Medical Center of Institut Pasteur
Paris, 75015, France
Location status: Recruiting
NCT Number: NCT06694766
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Paris, 75015, France
Location status: Recruiting
Yellow fever (YF), caused by the yellow fever virus (YFV), is an endemic disease in tropical and subtropical regions of South America and Africa. The virus is transmitted to humans by mosquitoes and can cause severe acute illness, leading to death in 20 to 60% of cases. There is currently no antiviral treatment available.
The yellow fever vaccine is a live attenuated virus vaccine recommended for individuals living in or traveling to tropical regions of Africa and South America. Under the International Health Regulations (IHR), cross-border travelers aged one year and older must present an immunization certificate issued by a government-approved international vaccination center. Globally, between twenty and sixty million doses are administered each year.
In France, the vaccine used against Yellow Fever is Stamaril® (Sanofi Pasteur MSD), which utilizes the 17D-204 strain. Due to insufficient data on the tolerance and immunogenicity induced by yellow fever vaccination during pregnancy, specific precautions and guidelines are recommended in this scenario. Currently, pregnancy is a relative contraindication for yellow fever vaccination. It may be considered for pregnant women who cannot postpone travel, are traveling to a yellow fever endemic area, and where the benefit-risk ratio of vaccination is deemed favorable by the attending physician.
This research consists of 2 sections:
All women will participate in the tolerance assessment component. If they wish and sign the written consent, they may also participate in the immunogenicity assessment component. Following the telephone call, an appointment at the CMIP will be scheduled.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Common :
Specific to both groups :
Exclusion criteria
Criteria common to both sections (tolerance and immunogenicity):
Specific criteria for participants in the immunogenicity section:
A blood sample collection of 18.5 mL will be required for the immunogenicity component.
Time frame: 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.
Time frame: 36 months
The data collected for safety assessment regarding women will include:
All adverse reactions will be collected following MedDRA guidelines. The proportion of averse events will be compared to that of the non pregnant women group and to that of histoical series.
Time frame: 36 months
Data collected for safety assessment regarding the fœtus and newborn will include :
Time frame: 36 months
This collection could allow :
Contact information is provided by the study sponsor or research team.
Institut Pasteur
Industry
Comparative Study of Tolerance and Immunogenicity Induced by Primary Yellow Fever Vaccination in Pregnant and Non-pregnant Women
Acronym: VAC-SIP-YF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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