Browsing by Author "Dintwe, One"

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    Phase 1 Human Immunodeficiency Virus (HIV) Vaccine Trial to Evaluate the Safety and Immunogenicity of HIV Subtype C DNA and MF59-Adjuvanted Subtype C Envelope Protein.
    (2021-Jan-23) Hosseinipour, Mina C.; Innes, Craig; Naidoo, Sarita; Mann, Philipp; Hutter, Julia; Ramjee, Gita; Sebe, Modulakgotla; Maganga, Lucas; Herce, Michael E.; deCamp, Allan C.; Marshall, Kyle; Dintwe, One; Andersen-Nissen, Erica; Tomaras, Georgia D.; Mkhize, Nonhlanhla; Morris, Lynn; Jensen, Ryan; Miner, Maurine D.; Pantaleo, Giuseppe; Ding, Song; Van Der Meeren, Olivier; Barnett, Susan W.; McElrath, Juliana M. ; Corey, Lawrence; Kublin, James G.
    BACKGROUND: The Pox-Protein Public-Private Partnership is performing a suite of trials to evaluate the bivalent subtype C envelope protein (TV1.C and 1086.C glycoprotein 120) vaccine in the context of different adjuvants and priming agents for human immunodeficiency virus (HIV) type 1 (HIV-1) prevention. METHODS: In the HIV Vaccine Trials Network 111 trial, we compared the safety and immunogenicity of DNA prime followed by DNA/protein boost with DNA/protein coadministration injected intramuscularly via either needle/syringe or a needle-free injection device (Biojector). One hundred thirty-two healthy, HIV-1-uninfected adults were enrolled from Zambia, South Africa, and Tanzania and were randomized to 1 of 6 arms: DNA prime, protein boost by needle/syringe; DNA and protein coadministration by needle/syringe; placebo by needle/syringe; DNA prime, protein boost with DNA given by Biojector; DNA and protein coadministration with DNA given by Biojector; and placebo by Biojector. RESULTS: All vaccinations were safe and well tolerated. DNA and protein coadministration was associated with increased HIV-1 V1/V2 antibody response rate, a known correlate of decreased HIV-1 infection risk. DNA administration by Biojector elicited significantly higher CD4+ T-cell response rates to HIV envelope protein than administration by needle/syringe in the prime/boost regimen (85.7% vs 55.6%; P = .02), but not in the coadministration regimen (43.3% vs 48.3%; P = .61). CONCLUSIONS: Both the prime/boost and coadministration regimens are safe and may be promising for advancement into efficacy trials depending on whether cellular or humoral responses are desired. CLINICAL TRIALS REGISTRATION: South African National Clinical Trials Registry (application 3947; Department of Health [DoH] no. DOH-27-0715-4917) and ClinicalTrials.gov (NCT02997969).
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    Protein Dose-Sparing Effect of AS01B Adjuvant in a Randomized Preventive HIV Vaccine Trial of ALVAC-HIV (vCP2438) and Adjuvanted Bivalent Subtype C gp120.
    (2024-Aug-16) Chirenje, Zvavahera M.; Laher, Fatima; Dintwe, One; Muyoyeta, Monde; deCamp, Allan C.; He, Zonglin; Grunenberg, Nicole; Laher, Faatima, O.; Seaton, Kelly E.; Polakowski, Laura; Davis, Amanda S. W.; Maganga, Lucas; Baden, Lindsey R.; Mayer, Kenneth; Kalams, Spyros ; Keefer, Michael; Edupuganti, Srilatha; Rodriguez, Benigno; Frank, Ian; Scott, Hyman; Stranix-Chibanda, Lynda; Gurunathan, Sanjay; Koutsoukos, Marguerite; Van Der Meeren, Olivier; DiazGranados, Carlos A.; Paez, Carmen; Andersen-Nissen, Erica; Kublin, James; Corey, Lawrence ; Ferrari, Guido; Tomaras, Georgia; McElrath, Juliana M.
    BACKGROUND: HVTN 120 is a phase 1/2a randomized double-blind placebo-controlled human immunodeficiency virus (HIV) vaccine trial that evaluated the safety and immunogenicity of ALVAC-HIV (vCP2438) and MF59- or AS01B-adjuvanted bivalent subtype C gp120 Env protein at 2 dose levels in healthy HIV-uninfected adults. METHODS: Participants received ALVAC-HIV (vCP2438) alone or placebo at months 0 and 1. At months 3 and 6, participants received either placebo, ALVAC-HIV (vCP2438) with 200 μg of bivalent subtype C gp120 adjuvanted with MF59 or AS01B, or ALVAC-HIV (vCP2438) with 40 μg of bivalent subtype C gp120 adjuvanted with AS01B. Primary outcomes were safety and immune responses. RESULTS: We enrolled 160 participants, 55% women, 18-40 years old (median age 24 years) of whom 150 received vaccine and 10 placebo. Vaccines were generally safe and well tolerated. At months 6.5 and 12, CD4+ T-cell response rates and magnitudes were higher in the AS01B-adjuvanted groups than in the MF59-adjuvanted group. At month 12, HIV-specific Env-gp120 binding antibody response magnitudes in the 40 μg gp120/AS01B group were higher than in either of the 200 μg gp120 groups. CONCLUSIONS: The 40 μg dose gp120/AS01B regimen elicited the highest CD4+ T-cell and binding antibody responses. Clinical Trials Registration . NCT03122223.