Details

Autor(en) / Beteiligte

• Baden, Lindsey R.
• Walsh, Stephen R.
• Seaman, Michael S.
• Tucker, Robert P.
• Krause, Kathleen H.
• Patel, Alka
• Johnson, Jennifer A.
• Kleinjan, Jane
• Yanosick, Katherine E.
• Perry, James
• Zablowsky, Elise
• Abbink, Peter
• Peter, Lauren
• Iampietro, Mark Justin
• Cheung, Ann
• Pau, Maria G.
• Weijtens, Mo
• Goudsmit, Jaap
• Swann, Edith
• Wolff, Mark
• Loblein, Hayley
• Dolin, Raphael
• Barouch, Dan H.

Titel

First-in-Human Evaluation of the Safety and Immunogenicity of a Recombinant Adenovirus Serotype 26 HIV-1 Env Vaccine (IPCAVD 001)

Ist Teil von

• The Journal of infectious diseases, 2013-01, Vol.207 (2), p.240-247

Ort / Verlag

Oxford: Oxford University Press

Erscheinungsjahr

2013

Quelle

Oxford Journals 2020 Medicine

Beschreibungen/Notizen

• 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, doubleblinded, 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 (IO 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 10⁹, 10¹⁰, 10¹¹ vp 3-dose and the 10¹⁰ and 5 × 10¹⁰ 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/10⁶ 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 × 10¹⁰ vp or less. Ad26 is a promising new vaccine vector for HIV-1.