MalariaNCT00772642
Immune Parameters in the Cord Blood of Newborns Exposed to Malaria in the Womb
An observational study of Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
Trial summary
This study, conducted by the Malaria Research and Training Center at the University of Bamako, Mali, and the NIAID, will examine how exposure to the malaria parasite in the womb affects the developing immune system of newborns. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Malaria
- How many people
- 120 participants
- Where
- 1 siteMali
- Study dates
- 8 Oct 2008to 10 Sep 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 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years
- Healthy female in 3rd trimester of pregnancy
- Resident of Bancoumana
- Willingness to allow cord and placental blood samples to be stored and used for future studies of the immune response to malaria
- Ability to give informed consent and willingness to comply with study requirements and procedures
Who cannot join
- Currently taking corticosteroids or other immunosuppressants
- Underlying heart disease, bleeding disorder, or other condition that in the judgment of the Principal Investigator (PI) could increase the risk to the volunteer
- Fever greater than or equal to 37.5 degree C or evidence of an acute infection
- Anemia (hemoglobin less than 9 g/dL)
- Participation in another clinical protocol that requires the administration of an experimental vaccine or experimental treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Profiling Immunological Parameters in the Cord Blood of Neonates Exposed to Plasmodium Falciparum in Utero
This study, conducted by the Malaria Research and Training Center at the University of Bamako, Mali, and the NIAID, will examine how exposure to the malaria parasite in the womb affects the developing immune system of newborns. Little is known about how such exposure in the womb may affect the immune system or alter the risk of malaria or responsiveness to vaccination after birth. A better understanding of this process may provide information useful for childhood vaccination strategies in areas where malaria is widespread.
Women 18 years of age and older who live in Bancoumana and are in their last trimester of pregnancy and in good health may be eligible for this study.
Read more
Participants have blood samples drawn from a finger stick and through a needle placed in a vein two times for this study: when they enroll in the study and again when they go to the Bancoumana Health Center to deliver their baby. After the baby and placenta are delivered, blood is collected from the umbilical cord and placenta.
...
Read the detailed description
In malaria endemic areas the fetus is at risk for in utero exposure to Plasmodium falciparum or its soluble products. Little is known about how this exposure modulates the developing fetal immune system, or how this may alter the risk of malaria or responsiveness to vaccination after birth. A clearer understanding of this process may inform childhood vaccination strategies in malaria endemic areas. The objective of this cross-sectional exploratory study is to define the immune profile associated with in utero exposure to P. falciparum by analyzing cord blood samples collected at a site of high malaria transmission in Mali, and to compare this profile to that of U.S. cord blood samples. Pregnant women will be invited to participate in this study during the 3rd trimester of pregnancy. A finger stick blood draw will be collected from the mother at enrollment and peri-partum to determine if she is infected with P. falciparum. Cord blood and placental blood samples will be collected post-partum and processed to obtain mononuclear cells and serum. Cord blood can be obtained from the placenta after delivery without risk to mother or infant and will be used for research purposes only. Mononuclear cells will be analyzed by flow cytometry to characterize subsets of B, T and innate immune cells. Functional assays such as the B and T cell ELISPOT assay and measurements of cytokines in response to in vitro stimulation will also be performed.
- Conditions
- Malaria
- Keywords
- Cross-Sectional, Plasmodium Falciparum Malaria, Cord Blood, Immunology, Mali, Malaria
- Medical subject headings
- Malaria, Malaria, Falciparum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study start8 Oct 2008
- Study completion10 Sep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772642
- Sponsor's protocol ID
- 999909004
- Other IDs
- 09-I-N004
- Status last verified
- 10 Sep 2010
- First submitted
- 11 Oct 2008
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Breman JG. The ears of the hippopotamus: manifestations, determinants, and estimates of the malaria burden. Am J Trop Med Hyg. 2001 Jan-Feb;64(1-2 Suppl):1-11. doi: 10.4269/ajtmh.2001.64.1.
PubMed 11425172Brustoski K, Kramer M, Moller U, Kremsner PG, Luty AJ. Neonatal and maternal immunological responses to conserved epitopes within the DBL-gamma3 chondroitin sulfate A-binding domain of Plasmodium falciparum erythrocyte membrane protein 1. Infect Immun. 2005 Dec;73(12):7988-95. doi: 10.1128/IAI.73.12.7988-7995.2005.
PubMed 16299291Desowitz RS. Prenatal immune priming in malaria: antigen-specific blastogenesis of cord blood lymphocytes from neonates born in a setting of holoendemic malaria. Ann Trop Med Parasitol. 1988 Apr;82(2):121-5. doi: 10.1080/00034983.1988.11812218.
