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1. 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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2. 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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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

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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4. 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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6. 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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7. Effects of Acute Mental Stress and Exercise on T-Wave Alternans in Patients With Implantable Cardioverter Defibrillators and Controls

Author

Kop, Willem J., primary, Krantz, David S., additional, Nearing, Bruce D., additional, Gottdiener, John S., additional, Quigley, John F., additional, O’Callahan, Mark, additional, DelNegro, Albert A., additional, Friehling, Ted D., additional, Karasik, Pamela, additional, Suchday, Sonia, additional, Levine, Joseph, additional, and Verrier, Richard L., additional

Published
2004
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9. Short Communication: The Role of Dendritic Cells in the Infection of CD4+T Cells with the Human Immunodeficiency Virus: Use of Dendritic Cells from Individuals Homozygous for the Δ32CCR5Allele as a Model

Author

DYBUL, MARK, primary, WEISSMAN, DREW, additional, RUBBERT, ANDREA, additional, MACHADO, ELIZABETH, additional, COHN, MICHAEL, additional, EHLER, LINDA, additional, O'CALLAHAN, MARK, additional, MIZELL, STEPHANIE, additional, and FAUCI, ANTHONY S., additional

Published
1998
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