Follow-up of Immunological Pattern and Pregnancy Outcomes in Women Previously Received Placental Malaria Vaccine (PRIMVACLongT)

Groupe de Recherche Action en Sante

Status

Active, not recruiting

Conditions

Malaria in Pregnancy

Study type

Observational

Funder types

Other

Identifiers

NCT05426187

PRIMVAC Long Term study

Details and patient eligibility

About

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 occurred. In case of pregnancy, the participant will be followed up until the delivery.

Study Design: Long term observational study comparing the immunology trend of 3 groups of i) women who received the PRIMVAC Vaccine or Placebo during the phase 1b trial in Burkina Faso; ii) women of the same age and nulligravid who did not participate in the phase 1b trial iii) women of the same age and primigravid who did not participate in the phase 1b trial

Co Primary objectives

To assess the dynamics of humoral immune response to the vaccine antigen during long term follow up of the study participants
To evaluate the functional durability of the humoral immune responses of women who participated in the phase 1b vaccine trial compared to women of the same age

Secondary objectives

To assess the cellular immune response during the follow-up period
To assess the incidence of clinical malaria on study participants
To assess the prevalence of Placental Malaria in study participants and adverse outcomes such as maternal anemia, low birth weight, stillbirth and prematurity.

Full 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 same age and nulligravid who did not participate in the phase 1b trial
Women of the same age and primigravid who did not participate in the phase 1b trial

The proposed cohort study will build on the previous phase 1b study which was conducted within the health district of Saponé (ClinicalTrials.gov Identifier: NCT02658253). The enrolment and follow up of the subjects will last 12 months. Pregnancy which occurred during the follow up period will monitored until the delivery. An additional six months is necessary for sample analysis in the laboratory, the data analysis and the preparation of reports and publications.

Enrollment

90 estimated patients

Sex

Female

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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