MalariaNCT03304704
Community Dynamics of Malaria Transmission and Mosquito Feeding in Bancoumana, Mali
An observational study of Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in Mali.
Trial summary
Background: Half of the world's population is at risk of malaria. Malaria is a disease that affects many people in Mali and other parts of Africa. It is caused by germs spread by mosquito bites. Malaria may be mild. But it can also be serious or can lead to death if it is not diagnosed and treated promptly. Read more about this study
- Who is it for?
- Ages 6 months to 65 years
- Conditions the study is for
- Malaria
- How many people
- 1,928 participants
- Where
- 3 sitesMali
- Study dates
- 28 Jan 2018to 12 Jul 2020
- 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 6 months to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Known resident of Bancoumana, Doneguebougou or the surrounding villages; and Willingness to allow stored laboratory specimens to be used for future research@@@@@@
Who may be able to join
- GENOTYPE ONLY COHORT
- Any age
- Known resident of Bancoumana or the surrounding villages
- Acceptance and signature of the written informed consent and the assent for children aged 12-17 years
- Willingness to allow stored laboratory specimens to be used for future research
- PARASITE SURVEILLANCE COHORT
Show all 17Show fewer
- 6 months to 65 years of age
- Known resident of Bancoumana or the surrounding villages
- Willingness to allow stored laboratory specimens to be used for future research
- Acceptance and signature of the written informed consent and the assent for children aged 12-17 years
- DSF COHORT
- Aged between 5 and 65 years, inclusive
- Good general health as determined by review of medical history and/or clinical testing at the time of screening
- Known resident of Bancoumana or the surrounding villages
- Willingness to allow stored laboratory specimens to be used for future research
- Willingness to undergo DSF
- Acceptance and signature of the written informed consent and the assent for children aged 12-17 years
Who cannot join
- GENOTYPE ONLY COHORT
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the study protocol
- Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol
- PARASITE SURVEILLANCE CHORT
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the study protocol
- Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol
Show all 12Show fewer
- Currently enrolled participant in protocol 17-I-N006 or another active LMIV/MRTC vaccine clinical trial
- DSF COHORT
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the study protocol
- Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol
- Currently enrolled participant in protocol 17-I-N006 or another LMIV/MRTC vaccine clinical trial
- History of severe reaction to mosquito bites
Trial locations and contacts
3 sites in 1 country.
Mali3 sites
Bancoumana Malaria Vaccine Center
Bamako
Univ of Sciences, Techniques and Technology
Bamako
Doneguebougou Facility
Donéguébougou
About this study
Official title: Community Dynamics of Malaria Transmission and Mosquito Feeding in Bancoumana and Doneguebougou, Mali
Background:
Half of the world's population is at risk of malaria. Malaria is a disease that affects many people in Mali and other parts of Africa. It is caused by germs spread by mosquito bites. Malaria may be mild. But it can also be serious or can lead to death if it is not diagnosed and treated promptly. Researchers want to learn more about the disease so they can develop new approaches to malaria control.
Read more
Objective:
To collect data on how mosquitoes spread malaria and how many people get malaria in the community by comparing different areas, seasons, and years.
Eligibility:
Residents of a certain area of Mali who are of any age
Design:
Participants will be screened with a physical exam and medical history.
All participants will have at least 1 visit. They will answer questions about their health and malaria. They may have a physical exam. They will have blood collected.
Some participants will have 1 visit every month for 3 years. They will repeat the procedures above.
These participants will have mosquitoes collected in their home monthly. They may be able to catch some of the mosquitoes alive or may need to use a spray to kill the mosquitoes. Participants in this part of the study can be up to 65 years old.
Some participants will also have about 60 mosquitoes directly feed on their arm or leg for 15-20 minutes each month. These participants must be 5-65 years old.
...
