Cell-Mediated Immune Predictors of Vaccine Effect on Viral Load and CD4 Count in a Phase 2 Therapeutic HIV-1 Vaccine Clinical Trial.

ABSTRACT:

Background

In a placebo-controlled trial of the peptide-based therapeutic HIV-1 p24^Gag vaccine candidate Vacc-4x, participants on combination antiretroviral therapy (cART) received six immunizations over 18weeks, followed by analytical treatment interruption (ATI) between weeks 28 and 52. Cell-mediated immune responses were investigated as predictors of Vacc-4x effect (VE) on viral load (VL) and CD4 count during ATI.

Methods

All analyses of week 28 responses and fold-changes relative to baseline considered per-protocol participants (Vacc-4x:placebo=72:32) resuming cART after week 40. Linear regression models with interaction tests were used. VE was estimated as the Vacc-4x-placebo difference in log₁₀-transformed VL (VE^VL) or CD4 count (VE

SUBMITTER: Huang Y 

PROVIDER: S-EPMC5652289 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature