EV01: a phase I trial in healthy HIV negative volunteers to evaluate a clade C HIV vaccine, NYVAC-C undertaken by the EuroVacc Consortium - PubMed (original) (raw)
Clinical Trial
. 2008 Jun 13;26(25):3153-61.
doi: 10.1016/j.vaccine.2008.03.083. Epub 2008 May 27.
Ruth Goodall, Tristan Barber, Alexandre Harari, Ana Guimaraes-Walker, Mona Khonkarly, Neil C Sheppard, Yolanda Bangala, Marie-Joelle Frachette, Ralf Wagner, Peter Liljeström, Jean-Pierre Kraehenbuhl, Marc Girard, Jaap Goudsmit, Mariano Esteban, Jonathan Heeney, Quentin Sattentau, Sheena McCormack, Abdel Babiker, Giuseppe Pantaleo, Jonathan Weber; EuroVacc Consortium
Collaborators, Affiliations
- PMID: 18502002
- DOI: 10.1016/j.vaccine.2008.03.083
Clinical Trial
EV01: a phase I trial in healthy HIV negative volunteers to evaluate a clade C HIV vaccine, NYVAC-C undertaken by the EuroVacc Consortium
Pierre-Alexandre Bart et al. Vaccine. 2008.
Abstract
NYVAC-C (vP2010), a recombinant vector expressing HIV subtype C gag, pol, env and nef antigens, was tested in a phase I study in healthy, HIV negative volunteers in London and Lausanne. Twenty-four participants were randomised to receive NYVAC-C (20) or matching placebo (4) at weeks 0 and 4, and assessed for safety and immunogenicity over 48 weeks. There were no serious adverse events, and no clinical or laboratory abnormalities or other events that led to withdrawal, interruption or dose reduction of the NYVAC-C/placebo. Half of the 10 assessed responded in the ELISpot assay under stringent criteria, which informed the sample size for a DNA-NYVAC-C comparison to NYVAC-C alone.
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