Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Study Group 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
Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.
Diagnostic Test: Assessment of body temperature
Axillary body temperature of all subjects recorded by a digital thermometer at the time of survey.
|
Outcome Measures
Primary Outcome Measures
- Number of subjects infected with P. falciparum parasitaemia (using microscopy) [From Day 0 to Year 10]
Infection with P. falciparum determined using a blood smear slide and determined using microscopy
- Number of subjects using malaria control interventions [From Day 0 to Year 10]
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
Secondary Outcome Measures
- Number of subjects by demography and medical history characteristics [From Day 0 to Year 10]
Parameters used to assess this outcome were gender, age and medical history
- Number of subjects infected with Plasmodium species other than P. falciparum (using microscopy) [From Day 0 to Year 10]
Infection with Plasmodium species other than P. falciparum determined using a blood smear slide and microscopy
- 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 [From Day 0 to Year 10]
Vaccination record of receipt of dose 3 of the DTP/HepB/Hib pentavalent and the first dose of the measles EPI vaccines
- Number of subjects using anti-malarial therapy in the 14 days prior to the visit [From Day 0 to Year 10]
Any anti-malarial therapy received in the last 14 days
- Number of subjects with measured fever at the visit [From Day 0 to Year 10]
Any measured fever at time of visit (axillary temperature greater than or equal to [≥] 37.5 degrees Celsius [°C])
- Number of subjects with reported fever in the 24 hours prior to the visit [From Day 0 to Year 10]
Any reported fever occurring in the last 24 hours
- Number of subjects demonstrating care seeking behaviour [From Day 0 to Year 10]
Visits to health providers following reported fever or malaria in the previous 14 days
- Number of subjects in each geo-referenced segment [From Day 0 to Year 10]
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
- Number of subjects experiencing risk factors [From Day 0 to Year 10]
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)
Eligibility Criteria
Criteria
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.
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A male or female 6 months to <10 years of age at the time of survey.
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Signed informed consent or thumb-printed and witnessed informed consent obtained from the parent(s)/LAR(s) of the child.
Exclusion Criteria:
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Child in care.
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Current active participation in any trial involving administration of an investigational malaria vaccine or malaria drug.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Nouna | Burkina Faso | ||
| 2 | GSK Investigational Site | Ouagadougou | Burkina Faso | 2208 | |
| 3 | GSK Investigational Site | Kintampo | Ghana | ||
| 4 | GSK Investigational Site | Navrongo | Ghana | ||
| 5 | GSK Investigational Site | Kisumu | Kenya | 40100 | |
| 6 | GSK Investigational Site | Kisumu | Kenya | 40100 | |
| 7 | GSK Investigational Site | Kisumu | Kenya | 40102 | |
| 8 | GSK Investigational Site | Blantyre 3 | Malawi | ||
| 9 | GSK Investigational Site | Mangochi | Malawi | ||
| 10 | GSK Investigational Site | Dakar | Senegal | 12500 | |
| 11 | GSK Investigational Site | Dakar | Senegal | 16556 | |
| 12 | GSK Investigational Site | Tanga | Tanzania |
Sponsors and Collaborators
- GlaxoSmithKline
- The PATH Malaria Vaccine Initiative (MVI)
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 116682