7 percent of 108 healthy volunteers reported urticaria; unresolved urticaria persisted at 12 months in four participants
By Elana Gotkine HealthDay Reporter
MONDAY, May 5, 2025 (HealthDay News) — Urticaria is seen in association with experimental HIV-1 mRNA vaccination, according to a study published online April 29 in the Annals of Internal Medicine.
Sharon A. Riddler, M.D., from the University of Pittsburgh, and colleagues examined the safety and tolerability of three investigational HIV-1 trimer mRNA vaccines in a phase 1, randomized trial. A total of 108 volunteers aged 18 to 55 years without HIV-1 were randomly assigned to six vaccine groups (gp140 soluble trimer, gp151 membrane-bound trimer, and gp151 CD4KO membrane-bound trimer at doses of 100 and 250 mcg).
The researchers found that mild-to-moderate local and systemic solicited events occurred frequently. A total of 190 unsolicited adverse events were reported by 80 participants; 30 were considered to be related to a study product. Overall, 73 percent of the related adverse events were mild; the rest were moderate. Of the related adverse events, urticaria was reported by seven participants (7 percent); at 12 months, four of these participants had unresolved, intermittent urticaria. No associations were seen for demographic characteristics, history of allergy or medication use, or COVID-19 with urticaria in a post-hoc analysis. Among participants with versus without urticaria, 100 versus 37 percent reported previous Moderna COVID-19 vaccination; 29 versus 76 percent reported previous Pfizer-BioNTech COVID-19 vaccination; and 0 versus 5 percent reported no previous mRNA COVID-19 vaccination.
“The HVTN 302 study vaccines were generally safe and tolerable, with frequent but typically mild-to-moderate local and systemic reactogenicity events, as seen previously with licensed mRNA COVID-19 vaccines,” the authors write.
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