news release
Wednesday, October 16, 2024
NIH clinical trial addresses knowledge gap on vaccine use in adolescents
what:
A National Institutes of Health (NIH)-funded clinical trial of the mpox vaccine in adolescents showed that the vaccine was safe and produced antibody responses comparable to those seen in adults, according to a planned interim analysis of study data. was found to have been generated. In the current clade I mpox epidemic, adolescents are also among the mpox-affected populations. Interim results from this study were presented at the IDWeek2024 conference in Los Angeles.
The first case of mpox infection in humans was recorded in the Democratic Republic of Congo (DRC) in 1970. Two types of viruses have been identified that cause mpox. Clade I is endemic to Central Africa and can cause severe disease. Clade II, endemic to West Africa, causes a global mpox epidemic that began in 2022 and tends to have milder symptoms. People with compromised immune systems, children, and pregnant women are especially susceptible to severe mpox, regardless of viral clade. The majority of people affected by the current clade I outbreak in the Democratic Republic of the Congo and other African countries are adolescents and children. The modified vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine has been approved in several countries for the prevention of Mpox and smallpox in adults, but there are insufficient data to support its approval in people younger than 18 years.
The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) is sponsoring a mid-term study in the United States to evaluate the safety and immune response of two doses of MVA-BN in adolescents aged 12 to 17 years. The results are compared with the general population of young people. Adults between 18 and 50 years old. In a planned interim analysis, study investigators will measure antibody levels two weeks after the second dose (study day 43) and monitor safety for up to 180 days after the second dose (study day 210). did. Analysis showed that the MVA-BN vaccine produced antibody levels in adolescents comparable to those observed in adults at day 43, and the vaccine was well tolerated by day 210 of the study. I found out that The overall frequency of adverse events was similar between study groups. Reports of dizziness were more common in adolescents than adults, but were similar to the frequency of dizziness reported when other vaccines are administered to adolescents.
According to the research team, this interim data supports the safety and quality of the immune response generated by the MVA-BN vaccine in adolescents, and the findings are relevant to the United States and other regions where mpox cases are occurring. It is said that there is. The authors emphasized the need to evaluate the MVA-BN vaccine in younger children to extend the evidence to all people affected by mpox.
NIH is grateful to the research facilities and volunteers who participated in the study to improve mpox responses.
For more information about this study, visit ClinicalTrials.gov and use identifier NCT05512949.
NIAID conducts and conducts research at the NIH, throughout the United States, and around the world to study the causes of infectious and immune-mediated diseases and to develop better ways to prevent, diagnose, and treat these diseases. We support you. News releases, fact sheets, and other NIAID-related materials are available on the NIAID website.
About the National Institutes of Health (NIH): The nation’s medical research agency, NIH includes 27 institutes and centers and is part of the U.S. Department of Health and Human Services. NIH is the primary federal agency that conducts and supports basic, clinical, and translational medical research, investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, please visit www.nih.gov.
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reference
CM Healy et al. Safety and immunogenicity of Mpox vaccination in adolescents. ID Week 2024. Saturday, October 19, 2024.
