MalariaNCT02659566
Impact of Antimalarial Treatment on Measures of T Cell Suppression/Regulation in Healthy Adults From Doneguebougou, Mali
An observational study of Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
Trial summary
Background: Malaria is a disease that affects many people in the country of Mali and other parts of Africa. It is caused by germs that are spread by mosquito bites. Malaria may be mild, but can also be serious or can lead to death if not diagnosed and treated promptly. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- How many people
- 290 participants
- Where
- 1 siteMali
- Study dates
- 15 Jan 2016to 12 Jun 2018
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A study participant must satisfy the following criteria to be enrolled in this study:
- Provide individual informed consent
- Adult between ages of 18 and 60
- Willingness to have blood samples stored for future research
- Known resident of Ouelessebougou or surrounding area
Who cannot join
- A subject will be excluded from participating in this trial if any one of the following criteria is fulfilled:
- Known to be pregnant (by history) or positive pregnancy test
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, psychiatric, or renal disease by history and/or physical examination that may impact the subject s overall health and immune system
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply with the study protocol
- Use of chronic (greater than or equal to14 days) oral or intravenous corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone >10 mg/day) or immunosuppressive drugs within 30 days of Study Day 0
- Receipt of Coartem within less than 14 days from Study Day 0
Show all 11Show fewer
- Known allergies or contraindications (such as significant cardiac disease prolonged QTc >450 ms; currently taking medications that may prolong your QTc; serious side effects from Coartem in the past) to study treatment (Coartem [artemether/lumefantrine])
- Receipt of investigational malaria vaccine within the last 5 years
- Enrollment in another investigational trial during the study period (participating in screening for other investigational trials is permitted)
- Tested positive for HIV or Hepatitis B or Hepatitis C.
- Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial, interfere with the evaluation of the study objectives, or would render the subject unable to comply with the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Antimalarial Treatment on Measures of T Cell Suppression/Regulation in Healthy Adults From Ouelessebougou, Mali
Background:
Malaria is a disease that affects many people in the country of Mali and other parts of Africa. It is caused by germs that are spread by mosquito bites. Malaria may be mild, but can also be serious or can lead to death if not diagnosed and treated promptly. Children younger than 5 years and pregnant women are at highest risk of malaria. Researchers want to better understand how malaria infection suppresses the immune system. They want to compare a group of adults who receive antimalarial treatment to a group that does not receive it.
Read more
Objective:
To investigate the effect of antimalarial treatment at the beginning of the dry season on the immune system and malaria episodes.
Eligibility:
Healthy adults ages 18-60 who live in the area of Doneguebougou, Mali.
Design:
Participants will be screened with a physical exam and health questions.
If participants are found to be sick at the screening visit, they will get initial care at the study clinic free of charge. They may get referrals for consultation.
Participants will be randomly assigned to a group. One group will get an approved antimalarial drug called Coartem . The other will not receive it.
Participants in the Coartem group will take the drug for 3 days.
All participants will have blood tests.
Al participants will be seen about once a month for about 1 year. At each visit, they will be asked how they are feeling and be examined. Blood will be drawn.
If participants become sick at any time, they will come to the clinic to be examined.
Read the detailed description
Malaria, caused by Plasmodium falciparum, is a devastating disease that causes significant mortality and morbidity both directly and indirectly in endemic regions. Lower all-cause mortality in children under five years of age have resulted from better malaria transmission control measures in endemic regions.
It has been seen in multiple studies that malaria infection, including asymptomatic carriage, suppresses or modulates the immune system; how exactly this suppression is achieved is unclear. Currently, efforts to develop long-lasting, effective vaccines to combat malaria have not been successful. One of the impediments of concern is poor immune response to the vaccine candidates. Understanding the immunomodulatory effects of malaria infection to vaccine responses and to subsequent malaria infection is thus key in these efforts.
