MalariaNCT04650815
Malaria Transmission in Humans and Mosquitoes at the Area of Sabou, Burkina Faso
An observational study of Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in Burkina Faso.
Trial summary
Background: Malaria is a disease that affects many people in Burkina Faso. It is caused by germs that are spread by mosquito bites. A vaccine that blocks the spread of malaria is important to get rid of the disease. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Malaria
- How many people
- 608 participants
- Where
- 2 sitesBurkina Faso
- Study dates
- 10 Jun 2021to 25 Jun 2024
- 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 and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Up to 900 volunteers (ages 0.5 - 65 years) from Sabou Health District area will be recruited for this study.
- HOUSEHOLD INCLUSION CRITERIA:
In order to be included in the study, households must meet all of the following inclusion criteria:
- Household with at least 3 residents eligible for participation.
- Household with at least one compound member who is below 5 years of age whose parents or caretakers are willing to provide informed consent for the child to participate
- Household with at least one compound member aged 5-15 years whose parents or caretakers are willing to provide informed consent for the child to participate
- Household members willing to accommodate mosquito sampling in their compound, both indoors and outdoors.
SUBJECT INCLUSION CRITERIA:
- 0.5 to 65 years of age
- Known resident within the study area and planning to remain for the duration of the study
- Acceptance and signature of the written informed consent and the assent for children aged 12-19 years who are not otherwise emancipated
SUBJECT EXCLUSION CRITERIA:
- Major congenital defect diagnosed based on medical history and examination
- 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.
- Current participation in malaria vaccine trials or participation in such trials in the last 2 years
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Community Dynamics of Malaria Transmission in Humans and Mosquitoes at the Area of Sabou, Burkina Faso
Background:
Malaria is a disease that affects many people in Burkina Faso. It is caused by germs that are spread by mosquito bites. A vaccine that blocks the spread of malaria is important to get rid of the disease. To see if a vaccine works, researchers need to find out how many malaria infections are happening in the community.
Read more
Objective:
To learn how often people of all ages who live in Sabou, Burkina Faso, get malaria.
Eligibility:
Healthy people ages 6 months to 65 years who reside in Sabou in a household with adults and children.
Design:
Participants will be screened with questions about their health. They will have a physical exam.
Participants will be asked about any malaria symptoms they are having. They will be asked about the use of bed nets. Their vital signs, like blood pressure and temperature, will be measured.
They will have blood taken from their arm with a needle.
Participants who have a fever will have a malaria test. Those who test positive for malaria will be referred to the local health facility for treatment.
Participants will have monthly study visits. Blood will be taken from a finger.
Participants may be invited to take part in 2 mosquito feeding experiments. Mosquitos that do not carry malaria will bite their arm. And a small amount of blood will be fed to mosquitos in a laboratory.
Participants' homes will be examined for mosquitoes. Researchers will remove all mosquitoes they collect. Participants' homes will be sprayed with a chemical to kill mosquitoes and other insects.
Participation will last for 12 months.
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 vaccines 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 elsewhere on the continent in Mali, and we expect to expand TBV studies here in Burkina Faso in the future. This protocol will use a longitudinal cohort to gather information on the rates of blood smear positive individuals by month, season and year at Sabou Health district area, Burkina Faso. Individuals in the villages 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. Parasite rates in locally caught mosquitoes will be assessed longitudinally for differences by season and year.
A total of 600 volunteers from Sabou area will be enrolled. Participants aged 0.5-65 years will have monthly blood sampling and mosquito collection at their household. Participants will be followed for up to 1 year, to collect data that will guide the design of future community-based trials of TBV.
