Objectives: The safety, immunogenicity, impact on the latent reservoir and rebound of viral load after therapeutic
HIV-1 vaccination with recombinant modified vaccinia Ankara-based (MVA-B) HIV-1 vaccine expressing monomeric
gp120 and the fused Gag-Pol-Nef polyprotein of clade B with or without a drug to reactivate latent ...»»»»
Objectives: The safety, immunogenicity, impact on the latent reservoir and rebound of viral load after therapeutic
HIV-1 vaccination with recombinant modified vaccinia Ankara-based (MVA-B) HIV-1 vaccine expressing monomeric
gp120 and the fused Gag-Pol-Nef polyprotein of clade B with or without a drug to reactivate latent HIV-1
(disulfiram) were assessed.
Methods: HIV-1-infected patients were randomized to receive three injections of MVA-B (n¼20) or placebo
(n¼10). Twelve patients (eight who received vaccine and four who were given placebo) received a fourth dose
of MVA-B followed by 3 months of disulfiram. Combined ART (cART) was discontinued 8 weeks after the last dose
of MVA-B. Clinical Trials.gov identifier: NCT01571466.
Results: MVA-B was safe and well tolerated. A minor, but significant, increase in the T cell responses targeting vaccine
inserts of Gag was observed [a median of 290, 403 and 435 spot-forming-cells/106 PBMCs at baseline, after
two vaccinations and after three vaccinations, respectively; P¼0.02 and P¼0.04]. After interruption of cART, a
modest delay in the rebound of the plasma viral load in participants receiving vaccine but not disulfiram was
observed compared with placebo recipients (P¼0.01). The dynamics of the viral load rebound did not change in
patients receiving MVA-B/disulfiram. No changes in the proviral reservoir were observed after disulfiram treatment.
Conclusions: MVA-B vaccination was a safe strategy to increase Gag-specific T cell responses in chronically HIV-1-
infected individuals, but it did not have a major impact on the latent reservoir or the rebound of plasma viral load
after interruption of cART when given alone or in combination with disulfiram.^^^^