In order to further understand how the presence of parasitemia may modulate the immune system, we propose to study the effects of treating a portion of adult volunteers with a treatment course of artemether/lumefantrine (Coartem ) at the beginning of the dry season (approximately January) in Ouelessebougou, Mali to clear parasitemia carriage during the dry season and following them for the next 10-12 months through an entire dry and wet season. We will enroll 50% blood smear or polymerase chain reaction (PCR) positive volunteers and distribute them equally into two groups at the beginning of the dry season, those who receive or do not receive antimalarial treatment. These subjects will then be followed monthly throughout the dry and rainy seasons to determine the effect of this treatment on T cell markers of suppression/regulation and the incidence of asymptomatic malaria infection and clinical malaria. We hypothesize that markers of T cell suppression/regulation throughout the dry season will be lower in adults who receive a single pre-emptive treatment with Coartem .
- Conditions
- Malaria
- Keywords
- Markers, Parasitemia, Coartem, Plasmodium, Infection
- Medical subject headings
- Malaria, Parasitemia, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the percentage of T cells expressing PD-1 during scheduled visits by comparing markers of T cell suppression/regulation in adults (specifically PD-1) who receive or do not receive antimalarial treatment at the beginning of dry season ...
Measured: Twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study start15 Jan 2016
- Primary completion12 Jun 2018
- Study completion12 Jun 2018
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Michal Fried, Ph.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659566
- Sponsor's protocol ID
- 999916051
- Other IDs
- 16-I-N051
- Status last verified
- 12 Jun 2018
- First submitted
- 15 Jan 2016
- Last updated
- 14 Jun 2018
- Results posted
- No
Publications
Cunnington AJ, Riley EM. Suppression of vaccine responses by malaria: insignificant or overlooked? Expert Rev Vaccines. 2010 Apr;9(4):409-29. doi: 10.1586/erv.10.16.
PubMed 20370551Illingworth J, Butler NS, Roetynck S, Mwacharo J, Pierce SK, Bejon P, Crompton PD, Marsh K, Ndungu FM. Chronic exposure to Plasmodium falciparum is associated with phenotypic evidence of B and T cell exhaustion. J Immunol. 2013 Feb 1;190(3):1038-47. doi: 10.4049/jimmunol.1202438. Epub 2012 Dec 21.
PubMed 23264654Moormann AM, Snider CJ, Chelimo K. The company malaria keeps: how co-infection with Epstein-Barr virus leads to endemic Burkitt lymphoma. Curr Opin Infect Dis. 2011 Oct;24(5):435-41. doi: 10.1097/QCO.0b013e328349ac4f.
PubMed 21885920
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Antimalarial Treatment on Measures of T Cell Suppression/Regulation in Healthy Adults From Ouelessebougou, Mali
- ClinicalTrials.gov ID
- NCT02659566
- Acronym / sponsor ID
- 999916051
- Conditions
- Malaria
- Keywords
- Markers, Parasitemia, Coartem, Plasmodium, Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 15 Jan 2016
- Primary completion
- 12 Jun 2018 (actual)
- Study completion
- 12 Jun 2018 (actual)
- First posted
- 20 Jan 2016 (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.
Background:
Malaria is a disease that affects many people in the country of Mali and other parts of Africa. It is caused by germs that are spread by mosquito bites. Malaria may be mild, but can also be serious or can lead to death if not diagnosed and treated promptly. Children younger than 5 years and pregnant women are at highest risk of malaria. Researchers want to better understand how malaria infection suppresses the immune system. They want to compare a group of adults who receive antimalarial treatment to a group that does not receive it.
Objective:
To investigate the effect of antimalarial treatment at the beginning of the dry season on the immune system and malaria episodes.
Eligibility:
Healthy adults ages 18-60 who live in the area of Doneguebougou, Mali.
Design:
Participants will be screened with a physical exam and health questions.
If participants are found to be sick at the screening visit, they will get initial care at the study clinic free of charge. They may get referrals for consultation.
Participants will be randomly assigned to a group. One group will get an approved antimalarial drug called Coartem . The other will not receive it.
Participants in the Coartem group will take the drug for 3 days.
All participants will have blood tests.
