Evaluating the Safety and Immune Response of an Adenovirus-Based HIV Vaccine in HIV-Uninfected Adults

Summary

The purpose of this study is to evaluate the safety and immune response of an adenovirus-based HIV vaccine in HIV-uninfected adults.

Timeline

Start

2010-07

Primary completion

2012-09

Completion

2016-05

Publications

• Background Mast TC, Kierstead L, Gupta SB, Nikas AA, Kallas EG, Novitsky V, Mbewe B, Pitisuttithum P, Schechter M, Vardas E, Wolfe ND, Aste-Amezaga M, Casimiro DR, Coplan P, Straus WL, Shiver JW. International epidemiology of human pre-existing adenovirus (Ad) type-5, type-6, type-26 and type-36 neutralizing antibodies: correlates of high Ad5 titers and implications for potential HIV vaccine trials. Vaccine. 2010 Jan 22;28(4):950-7. doi: 10.1016/j.vaccine.2009.10.145. Epub 2009 Nov 17.
• Background Priddy FH, Brown D, Kublin J, Monahan K, Wright DP, Lalezari J, Santiago S, Marmor M, Lally M, Novak RM, Brown SJ, Kulkarni P, Dubey SA, Kierstead LS, Casimiro DR, Mogg R, DiNubile MJ, Shiver JW, Leavitt RY, Robertson MN, Mehrotra DV, Quirk E; Merck V520-016 Study Group. Safety and immunogenicity of a replication-incompetent adenovirus type 5 HIV-1 clade B gag/pol/nef vaccine in healthy adults. Clin Infect Dis. 2008 Jun 1;46(11):1769-81. doi: 10.1086/587993.
• Baden LR, Liu J, Li H, Johnson JA, Walsh SR, Kleinjan JA, Engelson BA, Peter L, Abbink P, Milner DA Jr, Golden KL, Viani KL, Stachler MD, Chen BJ, Pau MG, Weijtens M, Carey BR, Miller CA, Swann EM, Wolff M, Loblein H, Seaman MS, Dolin R, Barouch DH. Induction of HIV-1-specific mucosal immune responses following intramuscular recombinant adenovirus serotype 26 HIV-1 vaccination of humans. J Infect Dis. 2015 Feb 15;211(4):518-28. doi: 10.1093/infdis/jiu485. Epub 2014 Aug 26.

Drugs

Indications