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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

2020; Oxford University Press; Volume: 72; Issue: 1 Linguagem: Inglês

10.1093/cid/ciz1239

1537-6591

Mina C. Hosseinipour, Craig Innes, Sarita Naidoo, Philipp Mann, Julia Hütter, Gita Ramjee, Modulakgotla Sebe, Lucas Maganga, Michael E. Herce, Allan C. deCamp, Kyle Marshall, One Dintwe, Erica Andersen‐Nissen, Georgia D. Tomaras, Nonhlanhla N. Mkhize, Lynn Morris, Ryan L. Jensen, Maurine D. Miner, Giuseppe Pantaleo, S.-W Ding, Olivier Van Der Meeren, Susan W. Barnett, M. Juliana McElrath, Lawrence Corey, James G. Kublin, Nicole Frahm, Barbara Metch, Marguerite Koutsoukos, Stewart Reid, Bupe Sichalwe, Mah Asombang, Christine Namakobo, Sam Mundia, Lumbwe Banda, Joyce Mapanza, Jacinta Shilimi, Emmanuel Kapesa, Abisai Kisinda, Cornelia Lueer, Lilian Njovu, Wiston William, Faith Mlagalila, Elizabeth Ntapara, Willhelmina Olomi, Nnhamo Chiwerengo, Revocatus Kunambi, Bahati Myombe, Rosemary Mwilinga, Neema Mbinda, Joyce Masala, Joseph Mapunda, On Ho, Denelle Reilly, Liz Briesemeister, Marianne Hansen, Jill Zeller, Simbarashe Takuva, Caroline Brackett, Jack Heptinstall, Kelly E. Seaton, David Beaumont, Lu Zhang, Sheetal Sawant, Marcella Sarzotti‐Kelsoe, Tandile Hermanus, Valerie Bekker, Stephen De Rosa, Saleha Omarjee, Stephany Wilcox, Shamiska Rohith, Asiphe Basethi, R Da Costa Noble, Daryl E. Morris,

HIV/AIDS drug development and treatment

Abstract 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).