Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

Malaria Clinical Trial

Official title:

Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02251704
• Other study ID #: 116682
• Status: Recruiting
• Phase: Phase 4
• Start date: October 22, 2014
• Est. completion date: August 5, 2024

Study information

• Verified date: February 2024
• Source: GlaxoSmithKline
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54000
• Est. completion date: August 5, 2024
• Est. primary completion date: August 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malaria
• Malaria Vaccines

Intervention

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.

Locations

Country	Name	City	State
Burkina Faso	GSK Investigational Site	Nouna
Burkina Faso	GSK Investigational Site	Ouagadougou
Ghana	GSK Investigational Site	Kintampo
Ghana	GSK Investigational Site	Navrongo
Kenya	GSK Investigational Site	Kisumu
Kenya	GSK Investigational Site	Kisumu
Kenya	GSK Investigational Site	Kisumu
Malawi	GSK Investigational Site	Blantyre 3
Malawi	GSK Investigational Site	Mangochi
Senegal	GSK Investigational Site	Dakar
Senegal	GSK Investigational Site	Dakar
Tanzania	GSK Investigational Site	Tanga

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	The PATH Malaria Vaccine Initiative (MVI)

Countries where clinical trial is conducted

Burkina Faso,  Ghana,  Kenya,  Malawi,  Senegal,  Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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