PubMed 2460040
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profiling Immunological Parameters in the Cord Blood of Neonates Exposed to Plasmodium Falciparum in Utero
- ClinicalTrials.gov ID
- NCT00772642
- Acronym / sponsor ID
- 999909004
- Conditions
- Malaria
- Keywords
- Cross-Sectional, Plasmodium Falciparum Malaria, Cord Blood, Immunology, Mali, Malaria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 8 Oct 2008
- Study completion
- 10 Sep 2010
- First posted
- 15 Oct 2008 (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.
This study, conducted by the Malaria Research and Training Center at the University of Bamako, Mali, and the NIAID, will examine how exposure to the malaria parasite in the womb affects the developing immune system of newborns. Little is known about how such exposure in the womb may affect the immune system or alter the risk of malaria or responsiveness to vaccination after birth. A better understanding of this process may provide information useful for childhood vaccination strategies in areas where malaria is widespread.
Women 18 years of age and older who live in Bancoumana and are in their last trimester of pregnancy and in good health may be eligible for this study.
Participants have blood samples drawn from a finger stick and through a needle placed in a vein two times for this study: when they enroll in the study and again when they go to the Bancoumana Health Center to deliver their baby. After the baby and placenta are delivered, blood is collected from the umbilical cord and placenta.
...
Detailed description
In malaria endemic areas the fetus is at risk for in utero exposure to Plasmodium falciparum or its soluble products. Little is known about how this exposure modulates the developing fetal immune system, or how this may alter the risk of malaria or responsiveness to vaccination after birth. A clearer understanding of this process may inform childhood vaccination strategies in malaria endemic areas. The objective of this cross-sectional exploratory study is to define the immune profile associated with in utero exposure to P. falciparum by analyzing cord blood samples collected at a site of high malaria transmission in Mali, and to compare this profile to that of U.S. cord blood samples. Pregnant women will be invited to participate in this study during the 3rd trimester of pregnancy. A finger stick blood draw will be collected from the mother at enrollment and peri-partum to determine if she is infected with P. falciparum. Cord blood and placental blood samples will be collected post-partum and processed to obtain mononuclear cells and serum. Cord blood can be obtained from the placenta after delivery without risk to mother or infant and will be used for research purposes only. Mononuclear cells will be analyzed by flow cytometry to characterize subsets of B, T and innate immune cells. Functional assays such as the B and T cell ELISPOT assay and measurements of cytokines in response to in vitro stimulation will also be performed.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age greater than or equal to 18 years
- Healthy female in 3rd trimester of pregnancy
- Resident of Bancoumana
- Willingness to allow cord and placental blood samples to be stored and used for future studies of the immune response to malaria
- Ability to give informed consent and willingness to comply with study requirements and procedures
Key exclusion criteria (5 listed)
- Currently taking corticosteroids or other immunosuppressants
- Underlying heart disease, bleeding disorder, or other condition that in the judgment of the Principal Investigator (PI) could increase the risk to the volunteer
- Fever greater than or equal to 37.5 degree C or evidence of an acute infection
- Anemia (hemoglobin less than 9 g/dL)
- Participation in another clinical protocol that requires the administration of an experimental vaccine or experimental treatment.
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 2 Jul 2017.
- Background: PubMed 11425172Breman JG. The ears of the hippopotamus: manifestations, determinants, and estimates of the malaria burden. Am J Trop Med Hyg. 2001 Jan-Feb;64(1-2 Suppl):1-11. doi: 10.4269/ajtmh.2001.64.1.
- Background: PubMed 16299291Brustoski K, Kramer M, Moller U, Kremsner PG, Luty AJ. Neonatal and maternal immunological responses to conserved epitopes within the DBL-gamma3 chondroitin sulfate A-binding domain of Plasmodium falciparum erythrocyte membrane protein 1. Infect Immun. 2005 Dec;73(12):7988-95. doi: 10.1128/IAI.73.12.7988-7995.2005.
- Background: PubMed 2460040Desowitz RS. Prenatal immune priming in malaria: antigen-specific blastogenesis of cord blood lymphocytes from neonates born in a setting of holoendemic malaria. Ann Trop Med Parasitol. 1988 Apr;82(2):121-5. doi: 10.1080/00034983.1988.11812218.
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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 Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
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 5 inclusion and 5 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 2 Jul 2017. 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 Mali. 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?
On the ClinicalTrials.gov record for NCT00772642, which also lists 3 linked publications.
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 2 Jul 2017.