Safety and Immunogenicity of a PD-1-Enhanced HIV-1 Therapeutic DNA Vaccine: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase I Clinical Trial in People With HIV-1 on Antiretroviral Therapy
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ID: 320918
2026
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Abstract
BACKGROUND: Therapeutic vaccines represent a potential strategy for HIV-1 control without antiretroviral therapy (ART). We report a first-in-human study on ICVAX™, a PD-1-enhanced HIV-1 therapeutic DNA vaccine. METHODS: This NMPA-approved, randomized, double-blind, placebo-controlled, dose-escalation phase I trial (NCT06253533) was conducted at Shenzhen Third People's Hospital, China. Adults with HIV-1 aged 18-50 years on ART were sequentially allocated to 1, 2, or 4 mg dose groups of 15, each randomized 12:3 to ICVAX or placebo. Participants received intramuscular injections with electroporation at Weeks 0, 4, 8, 12, and 36. Primary safety, secondary immunological, and exploratory virological outcomes were recorded. RESULTS: All 45 participants completed the trial, with 12 per ICVAX cohort and 9 in pooled Placebo. Treatment-related adverse events occurred in 100% of placebo and 83.3% of ICVAX recipients, all mild and transient, predominantly local reactions. A ≥2-fold increase of peak ELISpot T-cell responses over baseline was achieved by 75%, 75%, and 58.3% of low-dose, mid-dose, and high-dose recipients, versus 33.3% for Placebo. ICVAX recipients also showed low-frequency Gag-specific T cells expressing CD107a and/or effector cytokines. CONCLUSIONS: ICVAX was well-tolerated and elicited robust antigen-specific T-cell responses in ART-suppressed people with HIV-1. Its efficacy will be assessed in future studies.
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| Authors | Qiaoli Peng, Yik Chun Wong, Wing Yin Cheng, Yun He, Chengxi Xie, Yirong Shi, Ting Wang, Yanhua Du, Xiaoyun Yang, Zhongfang Wang, Hui Wang, Hongzhou Lu, Zhiwei Chen, Xia Jin |
| Journal | The Journal of infectious diseases |
| Year | 2026 |
| DOI |
10.1093/infdis/jiag320
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| URL | |
| Keywords | Keywords not found |
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