Trial reportNature communications2025
Safety, immunogenicity and effect on viral rebound of HTI vaccines combined with a TLR7 agonist in early-treated HIV-1 infection: a randomized, placebo-controlled phase 2a trial.
Trial report in Nature communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04364035 (A Phase IIa Randomised, Double-blind, Placebo-controlled Study of HIV-1 Vaccines MVA.HTI and ChAdOx1.HTI With TLR7 Agonist Vesatolimod), which is not on this map. Cited by 22 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase IIa Randomised, Double-blind, Placebo-controlled Study of HIV-1 Vaccines MVA.HTI and ChAdOx1.HTI With TLR7 Agonist Vesatolimod (GS-9620) in Early Treated HIV-1 Infection
Who cites it
22 citing papers in PubMed.
- Therapeutic HIV-1 Tat vaccination promotes durable immune reconstitution and reservoir reduction in ART-treated adults with clade C infection: a 12-year follow-up study.Frontiers in immunology · 2026Trial
- Scientific synergy between prophylactic and therapeutic HIV vaccines-prevention and cure.NPJ vaccines · 2026Article
- Opportunities and challenges in achieving a functional cure for HIV.Infectious diseases & immunity · 2026Review
- What's Hot in HIV in 2025-A Basic and Translational Science Review From IDWeek 2025.The Journal of infectious diseases · 2026Review
- Therapeutic Vaccines for Chronic Viral Infections: From Immune Modulation to Clinical Translation.Vaccines · 2026Review
- Review
- Boosting SIV-specific CD8+ T cell responses prior to ART interruption extends time to SIVmac239 rebound.The Journal of clinical investigation · 2026Article
- Sex-Specific Factors Influencing HIV Infection.Immunological reviews · 2026Review
- Q4ddPCR: a flexible, 4-target assay for high-resolution HIV reservoir profiling.Nature communications · 2026Article
- Challenges in the Vaccination of HIV-Infected Individuals.Vaccines · 2025Review
- Predictors of virological outcomes after analytical interruption of antiretroviral therapy and HTI vaccination in early treated people with HIV-1._.Communications medicine · 2025Article
- Developing the next-generation of adenoviral vector vaccines.Human vaccines & immunotherapeutics · 2025Review
- HIV Virion Capturing Liposomes for Therapeutic Vaccination.bioRxiv : the preprint server for biology · 2025Article
- The role of analytical treatment interruptions in shaping HIV-specific immunity and HIV cure.Current opinion in HIV and AIDS · 2025Review
- Resist to persist: resistance of the HIV reservoir to immune-mediated clearance.Current opinion in HIV and AIDS · 2025Review
- The Effects of Cobicistat and Voriconazole on the Safety, Pharmacokinetics, and Pharmacodynamics of the TLR7 Agonist Vesatolimod in People with HIV.Infectious diseases and therapy · 2025Article
- Prospects for therapeutic T-cell vaccine strategies for HIV cure.Current opinion in HIV and AIDS · 2025Review
- Strategies to Minimize Time From HIV Acquisition to ART Initiation: The Barcelona Early-cART Program.Open forum infectious diseases · 2025Article
- Plasmacytoid and CD141+ Myeloid Dendritic Cells Cooperation with CD8+ T Cells in Lymph Nodes is Associated with HIV Control.MedComm · 2025Article
- HIV and the gut: implications for HIV persistence, immune dysfunction and cure strategies.Frontiers in immunology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
39 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Building on results from the AELIX-002 trial with HIVACAT T-cell immunogen (HTI)-based vaccines, the AELIX-003 (NCT04364035) trial tested the safety of the combination of ChAdOx1.HTI (C) and MVA.HTI (M), with the TLR7 agonist vesatolimod (VES), in a double-blind, placebo-controlled, randomized clinical trial in 50 virally suppressed early-treated men with HIV-1 infection. Secondary objectives included immunogenicity and effects on viral rebound kinetics during a 24-week antiretroviral treatment interruption (ATI). The most common treatment-related adverse events were mild-to-moderate injection-site pain, influenza-like illness, headache, and fatigue. Strong, broad, and HTI-focused T-cell responses were induced by vaccination. All participants experienced viral rebound in ATI; 33.3% and 23.5% (P = 0.4494) of CCMM + VES and placebo recipients, respectively, remained off antiretroviral therapy for 24 weeks. Post hoc analysis confirmed a correlation between levels of HTI-specific T cells and prolonged time off antiretroviral therapy. The combination of HTI vaccines and VES was safe and elicited robust T-cell responses.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.