Phase 1 safety and immunogenicity evaluation of ADVAX, a multigenic, DNA-based clade C/B' HIV-1 candidate vaccine.

PloS One
Sandhya VasanDavid D Ho

Abstract

We conducted a Phase I dose escalation trial of ADVAX, a DNA-based candidate HIV-1 vaccine expressing Clade C/B' env, gag, pol, nef, and tat genes. Sequences were derived from a prevalent circulating recombinant form in Yunnan, China, an area of high HIV-1 incidence. The objective was to evaluate the safety and immunogenicity of ADVAX in human volunteers. ADVAX or placebo was administered intramuscularly at months 0, 1 and 3 to 45 healthy volunteers not at high risk for HIV-1. Three dosage levels [0.2 mg (low), 1.0 mg (mid), and 4.0 mg (high)] were tested. Twelve volunteers in each dosage group were assigned to receive ADVAX and three to receive placebo in a double-blind design. Subjects were followed for local and systemic reactogenicity, adverse events, and clinical laboratory parameters. Study follow up was 18 months. Humoral immunogenicity was evaluated by anti-gp120 binding ELISA. Cellular immunogenicity was assessed by a validated IFNgamma ELISpot assay and intracellular cytokine staining. ADVAX was safe and well-tolerated, with no vaccine-related serious adverse events. Local and systemic reactogenicity events were reported by 64% and 42% of vaccine recipients, respectively. The majority of events were mild. The IFNgamma...Continue Reading

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Citations

Jun 8, 2013·Current Opinion in HIV and AIDS·Jean-Louis ExclerNina D Russell
Nov 25, 2011·Journal of Pharmaceutical Sciences·Jamie BetkerThomas J Anchordoquy
Sep 6, 2011·Drug Discovery Today·Chintan ChhatbarSunit Kumar Singh
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Jun 25, 2015·Microbiology Spectrum·John S Tregoning, Ekaterina Kinnear

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Methods Mentioned

BETA
contraception
flow cytometry
FCS
ELISA

Clinical Trials Mentioned

NCT00249106

Software Mentioned

Treestar
PESTLE
FlowJo
SPICE

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