Safety and immunogenicity of a multivalent HIV vaccine comprising envelope protein with either DNA or NYVAC vectors (HVTN 096): a phase 1b, double-blind, placebo-controlled trial

Publication date: Available online 7 October 2019Source: The Lancet HIVAuthor(s): Giuseppe Pantaleo, Holly Janes, Shelly Karuna, Shannon Grant, G Laissa Ouedraogo, Mary Allen, Georgia D Tomaras, Nicole Frahm, David C Montefiori, Guido Ferrari, Song Ding, Carter Lee, Merlin L Robb, Mariano Esteban, Ralf Wagner, Pierre-Alexandre Bart, Nils Rettby, M Juliana McElrath, Peter B Gilbert, James G KublinSummaryBackgroundUp to now, immunisation regimens that have been assessed for development of HIV vaccines have included purified envelope (Env) protein among the boosting components of the regimen. We postulated that co-administration of Env protein with either a DNA or NYVAC vector during priming would result in early generation of antibody responses to the Env V1/V2 region, which are important markers for effective protection against infection. We aimed to assess the safety and immunogenicity of a multivalent HIV vaccine including either DNA or NYVAC vectors alone or in combination with Env glycoprotein (gp120) followed by a co-delivered NYVAC and Env protein boost.MethodsWe did a single-centre, double-blind, placebo-controlled phase 1b trial at the Centre Hospitalier Universitaire Vaudois (Lausanne, Switzerland). We included healthy volunteers aged 18–50 years who were at low risk of HIV infection. We randomly allocated participants using computer-generated random numbers to one of four vaccination schedules or placebo (4:1), and within these schedules participants were allocated...
Source: The Lancet HIV - Category: Infectious Diseases Source Type: research