VAC-SIP-YF (Vaccination- Safety & Immunogenicity During Pregnancy- Yellow Fever)

Launched by INSTITUT PASTEUR · Nov 15, 2024

Keywords

ClinConnect Summary

The VAC-SIP-YF trial is a study designed to understand how well the yellow fever vaccine works when given to pregnant women compared to women who receive the vaccine when they are not pregnant. The researchers want to see if the vaccine is safe and if both mothers and their babies can tolerate it well. This information is important to ensure that pregnant women can be protected from yellow fever without any harm to them or their babies.

To participate in this study, women must be over 18 years old and female. They need to give their consent after being informed about the study. The study will include women who are getting their first yellow fever vaccination during pregnancy and those who have received it outside of pregnancy. Women who have had a second yellow fever vaccination, have certain medical conditions, or cannot provide consent will not be eligible. Participants can expect to provide some blood samples for testing and will be monitored for their response to the vaccine throughout the study.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• Common :
• • Person over 18 years of age at the time of the first yellow fever vaccination
• • Female gender
• • Oral consent obtained after subject has been informed
• • Subject covered by Social Security with the exception of Aide Médicale d'Etat
• Specific to both groups :
• • For women vaccinated during pregnancy (case): Primary yellow fever vaccination during pregnancy
• • For women vaccinated outside pregnancy (control): Primary yellow fever vaccination outside pregnancy
• Exclusion Criteria:
• Criteria common to both sections (tolerance and immunogenicity):
• • Subject having received a second yellow fever vaccination
• • Persons unable to give informed consent for participation
• • Women born in areas where yellow fever is endemic
• • Female adults under legal protection (guardianship or trusteeship)
• Specific criteria for participants in the immunogenicity section:
• • Medical condition imcompatible with 18.5 mL blood
• • Women who have not given written consent to participate in the study. immunogenicity