{"doi":"10.1093/cid/ciz1239","title":"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","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).","journal":"Clinical Infectious Diseases","year":2020,"id":95687,"datarank":1.2291080157288286,"base_score":3.58351893845611,"endowment":3.58351893845611,"self_citation_contribution":0.5375278407684165,"citation_network_contribution":0.6915801749604121,"self_endowment_contribution":0.5375278407684165,"citer_contribution":0.6915801749604121,"corpus_percentile":null,"corpus_rank":null,"citation_count":35,"citer_count":23,"citers_with_citation_signal":21,"citers_with_endowment":21,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.5532,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT02997969"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":355221,"name":"Craig Innes","orcid":"0000-0002-6872-5687","position":1,"is_corresponding":false},{"id":420011,"name":"Sarita Naidoo","orcid":"0000-0001-5067-1601","position":2,"is_corresponding":false},{"id":288613,"name":"Philipp Mann","orcid":"0000-0001-8130-2032","position":3,"is_corresponding":false},{"id":302716,"name":"Julia Hütter","orcid":"0000-0002-7989-0450","position":4,"is_corresponding":false},{"id":454235,"name":"Gita Ramjee","orcid":null,"position":5,"is_corresponding":false},{"id":475182,"name":"Modulakgotla Sebe","orcid":"0000-0003-4330-5499","position":6,"is_corresponding":false},{"id":347964,"name":"Lucas Maganga","orcid":"0000-0001-7519-0628","position":7,"is_corresponding":false},{"id":420010,"name":"Michael E. 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