Evaluating malaria vaccine candidates for pregnant women
In-Vitro Testing of Pregnancy Malaria Vaccine Candidates
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 |
|---|---|
| Enrollment | 7476 (estimated) |
| Ages | 15 Years to 25 Years |
| Sex | Female |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bamako) |
| Trial ID | NCT02471378 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 15-25 who are malaria positive.
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.
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 performed: While there have been various studies on malaria vaccines, this specific approach targeting pregnancy malaria is novel and has not been extensively tested.
Eligibility criteria
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 this trial is running
Bamako
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.