Browsing by Author "Hutter J"

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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 MC; Innes C; Naidoo S; Mann P; Hutter J; Ramjee G; Sebe M; Maganga L; Herce ME; deCamp AC; Marshall K; Dintwe O; Andersen-Nissen E; Tomaras GD; Mkhize N; Morris L; Jensen R; Miner MD; Pantaleo G; Ding S; Van Der Meeren O; Barnett SW; McElrath MJ; Corey L; Kublin JG; National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.; NIMR-Mbeya Medical Research Center, Mbeya, Tanzania.; Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.; Aurum Institute, Klerksdorp, South Africa.; GSK Vaccines, Rixensart, Belgium.; Cape Town HVTN Immunology Laboratory, Cape Town, South Africa.; EuroVacc Foundation, Lausanne, Switzerland.; UNC Project-Malawi, Lilongwe, Malawi.; University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.; Aurum Institute, Tembisa, South Africa.; HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.; GSK Vaccines, Cambridge, Massachusetts, USA.; Division of Immunology and Allergy, Centre Hospitalier Universitaire Vaudois, University of Lausanne, Lausanne, Switzerland.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, USA.; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    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).