Gene expression signatures after immunisation with an HIV-1 recombinant Vesicular Stomatitis Virus (VSV) vaccine following three priming doses of IL-12 pDNA enhanced HIV-1 multi-antigen pDNA vaccine (BIOVACSAFE protocol HVTN087)
The time course of whole blood gene expression was measured after the fourth immunisation at month 6 in participants who had been randomised into vaccine or placebo group 1 of the clinical protocol HVTN087 - A phase 1 trial to evaluate the safety, tolerability, and immunogenicity of an IL-12 pDNA enhanced HIV-1 multi-antigen pDNA vaccine delivered intramuscularly with electroporation, with an HIV-1 rVSV vaccine boost, in healthy HIV-uninfected adult participants (NCT01578889).
Overall design
A pre-immunisation baseline sample was drawn prior to the fourth immunisation at month 6 (designated day 0) and further samples collected on days 1, 3, 7 and 14 after the immunisation. All samples were collected into PaxGene tubes. On day 0 participants received either: an intramuscular rVSVHIVGAG vaccine; intramuscular saline placebo; or in two cases no injection (treatment = VSVHIVGAG / PLACEBO / NONE respectively). Participants had previously received either three intramuscular placebo injections, or three intramuscular priming doses of IL-12 pDNA enhanced HIV-1 multi-antigen pDNA vaccine by electroporation at months 0, 1 and 3. Participants in group = 1 received all three DNA primes plus the booster VSVHIVGAG vaccine (vaccinations received = DDDV); whereas those in groups 1A, 1B, 1D and 1E had experienced some protocol deviations in that they missed one or more DNA primes or the VSV vaccination, indicated by - in vaccinations received characteristic (vaccinations received = DDD- / DD-V / D-DV / D--- respectively).
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