Correlating Protection Against Malaria With Serum Profiles Against Plasmodium Falciparum Antigen Repertoires
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Purpose
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 |
|---|
|
Malaria Schistosomiasis Hiv Infection |
| Study Type: | Observational |
| 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
| Estimated Enrollment: | 500 |
| Study Start Date: | August 2010 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Children 1-5 years old |
| Children 6-10 years old |
| Adults 25 years and above |
Eligibility| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Randomly selected individuals living in Abedi, Apac District, Uganda.
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
Contacts and Locations| Uganda | |
| Medical Biotech Laboratories | |
| Kampala, Uganda | |
More Information
No publications provided
| Responsible Party: | Teun Bousema, London School of Hygiene & Tropical Medicine |
| ClinicalTrials.gov Identifier: | NCT01214876 History of Changes |
| Other Study ID Numbers: | FIGHTMAL |
| Study First Received: | October 4, 2010 |
| Last Updated: | March 3, 2011 |
| Health Authority: | Uganda: Medical Biotech Laboratories United Kingdom: London School of Hygiene & Tropical Medicine Italy: University of Perugia |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Malaria Schistosomiasis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Protozoan Infections Parasitic Diseases Trematode Infections Helminthiasis |
ClinicalTrials.gov processed this record on June 17, 2013