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

Malaria Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214876
• Other study ID #: FIGHTMAL
• Status: Completed
• Phase: N/A
• First received: October 4, 2010
• Last updated: March 3, 2011
• Start date: August 2010
• Est. completion date: March 2011

Study information

• Verified date: August 2010
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: Medical Biotech LaboratoriesUnited Kingdom: London School of Hygiene & Tropical MedicineItaly: University of Perugia
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hiv Infection
• Malaria
• Schistosomiasis

Locations

Country	Name	City	State
Uganda	Medical Biotech Laboratories	Kampala

Sponsors (6)

Lead Sponsor	Collaborator
Radboud University	Imperial College London, London School of Hygiene and Tropical Medicine, Medical Biotech Laboratories, Microtest Matrices Ltd, University Of Perugia

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		No
Secondary	Geographical patterns in malaria morbidity	Households are geo-located by GPS and hotspots of malaria transmission will be determined and related to serological profiles.		No
Secondary	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.		No