Correlating Protection Against Malaria With Serum Profiles Against Plasmodium Falciparum Antigen Repertoires

Completed

• Conditions: Hiv Infection; Malaria; Schistosomiasis

• Registration Number: NCT01214876
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-08
• Study Start: 2010-08
• Study First Submitted: 2010-10-04
• Study First Submitted QC: 2010-10-04
• Study First Posted: 2010-10-05
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Last Update Submitted: 2011-03-03
• Last Update Posted: 2011-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• age 1-5 years, 6-10 years or 25 yearsand above
• written informed consent must be given
• the individual must have been resident of the area since birth or for a minimum period of two years
• the individual must be willing to submit required information and to participate in repeated sampling (total blood volume ~2.5 mL over a period of 12 months)
• Absence of danger signs (as defined by WHO) or clinical features of AIDS. An HIV-test will be offered to all participants at enrolment and completion of the study.

Exclusion Criteria

• unwillingness to sign consent form
• unwillingness to reside in the study area during the follow-up period

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Asymptomatic parasite carriage and immune responses in different age-groups exposed to intense malaria transmission		ASYMPTOMATIC PARASITE CARRIAGE will be confirmed by microscopy and PCR.
Geographical patterns in malaria morbidity		Households are geo-located by GPS and hotspots of malaria transmission will be determined and related to serological profiles.

Trial Locations

Locations (1)

Medical Biotech Laboratories; 🇺🇬 Kampala, Uganda