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

NCT06694766 | Recruiting

• 2 other identifiers: 2023-0712023-A02595-40
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Yellow Fever Vaccine

Keywords

Yellow Fever Vaccination Tolerance Immunogenicity Pregnancy

Outcome Measures

Primary Outcomes (1)

• Describe the immunogenicity induced by primary yellow fever vaccination during pregnancy and compare it to the immunogenicity induced by primary vaccination outside pregnancy

  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.

  36 months

Secondary Outcomes (3)

• Describe the safety of yellow fever vaccination during pregnancy in women who have been vaccinated

  36 months

• Describe the tolerability of yellow fever vaccination during pregnancy in the fetus and newborn.

  36 months

• Create a biological collection for future studies on infectious/tropical diseases and the immune response to vaccination

  36 months

Study Arms (2)

women vaccinated during pregnancy

OTHER

Participants who received a yellow fever vaccination during pregnancy

Procedure: Blood sample collection

women vaccinated outside pregnancy

OTHER

Participants who received a yellow fever vaccination outside pregnancy

Procedure: Blood sample collection

Interventions

Blood sample collection PROCEDURE

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

women vaccinated during pregnancy; women vaccinated outside pregnancy

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Pasteur: lead
• Cerballiance: collaborator

Study Sites (1)

Medical Center of Institut Pasteur

Paris, 75015, France

RECRUITING

Study Officials

• Kaoutar JIDAR, MD

  Medical Center of l'Institut Pasteur (CMIP)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaoutar JIDAR, MD

CONTACT

0140613817; kaoutar.jidar@pasteur.fr

Julia ABAD

CONTACT

julia.abad@pasteur.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: * women vaccinated during pregnancy * women vaccinated outside pregnancy

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: November 19, 2024
• Study Start: March 24, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2030
• Last Updated: December 15, 2025

Record last verified: 2025-11

Locations

FR (1)