Read the detailed description
A vaccine that interrupts malaria transmission is critical to eradicate the disease, but improved assays are needed to measure the efficacy of vaccines. Transmission-blocking vaccines (TBVs) work by inducing antibodies in vaccinees that inhibit parasite development in the mosquito interrupting transmission. Efficacy of vaccines may be estimated by in vitro membrane feeding assays using immune sera and laboratory mosquitoes, but qualified assays that measure transmission in the field are needed to assess transmission-blocking interventions in natura. Clinical trials of TBV have started in Bancoumana and Doneguebougou, and we expect to expand TBV studies here and in adjacent areas in the future. This protocol will use a longitudinal cohort to gather information on mosquito feeding and infection patterns in Bancoumana, Doneguebougou and surrounding villages in Mali. Individuals actively participating in LMIV vaccine trials will be approached first for participation, including permission to contact their household and neighbors of their compound for participation. Households will be identified using census data and individuals will be consented for participation. Malaria smears will be obtained at monthly visits, in conjunction with mosquito collections in/around village residences and with direct skin feeds (DSFs) using insectary-raised mosquitoes. Parasite transmission to mosquitoes will be assessed longitudinally for differences by season and year, and compared between wild-caught and laboratory-raised mosquitoes. Data will also be obtained on gametocyte and parasite carriage rates by season and year. Genotyping of individual subjects will be performed to pair with the bloodmeals of wild-caught mosquitoes.
A total of 3,200 volunteers from Bancoumana, Doneguebougou and surrounding areas will be enrolled into three distinct cohorts. The Genotype Only Cohort (n=1000), which will include the vaccine trial participants, will complete a single visit to obtain a blood sample for genotyping with no additional follow up. The DSF Cohort (n=1200) will enroll subjects aged 5 to 65 years for monthly blood sampling, DSF, and mosquito collection at their household. The Parasite Surveillance Cohort (n=1000) will enroll subjects under the age of 5 years (as young as 6 months) and subjects of any age who are unwilling to participate in DSF; they will have monthly blood sampling and mosquito collection at their household. Enrollment into the Genotype and Parasite Surveillance Cohorts will be linked to full enrollment of the DSF Cohort. Participants in the Parasite Surveillance and DSF cohorts, will be followed for up to 3 years, to collect data that will guide the design of future community-based trials of TBV.
- Conditions
- Malaria
- Keywords
- Assays, Direct Skin Feeds, Infection, Parasite, Gametocyte, Natural History
- Medical subject headings
- Malaria, Infections
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 |
|---|---|---|
| DSF Cohort | Accrual/Screening up to 1800 will include volunteers between the ages of 5 and 17 years and will be enrolled for genotyping and monthly blood sampling | |
| Genotype Cohort | Accrual/Screening up to 1500 will complete a single visit with blood draw for genotyping for future fidelity assessments with blood-fed, spray wild-caught mosquitoes. | |
| Parasite Surveillance Cohort | Accrual/Screening up to 1500 will be enrolled for genotyping and a minimum of six monthly blood sampling and mosquito wild catches wild-caught mosquitoes within their compound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of estimated rates of Infection rate in mosquitoes by DSF measured as the rate (per blood-fed mosquito) of malaria transmission (human to mosquito)
Infection rate in mosquitoes by DSF measured as the rate (per blood-fed mosquito) of malaria transmission (human to mosquito; and Infection rate in live wild-caught mosquitoes measured as the rate (per blood-fed mosquito) of malaria transmission (human to mosquito)
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start28 Jan 2018
- Primary completion12 Jul 2020
- Study completion12 Jul 2020
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
- 1,928 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jennifer C Hume, Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304704
- Sponsor's protocol ID
- 999917180
- Other IDs
- 17-I-N180
- Status last verified
- Feb 2025
- First submitted
- 6 Oct 2017
- Last updated
- 10 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Toure YT, Doumbo O, Toure A, Bagayoko M, Diallo M, Dolo A, Vernick KD, Keister DB, Muratova O, Kaslow DC. Gametocyte infectivity by direct mosquito feeds in an area of seasonal malaria transmission: implications for Bancoumana, Mali as a transmission-blocking vaccine site. Am J Trop Med Hyg. 1998 Sep;59(3):481-6. doi: 10.4269/ajtmh.1998.59.481.
