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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.

Publication ,  Journal Article
Stieh, DJ; Barouch, DH; Comeaux, C; Sarnecki, M; Stephenson, KE; Walsh, SR; Sawant, S; Heptinstall, J; Tomaras, GD; Kublin, JG; McElrath, MJ ...
Published in: J Infect Dis
April 18, 2023

BACKGROUND: Developing a cross-clade, globally effective HIV vaccine remains crucial for eliminating HIV. METHODS: This placebo-controlled, double-blind, phase 1/2a study 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 end points were safety and antibody responses. RESULTS: In total 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) after 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. Clinical Trials Registration. NCT02935686.

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Published In

J Infect Dis

DOI

EISSN

1537-6613

Publication Date

April 18, 2023

Volume

227

Issue

8

Start / End Page

939 / 950

Location

United States

Related Subject Headings

  • Microbiology
  • Immunogenicity, Vaccine
  • Humans
  • HIV-1
  • HIV Infections
  • HIV Antibodies
  • Genetic Vectors
  • Adult
  • AIDS Vaccines
  • 42 Health sciences
 

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ICMJE
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Stieh, D. J., Barouch, D. H., Comeaux, C., Sarnecki, M., Stephenson, K. E., Walsh, S. R., … ASCENT/HVTN118/HPX2003 Study Team. (2023). 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. J Infect Dis, 227(8), 939–950. https://doi.org/10.1093/infdis/jiac445
Stieh, Daniel J., Dan H. Barouch, Christy Comeaux, Michal Sarnecki, Kathryn E. Stephenson, Stephen R. Walsh, Sheetal Sawant, et al. “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.J Infect Dis 227, no. 8 (April 18, 2023): 939–50. https://doi.org/10.1093/infdis/jiac445.
Stieh DJ, Barouch DH, Comeaux C, Sarnecki M, Stephenson KE, Walsh SR, et al. 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. J Infect Dis. 2023 Apr 18;227(8):939–50.
Stieh, Daniel J., et al. “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.J Infect Dis, vol. 227, no. 8, Apr. 2023, pp. 939–50. Pubmed, doi:10.1093/infdis/jiac445.
Stieh DJ, Barouch DH, Comeaux C, Sarnecki M, Stephenson KE, Walsh SR, Sawant S, Heptinstall J, Tomaras GD, Kublin JG, McElrath MJ, Cohen KW, De Rosa SC, Alter G, Ferrari G, Montefiori D, Mann P, Nijs S, Callewaert K, Goepfert PA, Edupuganti S, Karita E, Seaman MS, Corey L, Baden LR, Pau MG, Schuitemaker H, Tomaka F, ASCENT/HVTN118/HPX2003 Study Team. 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. J Infect Dis. 2023 Apr 18;227(8):939–950.
Journal cover image

Published In

J Infect Dis

DOI

EISSN

1537-6613

Publication Date

April 18, 2023

Volume

227

Issue

8

Start / End Page

939 / 950

Location

United States

Related Subject Headings

  • Microbiology
  • Immunogenicity, Vaccine
  • Humans
  • HIV-1
  • HIV Infections
  • HIV Antibodies
  • Genetic Vectors
  • Adult
  • AIDS Vaccines
  • 42 Health sciences