Correlating Protection Against Malaria With Serum Profiles Against Plasmodium Falciparum Antigen Repertoires
A longitudinal study on immune responses in relation to protection against clinical malaria episodes will be conducted in Apac District, Uganda. Three cohorts will be recruited: children 1 to 5 years of age (n=250), children 6 to 10 years of age (n=125) and adults 25 and above (n=125). After finger prick sampling (~300µL) and examination at enrolment, participants will be followed up for one year. Follow-up will include fortnightly active case detection and three-monthly cross-sectional surveys. Clinical malaria attacks and the associated clinical and parasitological parameters will be related to immunological profiles determined utilizing a protein microarray as a capture substratum to profile the humoral immune response against a vast number of parasite antigens.
For individuals who experience a clinical malaria attack or who are diagnosed with high density parasitaemia (≥15,000 parasites/µL) during cross-sectional surveys, a 5mL blood sample is obtained to determine the diversity of parasite antigens in the population in relation to antigen recognition in the cohort.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
- Immune correlates of protection against clinical malaria episodes with plasmodium falciparum [ Designated as safety issue: No ]
IMMUNE RESPONSES: protein array.
CLINICAL MALARIA EPISODES: (reported) fever with i) P. falciparum parasites; ii) ... at a density >=5,000 parasites/ul; iii) ... at a density >=10,000 parasites/ul IMMUNOLOGICALLY PROTECTED INDIVIDUALS: parasitaemic during follow-up without reporting to the health facility with indicators of a clinical malaria episode
- Geographical patterns in malaria morbidity [ Designated as safety issue: No ]Households are geo-located by GPS and hotspots of malaria transmission will be determined and related to serological profiles.
- Asymptomatic parasite carriage and immune responses in different age-groups exposed to intense malaria transmission [ Designated as safety issue: No ]ASYMPTOMATIC PARASITE CARRIAGE will be confirmed by microscopy and PCR.
Biospecimen Retention: Samples With DNA
Plasma samples Human DNA samples Parasite DNA samples
|Study Start Date:||August 2010|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
|Children 1-5 years old|
|Children 6-10 years old|
|Adults 25 years and above|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01214876
|Medical Biotech Laboratories|