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.

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Key information

Conditions

Malaria Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infection HIV Infections Helminthiasis Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections RNA Virus Infections Retroviridae Infections Schistosomiasis Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Trematode Infections Urogenital Diseases Vector Borne Diseases Virus Diseases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Biotech Laboratories

Kampala, Uganda

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 outcomes

Geographical patterns in malaria morbidity

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

ASYMPTOMATIC PARASITE CARRIAGE will be confirmed by microscopy and PCR.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

Imperial College London
London School of Hygiene and Tropical Medicine
Medical Biotech Laboratories
Microtest Matrices Ltd
University Of Perugia

Registry information

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Oct 5, 2010
Registry last updated: Mar 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed