Evaluating malaria vaccine candidates for pregnant women
Official title: In-Vitro Testing of Pregnancy Malaria Vaccine Candidates
Run by National Institutes of Health Clinical Center (CC) · NCT02471378 · Data updated 2026-11-12
This study is testing a new malaria vaccine for pregnant women to see if it can help protect them and their babies from malaria infections.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 15 Years to 25 Years |
| Sex | Women only |
| Enrollment | 7476 (estimated) |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bamako) |
| Status | Recruiting |
| Started | July 28, 2015 |
| Main results expected | June 30, 2028 |
| Study ends | June 30, 2028 |
| Registry record updated | October 8, 2026 |
| Trial ID | NCT02471378 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women aged 15-25 who are malaria positive.
✕Probably not a fit
Patients with severe anemia or those who have previously participated in the study during the same pregnancy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to develop a vaccine to prevent malaria infections during pregnancy, which poses significant risks to both mothers and their unborn children. Researchers will recruit pregnant women aged 15-25 in Mali, who are malaria positive, to participate in in-vitro tests using blood samples. The study will assess the functional activity of antibodies raised against malaria vaccine candidates, comparing them to naturally acquired antibodies. Participants will provide consent for their blood samples to be used in future research and may receive treatment for malaria or anemia if needed.
Why it matters
Potential benefit: If successful, this research could lead to a vaccine that significantly reduces malaria infections in pregnant women, improving maternal and fetal health outcomes.
How similar studies have gone: While there have been various studies on malaria vaccines, this specific approach targeting pregnancy malaria is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
* 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
Where it's running
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Ouelessebougou Clinical Research Center
Bamako, Mali Recruiting
Study contacts
- Principal investigator: Michal Fried, Ph.D. — National Institute of Allergy and Infectious Diseases (NIAID)
- Study coordinator: Michal Fried, Ph.D.
- Email: michal.fried@nih.gov
- Phone: (240) 747-7880
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.