This clinical research project is for clinical trials related to active immunity (vaccines) and passive immunity (monoclonal antibodies) directed against HIV that are evaluated in HIV-infected volunteers through clinical trials conducted by the VRC Clinical Trials Program at the NIH Clinical Center. A brief summary of each study to date follows. VRC 101 (06-I-0056) was the first Phase I therapeutic study of two candidate HIV-1 vaccines developed by the VRC and administered in a prime-boost regimen. A manuscript describing results was published: J Infect Dis. 2013 Jun 15;207(12):1829-40. VRC 601 (13-I-0189) is the first Phase I dose-escalation study in HIV-infected volunteers of a human monoclonal antibody, identified as VRC-HIVMAB060-00-VP (VRC01), which has broad HIV-1 neutralizing activity and was developed by the VRC/NIAID/NIH. A manuscript describing results was published: Sci Transl Med. 2015 Dec 23;7(319):319ra206. VRC 607 (16-I-0147) is the first Phase I single dose study of the safety and virologic effect of monoclonal antibody VRC01LS administered intravenously to HIV-infected adults. VRC01LS is a next generation MAb developed by the VRC to extend the antibody half-life. VRC 603 (18-I-0030) is the first Phase I dose-escalation study of the safety of AAV8-VRC07 (VRC-HIVAAV070-00-GT) recombinant AAV vector expressing VRC07 HIV-1 neutralizing antibody in antiretroviral treated, HIV-1 infected adults with controlled viremia.

Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Niaid Extramural Activities
Zip Code
Bar, Katharine J; Sneller, Michael C; Harrison, Linda J et al. (2016) Effect of HIV Antibody VRC01 on Viral Rebound after Treatment Interruption. N Engl J Med 375:2037-2050
Lynch, Rebecca M; Boritz, Eli; Coates, Emily E et al. (2015) Virologic effects of broadly neutralizing antibody VRC01 administration during chronic HIV-1 infection. Sci Transl Med 7:319ra206
Rudicell, Rebecca S; Kwon, Young Do; Ko, Sung-Youl et al. (2014) Enhanced potency of a broadly neutralizing HIV-1 antibody in vitro improves protection against lentiviral infection in vivo. J Virol 88:12669-82
Casazza, Joseph P; Bowman, Kathryn A; Adzaku, Selorm et al. (2013) Therapeutic vaccination expands and improves the function of the HIV-specific memory T-cell repertoire. J Infect Dis 207:1829-40
Rosenberg, Eric S; Graham, Barney S; Chan, Ellen S et al. (2010) Safety and immunogenicity of therapeutic DNA vaccination in individuals treated with antiretroviral therapy during acute/early HIV-1 infection. PLoS One 5:e10555