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.
Détails
Télécharger: 31900486_BIB_51B64C338E47.pdf (5727.72 [Ko])
Etat: Public
Version: Final published version
Licence: CC BY 4.0
Etat: Public
Version: Final published version
Licence: CC BY 4.0
ID Serval
serval:BIB_51B64C338E47
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
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.
Périodique
Clinical infectious diseases
Collaborateur⸱rice⸱s
HVTN 111 Protocol Team
Contributeur⸱rice⸱s
Frahm N., Metch B., Koutsoukos M., Reid S., Sichalwe B., Asombang M., Namakobo C., Mundia S., Banda L., Mapanza J., Shilimi J., Kapesa E., Kisinda A., Lueer C., Njovu L., William W., Mlagalila F., Ntapara E., Olomi W., Chiwerengo N., Kunambi R., Myombe B., Mwilinga R., Mbinda N., Masala J., Mapunda J., Ho O., Reilly D., Briesemeister L., Hansen M., Zeller J., Takuva S., Brackett C., Heptinstall J., Seaton K., Beaumont D., Zhang L., Sawant S., Sarzotti-Kelsoe M., Hermanus T., Bekker V., De Rosa S., Omarjee S., Wilcox S., Rohith S., Basethi A., Noble R., Morris D.
ISSN
1537-6591 (Electronic)
ISSN-L
1058-4838
Statut éditorial
Publié
Date de publication
23/01/2021
Peer-reviewed
Oui
Volume
72
Numéro
1
Pages
50-60
Langue
anglais
Notes
Publication types: Clinical Trial, Phase I ; Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Publication Status: ppublish
Résumé
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.
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.
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).
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.
South African National Clinical Trials Registry (application 3947; Department of Health [DoH] no. DOH-27-0715-4917) and ClinicalTrials.gov (NCT02997969).
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.
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).
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.
South African National Clinical Trials Registry (application 3947; Department of Health [DoH] no. DOH-27-0715-4917) and ClinicalTrials.gov (NCT02997969).
Mots-clé
AIDS Vaccines/therapeutic use, Adult, DNA, HIV Antibodies, HIV Infections/prevention & control, HIV-1/genetics, Humans, Immunization, Secondary, Immunogenicity, Vaccine, Polysorbates, South Africa, Squalene, Tanzania, Zambia, Biojector, DNA prime/protein boost, HIV vaccine, subtype C
Pubmed
Web of science
Open Access
Oui
Création de la notice
10/01/2020 11:03
Dernière modification de la notice
08/08/2024 6:33