MalariaNCT00471302
Normal Immunological Parameters Among Healthy Volunteers in Kambila, Mali
An observational study of Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
Trial summary
This study will determine the immune response to malaria infection in healthy volunteers compared with malaria patients. Malaria affects millions of people in Mali and Africa. It can cause fever, headaches, body aches, and weakness. Without treatment, the disease can be very serious in children. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- How many people
- 310 participants
- Where
- 1 siteMali
- Study dates
- 1 Aug 2007to 23 May 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adults in a malaria endemic area in Mali
Who may be able to join
- Age 18 - 55 years
- Resident of Kambila, Tieneguebougou or Kalifabougou
- Adequate venous access
- Willingness to allow 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
- Anemia (hemoglobin less than 11 g/dL).
- Currently taking antimalarials, corticosteroids or other immunosuppressants.
- Underlying heart disease, bleeding disorder, or other conditions that in the judgment of the Principal Investigator (PI) could increase the risk to the volunteer.
- Fever greater than or equal to 37.5 degrees Celsius or evidence of an acute infection.
- Current pregnancy, as determined by urine dipstick test for pregnancy.
- 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: Establishment of Normal Immunological Parameters Among Healthy Volunteers in Kambila, Tieneguebougou, and Kalifabougou, Mali
This study will determine the immune response to malaria infection in healthy volunteers compared with malaria patients. Malaria affects millions of people in Mali and Africa. It can cause fever, headaches, body aches, and weakness. Without treatment, the disease can be very serious in children. Developing an effective vaccine against the parasite that causes malaria is a crucial step toward controlling the disease; however, vaccines tested so far have provided very short-lived protection. A better understanding of the natural immunity to malaria may provide insight that can be applied to developing a more effective vaccine.
People 18 years of age or older who live in Kambila, Tieneguebougou or Kalifabougou, Mali, and are in good health may be eligible for this study.
Participants undergo a complete physical examination at the start of the study and then once a year for the 4-year duration of the study. They have a maximum of nine clinic visits a year to collect blood samples for research. The visits last about one hour, including a 30-minute observation time after the blood draw.
Read the detailed description
Malaria results in at least 2.7 million deaths per year, the majority among African children. The development of a vaccine
against Plasmodium falciparum is regarded as a crucial step toward control of this disease. Unfortunately, vaccine
candidates have resulted in short-lived protection at best. The ineffectiveness of current vaccines may reflect the kinetics
of naturally acquired immunity to malaria in that multiple infections are required over years before partial protection is
achieved and then immunity is lost, or becomes less effective, in the absence of recurrent infection. The mechanisms
underlying the delayed acquisition and presumably rapid loss of humoral immunity are poorly understood. A more
detailed understanding of these processes at the cellular level may be important for vaccine development. We are
currently studying the cellular basis of humoral immunity to P. falciparum through research collaboration between the
Malaria Research and Training Center (MRTC) in Bamako, Mali and the National Institutes of Health (NIH) in the United
States. This protocol supports that research by ensuring a supply of blood samples from healthy Malian adults in order to
establish normal immunologic parameters for this population and to optimize research assays performed at the MRTC.
- Conditions
- Malaria
- Keywords
- Immunology, Mali, Donor, Natural History
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Healthy adults in a malaria endemic area in Mali |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishing immunological parameters
Establishing immunological parameters in healthy malaria-exposed adults including phenotypic and functional measurements of dendritic cells, monocytes, NK cells, B cells and T cells
Measured: Before and during the 6-month malaria season
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2007 (estimated)
- Study start1 Aug 2007
- Primary completion31 Dec 2021
- Study completion23 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Bamako
- Responsible party
- Sponsor
- Investigators
- Peter D Crompton, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471302
- Sponsor's protocol ID
- 999907141
- Other IDs
- 07-I-N141
- Status last verified
- May 2022
- First submitted
- 8 May 2007
- Last updated
- 1 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Normal Immunological Parameters Among Healthy Volunteers in Kambila, Tieneguebougou, and Kalifabougou, Mali
- ClinicalTrials.gov ID
- NCT00471302
- Acronym / sponsor ID
- 999907141
- Conditions
- Malaria
- Keywords
- Immunology, Mali, Donor, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- University of Bamako
- Study start
- 1 Aug 2007 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 23 May 2022 (actual)
- First posted
- 9 May 2007 (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 will determine the immune response to malaria infection in healthy volunteers compared with malaria patients. Malaria affects millions of people in Mali and Africa. It can cause fever, headaches, body aches, and weakness. Without treatment, the disease can be very serious in children. Developing an effective vaccine against the parasite that causes malaria is a crucial step toward controlling the disease; however, vaccines tested so far have provided very short-lived protection. A better understanding of the natural immunity to malaria may provide insight that can be applied to developing a more effective vaccine.
People 18 years of age or older who live in Kambila, Tieneguebougou or Kalifabougou, Mali, and are in good health may be eligible for this study.
Participants undergo a complete physical examination at the start of the study and then once a year for the 4-year duration of the study. They have a maximum of nine clinic visits a year to collect blood samples for research. The visits last about one hour, including a 30-minute observation time after the blood draw.
Detailed description
Malaria results in at least 2.7 million deaths per year, the majority among African children. The development of a vaccine
against Plasmodium falciparum is regarded as a crucial step toward control of this disease. Unfortunately, vaccine
candidates have resulted in short-lived protection at best. The ineffectiveness of current vaccines may reflect the kinetics
of naturally acquired immunity to malaria in that multiple infections are required over years before partial protection is
achieved and then immunity is lost, or becomes less effective, in the absence of recurrent infection. The mechanisms
underlying the delayed acquisition and presumably rapid loss of humoral immunity are poorly understood. A more
detailed understanding of these processes at the cellular level may be important for vaccine development. We are
currently studying the cellular basis of humoral immunity to P. falciparum through research collaboration between the
Malaria Research and Training Center (MRTC) in Bamako, Mali and the National Institutes of Health (NIH) in the United
States. This protocol supports that research by ensuring a supply of blood samples from healthy Malian adults in order to
establish normal immunologic parameters for this population and to optimize research assays performed at the MRTC.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Healthy adults in a malaria endemic area in Mali |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adults in a malaria endemic area in Mali
Key inclusion criteria (5 listed)
- Age 18 - 55 years
- Resident of Kambila, Tieneguebougou or Kalifabougou
- Adequate venous access
- Willingness to allow 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 (6 listed)
- Anemia (hemoglobin less than 11 g/dL).
- Currently taking antimalarials, corticosteroids or other immunosuppressants.
- Underlying heart disease, bleeding disorder, or other conditions that in the judgment of the Principal Investigator (PI) could increase the risk to the volunteer.
- Fever greater than or equal to 37.5 degrees Celsius or evidence of an acute infection.
- Current pregnancy, as determined by urine dipstick test for 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
Establishing immunological parameters
Time frame: Before and during the 6-month malaria season
Establishing immunological parameters in healthy malaria-exposed adults including phenotypic and functional measurements of dendritic cells, monocytes, NK cells, B cells and T cells
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 Jun 2022.
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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.
Peter D Crompton, M.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 6 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 Jun 2022. 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?
Establishing immunological parameters (time frame: Before and during the 6-month malaria season). It is what the study was designed to measure, not a finding.
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 Jun 2022.