
Bavarian Nordic said today that the first of two clinical trials of the use of its Jynneos (MVA-BN) mpox/smallpox vaccine has begun in vulnerable populations: infants and children 2 years old and younger, and pregnant or breastfeeding women.
The first participants have been vaccinated in a study to evaluate the safety and immunogenicity of Jynneos in 344 infants aged 4 to 24 months. Recruitment has also started in a second safety and immunogenicity study, which will enroll 359 pregnant or breastfeeding women. Both studies will be conducted in the Democratic Republic of the Congo, the epicenter of an ongoing mpox outbreak that includes babies, young children, and pregnant women.
Funded by EDCTP3, CEPI
Bavarian Nordic President and CEO Paul Chaplin, PhD, said, "These new studies will fill the gap by providing important data about the use of MVA-BN in infants and pregnant women, and we applaud the study partners as well as the funding partners, EDCTP3 and CEPI [Coalition for Epidemic Preparedness Innovations] for supporting this important work, which could help support a label expansion for MVA-BN to include the most vulnerable populations."
Both studies are part of the PregInPoxVac research project, led by the University of Antwerp and the University of Kinshasa.
In addition, Bavarian Nordic is sponsoring a trial of Jynneos in children aged 2 to 11 years old, which has received funding support from CEPI. It expects results from this trial later this year.