NCT02471378

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,476

participants targeted

Target at P75+ for all trials

Timeline
24mo left

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Jul 2015Jun 2028

First Submitted

Initial submission to the registry

June 12, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

July 28, 2015

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

May 18, 2026

Status Verified

May 14, 2026

Enrollment Period

10.9 years

First QC Date

June 12, 2015

Last Update Submit

May 15, 2026

Conditions

Malaria

Keywords

AssaysWomenInfectedAntibodiesPlasmodium FalciparumNatural History

Outcome Measures

Primary Outcomes (1)

  • Measure of functional activity of animal IgG against vaccine candidates to block binding of fresh pregnancy malaria isolates to the placental receptor CSA

    Approximately 1 year

Study Arms (1)

Pregnant Women 15-25 years old

Malaria-infected pregnant Women

Eligibility Criteria

Age15 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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@@@@@@

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ouelessebougou Clinical Research Center

Bamako, Mali

RECRUITING

Related Publications (4)

  • Fried M, Nosten F, Brockman A, Brabin BJ, Duffy PE. Maternal antibodies block malaria. Nature. 1998 Oct 29;395(6705):851-2. doi: 10.1038/27570. No abstract available.

    PMID: 9804416BACKGROUND

  • Bordbar B, Tuikue-Ndam N, Bigey P, Doritchamou J, Scherman D, Deloron P. Identification of Id1-DBL2X of VAR2CSA as a key domain inducing highly inhibitory and cross-reactive antibodies. Vaccine. 2012 Feb 8;30(7):1343-8. doi: 10.1016/j.vaccine.2011.12.065. Epub 2012 Jan 5.

    PMID: 22226864BACKGROUND

  • Fried M, Avril M, Chaturvedi R, Fernandez P, Lograsso J, Narum D, Nielsen MA, Oleinikov AV, Resende M, Salanti A, Saveria T, Williamson K, Dicko A, Scherf A, Smith JD, Theander TG, Duffy PE. Multilaboratory approach to preclinical evaluation of vaccine immunogens for placental malaria. Infect Immun. 2013 Feb;81(2):487-95. doi: 10.1128/IAI.01106-12. Epub 2012 Dec 3.

    PMID: 23208604BACKGROUND

  • Sharma A, Jenkins B, Akue A, Lambert LE, Orr-Gonzalez S, Thomas ML, Mahamar A, Diarra BS, Dicko A, Fried M, Duffy PE. Plasmodium falciparum in Aotus nancymaae: A New Model for Placental Malaria. J Infect Dis. 2022 Aug 26;226(3):521-527. doi: 10.1093/infdis/jiac096.

    PMID: 35290467DERIVED

MeSH Terms

Conditions

MalariaMalaria, Falciparum

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Michal Fried, Ph.D.

    National Institute of Allergy and Infectious Diseases (NIAID)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michal Fried, Ph.D.

CONTACT

(240) 747-7880michal.fried@nih.gov

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2015

First Posted

June 15, 2015

Study Start

July 28, 2015

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2028

Last Updated

May 18, 2026

Record last verified: 2026-05-14

Data Sharing

IPD Sharing
Will not share

Locations

MA(1)