Status:
ACTIVE_NOT_RECRUITING
Follow-up of Immunological Pattern and Pregnancy Outcomes in Women Previously Received Placental Malaria Vaccine
Lead Sponsor:
Groupe de Recherche Action en Sante
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
European Vaccine Initiative
Conditions:
Malaria in Pregnancy
Eligibility:
FEMALE
18-35 years
Brief Summary
Study Population: Participants of the previous PRIMVAC vaccine trial and women aged 18 to 35 years Sample Size: 90 Study duration: 21 months Subject duration: 12 months if pregnancy doesn't occurre...
Detailed Description
It is a long-term observational study comparing the immunology trend of 3 groups of women: * Women who received the PRIMVAC Vaccine or Placebo during the phase 1b trial in Burkina Faso * Women of the...
Eligibility Criteria
Inclusion
- Any participant of the previous PRIMVAC vaccine phase Ib trial
- Nulligravid and primigravid women aged 18-35 years
- Residing in study region and environs
- Available and willing to participate in follow-up for the duration of study
- Participant who accept blood sample collection
- Appear to be in generally good health based on clinical and laboratory investigation
- Signed informed consent
Exclusion
- Participants who refused to sign informed consent
- Use of an investigational or non-registered drug or vaccine other than the previous study vaccine
- Chronic administration of immunosuppressants or other immune-modifying drugs
- Confirmed or suspected immunosuppressive or immunodeficient condition
- Confirmed or suspected autoimmune disease
- Simultaneous participation in any interventional clinical trial
- Women of control groups with positif pregnancy test at the enrolment
Key Trial Info
Start Date :
February 18 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05426187
Start Date
February 18 2022
End Date
December 31 2024
Last Update
April 18 2024
Active Locations (1)
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1
Groupe de Recherche Action en Santé
Ouagadougou, Burkina Faso