Comparing yellow fever vaccination effects during and outside of pregnancy
Comparative Study of Tolerance and Immunogenicity Induced by Primary Yellow Fever Vaccination in Pregnant and Non-pregnant Women
This study tests how well the yellow fever vaccine works and how safe it is for pregnant women compared to those who are not pregnant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Institut Pasteur Industry-sponsored |
| Locations | 1 site (Paris) |
| Trial ID | NCT06694766 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the immunogenicity and tolerance of the yellow fever vaccine when administered to pregnant women compared to those vaccinated outside of pregnancy. It involves collecting blood samples to assess the immune response and any potential adverse effects on both the mother and fetus. Given the risks associated with yellow fever, especially in endemic regions, understanding the safety and efficacy of vaccination during pregnancy is crucial for public health. The study is conducted at the Institut Pasteur in Paris, focusing on women who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women over 18 years of age who are receiving their primary yellow fever vaccination.
Not a fit: Patients who have previously received a yellow fever vaccination or those with medical conditions incompatible with blood sample collection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety and effectiveness of yellow fever vaccination during pregnancy, potentially guiding vaccination policies for pregnant women.
How similar studies have performed: While there is limited data on yellow fever vaccination during pregnancy, similar studies on vaccine safety in pregnant populations have shown promising results, indicating the potential for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Medical Center of Institut Pasteur — Paris, France (Recruiting)
Study contacts
- Principal investigator: Kaoutar JIDAR, MD — Medical Center of l'Institut Pasteur (CMIP)
- Study coordinator: Kaoutar JIDAR, MD
- Email: kaoutar.jidar@pasteur.fr
- Phone: 0140613817
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.