With a maternal vaccine already on the market to protect newborns from RSV, the outlook for another looked promising, but latest phase 3 trial of a new candidate is now halted over safety concerns.
A phase 3 trial of a maternal vaccine candidate for respiratory syncytial virus has been stopped early because the risk for preterm births is higher in the candidate vaccine group than in the placebo group., 5328 pregnant women had been vaccinated, about half of the intended 10,000 enrollees. Of these, 3557 received the candidate vaccine RSV prefusion F protein–based maternal vaccine, and another 1771 received a placebo.
The trial was conducted in pregnant women aged 18-49 years to assess the efficacy and safety of the vaccine. The women were randomly assigned 2:1 to receive the candidate vaccine or placebo between 24 and 34 weeks' gestation.The primary outcomes were any or severe medically assessed RSV-associated lower respiratory tract infection in infants from birth to 6 months and safety in infants from birth to 12 months.
"If a smaller percentage of participants from low- and middle-income countries had been enrolled in our trial, the relative risk for preterm birth in the vaccine group as compared with the placebo group might have been reduced in the overall trial population," they reported. "We do not know what caused the signal," the company's spokesperson added. "GSK completed all the necessary steps of product development including preclinical toxicology studies and clinical studies in nonpregnant women prior to starting the studies in pregnant women. There were no safety signals identified in any of the earlier parts of the clinical testing. There have been no safety signals identified in the other phase 3 trials for this vaccine candidate.
United Kingdom Latest News, United Kingdom Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Risk of Preterm Birth Is Dramatically Rising as The World Gets HotterThe Best in Science News and Amazing Breakthroughs
Read more »
Exposure to Phthalates Increases Risk for Premature BirthExposure to phthalates is responsible for a significant portion of premature births, according to an extensive prospective study.
Read more »
Research Links 55,000+ Preterm Births To This Common ExposureA concerning but important finding.
Read more »
Wrong RSV Shots Given to Some Pregnant Women, Young KidsMore than two dozen toddlers and at least 128 pregnant women received RSV vaccines they should not have gotten, U.S. health officials say.
Read more »
New RSV vaccine 90% effective at preventing infant hospitalizationsJustin Boggs is a writer for the E.W. Scripps company. Justin covers anything from politics to sports and entertainment.
Read more »
COVID-19, Flu, and RSV: CDC Updates and Simplifies Respiratory Virus RecommendationsScience, Space and Technology News 2024
Read more »