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

NCT05426187 | Active Not Recruiting

• 1 other identifier: PRIMVAC Long Term study
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Malaria in Pregnancy

Keywords

vaccine; nulligravid; immunology

Outcome Measures

Primary Outcomes (5)

• Geometric mean titer of antibodies

  Level of total Immunoglobin (IgG) and the level of the isotypic subtypes (IgG1, IgG2, IgG3, IgG4)

  month 0

• Geometric mean titer of antibodies

  Level of total Immunoglobin (IgG) and the level of the isotypic subtypes (IgG1, IgG2, IgG3, IgG4)

  month 6

• Geometric mean titer of antibodies

  Level of total Immunoglobin (IgG) and the level of the isotypic subtypes (IgG1, IgG2, IgG3, IgG4)

  month 12

• Cross-reactivity against different VAR2CSA variants expressed on the surface of erythrocytes parasitized by various strains of Plasmodium falciparum by flow cytometry

  VAR2CSA variants

  month 0

• Percentage of binding inhibitory activity using various VAR2CSA expressing strains by CSA-binding inhibition assay (BIA) at different timepoints during the twelve months of follow up.

  binding inhibitory activity

  month 0

Study Arms (3)

Group 1

Women who received the PRIMVAC Vaccine or Placebo during the phase 1b trial in Burkina Faso

Group 2

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

Group 3

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

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Placental malaria concern only the women
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Groupe de Recherche Action en Sante: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• European Vaccine Initiative: collaborator

Study Sites (1)

Groupe de Recherche Action en Santé

Ouagadougou, Burkina Faso

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood smear dried blood spot venous blood

Study Officials

• Alphonse Ouedraogo, MD, PhD

  Groupe de Recherche Action en Sante

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 21, 2022
• Study Start: February 18, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)