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First-in-human evaluation of the safety and immunogenicity of a recombinant adenovirus serotype 26 HIV-1 Env vaccine (IPCAVD 001).

2013 Jan 15

Journal Article

Baden, L.R.; Walsh, S.R.; Seaman, M.S.; Tucker, R.P.; Krause, K.H.; Patel, A.; Johnson, J.A.; Kleinjan, J.; Yanosick, K.E.; Perry, J.; Zablowsky, E.; Abbink, P.; Peter, L.; Iampietro, J.; Cheung, A.; Pau, M.G.; Weijtens, M.; Goudsmit, J.; Swann, E.; Wolff, M.; Loblein, H.; Dolin, R.; Barouch, D.H.

J Infect Dis






Adenoviruses, Human; AIDS Vaccines; Double-Blind Method; Female; Gene Products, env; HIV Antibodies; HIV Infections; HIV-1; Humans; Leukocytes, Mononuclear; Male; Treatment Outcome; Vaccines, Synthetic

BACKGROUND: We report the first-in-human safety and immunogenicity assessment of a prototype Ad26 vector-based human immunodeficiency virus (HIV) vaccine in humans.METHODS: Sixty Ad26-seronegative, healthy, HIV-uninfected subjects were enrolled in a randomized, double-blinded, placebo-controlled, dose-escalation phase 1 study. Five groups of 12 subjects received 10(9)-10(11) vp of the Ad26-EnvA vaccine (N = 10/group) or placebo (N = 2/group) at weeks 0 and 24 or weeks 0, 4, and 24. Safety and immunogenicity were assessed.RESULTS: Self-limited reactogenicity was observed after the initial immunization at the highest (10(11) vp) dose. No product-related SAEs were observed. All subjects who received the Ad26-EnvA vaccine developed Ad26 NAb titers, EnvA-specific enzyme-linked immunosorbent assays (ELISA) titers, and EnvA-specific enzyme-linked immunospot assays (ELISPOT) responses. These responses persisted at week 52. At week 28 in the 10(9), 10(10), 10(11) vp 3-dose and the 10(10) and 5 × 10(10) vp 2-dose groups, geometric mean EnvA ELISA titers were 6113, 12 470, 8545, 3470, and 9655 and mean EnvA ELISPOT responses were 397, 178, 736, 196, and 1311 SFC/10(6) peripheral blood mononuclear cells, respectively.CONCLUSION: This Ad26 vectored vaccine was generally safe and immunogenic at all doses tested. Reactogenicity was minimal with doses of 5 × 10(10) vp or less. Ad26 is a promising new vaccine vector for HIV-1.CLINICAL TRIALS REGISTRATION: NCT00618605.

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