Correlating Protection Against Malaria With Serum Profiles Against Plasmodium Falciparum Antigen Repertoires
|ClinicalTrials.gov Identifier: NCT01214876|
Recruitment Status : Completed
First Posted : October 5, 2010
Last Update Posted : March 4, 2011
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.
|Condition or disease|
|Malaria Schistosomiasis Hiv Infection|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Study Start Date :||August 2010|
|Primary Completion Date :||March 2011|
|Study Completion Date :||March 2011|
|Children 1-5 years old|
|Children 6-10 years old|
|Adults 25 years and above|
- Immune correlates of protection against clinical malaria episodes with plasmodium falciparum
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 morbidityHouseholds 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 transmissionASYMPTOMATIC PARASITE CARRIAGE will be confirmed by microscopy and PCR.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01214876
|Medical Biotech Laboratories|