Plasmodium Falciparum MalariaNCT00314899
Fetal Immunity to Falciparum Malaria
An observational study of Plasmodium Falciparum Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Plasmodium Falciparum Malaria
- How many people
- 500 participants
- Where
- 1 siteKenya
- Study dates
- 15 Sep 2006to 15 Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Inclusion criteria for American participants: Participants must be in good health, between the ages of 18 to 65, and have never been exposed to malaria.
- Inclusion criteria for Kenyan control subjects: Participants must be in general good health and either have been exposed to malaria or be infected with malaria, but asymptomatic. Exposure will be determined by the presence of antibodies to malarial blood-stage antigens, eg, MSP1-42. Subjects must be aged 18 to 55 years, inclusive.
Who cannot join
- 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*.
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- 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.
- Muconium aspiration, respiratory distress syndrome, or condition to require neonatal resuscitation.
- Extremely low birth weight (less than 1500 grams).
- Refuse to continue to participate in the study.
- Participants who move outside the study area during the course of the study will be dropped from further participation. However, data collected to that point may be included in analysis.
- No prior screening will be performed for the American control subjects, other than that they state they are healthy and have no acute or chronic medical problems. For the Kenyan adult control subjects, they will also be queried about their general overall perceived health and will have no known acute or chronic illnesses. A FSB sample will be obtained from the Kenyan control subjects and tested for anti-bodies to MSP142, a blood smear for malaria, and hemoglobin concentration by Hemacue test. If the hemoglobin concentration is <10 gm/dL, the subject will not be asked to donate blood and will be referred to the appropriate health care deliverers to receive appropriate treatment (oral iron supplements).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fetal Immunity to Plasmodium Falciparum Malaria
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.
Read the detailed description
The primary aim of this study is to determine how prenatal exposure to malaria influences development of humoral and cellular immune responses to malaria blood stage antigens from birth to 3 years of age. In addition, the study will determine the risk factors and mechanisms associated with congenital malaria or exposure of the fetus to malaria blood stage antigens, assess how prenatal exposure to malaria affects susceptibility to malaria infection during infancy, and evaluate how perinatal exposure to malaria affects growth and development during infancy. A primary goal of this research will be to examine a cohort of infants from birth to 36 months of age; the predictive value of allele-specific invasion inhibitory antibodies to Merozoite Surface Protein 1 (MSP1) and antibody titers to MSP1 will be evaluated with respect to type and magnitude of neonatal cellular and humoral immune response to MSP1. An understanding of natural immunity to MSP1, and the influence of prenatal exposure, may be critical to informed interpretation of immunologic, parasitologic, and clinical endpoints of vaccine trials using blood stage antigens that will be ultimately directed to infants and children. Healthy adult pregnant women (greater than or equal to 15 years of age) and their healthy offspring (beginning at birth) will be followed until they are 36 months old. Newborns will be examined at birth and at 6, 12, 18, 24, 30 and 36 months of age. Enrollment will occur at time of first visit to the antenatal clinic during the second trimester when peripheral blood, stool, and urine samples will be obtained from each pregnant woman. A finger stick blood sample will be obtained from the mothers at each subsequent antenatal visit to assess the presence of malaria during pregnancy. An ultrasound examination will be done on the mothers at the initial antenatal visit to assess gestational age and at 26-30 weeks to assure proper growth and development of fetus and to screen for any potential problems. At delivery venous and finger stick blood, stool, and urine will be obtained from the mother. Umbilical cord and placental blood, and a placental biopsy will be obtained, and thereafter infants will be followed every 6 months (plus or minus 2 months). A physical examination of infants will be done and peripheral blood, stool, and urine will be obtained from infants. The study population will also include about 20 healthy adult North American control subjects with no malaria exposure or infection and about 40 adult Kenyans who either have been exposed to malaria or have asymptomatic malaria infection.
- Conditions
- Plasmodium Falciparum Malaria
- Keywords
- Malaria, Plasmodium falciparum, Kenya, immunity
- Medical subject headings
- Malaria, Falciparum, Malaria
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2006 (estimated)
- Study start15 Sep 2006
- Primary completion15 Nov 2009
- Study completion15 Apr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasmodium Falciparum MalariaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Other
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314899
- Sponsor's protocol ID
- 05-0074
- Status last verified
- Apr 2009
- First submitted
- 13 Apr 2006
- Last updated
- 1 Feb 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Immunity to Plasmodium Falciparum Malaria
- ClinicalTrials.gov ID
- NCT00314899
- Acronym / sponsor ID
- 05-0074
- Conditions
- Plasmodium Falciparum Malaria
- Keywords
- Malaria, Plasmodium falciparum, Kenya, immunity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 15 Sep 2006
- Primary completion
- 15 Nov 2009 (actual)
- Study completion
- 15 Apr 2010 (actual)
- First posted
- 17 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary aim of this study is to determine how prenatal exposure to malaria influences development of humoral and cellular immune responses to malaria blood stage antigens from birth to 3 years of age. In addition, the study will determine the risk factors and mechanisms associated with congenital malaria or exposure of the fetus to malaria blood stage antigens, assess how prenatal exposure to malaria affects susceptibility to malaria infection during infancy, and evaluate how perinatal exposure to malaria affects growth and development during infancy. A primary goal of this research will be to examine a cohort of infants from birth to 36 months of age; the predictive value of allele-specific invasion inhibitory antibodies to Merozoite Surface Protein 1 (MSP1) and antibody titers to MSP1 will be evaluated with respect to type and magnitude of neonatal cellular and humoral immune response to MSP1. An understanding of natural immunity to MSP1, and the influence of prenatal exposure, may be critical to informed interpretation of immunologic, parasitologic, and clinical endpoints of vaccine trials using blood stage antigens that will be ultimately directed to infants and children. Healthy adult pregnant women (greater than or equal to 15 years of age) and their healthy offspring (beginning at birth) will be followed until they are 36 months old. Newborns will be examined at birth and at 6, 12, 18, 24, 30 and 36 months of age. Enrollment will occur at time of first visit to the antenatal clinic during the second trimester when peripheral blood, stool, and urine samples will be obtained from each pregnant woman. A finger stick blood sample will be obtained from the mothers at each subsequent antenatal visit to assess the presence of malaria during pregnancy. An ultrasound examination will be done on the mothers at the initial antenatal visit to assess gestational age and at 26-30 weeks to assure proper growth and development of fetus and to screen for any potential problems. At delivery venous and finger stick blood, stool, and urine will be obtained from the mother. Umbilical cord and placental blood, and a placental biopsy will be obtained, and thereafter infants will be followed every 6 months (plus or minus 2 months). A physical examination of infants will be done and peripheral blood, stool, and urine will be obtained from infants. The study population will also include about 20 healthy adult North American control subjects with no malaria exposure or infection and about 40 adult Kenyans who either have been exposed to malaria or have asymptomatic malaria infection.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- Up to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plasmodium Falciparum Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.