Skip to main content

Urticaria Reported in Trial of Investigational HIV mRNA Vaccines

By Elana Gotkine HealthDay Reporter

Medically reviewed by Carmen Pope, BPharm. Last updated on May 5, 2025.

via HealthDay

MONDAY, May 5, 2025 -- 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)

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

© 2025 HealthDay. All rights reserved.

Read this next

FDA Approves Twice-Yearly Yeztugo for Preexposure Prophylaxis to Cut HIV Risk

FRIDAY, June 20, 2025 -- The U.S. Food and Drug Administration has approved Yeztugo (lenacapavir), an injectable HIV-1 capsid inhibitor, as preexposure prophylaxis (PrEP) to...

Worse Outcomes Seen for Unvaccinated Patients Hospitalized With COVID-19, AKI

WEDNESDAY, June 18, 2025 -- For patients hospitalized with COVID-19 infection and acute kidney injury (AKI), those who are unvaccinated have worse outcomes in terms of kidney...

Anal Cancer Screening Cost-Effective for HIV+ Men Who Have Sex With Men ≥35 Years of Age

TUESDAY, June 17, 2025 -- For men who have sex with men (MSM) with HIV, aged 35 years or older, anal cancer screening is cost-effective, according to a study published online June...

More news resources

Subscribe to our newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.