PubMed 9749648Diallo M, Toure AM, Traore SF, Niare O, Kassambara L, Konare A, Coulibaly M, Bagayogo M, Beier JC, Sakai RK, Toure YT, Doumbo OK. Evaluation and optimization of membrane feeding compared to direct feeding as an assay for infectivity. Malar J. 2008 Dec 2;7:248. doi: 10.1186/1475-2875-7-248.
PubMed 19055715Drakeley C, Sutherland C, Bousema JT, Sauerwein RW, Targett GA. The epidemiology of Plasmodium falciparum gametocytes: weapons of mass dispersion. Trends Parasitol. 2006 Sep;22(9):424-30. doi: 10.1016/j.pt.2006.07.001. Epub 2006 Jul 17.
PubMed 16846756
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Dynamics of Malaria Transmission and Mosquito Feeding in Bancoumana and Doneguebougou, Mali
- ClinicalTrials.gov ID
- NCT03304704
- Acronym / sponsor ID
- 999917180
- Conditions
- Malaria
- Keywords
- Assays, Direct Skin Feeds, Infection, Parasite, Gametocyte, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,928 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 28 Jan 2018 (actual)
- Primary completion
- 12 Jul 2020 (actual)
- Study completion
- 12 Jul 2020 (actual)
- First posted
- 9 Oct 2017 (actual)
- 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:
Half of the world's population is at risk of malaria. Malaria is a disease that affects many people in Mali and other parts of Africa. It is caused by germs spread by mosquito bites. Malaria may be mild. But it can also be serious or can lead to death if it is not diagnosed and treated promptly. Researchers want to learn more about the disease so they can develop new approaches to malaria control.
Objective:
To collect data on how mosquitoes spread malaria and how many people get malaria in the community by comparing different areas, seasons, and years.
Eligibility:
Residents of a certain area of Mali who are of any age
Design:
Participants will be screened with a physical exam and medical history.
All participants will have at least 1 visit. They will answer questions about their health and malaria. They may have a physical exam. They will have blood collected.
Some participants will have 1 visit every month for 3 years. They will repeat the procedures above.
These participants will have mosquitoes collected in their home monthly. They may be able to catch some of the mosquitoes alive or may need to use a spray to kill the mosquitoes. Participants in this part of the study can be up to 65 years old.
Some participants will also have about 60 mosquitoes directly feed on their arm or leg for 15-20 minutes each month. These participants must be 5-65 years old.
...
Detailed description
A vaccine that interrupts malaria transmission is critical to eradicate the disease, but improved assays are needed to measure the efficacy of vaccines. Transmission-blocking vaccines (TBVs) work by inducing antibodies in vaccinees that inhibit parasite development in the mosquito interrupting transmission. Efficacy of vaccines may be estimated by in vitro membrane feeding assays using immune sera and laboratory mosquitoes, but qualified assays that measure transmission in the field are needed to assess transmission-blocking interventions in natura. Clinical trials of TBV have started in Bancoumana and Doneguebougou, and we expect to expand TBV studies here and in adjacent areas in the future. This protocol will use a longitudinal cohort to gather information on mosquito feeding and infection patterns in Bancoumana, Doneguebougou and surrounding villages in Mali. Individuals actively participating in LMIV vaccine trials will be approached first for participation, including permission to contact their household and neighbors of their compound for participation. Households will be identified using census data and individuals will be consented for participation. Malaria smears will be obtained at monthly visits, in conjunction with mosquito collections in/around village residences and with direct skin feeds (DSFs) using insectary-raised mosquitoes. Parasite transmission to mosquitoes will be assessed longitudinally for differences by season and year, and compared between wild-caught and laboratory-raised mosquitoes. Data will also be obtained on gametocyte and parasite carriage rates by season and year. Genotyping of individual subjects will be performed to pair with the bloodmeals of wild-caught mosquitoes.
