Laboratory Evaluation of Pregnancy Malaria Vaccine Candidates/In-vitro Testing of Pregnancy Malaria Vaccine Candidates

April 15, 2023 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

In-Vitro Testing of Pregnancy Malaria Vaccine Candidates

Background:

- Malaria is a disease that affects many people in African countries. It is caused by germs that are spread by mosquito bites. It can be fatal if not diagnosed and treated right away. Children younger than 5 and pregnant women are most at risk to get malaria. Researchers want to create a vaccine that will prevent malaria infection during pregnancy.

Objectives:

- To create a vaccine that will prevent malaria infection during pregnancy. To assess possible vaccines using in-vitro tests with parasites taken from pregnant women.

Eligibility:

- Pregnant women ages 15 25

Design:

  • The study site is an area in Mali, West Africa.
  • Participants:
  • Will have blood drawn.
  • Will give consent for the blood sample to be used for future research.
  • May have a physical exam.
  • Participants who have malaria or anemia will get treatment.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Malaria caused by Plasmodium falciparum continues to be a global problem with devastating consequences. Pregnancy malaria is associated with low birth weight (LBW), maternal anemia, and gestational hypertension; and both inflammation and the fetal response to infection may contribute to these poor outcomes. Pregnancy malaria (PM) is caused by P. falciparum-infected erythrocytes that bind to the placental receptor chondroitin sulfate A (CSA) and sequester in the placenta, where they cause disease and death for the mother and her offspring. Women become resistant to pregnancy malaria as they acquire antibodies that target surface proteins of placental parasites. Malaria vaccine candidates targeting the parasite s liver stage or blood stage may not protect pregnant women and their unborn children. The primary hypothesis in this study is that antibodies raised in animals against recombinant pregnancy malaria vaccine candidates will have a similar functional activity as naturally acquired antibodies. Up to 1597 malaria-infected pregnant women will be recruited into a cross sectional study that will be conducted in Ouelessebougou and neighboring districts, Mali. Women presenting for antenatal visit at the health centers in Ouelessebougou District will be enrolled. Samples collected from the women will be used in in-vitro assays to assess the functional activity of immunoglobulin G (IgG) raised against pregnancy malaria vaccine candidates as the primary outcome of this study. For our secondary outcomes, we will examine functional activity of naturally acquired antibodies specific to the vaccine candidates. Functional activity by IgG to vaccine candidates will be compared to the activity obtained with control proteins using appropriate statistical methods, including adjustment for possible confounders such as parasite density in the assay, to determine if the candidates elicit the type of immune response observed in naturally exposed population.

Study Type

Observational

Enrollment (Anticipated)

4791

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mali
      • Bamako, Mali
        • Recruiting
        • Ouelessebougou Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pregnant women age 15-25 years presenting for antenatal consultations or delivery at health centers or hospital in Ouelessebougou and neighboring districts@@@@@@

Description

  • INCLUSION CRITERIA:

A study participant must satisfy the following criteria to be enrolled in this study:

  • Pregnant women aged 15-25 years
  • Able to provide consent for self
  • Malaria positive by rapid diagnostic test (RDT)

EXCLUSION CRITERIA:

  • Severe anemia defined as HGB<7 gr/dL, that may be worsened by 10 mL phlebotomy
  • Conditions that in the judgment of the investigator could increase the risk to the volunteer
  • Prior enrollment to the study during the same pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Pregnant Women 15-25 years old
Malaria-infected pregnant Women

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure of functional activity of animal IgG against vaccine candidates to block binding of fresh pregnancy malaria isolates to the placental receptor CSA
Time Frame: Approximately 1 year
Approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2015

Primary Completion (Anticipated)

June 30, 2024

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

June 12, 2015

First Submitted That Met QC Criteria

June 12, 2015

First Posted (Estimate)

June 15, 2015

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 15, 2023

Last Verified

April 14, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999915147
  • 15-I-N147

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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