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Safety and Immunogenicity of a DNA Vaccine With Subtype C gp120 Protein Adjuvanted With MF59 or AS01B: A Phase 1/2a HIV-1 Vaccine Trial.
- Source :
-
Journal of acquired immune deficiency syndromes (1999) [J Acquir Immune Defic Syndr] 2024 Aug 01; Vol. 96 (4), pp. 350-360. Date of Electronic Publication: 2024 Jun 21. - Publication Year :
- 2024
-
Abstract
- Background: An effective vaccine is required to end the HIV pandemic. We evaluated the safety and immunogenicity of a DNA (DNA-HIV-PT123) vaccine with low- or high-dose bivalent (TV1.C and 1086.C glycoprotein 120) subtype C envelope protein combinations, adjuvanted with MF59 or AS01B.<br />Methods: HIV Vaccine Trials Network (HVTN)108 was a randomized, placebo-controlled, double-blind, phase 1/2a trial conducted in the United States and South Africa. HIV-negative adults were randomly assigned to 1 of 7 intervention arms or placebo to assess DNA prime with DNA/protein/adjuvant boosts, DNA/protein/adjuvant co-administration, and low-dose protein/adjuvant regimens. HVTN111 trial participants who received an identical regimen were also included. Outcomes included safety and immunogenicity 2 weeks and 6 months after final vaccination.<br />Results: From June 2016 to July 2018, 400 participants were enrolled (N = 334 HVTN108, N = 66 HVTN111); 370 received vaccine and 30 received placebo. There were 48 grade 3 and 3 grade 4 reactogenicity events among 39/400 (9.8%) participants, and 32 mild/moderate-related adverse events in 23/400 (5.8%) participants. All intervention groups demonstrated high IgG response rates (>89%) and high magnitudes to HIV-1 Env gp120 and gp140 proteins; response rates for AS01B-adjuvanted groups approached 100%. V1V2 IgG magnitude, Fc-mediated functions, IgG3 Env response rates, and CD4+ T-cell response magnitudes and rates were higher in the AS01B-adjuvanted groups. The AS01B-adjuvanted low-dose protein elicited greater IgG responses than the higher protein dose.<br />Conclusions: The vaccine regimens were generally well tolerated. Co-administration of DNA with AS01B-adjuvanted bivalent Env gp120 elicited the strongest humoral responses; AS01B-adjuvanted regimens elicited stronger CD4+ T-cell responses, justifying further evaluation.ClinicalTrials.gov registration: NCT02915016, registered 26 September 2016.<br /> (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)
- Subjects :
- Humans
Female
Male
Adult
Double-Blind Method
Middle Aged
Young Adult
Adjuvants, Vaccine administration & dosage
South Africa
Immunogenicity, Vaccine
Adolescent
United States
AIDS Vaccines immunology
AIDS Vaccines administration & dosage
AIDS Vaccines adverse effects
Vaccines, DNA immunology
Vaccines, DNA administration & dosage
Vaccines, DNA adverse effects
Squalene administration & dosage
Polysorbates administration & dosage
HIV Envelope Protein gp120 immunology
Adjuvants, Immunologic administration & dosage
HIV-1 immunology
HIV Infections immunology
HIV Infections prevention & control
HIV Antibodies blood
Subjects
Details
- Language :
- English
- ISSN :
- 1944-7884
- Volume :
- 96
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Journal of acquired immune deficiency syndromes (1999)
- Publication Type :
- Academic Journal
- Accession number :
- 38916429
- Full Text :
- https://doi.org/10.1097/QAI.0000000000003438