Cell-Mediated Immune Predictors of Vaccine Effect on Viral Load and CD4 Count in a Phase 2 Therapeutic HIV-1 Vaccine Clinical Trial.
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- doi: 10.1016/j.ebiom.2017.09.028
- issn: 2352-3964
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Y. Huang et al., « Cell-Mediated Immune Predictors of Vaccine Effect on Viral Load and CD4 Count in a Phase 2 Therapeutic HIV-1 Vaccine Clinical Trial. », Serveur académique Lausannois, ID : 10.1016/j.ebiom.2017.09.028
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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. 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 log 10 -transformed VL (VE VL ) or CD4 count (VE CD4 ). A lower fold-change of CD4+ T-cell proliferation was associated with VE CD4 at week 48 (p=0.036, multiplicity adjusted q=0.036) and week 52 (p=0.040, q=0.080). A higher fold-change of IFN-γ in proliferation supernatants was associated with VE VL at week 44 (p=0.047, q=0.07). A higher fold-change of TNF-α was associated with VE VL at week 44 (p=0.045, q=0.070), week 48 (p=0.028, q=0.070), and week 52 (p=0.037, q=0.074). A higher fold-change of IL-6 was associated with VE VL at week 48 (p=0.017, q=0.036). TNF-α levels (>median) were associated with VE CD4 at week 48 (p=0.009, q=0.009). These exploratory analyses highlight the potential value of investigating biomarkers in T-cell proliferation supernatants for VE in clinical studies.