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1. 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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2. Safety and tolerability of AAV8 delivery of a broadly neutralizing antibody in adults living with HIV: a phase 1, dose-escalation trial

Author

Casazza, Joseph P., Cale, Evan M., Narpala, Sandeep, Yamshchikov, Galina V., Coates, Emily E., Hendel, Cynthia S., Novik, Laura, Holman, LaSonji A., Widge, Alicia T., Apte, Preeti, Gordon, Ingelise, Gaudinski, Martin R., Conan-Cibotti, Michelle, Lin, Bob C., Nason, Martha C., Trofymenko, Olga, Telscher, Shinyi, Plummer, Sarah H., Wycuff, Diane, Adams, William C., Pandey, Janardan P., McDermott, Adrian, Roederer, Mario, Sukienik, Avery N., O’Dell, Sijy, Gall, Jason G., Flach, Britta, Terry, Travis L., Choe, Misook, Shi, Wei, Chen, Xuejun, Kaltovich, Florence, Saunders, Kevin O., Stein, Judy A., Doria-Rose, Nicole A., Schwartz, Richard M., Balazs, Alejandro B., Baltimore, David, Nabel, Gary J., Koup, Richard A., Graham, Barney S., Ledgerwood, Julie E., and Mascola, John R.

Published
2022
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3. Safety and immunogenicity of a trivalent virus-like particle vaccine against western, eastern, and Venezuelan equine encephalitis viruses: a phase 1, open-label, dose-escalation, randomised clinical trial

Author

Butler, Ellie, Winter, Jean, Xu, Jianguo, Sherman, Amy, Kelley, Colleen, Fredrick, Rameses, Rouphael, Nadine, Phadke, Varun, Whitney, Cynthia, Alvarez, Alicarmen, Dennis, Renata, Fineman, Rebecca, Lankford-Turner, Pamela, Yi, Sha, Lai, Lilin, Burch, Gena, Gupta, Shanker, Berkowitz, Nina, Carter, Cristina, Beck, Allison, Larkin, Brenda, Taylor, Stephanie, Alger, Mandy, Bahorich, Jessica, Lynch Chamberlain, Amy, Chang, Ya-chen, Chaudhuri, Rajoshi, Cooper, Jonathan, Demirji, Jacob, Yang, Fan, Fernald, Alissa, Gollapudi, Deepika, Holland-Linn, Janel, Kueltzo, Lisa, Lee, James, Liu, Jie, Liu, Xun, Mowery, Rachel, O'Connell, Sarah, Rosales-Zavala, Erwin, Sands, Jason, Wang, Xin, Weng, Shaojie, Witter, Sara, Coates, Emily E, Edupuganti, Srilatha, Chen, Grace L, Happe, Myra, Strom, Larisa, Widge, Alicia, Florez, Maria Burgos, Cox, Josephine H, Gordon, Ingelise, Plummer, Sarah, Ola, Abidemi, Yamshchikov, Galina, Andrews, Charla, Curate-Ingram, Sharon, Morgan, Patricia, Nagar, Shashi, Collins, Matthew H, Bray, Amy, Nguyen, Thuy, Stein, Judy, Case, Christopher L, Kaltovich, Florence, Wycuff, Diane, Liang, C Jason, Carlton, Kevin, Vazquez, Sandra, Mascola, John R, and Ledgerwood, Julie E

Published
2022
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4. 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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5. 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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6. 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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7. Safety and immunogenicity of a trivalent virus-like particle vaccine against western, eastern, and Venezuelan equine encephalitis viruses: a phase 1, open-label, dose-escalation, randomised clinical trial

