University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
UNC Project-Malawi, Lilongwe, Malawi.
Clin Infect Dis. 2021 Jan 23;72(1):50-60. doi: 10.1093/cid/ciz1239.
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).
痘病毒蛋白公私合作伙伴关系正在进行一系列试验，以评估双价 C 型包膜蛋白（TV1.C 和 1086.C 糖蛋白 120）疫苗在不同佐剂和 HIV 型 1（HIV-1）预防的启动子的情况下的效果。
在 HIV 疫苗试验网络 111 试验中，我们比较了 DNA 初免后 DNA/蛋白加强与 DNA/蛋白联合肌肉内注射（通过针/注射器或无针注射装置（Biojector））的安全性和免疫原性。来自赞比亚、南非和坦桑尼亚的 132 名健康、未感染 HIV-1 的成年人被纳入研究，并随机分为 6 组之一：DNA 初免、针/注射器蛋白加强；针/注射器 DNA 和蛋白联合使用；针/注射器安慰剂；Biojector 给予 DNA 初免、蛋白加强；Biojector 给予 DNA 和蛋白联合使用；Biojector 给予安慰剂。
所有疫苗接种均安全且耐受性良好。DNA 和蛋白联合使用与 HIV-1 V1/V2 抗体反应率增加相关，这是 HIV-1 感染风险降低的已知相关因素。在初免/加强方案中，Biojector 给予 DNA 比针/注射器给予 DNA 更能引起更高的 HIV 包膜蛋白 CD4+T 细胞反应率（85.7%比 55.6%；P=0.02），但在联合使用方案中则不然（43.3%比 48.3%；P=0.61）。
初免/加强和联合使用方案均安全，根据是否需要细胞或体液反应，可能有希望推进到疗效试验。
南非国家临床试验注册处（申请 3947；卫生部[DoH]号 DOH-27-0715-4917）和 ClinicalTrials.gov（NCT02997969）。
