Fetal Immunity to Falciparum Malaria

NCT00314899 | Completed

• 1 other identifier: 05-0074
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out what effect malaria in the mother has on the development of her child's immune system response to malaria and whether being exposed to malaria in the womb makes a child more likely to get malaria. The study will also assess the effect that exposure to malaria in the womb has on the child's growth and development over the first three years of life. Study participants will include 480 healthy pregnant women (greater than or equal to 15 years of age), their healthy offspring, 20 healthy people from the United States with no malaria exposure or disease and 40 adult Kenyans who have previously been exposed to malaria or have malaria with no signs of infection. Study procedures will include an ultrasound (procedure to assess the baby's growth and development in the womb), blood, urine, and stool collections. Newborns will be examined at birth, and at 6, 12, 18, 24, 30 and 36 months of age.

Conditions

Plasmodium Falciparum Malaria

Keywords

Malaria, Plasmodium falciparum, Kenya, immunity

Eligibility Criteria

• Age: Up to 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• At least greater than or equal to 15 years of age.
• Willingness to provide informed consent.
• Confirmed pregnancy.
• Apparent good health.
• Long-term residence in Msambweni locations who anticipate residing in the area during the study period (at least 3 years). Women whose immediate and/or extended families do not reside in Kwale District will be discouraged from enrolling in the study.
• Willingness to donate blood (peripheral venous blood or fingerstick blood as per the protocol) during ANC visits and at the time of delivery.
• Willingness to release human immunodeficiency virus (HIV) testing results from the voluntary counseling and treatment (VCT) program, or be tested by our staff and, if positive, to have their infants tested for HIV at 12 and 24 months of age.
• Willingness of the infant's mother to participate in prenatal and postnatal care at Msambweni District Hospital.
• Willingness of the mother/caregivers to participate in a prospective survey that involves bi-annual venipuncture (3-5 mL blood volume) of the infant commencing at 6 months (plus or minus 2 months of age) and ending at age 36 months.
• Multiple births can be included.
• Pregnant women will be allowed to enroll irrespective of their gestational age, although they cannot enroll at delivery because they cannot undergo adequate consent. However, potential participants will be strongly encouraged to come to the clinic for prenatal care early in the second trimester (ideally \<16 weeks gestation) both to ensure adequate prenatal care for the mother and unborn infant and to provide sufficient follow-up time to collect multiple antenatal study samples from the mother.

You may not qualify if:

• Preterm delivery less than 34 weeks gestation.
• Failure to deliver in the hospital.
• Evidence of placenta previa.
• Maternal chorioamnionitis.
• Receipt of immunosuppressive drugs during pregnancy.
• Hemoglobin less than 6.07 g/dL for females\*.
• More One plus or greater glucose in urine.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding enrollment in the study.
• Simultaneous participation in any other interventional clinical trial.
• Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurological condition, or any other findings that in the opinion of the CO or PI may increase the risk of participating in the study.
• Other conditions that in the opinion of the CO or PI would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol.
• These values may change base on survey of adult normal laboratory test values in Msambweni. Values for children will be revised based on a survey of pediatric normal values in Msambweni.
• Censoring events for the mother and newborn (and, by default, the infant's mother):
• Mother delivers elsewhere, migrates out of area, dies, spontaneous abortion or stillbirth.
• APGAR score for the infant of less than 5 at 10 minutes after birth.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

KEMRI Centre for Geographic Medicine Research

Nairobi, Kenya

Location

MeSH Terms

Conditions

Malaria, Falciparum; Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Design

• Study Type: observational
• Time Perspective: OTHER
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 13, 2006
• First Posted: April 17, 2006
• Study Start: September 15, 2006
• Primary Completion: November 15, 2009
• Study Completion: April 15, 2010
• Last Updated: February 1, 2019

Record last verified: 2009-04

Locations

KE (1)