ABSTRACTEbola viruses represent a class of filoviruses that causes severe hemorrhagic fever with high mortality. Recognized first in 1976 in the Democratic Republic of Congo, outbreaks continue to occur in equatorial Africa. A safe and effective Ebola virus vaccine is needed because of its continued emergence and its potential for use for biodefense. We report the safety and immunogenicity of an Ebola virus vaccine in its first phase I human study. A three-plasmid DNA vaccine encoding the envelope glycoproteins (GP) from the Zaire and Sudan/Gulu species as well as the nucleoprotein was evaluated in a randomized, placebo-controlled, double-blinded, dose escalation study. Healthy adults, ages 18 to 44 years, were randomized to receive three injections of vaccine at 2 mg (n= 5), 4 mg (n= 8), or 8 mg (n= 8) or placebo (n= 6). Immunogenicity was assessed by enzyme-linked immunosorbent assay (ELISA), immunoprecipitation-Western blotting, intracellular cytokine staining (ICS), and enzyme-linked immunospot assay. The vaccine was well-tolerated, with no significant adverse events or coagulation abnormalities. Specific antibody responses to at least one of the three antigens encoded by the vaccine as assessed by ELISA and CD4+T-cell GP-specific responses as assessed by ICS were detected in 20/20 vaccinees. CD8+T-cell GP-specific responses were detected by ICS assay in 6/20 vaccinees. This Ebola virus DNA vaccine was safe and immunogenic in humans. Further assessment of the DNA platform alone and in combination with replication-defective adenoviral vector vaccines, in concert with challenge and immune data from nonhuman primates, will facilitate evaluation and potential licensure of an Ebola virus vaccine under the Animal Rule.

Published
2006
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49. Correction: Corrigendum: Protection against malaria at 1 year and immune correlates following PfSPZ vaccination

Author

Ishizuka, Andrew S, Lyke, Kirsten E, DeZure, Adam, Berry, Andrea A, Richie, Thomas L, Mendoza, Floreliz H, Enama, Mary E, Gordon, Ingelise J, Chang, Lee-Jah, Sarwar, Uzma N, Zephir, Kathryn L, Holman, LaSonji A, James, Eric R, Billingsley, Peter F, Gunasekera, Anusha, Chakravarty, Sumana, Manoj, Anita, Li, MingLin, Ruben, Adam J, Li, Tao, Eappen, Abraham G, Stafford, Richard E, K C, Natasha, Murshedkar, Tooba, DeCederfelt, Hope, Plummer, Sarah H, Hendel, Cynthia S, Novik, Laura, Costner, Pamela J M, Saunders, Jamie G, Laurens, Matthew B, Plowe, Christopher V, Flynn, Barbara, Whalen, William R, Todd, J P, Noor, Jay, Rao, Srinivas, Sierra-Davidson, Kailan, Lynn, Geoffrey M, Epstein, Judith E, Kemp, Margaret A, Fahle, Gary A, Mikolajczak, Sebastian A, Fishbaugher, Matthew, Sack, Brandon K, Kappe, Stefan H I, Davidson, Silas A, Garver, Lindsey S, Björkström, Niklas K, Nason, Martha C, Graham, Barney S, Roederer, Mario, Sim, B Kim Lee, Hoffman, Stephen L, Ledgerwood, Julie E, and Seder, Robert A

Abstract

Nat. Med.; 10.1038/nm.4110; corrected online 18 May 2016 In the version of this article initially published online, the authors omitted a funding source, The Bill and Melinda Gates Foundation (Investment ID: 24922). The error has been corrected for the print, PDF and HTML versions of this article.

Published
2016
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50. Safety, immunogenicity and efficacy of modified vaccinia Ankara (MVA) against Dryvax® challenge in vaccinia-naïve and vaccinia-immune individuals

Author

Parrino, Janie, McCurdy, Lewis H., Larkin, Brenda D., Gordon, Ingelise J., Rucker, Steven E., Enama, Mary E., Koup, Richard A., Roederer, Mario, Bailer, Robert T., Moodie, Zoe, Gu, Lin, Yan, Lihan, and Graham, Barney S.

Subjects
*VACCINIA, *VACCINATION, *T cells, *IMMUNE response, *ORTHOPOXVIRUSES
Abstract

Abstract: Modified vaccinia Ankara (MVA) was evaluated as an alternative to Dryvax® in vaccinia-naïve and vaccinia-immune adult volunteers. Subjects received intramuscular MVA or placebo followed by Dryvax® challenge at 3 months. Two or more doses of MVA prior to Dryvax® reduced severity of lesion formation, decreased magnitude and duration of viral shedding, and augmented post-Dryvax® vaccinia-specific CD8+ T cell responses and extracellular enveloped virus protein-specific antibody responses. MVA vaccination is safe and immunogenic and improves the safety and immunogenicity of subsequent Dryvax® vaccination supporting the potential for using MVA as a vaccine in the general population to improve immunity to orthopoxviruses. [Copyright &y& Elsevier]

Published
2007
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