Journal
VACCINE
Volume 26, Issue 25, Pages 3153-3161Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.vaccine.2008.03.083
Keywords
HIV preventative vaccine; NYVAC-C; phase I
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Funding
- Medical Research Council [G0000635, MC_U122861400] Funding Source: Medline
- Medical Research Council [G0000635, MC_U122861400] Funding Source: researchfish
- National Institute for Health Research [NF-SI-0507-10313] Funding Source: researchfish
- MRC [G0000635, MC_U122861400] Funding Source: UKRI
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NYVAC-C (vP2010), a recombinant vector expressing HIV subtype C gag, pot, 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. (C) 2008 Elsevier Ltd. All rights reserved.
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