- Conditions
- Malaria
- Keywords
- Assays, BLOOD SAMPLING, Parasites, Gametocyte, Infection, 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 |
|---|---|---|
| 0.5 - 5 Years | Infants and Children up to age 5 years in the Sabou Health District | |
| 10 - 18 Years | Children ranging in age 10 to 18 years in the Sabou Health District | |
| 19 + Years | Adults ranging in ages 19 years to 65 years in the Sabou Health District | |
| 5 - 10 Years | Children ranging in age 5 years through 10 years in the Sabou Health District |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of blood smear positive individuals by age over the course of one year. These estimates will be stratified by age brackets of transmission interest (0.5-5, 5-10, 10-18, 19+ years old)
Monthly rates of blood smear positive individuals by age over the course of one year
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start10 Jun 2021
- Primary completion25 Jun 2024
- Study completion25 Jun 2024
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 608 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Patrick E Duffy, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650815
- Sponsor's protocol ID
- 10000135
- Other IDs
- 000135-I
- Status last verified
- Mar 2026
- First submitted
- 2 Dec 2020
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data because collected data will be used to guide the design of future community-based trials of TBV.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Dynamics of Malaria Transmission in Humans and Mosquitoes at the Area of Sabou, Burkina Faso
- ClinicalTrials.gov ID
- NCT04650815
- Acronym / sponsor ID
- 10000135
- Conditions
- Malaria
- Keywords
- Assays, BLOOD SAMPLING, Parasites, Gametocyte, Infection, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 608 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 3 Dec 2020 (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:
Malaria is a disease that affects many people in Burkina Faso. It is caused by germs that are spread by mosquito bites. A vaccine that blocks the spread of malaria is important to get rid of the disease. To see if a vaccine works, researchers need to find out how many malaria infections are happening in the community.
Objective:
To learn how often people of all ages who live in Sabou, Burkina Faso, get malaria.
Eligibility:
Healthy people ages 6 months to 65 years who reside in Sabou in a household with adults and children.
Design:
Participants will be screened with questions about their health. They will have a physical exam.
Participants will be asked about any malaria symptoms they are having. They will be asked about the use of bed nets. Their vital signs, like blood pressure and temperature, will be measured.
They will have blood taken from their arm with a needle.
Participants who have a fever will have a malaria test. Those who test positive for malaria will be referred to the local health facility for treatment.
Participants will have monthly study visits. Blood will be taken from a finger.
Participants may be invited to take part in 2 mosquito feeding experiments. Mosquitos that do not carry malaria will bite their arm. And a small amount of blood will be fed to mosquitos in a laboratory.
Participants' homes will be examined for mosquitoes. Researchers will remove all mosquitoes they collect. Participants' homes will be sprayed with a chemical to kill mosquitoes and other insects.
Participation will last for 12 months.
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 vaccines 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 elsewhere on the continent in Mali, and we expect to expand TBV studies here in Burkina Faso in the future. This protocol will use a longitudinal cohort to gather information on the rates of blood smear positive individuals by month, season and year at Sabou Health district area, Burkina Faso. Individuals in the villages 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. Parasite rates in locally caught mosquitoes will be assessed longitudinally for differences by season and year.
A total of 600 volunteers from Sabou area will be enrolled. Participants aged 0.5-65 years will have monthly blood sampling and mosquito collection at their household. Participants will be followed for up to 1 year, 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
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.5 - 5 Years | – | –Infants and Children up to age 5 years in the Sabou Health District |
| 10 - 18 Years | – | –Children ranging in age 10 to 18 years in the Sabou Health District |
| 19 + Years | – | –Adults ranging in ages 19 years to 65 years in the Sabou Health District |
| 5 - 10 Years | – | –Children ranging in age 5 years through 10 years in the Sabou Health District |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Up to 900 volunteers (ages 0.5 - 65 years) from Sabou Health District area will be recruited for this study.
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 blood smear positive individuals by age over the course of one year. These estimates will be stratified by age brackets of transmission interest (0.5-5, 5-10, 10-18, 19+ years old)
Time frame: one year
Monthly rates of blood smear positive individuals by age over the course of one year
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 30 Mar 2026.
- Individual participant dataSharing planned: No. No plan to share individual participant data because collected data will be used to guide the design of future community-based trials of TBV.
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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.
Patrick E Duffy, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
2 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 2 sites in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Burkina Faso. 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 blood smear positive individuals by age over the course of one year. These estimates will be stratified by age brackets of transmission interest (0.5-5, 5-10, 10-18, 19+ years old) (time frame: one year). 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 30 Mar 2026.