MalariaNCT04969913
Community Dynamics of Malaria Transmission in Humans and Mosquitoes at Maferinyah Sub-Prefecture, Guinea
An observational study of Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in 2 countries.
Trial summary
Background: Half of the world s population is at risk of malaria. In 2015, there were 214 million cases of malaria and 438,000 deaths. A transmission-blocking vaccine (TBV) could help end the disease. Improved tests are needed to measure how well the vaccines work. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria
- How many people
- 400 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Mar 2022to 23 Oct 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy Guinean infants, children, and adults (any age) from Maferinyah sub-prefecture. Maferinyah is a town and sub-prefecture in the Forecariah Prefecture in the Kindia Region of western Guinea. Maferinyah is located about 50 kms directly to the west (and 75 kms by paved road) of Conakry, the capital city of Guinea
- SUBJECT INCLUSION CRITERIA:
- 6 months of age and above
- Known resident of Maferinyah sub-prefecture and planning to remain for duration of study
- 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 who are not otherwise emancipated
HOUSEHOLD INCLUSION CRITERIA:
To be eligible for participation, households must meet the following criteria:
- Household with at least 3 residents eligible for participation.
- Household with at least one compound member who is below 18 years of age 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 EXCLUSION CRITERIA:
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Immunology and Pathogenesis Laboratories
Bethesda, Maryland, 20892
About this study
Official title: Community Dynamics of Malaria Transmission in Humans and Mosquitoes at Maferinyah Sub-prefecture, Guinea
Background:
Half of the world s population is at risk of malaria. In 2015, there were 214 million cases of malaria and 438,000 deaths. A transmission-blocking vaccine (TBV) could help end the disease. Improved tests are needed to measure how well the vaccines work. Researchers want to collect data about malaria infection as the first step in testing a TBV in rural Guinea.
Read more
Objective:
To study community dynamics of malaria transmission by estimating the rate of blood smear positive people by month and season.
Eligibility:
People 6 months of age and older who live in Maf(SqrRoot)(Registered Trademark)rinyah sub-prefecture and plan to remain during the study. Households with at least 3 people who are eligible to take part in the study are also needed.
Design:
Participants will be screened with a medical and medicine history. They will have a physical exam. Their height and weight will be measured. Their vital signs may be taken.
Participants will have a study visit each month for up to 3 years. They will get a study ID. They will be asked about any symptoms of malaria or changes in health. They will give blood samples. They may have a physical exam. Within 3 days of the study visits, live and dead mosquitoes may be gathered in and around their home. Insecticide spray will be used.
Participants can visit the clinic at any time if they feel ill. If they have malaria, they will be treated according to Guinea National Malaria Control Guidelines for adults and children.
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 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 TBVs have started elsewhere on the continent in Mali, and we expect to expand TBV studies in Guinea in the near future. This protocol will use a longitudinal cohort to gather information of malaria transmission based on the rates of blood smear positive individuals by month, season and year in at Maferinyah sub-prefecture, Guinea.
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 infection rates in locally caught mosquitoes will be assessed longitudinally for differences by season and year. A total of 400 volunteers from Maferinyah will be enrolled. Participants 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, BLOOD SAMPLING, Parasites, Gametocytes, 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 |
|---|---|---|
| 19 + years | Healthy adults over the age of 19 years | |
| Ages 11 - 18 years | Healthy children between the ages of 11 and 18 years | |
| Ages 5 - 10 years | Healthy children between the ages of 5 and 10 years | |
| Ages 6 months - 4 years | Healthy infants between the ages of 6 months and four years |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study community dynamics of malaria transmission by estimating the rate of blood smear positive individuals by month and season stratified by age
Rate of blood smear positive individuals by month and season stratified by age
Measured: Season and year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start7 Mar 2022
- Primary completion23 Oct 2024
- Study completion23 Oct 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
- 400 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
- NCT04969913
- Sponsor's protocol ID
- 10000160
- Other IDs
- 000160-I
- Status last verified
- Oct 2024
- First submitted
- 20 Jul 2021
- Last updated
- 24 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. 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 Maferinyah Sub-prefecture, Guinea
- ClinicalTrials.gov ID
- NCT04969913
- Acronym / sponsor ID
- 10000160
- Conditions
- Malaria
- Keywords
- Assays, BLOOD SAMPLING, Parasites, Gametocytes, Infection, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 21 Jul 2021 (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. In 2015, there were 214 million cases of malaria and 438,000 deaths. A transmission-blocking vaccine (TBV) could help end the disease. Improved tests are needed to measure how well the vaccines work. Researchers want to collect data about malaria infection as the first step in testing a TBV in rural Guinea.
Objective:
To study community dynamics of malaria transmission by estimating the rate of blood smear positive people by month and season.
Eligibility:
People 6 months of age and older who live in Maf(SqrRoot)(Registered Trademark)rinyah sub-prefecture and plan to remain during the study. Households with at least 3 people who are eligible to take part in the study are also needed.
Design:
Participants will be screened with a medical and medicine history. They will have a physical exam. Their height and weight will be measured. Their vital signs may be taken.
Participants will have a study visit each month for up to 3 years. They will get a study ID. They will be asked about any symptoms of malaria or changes in health. They will give blood samples. They may have a physical exam. Within 3 days of the study visits, live and dead mosquitoes may be gathered in and around their home. Insecticide spray will be used.
Participants can visit the clinic at any time if they feel ill. If they have malaria, they will be treated according to Guinea National Malaria Control Guidelines for adults and children.
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 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 TBVs have started elsewhere on the continent in Mali, and we expect to expand TBV studies in Guinea in the near future. This protocol will use a longitudinal cohort to gather information of malaria transmission based on the rates of blood smear positive individuals by month, season and year in at Maferinyah sub-prefecture, Guinea.
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 infection rates in locally caught mosquitoes will be assessed longitudinally for differences by season and year. A total of 400 volunteers from Maferinyah will be enrolled. Participants 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
- 4
| Arm | Type | Receives |
|---|---|---|
| 19 + years | – | –Healthy adults over the age of 19 years |
| Ages 11 - 18 years | – | –Healthy children between the ages of 11 and 18 years |
| Ages 5 - 10 years | – | –Healthy children between the ages of 5 and 10 years |
| Ages 6 months - 4 years | – | –Healthy infants between the ages of 6 months and four years |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy Guinean infants, children, and adults (any age) from Maferinyah sub-prefecture. Maferinyah is a town and sub-prefecture in the Forecariah Prefecture in the Kindia Region of western Guinea. Maferinyah is located about 50 kms directly to the west (and 75 kms by paved road) of Conakry, the capital city of Guinea
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 study community dynamics of malaria transmission by estimating the rate of blood smear positive individuals by month and season stratified by age
Time frame: Season and year
Rate of blood smear positive individuals by month and season stratified by age
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 24 Oct 2024.
- Individual participant dataSharing planned: No
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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)
2 sites in 2 countries: 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 2 countries.
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 24 Oct 2024. 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 United States, Guinea. 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 study community dynamics of malaria transmission by estimating the rate of blood smear positive individuals by month and season stratified by age (time frame: Season and 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 24 Oct 2024.