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The immunogenicity of an HIV-1 Gag conserved element DNA vaccine in people with HIV and receiving antiretroviral therapy.

Publication ,  Journal Article
Jacobson, JM; Felber, BK; Chen, H; Pavlakis, GN; Mullins, JI; De Rosa, SC; Kuritzkes, DR; Tomaras, GD; Kinslow, J; Bao, Y; Olefsky, M; Bear, J ...
Published in: AIDS
June 1, 2024

OBJECTIVE: The primary objective of the study was to assess the immunogenicity of an HIV-1 Gag conserved element DNA vaccine (p24CE DNA) in people with HIV (PWH) receiving suppressive antiretroviral therapy (ART). DESIGN: AIDS Clinical Trials Group A5369 was a phase I/IIa, randomized, double-blind, placebo-controlled study of PWH receiving ART with plasma HIV-1 RNA less than 50 copies/ml, current CD4 + T-cell counts greater than 500 cells/μl, and nadir CD4 + T-cell counts greater than 350 cells/μl. METHODS: The study enrolled 45 participants randomized 2 : 1 : 1 to receive p24CE DNA vaccine at weeks 0 and 4, followed by p24CE DNA admixed with full-length p55 Gag DNA vaccine at weeks 12 and 24 (arm A); full-length p55 Gag DNA vaccine at weeks 0, 4, 12, and 24 (arm B); or placebo at weeks 0, 4, 12, and 24 (arm C). The active and placebo vaccines were administered by intramuscular electroporation. RESULTS: There was a modest, but significantly greater increase in the number of conserved elements recognized by CD4 + and/or CD8 + T cells in arm A compared with arm C ( P  = 0.014). The percentage of participants with an increased number of conserved elements recognized by T cells was also highest in arm A (8/18, 44.4%) vs. arm C (0/10, 0.0%) ( P  = 0.025). There were no significant differences between treatment groups in the change in magnitude of responses to total conserved elements. CONCLUSION: A DNA-delivered HIV-1 Gag conserved element vaccine boosted by a combination of this vaccine with a full-length p55 Gag DNA vaccine induced a new conserved element-directed cellular immune response in approximately half the treated PWH on ART.

Duke Scholars

Published In

AIDS

DOI

EISSN

1473-5571

Publication Date

June 1, 2024

Volume

38

Issue

7

Start / End Page

963 / 973

Location

England

Related Subject Headings

  • gag Gene Products, Human Immunodeficiency Virus
  • Virology
  • Viral Load
  • Vaccines, DNA
  • Treatment Outcome
  • Placebos
  • Middle Aged
  • Male
  • Injections, Intramuscular
  • Humans
 

Citation

APA
Chicago
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MLA
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Jacobson, J. M., Felber, B. K., Chen, H., Pavlakis, G. N., Mullins, J. I., De Rosa, S. C., … ACTG 5369 Study Team, . (2024). The immunogenicity of an HIV-1 Gag conserved element DNA vaccine in people with HIV and receiving antiretroviral therapy. AIDS, 38(7), 963–973. https://doi.org/10.1097/QAD.0000000000003804
Jacobson, Jeffrey M., Barbara K. Felber, Huichao Chen, George N. Pavlakis, James I. Mullins, Stephen C. De Rosa, Daniel R. Kuritzkes, et al. “The immunogenicity of an HIV-1 Gag conserved element DNA vaccine in people with HIV and receiving antiretroviral therapy.AIDS 38, no. 7 (June 1, 2024): 963–73. https://doi.org/10.1097/QAD.0000000000003804.
Jacobson JM, Felber BK, Chen H, Pavlakis GN, Mullins JI, De Rosa SC, et al. The immunogenicity of an HIV-1 Gag conserved element DNA vaccine in people with HIV and receiving antiretroviral therapy. AIDS. 2024 Jun 1;38(7):963–73.
Jacobson, Jeffrey M., et al. “The immunogenicity of an HIV-1 Gag conserved element DNA vaccine in people with HIV and receiving antiretroviral therapy.AIDS, vol. 38, no. 7, June 2024, pp. 963–73. Pubmed, doi:10.1097/QAD.0000000000003804.
Jacobson JM, Felber BK, Chen H, Pavlakis GN, Mullins JI, De Rosa SC, Kuritzkes DR, Tomaras GD, Kinslow J, Bao Y, Olefsky M, Rosati M, Bear J, Heptinstall JR, Zhang L, Sawant S, Hannaman D, Laird GM, Cyktor JC, Heath SL, Collier AC, Koletar SL, Taiwo BO, Tebas P, Wohl DA, Belaunzaran-Zamudio PF, McElrath MJ, Landay AL, ACTG 5369 Study Team. The immunogenicity of an HIV-1 Gag conserved element DNA vaccine in people with HIV and receiving antiretroviral therapy. AIDS. 2024 Jun 1;38(7):963–973.

Published In

AIDS

DOI

EISSN

1473-5571

Publication Date

June 1, 2024

Volume

38

Issue

7

Start / End Page

963 / 973

Location

England

Related Subject Headings

  • gag Gene Products, Human Immunodeficiency Virus
  • Virology
  • Viral Load
  • Vaccines, DNA
  • Treatment Outcome
  • Placebos
  • Middle Aged
  • Male
  • Injections, Intramuscular
  • Humans