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Clinical Trials in France / NCT06694766
Recruiting Not applicable

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

NCT06694766 · tracked via the Priya Life Science France tracker
Sponsor
Institut Pasteur
Phase
Not applicable
Started
2025-03-24
Last updated
2025-12-15

Condition(s) studied

Yellow Fever Vaccine

Investigational drug(s) / intervention(s)

Blood sample collection

Blood sample collection: A blood sample collection of 18.5 mL will be required for the immunogenicity component.

Study summary

The aim of this study is to compare the immunogenicity induced by yellow fever vaccination administered during pregnancy with that induced by vaccination outside pregnancy, and to assess the maternal and fetal tolerance of this vaccination.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Describe the immunogenicity induced by primary yellow fever vaccination during pregnancy and compare it to the immunogenicity induced by primary vaccination outside pregnancy — 36 months
    Proportion of participants with a neutralizing antibody rate above 1/10. A serological analysis will be performed to measure neutralizing antibody response by using PRNT 80 seroneutralization techniques. Each woman vaccinated against YF during pregnancy will be matched with a woman vaccinated outside pregnancy based on age (+/- 5 years) and time since primary YF vaccination (+/- 6 months). We anticipate that vaccination against YF during pregnancy will be equivalent in term of immunogenicity compared to vaccination against YF realized among non-pregnant women of the same age range. Based on the hypothesis of a protective immune response rate of 90% in the pregnant women group, a sample size in each group of 135, with a normal approximation test of proportions, will allow a type 1 risk of 0.05, a power of 80% and a minimum difference of 5%, in order to reject the null hypothesis according to which the protective immune response rates in the two groups are not equivalent.

Trial sites (1)

FacilityCityRegionStatus
Medical Center of Institut Pasteur Paris France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06694766 on ClinicalTrials.gov ↗ ← All trials in France