MalariaNCT01214876
Correlating Protection Against Malaria With Serum Profiles Against Plasmodium Falciparum Antigen Repertoires
An observational study of Malaria and Schistosomiasis, run by Radboud University Medical Center at 1 site in Uganda.
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). Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria, Schistosomiasis, Hiv Infection
- How many people
- 500 participants
- Where
- 1 siteUganda
- Study dates
- Aug 2010to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Randomly selected individuals living in Abedi, Apac District, Uganda.
Who may be able to join
- 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.
Who cannot join
- unwillingness to sign consent form
- unwillingness to reside in the study area during the follow-up period
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Malaria, Schistosomiasis, Hiv Infection
- Medical subject headings
- Malaria, Schistosomiasis, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children 1-5 years old | Not described | |
| Children 6-10 years old | Not described | |
| Adults 25 years and above | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (2)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Medical Biotech Laboratories, University Of Perugia, Imperial College London, Microtest Matrices Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214876
- Sponsor's protocol ID
- FIGHTMAL
- Status last verified
- Aug 2010
- First submitted
- 4 Oct 2010
- Last updated
- 4 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlating Protection Against Malaria With Serum Profiles Against Plasmodium Falciparum Antigen Repertoires
- ClinicalTrials.gov ID
- NCT01214876
- Acronym / sponsor ID
- FIGHTMAL
- Conditions
- Malaria, Schistosomiasis, Hiv Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Medical Biotech Laboratories, University Of Perugia, Imperial College London, Microtest Matrices Ltd
- Study start
- Aug 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 5 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children 1-5 years old | – | – |
| Children 6-10 years old | – | – |
| Adults 25 years and above | – | – |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Randomly selected individuals living in Abedi, Apac District, Uganda.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- unwillingness to sign consent form
- unwillingness to reside in the study area during the follow-up period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Geographical patterns in malaria morbidity
Asymptomatic parasite carriage and immune responses in different age-groups exposed to intense malaria transmission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria and Schistosomiasis, run by Radboud University Medical Center at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune correlates of protection against clinical malaria episodes with plasmodium falciparum. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2011.