Trial reportAnnals of internal medicine2025
High Frequency of Chronic Urticaria Following an Investigational HIV-1 BG505 MD39.3 Trimer mRNA Vaccine in a Phase 1, Randomized, Open-Label Clinical Trial (HVTN 302).
Trial report in Annals of internal medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05217641 (A Phase 1, Randomized, Open-label Clinical Trial to Evaluate the Safety and Immunogenicity of BG505 MD39.3, BG505 MD39.3 gp151, and BG505 MD39.3 gp151 CD4KO HIV Trimer mRNA Vaccines in Healthy, HIV-uninfected Adult Participants), which is not on this map. Cited by 10 papers.
What it found
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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 1, Randomized, Open-label Clinical Trial to Evaluate the Safety and Immunogenicity of BG505 MD39.3, BG505 MD39.3 gp151, and BG505 MD39.3 gp151 CD4KO HIV Trimer mRNA Vaccines in Healthy, HIV-uninfected Adult Participants
Who cites it
10 citing papers in PubMed.
- Vaccination with mRNA-encoded membrane-anchored HIV envelope trimers elicited tier 2 neutralizing antibodies in a phase 1 clinical trial.Science translational medicine · 2025Trial
- Charting the Path Forward for HIV Immune-Based Prevention: Contributions of the Division of AIDS at NIAID.Vaccines · 2026Article
- RNA Therapeutics in Viral Infections and Cancer: Mechanisms, Challenges, and Prospects: A Review.Pharmaceutics · 2026Review
- COVID-19 mRNA vaccines: a prospective outlook from technological innovation to clinical practice.Frontiers in immunology · 2026Review
- Designing around immune memory to counter PEG immunogenicity.Nature materials · 2025Article
- Review
- Delivery Systems of mRNA Vaccines in the Treatment of Infectious Diseases: From Lipid Nanoparticles to Next-Generation Platforms.Advanced pharmaceutical bulletin · 2025Review
- Accelerated cGMP production of near-native HIV-1 Env trimers following electroporation transfection and immunogenicity analysis.NPJ vaccines · 2025Article
- Evolving rare B cell lineages for an effective HIV vaccine.Science (New York, N.Y.) · 2025Article
- Vaccination with an mRNA-encoded membrane-bound HIV envelope trimer induces neutralizing antibodies in animal models.Science translational medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
24 authors.
Funding
Abstract
backgroundThe mRNA platform is under investigation for many vaccines, including HIV-1 vaccines.
objectiveTo evaluate the safety and tolerability of 3 investigational HIV-1 trimer mRNA vaccines.
designSafety analysis of mRNA vaccination in a phase 1, randomized, open-label trial. (ClinicalTrials.gov: NCT05217641).
settingTen research sites in the United States.
participants108 volunteers aged 18 to 55 years without HIV-1.
interventionInvestigational HIV-1 BG505 MD39.3 trimer mRNA vaccines (gp140 soluble trimer, gp151 membrane-bound trimer, and gp151 CD4KO membrane-bound trimer) at doses of 100 and 250 mcg at 0, 2, and 6 months. MEASUREMENTS: Solicited and unsolicited adverse reactions and events reported during the 12 months after the first vaccination.
resultsParticipants ( LIMITATIONS: Lack of a placebo group, open-label study, and post hoc evaluation of urticarial risk.
conclusionUrticarial reactions associated with experimental HIV-1 mRNA vaccines were observed in this trial. Studies to investigate the mechanism and approaches to mitigate these reactions are underway to further advance HIV-1 vaccine research. PRIMARY FUNDING SOURCE: National Institutes of Health, National Institute of Allergy and Infectious Diseases.
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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.