Author

Coates, Emily E, primary, Edupuganti, Srilatha, additional, Chen, Grace L, additional, Happe, Myra, additional, Strom, Larisa, additional, Widge, Alicia, additional, Florez, Maria Burgos, additional, Cox, Josephine H, additional, Gordon, Ingelise, additional, Plummer, Sarah, additional, Ola, Abidemi, additional, Yamshchikov, Galina, additional, Andrews, Charla, additional, Curate-Ingram, Sharon, additional, Morgan, Patricia, additional, Nagar, Shashi, additional, Collins, Matthew H, additional, Bray, Amy, additional, Nguyen, Thuy, additional, Stein, Judy, additional, Case, Christopher L, additional, Kaltovich, Florence, additional, Wycuff, Diane, additional, Liang, C Jason, additional, Carlton, Kevin, additional, Vazquez, Sandra, additional, Mascola, John R, additional, Ledgerwood, Julie E, additional, Butler, Ellie, additional, Winter, Jean, additional, Xu, Jianguo, additional, Sherman, Amy, additional, Kelley, Colleen, additional, Fredrick, Rameses, additional, Rouphael, Nadine, additional, Phadke, Varun, additional, Whitney, Cynthia, additional, Alvarez, Alicarmen, additional, Dennis, Renata, additional, Fineman, Rebecca, additional, Lankford-Turner, Pamela, additional, Yi, Sha, additional, Lai, Lilin, additional, Burch, Gena, additional, Gupta, Shanker, additional, Berkowitz, Nina, additional, Carter, Cristina, additional, Beck, Allison, additional, Larkin, Brenda, additional, Taylor, Stephanie, additional, Alger, Mandy, additional, Bahorich, Jessica, additional, Lynch Chamberlain, Amy, additional, Chang, Ya-chen, additional, Chaudhuri, Rajoshi, additional, Cooper, Jonathan, additional, Demirji, Jacob, additional, Yang, Fan, additional, Fernald, Alissa, additional, Gollapudi, Deepika, additional, Holland-Linn, Janel, additional, Kueltzo, Lisa, additional, Lee, James, additional, Liu, Jie, additional, Liu, Xun, additional, Mowery, Rachel, additional, O'Connell, Sarah, additional, Rosales-Zavala, Erwin, additional, Sands, Jason, additional, Wang, Xin, additional, Weng, Shaojie, additional, and Witter, Sara, additional

Published
2022
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8. 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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9. 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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10. 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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12. 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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13. 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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16. Safety and tolerability of AAV8 delivery of a broadly neutralizing antibody in adults living with HIV: a phase 1, dose-escalation trial

Abstract

Adeno-associated viral vector-mediated transfer of DNA coding for broadly neutralizing anti-HIV antibodies (bnAbs) offers an alternative to attempting to induce protection by vaccination or by repeated infusions of bnAbs. In this study, we administered a recombinant bicistronic adeno-associated virus (AAV8) vector coding for both the light and heavy chains of the potent broadly neutralizing HIV-1 antibody VRC07 (AAV8-VRC07) to eight adults living with HIV. All participants remained on effective anti-retroviral therapy (viral load (VL) <50 copies per milliliter) throughout this phase 1, dose-escalation clinical trial (NCT03374202). AAV8-VRC07 was given at doses of 5 × 10¹⁰, 5 × 10¹¹ and 2.5 × 10¹² vector genomes per kilogram by intramuscular (IM) injection. Primary endpoints of this study were to assess the safety and tolerability of AAV8-VRC07; to determine the pharmacokinetics and immunogenicity of in vivo VRC07 production; and to describe the immune response directed against AAV8-VRC07 vector and its products. Secondary endpoints were to assess the clinical effects of AAV8-VRC07 on CD4 T cell count and VL and to assess the persistence of VRC07 produced in participants. In this cohort, IM injection of AAV8-VRC07 was safe and well tolerated. No clinically significant change in CD4 T cell count or VL occurred during the 1–3 years of follow-up reported here. In participants who received AAV8-VRC07, concentrations of VRC07 were increased 6 weeks (P = 0.008) and 52 weeks (P = 0.016) after IM injection of the product. All eight individuals produced measurable amounts of serum VRC07, with maximal VRC07 concentrations >1 µg ml⁻¹ in three individuals. In four individuals, VRC07 serum concentrations remained stable near maximal concentration for up to 3 years of follow-up. In exploratory analyses, neutralizing activity of in vivo produced VRC07 was similar to that of in vitro produced VRC07. Three of eight participants showed a non-idiotypic anti-drug antibody (ADA) response

Published
2022

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