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

This study has been completed.
Sponsor:
Collaborators:
London School of Hygiene and Tropical Medicine
Medical Biotech Laboratories
University Of Perugia
Imperial College London
Microtest Matrices Ltd
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT01214876
First received: October 4, 2010
Last updated: March 3, 2011
Last verified: August 2010
  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

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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
Study Population

Randomly selected individuals living in Abedi, Apac District, Uganda.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214876

Locations
Uganda
Medical Biotech Laboratories
Kampala, Uganda
Sponsors and Collaborators
Radboud University
London School of Hygiene and Tropical Medicine
Medical Biotech Laboratories
University Of Perugia
Imperial College London
Microtest Matrices Ltd
  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 September 30, 2014