Phase 1 HIV vaccine trial to evaluate the safety and immunogenicity of HIV subtype C DNA and MF59-adjuvanted subtype C Env protein.
- Hosseinipour MC University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.
- Innes C Aurum Institute, Klerksdorp, South Africa.
- Naidoo S HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.
- Mann P Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.
- Hutter J Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.
- Ramjee G HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.
- Sebe M Aurum Institute, Tembisa, South Africa.
- Maganga L NIMR-Mbeya Medical Research Center, Mbeya, Tanzania.
- Herce ME Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia.
- deCamp AC Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.
- Marshall K Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.
- Dintwe O Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.
- Andersen-Nissen E Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.
- Tomaras GD Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, United States of America.
- Mkhize N National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.
- Morris L National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.
- Jensen R Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.
- Miner MD Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.
- Pantaleo G Division of Immunology and Allergy, Centre Hospitalier Universitaire Vaudois, University of Lausanne, Lausanne, Switzerland.
- Ding S EuroVacc Foundation, Lausanne, Switzerland.
- Van Der Meeren O GSK Vaccines, Rixensart, Belgium.
- Barnett SW GSK Vaccines, Cambridge, Massachusetts, United States of America.
- McElrath MJ Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.
- Corey L Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.
- Kublin JG Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.
- 2020-01-05
Published in:
- Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. - 2020
English
BACKGROUND
The Pox-Protein Public-Private Partnership (P5) is performing a suite of trials to evaluate the bivalent subtype C envelope (Env) protein (TV1.C and 1086.C gp120) vaccine in the context of different adjuvants and priming agents for HIV-1 prevention.
METHODS
In the HIV Vaccine Trials Network (HVTN) 111 trial, we compared safety and immunogenicity of DNA prime followed by DNA/protein boost with DNA/protein co-administration 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 one of six arms: DNA prime, protein boost by needle/syringe; DNA and protein co-administration by needle/syringe; placebo by needle/syringe; DNA prime, protein boost with DNA given by Biojector; DNA and protein co-administration with DNA given by Biojector; and placebo by Biojector.
RESULTS
All vaccinations were safe and well tolerated. DNA and protein co-administration 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 Env than by needle/syringe in the prime/boost regimen (85.7% vs. 55.6%, p=0.02), but not in the co-administration regimen (43.3% vs. 48.3%, p=0.61).
CONCLUSIONS
Both the prime/boost and co-administration regimens are safe and may be promising for advancement into efficacy trials depending on whether cellular versus humoral responses are desired.Trial Registration: South African National Clinical Trials Registry (Application ID 3947; DoH number DOH-27-0715-4917) and ClinicalTrials.gov (NCT02997969).
The Pox-Protein Public-Private Partnership (P5) is performing a suite of trials to evaluate the bivalent subtype C envelope (Env) protein (TV1.C and 1086.C gp120) vaccine in the context of different adjuvants and priming agents for HIV-1 prevention.
METHODS
In the HIV Vaccine Trials Network (HVTN) 111 trial, we compared safety and immunogenicity of DNA prime followed by DNA/protein boost with DNA/protein co-administration 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 one of six arms: DNA prime, protein boost by needle/syringe; DNA and protein co-administration by needle/syringe; placebo by needle/syringe; DNA prime, protein boost with DNA given by Biojector; DNA and protein co-administration with DNA given by Biojector; and placebo by Biojector.
RESULTS
All vaccinations were safe and well tolerated. DNA and protein co-administration 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 Env than by needle/syringe in the prime/boost regimen (85.7% vs. 55.6%, p=0.02), but not in the co-administration regimen (43.3% vs. 48.3%, p=0.61).
CONCLUSIONS
Both the prime/boost and co-administration regimens are safe and may be promising for advancement into efficacy trials depending on whether cellular versus humoral responses are desired.Trial Registration: South African National Clinical Trials Registry (Application ID 3947; DoH number DOH-27-0715-4917) and ClinicalTrials.gov (NCT02997969).
- Language
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- English
- Open access status
- hybrid
- Identifiers
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- DOI 10.1093/cid/ciz1239
- PMID 31900486
- Persistent URL
- https://folia.unifr.ch/global/documents/145081
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