Comparative Study of Tolerance and Immunogenicity Induced by Primary Yellow Fever Vaccination in Pregnant and Non-pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Describe the immunogenicity induced by primary yellow fever vaccination during pregnancy and compare it to the immunogenicity induced by primary vaccination outside pregnancy
研究概览
简要总结
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.
详细描述
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:
- Tolerance section: related to yellow fever vaccination, will involve solely collecting retrospective data. This first component will be conducted during a telephone call led by the investigating physician.
- Immunogenicity section: to evaluate the immune response induced by yellow fever vaccination. This second component will be conducted during a visit to the CMIP, where a blood sample will be taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
women vaccinated outside pregnancy
Participants who received a yellow fever vaccination outside pregnancy
干预措施: Blood sample collection (Procedure)
women vaccinated during pregnancy
Participants who received a yellow fever vaccination during pregnancy
干预措施: Blood sample collection (Procedure)
结局指标
主要结局
Describe the immunogenicity induced by primary yellow fever vaccination during pregnancy and compare it to the immunogenicity induced by primary vaccination outside pregnancy
时间窗: 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.
次要结局
- 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)