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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInstitut Pasteur

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Blood sample collection

    Procedure/Surgery

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

Treatment groups

270 Participants
are divided into 2 treatment groups
Group A: women vaccinated during pregnancyOther 1 intervention
Group B: women vaccinated outside pregnancyOther 1 intervention

Trial outcomes

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.

Time frame
36 months

Secondary outcomes

1

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: * Occurrence of YEL-AND or YEL-AVD * Local adverse effects (pain, oedema, erythema, satellite lymph node) * Nausea, vomiting, diarrhea, fever, arthralgia, myalgia * Other adverse events that occurred after vaccination 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
2

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 : * Proportion of miscarriage, stillbirth, premature birth, and low weight birth and compare it to that of general population * From the infant health record: * Apgar, weight, size, and cranial perimeter at birth * Birth defect * Physical examination at birth (day 8), 9 month and 24 months of life

Time frame
36 months
3

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

This collection could allow : * analysis of cellular response to yellow fever vaccine e.g., activation of dendritic cells, NK cells, B lymphocytes and various T lymphocytes * exploration of participants' cellular immunity and identification of factors influencing the latter * Create a cohort of vaccinated women to assess immunogenicity and safety of all vaccines received during pregnancy

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut Pasteur

Lead sponsor

Cerballiance

Collaborator