Urticaria Reported in Trial of Investigational HIV mRNA Vaccines

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.Abstract/Full Text (subscription or payment may be required)Editorial (subscription or payment may be required).Sign up for our weekly HealthDay newsletter

Urticaria Reported in Trial of Investigational HIV mRNA Vaccines

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