Al participants will be seen about once a month for about 1 year. At each visit, they will be asked how they are feeling and be examined. Blood will be drawn.
If participants become sick at any time, they will come to the clinic to be examined.
Detailed description
Malaria, caused by Plasmodium falciparum, is a devastating disease that causes significant mortality and morbidity both directly and indirectly in endemic regions. Lower all-cause mortality in children under five years of age have resulted from better malaria transmission control measures in endemic regions.
It has been seen in multiple studies that malaria infection, including asymptomatic carriage, suppresses or modulates the immune system; how exactly this suppression is achieved is unclear. Currently, efforts to develop long-lasting, effective vaccines to combat malaria have not been successful. One of the impediments of concern is poor immune response to the vaccine candidates. Understanding the immunomodulatory effects of malaria infection to vaccine responses and to subsequent malaria infection is thus key in these efforts.
In order to further understand how the presence of parasitemia may modulate the immune system, we propose to study the effects of treating a portion of adult volunteers with a treatment course of artemether/lumefantrine (Coartem ) at the beginning of the dry season (approximately January) in Ouelessebougou, Mali to clear parasitemia carriage during the dry season and following them for the next 10-12 months through an entire dry and wet season. We will enroll 50% blood smear or polymerase chain reaction (PCR) positive volunteers and distribute them equally into two groups at the beginning of the dry season, those who receive or do not receive antimalarial treatment. These subjects will then be followed monthly throughout the dry and rainy seasons to determine the effect of this treatment on T cell markers of suppression/regulation and the incidence of asymptomatic malaria infection and clinical malaria. We hypothesize that markers of T cell suppression/regulation throughout the dry season will be lower in adults who receive a single pre-emptive treatment with Coartem .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Provide individual informed consent
- Adult between ages of 18 and 60
- Willingness to have blood samples stored for future research
- Known resident of Ouelessebougou or surrounding area
Key exclusion criteria (11 listed)
- A subject will be excluded from participating in this trial if any one of the following criteria is fulfilled:
- Known to be pregnant (by history) or positive pregnancy test
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, psychiatric, or renal disease by history and/or physical examination that may impact the subject s overall health and immune system
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply with the study protocol
- Use of chronic (greater than or equal to14 days) oral or intravenous corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone >10 mg/day) or immunosuppressive drugs within 30 days of Study Day 0
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
To measure the percentage of T cells expressing PD-1 during scheduled visits by comparing markers of T cell suppression/regulation in adults (specifically PD-1) who receive or do not receive antimalarial treatment at the beginning of dry season ...
Time frame: Twelve months
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 14 Jun 2018.
- Background: PubMed 20370551Cunnington AJ, Riley EM. Suppression of vaccine responses by malaria: insignificant or overlooked? Expert Rev Vaccines. 2010 Apr;9(4):409-29. doi: 10.1586/erv.10.16.
- Background: PubMed 23264654Illingworth J, Butler NS, Roetynck S, Mwacharo J, Pierce SK, Bejon P, Crompton PD, Marsh K, Ndungu FM. Chronic exposure to Plasmodium falciparum is associated with phenotypic evidence of B and T cell exhaustion. J Immunol. 2013 Feb 1;190(3):1038-47. doi: 10.4049/jimmunol.1202438. Epub 2012 Dec 21.
- Background: PubMed 21885920Moormann AM, Snider CJ, Chelimo K. The company malaria keeps: how co-infection with Epstein-Barr virus leads to endemic Burkitt lymphoma. Curr Opin Infect Dis. 2011 Oct;24(5):435-41. doi: 10.1097/QCO.0b013e328349ac4f.
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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.
Michal Fried, Ph.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
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 11 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 14 Jun 2018. 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.
What does the primary outcome measure?
To measure the percentage of T cells expressing PD-1 during scheduled visits by comparing markers of T cell suppression/regulation in adults (specifically PD-1) who receive or do not receive antimalarial treatment at the beginning of dry season ... (time frame: Twelve months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02659566, 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 14 Jun 2018; AzTrials last refreshed its copy on 8 Nov 2026.