MalariaNCT00341783
Assessment of Biologic Parameters in Preparation for Future Malaria Vaccine Trials in Don gu Bougou, Mali
An observational study of Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
There are about 300-500 million cases of malaria worldwide each year, with 2-3 million deaths. Plasmodium falciparum, one of four types of malaria, is responsible for most of these deaths. Read more about this study
- Who is it for?
- Ages Up to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- How many people
- 515 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2002to Jul 2005
- 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 Up to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Males or females aged 6 months to 45 years.
- Resident of Doneguebougou at the start of the study, and intent to remain a resident for the duration of the study.
- Willingness to participate in the study as evidenced by the completed informed consent document.
Who cannot join
- Clinical evidence of acute life-threatening illness requiring immediate medical care.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892
About this study
Official title: Assessment of Biologic Parameters in Preparation for Future Malaria Vaccine Trials in Doneguebougou, Mali
There are about 300-500 million cases of malaria worldwide each year, with 2-3 million deaths. Plasmodium falciparum, one of four types of malaria, is responsible for most of these deaths. Because of increasing resistance of this parasite to drugs and of mosquitoes to insecticides, a vaccine would be valuable in the fight against malaria.
Don gu bougou, Mali, is an area of seasonal malaria transmission that is being investigated as a possible suitable site for testing investigational malaria vaccines. The goal of this study is to characterize the population of this site in terms of common hematologic (blood) and biochemistry parameters that may be used to determine eligibility for participation in vaccine trials. The study will also assess the prevalence of preexisting medical conditions that might affect assessments of vaccine safety and efficacy. Also, the natural immunity to antigens in the investigational malaria vaccines will be determined.
Read more
Don gu bougou, Mali, was chosen because of its high malaria rates. Data will be collected at four time-points. At least 50 individuals will be recruited from each of the following age groups: 6 months-5 years; 6-10 years; 11-15 years; and 16-45 years. Village-wide consent will be obtained and about 25 of the 111 family compounds will be randomly selected. Individual consent will also be obtained.
Enrolled volunteers will undergo a baseline medical history and physical examination. Blood will be collected for various tests, and, for women of childbearing age, urine pregnancy tests will be administered.
At each of three followup visits, a brief medical history and physical exam will be conducted. Blood will be drawn for tests. Also, blood, urine, and/or stool tests not done at baseline will be done at one of the followup visits.
Read the detailed description
Doneguebougou, Mali, is an area of seasonal malaria transmission that is being investigated as a suitable site for testing investigational malaria vaccines. The overall goal of this study is to characterize the population of this site in terms of common hematologic and biochemistry parameters that may be used to determine eligibility for participation in vaccine trials, as well as in terms of preexisting medical conditions and preexisting immunity to potential malaria vaccine antigens, both of which might impact on the assessment of vaccine safety and efficacy. The development of high quality laboratory proficiency to assess these parameters in Mali will also be achieved by this study.
- Conditions
- Malaria
- Keywords
- Plasmodium, Falciparum, Screening, Malaria
- Medical subject headings
- Malaria
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study startJul 2002
- Study completionJul 2005
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 National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Enrolment
- 515 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341783
- Sponsor's protocol ID
- 999902248
- Other IDs
- 02-I-N248
- Status last verified
- Jul 2005
- First submitted
- 19 Jun 2006
- Last updated
- 7 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Biologic Parameters in Preparation for Future Malaria Vaccine Trials in Doneguebougou, Mali
- ClinicalTrials.gov ID
- NCT00341783
- Acronym / sponsor ID
- 999902248
- Conditions
- Malaria
- Keywords
- Plasmodium, Falciparum, Screening, Malaria
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 515 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jul 2002
- Study completion
- Jul 2005
- First posted
- 21 Jun 2006 (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.
There are about 300-500 million cases of malaria worldwide each year, with 2-3 million deaths. Plasmodium falciparum, one of four types of malaria, is responsible for most of these deaths. Because of increasing resistance of this parasite to drugs and of mosquitoes to insecticides, a vaccine would be valuable in the fight against malaria.
Don gu bougou, Mali, is an area of seasonal malaria transmission that is being investigated as a possible suitable site for testing investigational malaria vaccines. The goal of this study is to characterize the population of this site in terms of common hematologic (blood) and biochemistry parameters that may be used to determine eligibility for participation in vaccine trials. The study will also assess the prevalence of preexisting medical conditions that might affect assessments of vaccine safety and efficacy. Also, the natural immunity to antigens in the investigational malaria vaccines will be determined.
Don gu bougou, Mali, was chosen because of its high malaria rates. Data will be collected at four time-points. At least 50 individuals will be recruited from each of the following age groups: 6 months-5 years; 6-10 years; 11-15 years; and 16-45 years. Village-wide consent will be obtained and about 25 of the 111 family compounds will be randomly selected. Individual consent will also be obtained.
Enrolled volunteers will undergo a baseline medical history and physical examination. Blood will be collected for various tests, and, for women of childbearing age, urine pregnancy tests will be administered.
At each of three followup visits, a brief medical history and physical exam will be conducted. Blood will be drawn for tests. Also, blood, urine, and/or stool tests not done at baseline will be done at one of the followup visits.
Detailed description
Doneguebougou, Mali, is an area of seasonal malaria transmission that is being investigated as a suitable site for testing investigational malaria vaccines. The overall goal of this study is to characterize the population of this site in terms of common hematologic and biochemistry parameters that may be used to determine eligibility for participation in vaccine trials, as well as in terms of preexisting medical conditions and preexisting immunity to potential malaria vaccine antigens, both of which might impact on the assessment of vaccine safety and efficacy. The development of high quality laboratory proficiency to assess these parameters in Mali will also be achieved by this study.
Study design
Who may qualify
- Ages
- Up to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Males or females aged 6 months to 45 years.
- Resident of Doneguebougou at the start of the study, and intent to remain a resident for the duration of the study.
- Willingness to participate in the study as evidenced by the completed informed consent document.
Key exclusion criteria (1 listed)
- Clinical evidence of acute life-threatening illness requiring immediate medical care.
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
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2009.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 7 Jan 2009. 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 United States. 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 was stopped early. Results are not available in the source record.
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.
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 7 Jan 2009.