Mpox vaccination is safe for adolescents and produces a strong antibody response

Press release

Wednesday October 16, 2024

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WHAT :

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The National Institutes of Health has funded a clinical trial of a MPox According to an interim review of the data, the vaccine was found to be safe in adolescents and produced antibodies similar to those seen in adults. During the outbreak of clade I MPOX, adolescents are one of the populations affected. Interim results from this trial were announced at the IDWeek2024 conference in Los Angeles.

In 1970, the Democratic Republic of Congo recorded the first case of human mpox. There are two types of viruses that cause mpox. Clade I, which is prevalent in Central Africa, can cause severe disease. Clade II is endemic in West Africa and caused the global mpox outbreak that began in 2022. It tends to cause milder symptoms. Children, pregnant women, people with weakened immune systems, and others are at high risk of severe mpox, regardless of the type of virus. In the DRC and other African countries affected by the clade I outbreak, many children and adolescents are among the most seriously affected. In several countries, the modified Ankara–Bavarian Nordic (MVA–BN) vaccine has been approved for adults to prevent mpox or smallpox. However, there are insufficient data available for approval in persons under 18 years of age.

The NIH’s National Institute of Allergy and Infectious Diseases is conducting a mid-term study in the United States. It will evaluate the safety and immune response generated after two doses of MVA-BN for adolescents ages 12 to 17, comparing results with adults ages 18 to 50. Study investigators conducted a planned mid-term analysis. They measured antibodies two weeks after the second dose (study days 43 and 210), while monitoring safety for 180 days. The analysis showed that MVA-BN generated antibody levels comparable to those in adults at study day 43. The vaccine also demonstrated good tolerability through day 210. Overall, the frequency of adverse events was similar between study groups. Dizziness was reported more frequently in adolescents than in adults. However, reports were similar when other vaccines were given to adolescents.

The study team believes that preliminary data support the safety and quality of immunity generated by MVA-BN in adolescents. These findings are relevant to the United States as well as other countries where there have been outbreaks of MPOS. They also emphasized the importance of evaluating the MVA/BN vaccine in young children to broaden the evidence base to include all individuals affected by MPOS.

The NIH thanks the researchers and volunteers who participated in studies to improve response to MPOX.

Please visit ClinicalTrials.gov to learn more about the study and enter its ID. NCT05512949.

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The National Institutes of Health: The NIH is the medical research agency of the U.S. Department of Health and Human Services. It includes 27 institutes and centers. The NIH, the nation's medical research agency, is the primary federal agency that conducts and supports basic, translational, clinical, and other types of medical research. It also studies the causes, treatments, and cures of common and rare diseases. Visit the NIH for more information about its programs. www.nih.gov.

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