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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A02595-40 | Other Identifier | ID-RCB number |
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| Name | Class |
|---|---|
| Cerballiance | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| women vaccinated during pregnancy | Other | Participants who received a yellow fever vaccination during pregnancy |
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| women vaccinated outside pregnancy | Other | Participants who received a yellow fever vaccination outside pregnancy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample collection | Procedure | A blood sample collection of 18.5 mL will be required for the immunogenicity component. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Describe the safety of yellow fever vaccination during pregnancy in women who have been vaccinated | 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. |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaoutar JIDAR, MD | Contact | 0140613817 | +33 | kaoutar.jidar@pasteur.fr |
| Julia ABAD | Contact | julia.abad@pasteur.fr |
| Name | Affiliation | Role |
|---|---|---|
| Kaoutar JIDAR, MD | Medical Center of l'Institut Pasteur (CMIP) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Center of Institut Pasteur | Recruiting | Paris | 75015 | France |
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| 36 months |
| Describe the tolerability of yellow fever vaccination during pregnancy in the fetus and newborn. | Data collected for safety assessment regarding the fœtus and newborn will include :
| 36 months |
| Create a biological collection for future studies on infectious/tropical diseases and the immune response to vaccination | This collection could allow :
| 36 months |