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)

作者：Sharon A. Riddler, Zoe Moodie, Jesse L. Clark, Catherine Yen, Mary Allen, Briana D. Furch, Huiyin Lu, Shannon Grant, Kajari Mondal, Maija Anderson, Janine R. Maenza, Maria P. Lemos, Amanda S. Woodward Davis, Stephen R. Walsh, Magdalena E. Sobieszczyk, Ian Frank, Paul Goepfert, Kathryn E. Stephenson, Lindsey Robert Baden, Hong‐Van Tieu, Michael C. Keefer, M. Juliana McElrath, James G. Kublin, Lawrence Corey · 发表于：Annals of Internal Medicine · 年份：2025 · DOI：10.7326/annals-24-02701 · 被引用次数：14 · 研究领域：Drug-Induced Adverse Reactions、HIV Research and Treatment、Pharmacovigilance and Adverse Drug Reactions

BACKGROUND: The mRNA platform is under investigation for many vaccines, including HIV-1 vaccines. OBJECTIVE: To evaluate the safety and tolerability of 3 investigational HIV-1 trimer mRNA vaccines. DESIGN: Safety analysis of mRNA vaccination in a phase 1, randomized, open-label trial. (ClinicalTrials.gov: NCT05217641). SETTING: Ten research sites in the United States. PARTICIPANTS: 108 volunteers aged 18 to 55 years without HIV-1. INTERVENTION: Investigational 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. RESULTS: = 108) were randomly assigned to 6 vaccine groups. Mild to moderate local and systemic solicited events were common. Eighty participants reported 190 unsolicited adverse events (AEs); 30 were considered to be related to a study product. Most (73%) related AEs were mild, and the rest were moderate. Among related AEs, urticaria was reported by 7 of 108 participants (7% [95% CI, 3% to 13%]), 4 of whom had unresolved, intermittent urticaria at 12 months. In post hoc analyses, demographic characteristics, history of allergy or medication use, and COVID-19 were not associated with urticaria. In a comparison of participants with versus without urticaria, 100% (7 of 7; CI, 65% to 100%) versus 37% (37 of 101; CI, 28...