A total of 3,200 volunteers from Bancoumana, Doneguebougou and surrounding areas will be enrolled into three distinct cohorts. The Genotype Only Cohort (n=1000), which will include the vaccine trial participants, will complete a single visit to obtain a blood sample for genotyping with no additional follow up. The DSF Cohort (n=1200) will enroll subjects aged 5 to 65 years for monthly blood sampling, DSF, and mosquito collection at their household. The Parasite Surveillance Cohort (n=1000) will enroll subjects under the age of 5 years (as young as 6 months) and subjects of any age who are unwilling to participate in DSF; they will have monthly blood sampling and mosquito collection at their household. Enrollment into the Genotype and Parasite Surveillance Cohorts will be linked to full enrollment of the DSF Cohort. Participants in the Parasite Surveillance and DSF cohorts, will be followed for up to 3 years, to collect data that will guide the design of future community-based trials of TBV.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DSF Cohort | – | –Accrual/Screening up to 1800 will include volunteers between the ages of 5 and 17 years and will be enrolled for genotyping and monthly blood sampling |
| Genotype Cohort | – | –Accrual/Screening up to 1500 will complete a single visit with blood draw for genotyping for future fidelity assessments with blood-fed, spray wild-caught mosquitoes. |
| Parasite Surveillance Cohort | – | –Accrual/Screening up to 1500 will be enrolled for genotyping and a minimum of six monthly blood sampling and mosquito wild catches wild-caught mosquitoes within their compound |
Who may qualify
- Ages
- 6 months to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Known resident of Bancoumana, Doneguebougou or the surrounding villages; and Willingness to allow stored laboratory specimens to be used for future research@@@@@@
Key inclusion criteria (17 listed)
- GENOTYPE ONLY COHORT
- PARASITE SURVEILLANCE COHORT
- DSF COHORT
Key exclusion criteria (12 listed)
- GENOTYPE ONLY COHORT
- PARASITE SURVEILLANCE CHORT
- DSF COHORT
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
Measurement of estimated rates of Infection rate in mosquitoes by DSF measured as the rate (per blood-fed mosquito) of malaria transmission (human to mosquito)
Time frame: Up to 3 years
Infection rate in mosquitoes by DSF measured as the rate (per blood-fed mosquito) of malaria transmission (human to mosquito; and Infection rate in live wild-caught mosquitoes measured as the rate (per blood-fed mosquito) of malaria transmission (human to mosquito)
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 10 Feb 2025.
- Background: PubMed 9749648Toure YT, Doumbo O, Toure A, Bagayoko M, Diallo M, Dolo A, Vernick KD, Keister DB, Muratova O, Kaslow DC. Gametocyte infectivity by direct mosquito feeds in an area of seasonal malaria transmission: implications for Bancoumana, Mali as a transmission-blocking vaccine site. Am J Trop Med Hyg. 1998 Sep;59(3):481-6. doi: 10.4269/ajtmh.1998.59.481.
- Background: PubMed 19055715Diallo M, Toure AM, Traore SF, Niare O, Kassambara L, Konare A, Coulibaly M, Bagayogo M, Beier JC, Sakai RK, Toure YT, Doumbo OK. Evaluation and optimization of membrane feeding compared to direct feeding as an assay for infectivity. Malar J. 2008 Dec 2;7:248. doi: 10.1186/1475-2875-7-248.
- Background: PubMed 16846756Drakeley C, Sutherland C, Bousema JT, Sauerwein RW, Targett GA. The epidemiology of Plasmodium falciparum gametocytes: weapons of mass dispersion. Trends Parasitol. 2006 Sep;22(9):424-30. doi: 10.1016/j.pt.2006.07.001. Epub 2006 Jul 17.
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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.
Jennifer C Hume principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
3 sites 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 3 sites 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 17 inclusion and 12 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 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Measurement of estimated rates of Infection rate in mosquitoes by DSF measured as the rate (per blood-fed mosquito) of malaria transmission (human to mosquito) (time frame: Up to 3 years). 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 NCT03304704, 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 10 Feb 2025.