Bibliographic Details
| Title: |
Safety and Immunogenicity of Ad26-vectored HIV Vaccine with Mosaic Immunogens and a Novel Mosaic Envelope Protein in HIV-uninfected Adults: A Phase 1/2a Study. |
| Authors: |
Stieh, Daniel J, Barouch, Dan H, Comeaux, Christy, Sarnecki, Michal, Stephenson, Kathryn E, Walsh, Stephen R, Sawant, Sheetal, Heptinstall, Jack, Tomaras, Georgia D, Kublin, James G, McElrath, M Juliana, Cohen, Kristen W, Rosa, Stephen C De, Alter, Galit, Ferrari, Guido, Montefiori, David, Mann, Philipp, Nijs, Steven, Callewaert, Katleen, Goepfert, Paul A |
| Source: |
Journal of Infectious Diseases; 4/15/2023, Vol. 227 Issue 8, p939-950, 12p |
| Subject Terms: |
AIDS vaccines, IMMUNE response, C++, CLINICAL trial registries, HIV infections |
| Abstract: |
Background: Developing a cross-clade, globally effective HIV vaccine remains crucial for eliminating HIV.Methods: This placebo-controlled, double-blind, phase 1/2a study (NCT02935686) enrolled healthy HIV-uninfected adults at low risk for HIV infection. They were randomized (1:4:1) to receive 4 doses of an adenovirus 26-based HIV-1 vaccine encoding 2 mosaic Gag and Pol, and 2 mosaic Env proteins plus adjuvanted clade C gp140 (referred to here as clade C regimen), bivalent protein regimen (clade C regimen plus mosaic gp140), or placebo. Primary endpoints were safety and antibody responses.Results: 152/155 participants (clade C [n = 26], bivalent protein [n = 103], placebo [n = 26]) received ≥1 injection. The highest adverse event (AE) severity was grade 3 (local pain/tenderness: 12%, 2%, and 0% of the respective groups; solicited systemic AEs: 19%, 15%, 0%). HIV-1 mosaic gp140-binding antibody titers were 79,595 ELISA units [EU]/mL and 137,520 EU/mL in the clade C and bivalent protein groups (P < .001) post-dose 4 and 16,862 EU/mL and 25,162 EU/mL 6 months later. Antibody response breadth against clade C gp140 and clade C/non-clade C gp120 was highest in the bivalent protein group.Conclusions: Adding mosaic gp140 to the clade C regimen increased and broadened the elicited immune response without compromising safety or clade C responses. [ABSTRACT FROM AUTHOR] |
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| Database: |
Complementary Index |
