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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	20 November 2023
Main ID:	NCT02471378
Date of registration:	12/06/2015
Prospective Registration:	Yes
Primary sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Public title:	Laboratory Evaluation of Pregnancy Malaria Vaccine Candidates/In-vitro Testing of Pregnancy Malaria Vaccine Candidates
Scientific title:	In-Vitro Testing of Pregnancy Malaria Vaccine Candidates
Date of first enrolment:	July 28, 2015
Target sample size:	4791
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/ct2/show/NCT02471378
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Mali

Contacts

Name:	Michal Fried, Ph.D.
Address:
Telephone:	(240) 747-7880
Email:	michal.fried@nih.gov
Affiliation:

Name:	Michal Fried, Ph.D.
Address:
Telephone:
Email:
Affiliation:	National Institute of Allergy and Infectious Diseases (NIAID)

Name:	Almahamoudou Mahamar
Address:
Telephone:	(223) 762-3250
Email:	almahamar@icermali.org
Affiliation:

Key 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

Age minimum: 15 Years
Age maximum: 25 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Malaria

Intervention(s)

Primary Outcome(s)

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]

Secondary Outcome(s)

Secondary ID(s)

999915147

15-I-N147

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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