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

Long Term Follow-up of Immunological Pattern and Pregnancy Outcomes in Women Previously Enrolled in a Phase 1b Clinical Trial With the PRIMVAC Placental Malaria Candidate Vaccine

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Malaria in Pregnancy

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 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.

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

Study Locations

• Burkina Faso
  • Ouagadougou, Burkina Faso
    • Groupe de Recherche Action en Sante

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 31 years (Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Groupe de Recherche Action en Sante
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; European Vaccine Initiative
• Investigators: Principal Investigator: Alphonse Ouedraogo, MD, PhD, Groupe de Recherche Action en Sante

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: vaccine; immunology; nulligravid
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Mosquito-Borne Diseases; Malaria
• Other Study ID Numbers: PRIMVAC Long Term study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No