Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

Study Overview
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Brief Summary
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This epidemiology study is planned to run in parallel with the EPI-MAL-002 and EPI-MAL-003 studies, enrolling from the same health and demographic surveillance system (HDSS) (or equivalent system) populations. The co-primary objectives are to produce longitudinal estimates of parasite prevalence in humans, and record malaria control measures usage in areas where EPI-MAL-002 and EPI-MAL-003 studies will take place.

Detailed Description
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This study will involve up to 10 annual cross sectional surveys during malaria peak transmission with possible further extension, dependent on the duration of the EPI-MAL-002 and EPI-MAL-003 studies. Surveys will provide point estimates of parasite prevalence and subsequently a longitudinal assessment of the level of endemicity in each area covered by EPI-MAL-002 and EPI-MAL-003. This study will be conducted in parallel to EPI-MAL-002 and EPI-MAL-003 in order to assess parasite prevalence and malaria control measures before (EPI-MAL-002) and after (EPI-MAL-003) vaccine introduction. By taking into account variations in malaria transmission intensity (MTI) and malaria control intervention coverage, it will enable a more complete assessment of the benefits and risks of the vaccine introduction, and thereby more insight into the potential vaccine impact in EPI-MAL-002/-003, by adjusting incidence data for overall changes in transmission and other malaria control intervention coverage, and assist generalisation of results to other populations.

Official Title
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Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

Conditions
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Malaria, Malaria Vaccines

Intervention / Treatment
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* Procedure: Blood sampling
* Diagnostic Test: Assessment of body temperature


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects' whose parent(s)/Legally Acceptable Representative(s) [LAR(s)], in the opinion of the investigator, can and will comply with the requirements of the protocol. A male or female 6 months to <10 years of age at the time of survey. Signed informed consent or thumb-printed and witnessed informed consent obtained from the parent(s)/LAR(s) of the child. Exclusion Criteria: Child in care. Current active participation in any trial involving administration of an investigational malaria vaccine or malaria drug.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study Group<br>Subjects 6 months to <10 years of age enrolled in HDSS catchment areas at the sites participating in the EPI-MAL-002 and EPI-MAL-003 studies of the candidate malaria vaccine RTS,S/AS01E in sub-Saharan Africa. | Procedure: Blood sampling<br>* Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.<br>Diagnostic Test: Assessment of body temperature<br>* Axillary body temperature of all subjects recorded by a digital thermometer at the time of survey.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects infected with P. falciparum parasitaemia (using microscopy) | Infection with P. falciparum determined using a blood smear slide and determined using microscopy | From Day 0 to Year 10 | 
| Number of subjects using malaria control interventions | Malaria control interventions are mosquito net usage (including insecticide-treated nets [ITN] and long lasting insecticidal nets [LLIN]), indoor residual spraying (IRS), seasonal malaria chemoprevention (SMC), intermittent preventative treatment in infants (IPTi), and artemisinin-based combination therapy (ACT) therapy received within the last 14 days | From Day 0 to Year 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects by demography and medical history characteristics | Parameters used to assess this outcome were gender, age and medical history | From Day 0 to Year 10 | 
| Number of subjects infected with Plasmodium species other than P. falciparum (using microscopy) | Infection with Plasmodium species other than P. falciparum determined using a blood smear slide and microscopy | From Day 0 to Year 10 | 
| Number of subjects with uptake and timing of the third dose of DTP/HepB/Hib pentavalent and the first dose of the measles EPI vaccines | Vaccination record of receipt of dose 3 of the DTP/HepB/Hib pentavalent and the first dose of the measles EPI vaccines | From Day 0 to Year 10 | 
| Number of subjects using anti-malarial therapy in the 14 days prior to the visit | Any anti-malarial therapy received in the last 14 days | From Day 0 to Year 10 | 
| Number of subjects with measured fever at the visit | Any measured fever at time of visit (axillary temperature greater than or equal to [≥] 37.5 degrees Celsius [°C]) | From Day 0 to Year 10 | 
| Number of subjects with reported fever in the 24 hours prior to the visit | Any reported fever occurring in the last 24 hours | From Day 0 to Year 10 | 
| Number of subjects demonstrating care seeking behaviour | Visits to health providers following reported fever or malaria in the previous 14 days | From Day 0 to Year 10 | 
| Number of subjects in each geo-referenced segment | Positioning of the subject's residence is attributed to a segment with a unique ID from the grid referencing study area map in which the subject resides, where necessary, grouping small geographically proximate villages so that each segment has at least 10 study subjects to avoid personally identifiable information (PII), and proceeding as far as geographically appropriate | From Day 0 to Year 10 | 
| Number of subjects experiencing risk factors | Malaria risk factors are rural/urban area, construction material for the house, floor and roof, type of eaves (open/closed), use of electricity and water source (distance from and type) | From Day 0 to Year 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MTI, Malaria control interventions, Surveillance study, RTS,S/AS01, Malaria, Africa, Epidemiology, Plasmodium falciparum