- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01360112
Preventing the Spread of Malaria in Mali
Malaria Transmission Blocking Assay Development and Gametocyte Carriage in a Vaccine Testing Site in Mali
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Bamako, Mali
- University of Bamako, Faculty of Medicine, Pharmacy and Odontostomatology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
All of the following criteria must be fulfilled for a volunteer to participate in the study:
- Age between 3 months and 50 years, inclusive
- Good general health as a result of review of medical history and/or clinical testing at the time of screening
- Available for the duration of the study (1 year)
- Willingness to participate in the study as evidenced by signing the informed consent document, or by fingerprinting the consent document with the signature of a witness
- Known resident of the village of the study
- Willingness to allow stored laboratory specimens to be used for future research.
- In addition to the above criteria, the expanded adult cohort must be willing to consider participation in a future malaria vaccine trial.
EXCLUSION CRITERIA:
A volunteer will be excluded from participating in this study if any one of the following criteria is fulfilled:
- Pregnancy as determined by history or a positive urine Beta-hCG test at any point during the study.
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the study protocol.
- Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.
- Participation in another investigational vaccine or drug trial while this study is ongoing.
- Previous receipt of experimental malaria vaccine.
Baseline hemoglobin < 8.5 g/dL
In addition to above criteria, a volunteer will be excluded from participating in the transmission blocking assay part of the study if the following criteria is fulfilled:
- History of reactions to mosquito bites with severe itching or swelling, or lasting longer than 3 days
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
a) Mosquito infectivity by DF, DMFA (a, b, and c), and SMFA (d and e), as measured by infection rate (number of infected vs. un- nfected mosquitoes), and oocyst counts in infected mosquitoes, both determined using microscopy.
Time Frame: 24 months
|
24 months
|
b) The period prevalence and density of gametocytes throughout the study period, as detected by thick smear and nucleic acid based techniques
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
a)Antibody levels to sexual P. falciparum antigens, and other antigens of interest.
Time Frame: 24 months
|
24 months
|
b)Mosquito infectivity as measured by circumsporozoite protein (CSP) ELISA.
Time Frame: 24 months
|
24 months
|
c)Hemoglobin level as measured by HemoCue.
Time Frame: 24 months
|
24 months
|
d)Hemoglobin variants (hemoglobin S, C, alpha thalassemia), G6PD status, blood group/Rh.
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Diallo M, Toure AM, Traore SF, Niare O, Kassambara L, Konare A, Coulibaly M, Bagayogo M, Beier JC, Sakai RK, Toure YT, Doumbo OK. Evaluation and optimization of membrane feeding compared to direct feeding as an assay for infectivity. Malar J. 2008 Dec 2;7:248. doi: 10.1186/1475-2875-7-248.
- Cheru L, Wu Y, Diouf A, Moretz SE, Muratova OV, Song G, Fay MP, Miller LH, Long CA, Miura K. The IC(50) of anti-Pfs25 antibody in membrane-feeding assay varies among species. Vaccine. 2010 Jun 17;28(27):4423-9. doi: 10.1016/j.vaccine.2010.04.036. Epub 2010 Apr 29.
- Birkett AJ. PATH Malaria Vaccine Initiative (MVI): perspectives on the status of malaria vaccine development. Hum Vaccin. 2010 Jan;6(1):139-45. doi: 10.4161/hv.6.1.10462. Epub 2010 Jan 29. No abstract available.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999911143
- 11-I-N143
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Malaria
-
University of California, San FranciscoCenters for Disease Control and Prevention; University of Massachusetts, Amherst and other collaboratorsRecruitingPlasmodium Falciparum Malaria | Plasmodium Vivax MalariaLao People's Democratic Republic
-
University of OxfordWellcome Trust; Ministry of public Health AfghanistanCompletedVivax Malaria | Uncomplicated Falciparum MalariaAfghanistan
-
Menzies School of Health ResearchInternational Centre for Diarrhoeal Disease Research, Bangladesh; Addis Ababa... and other collaboratorsCompletedMalaria | Vivax Malaria | Falciparum MalariaEthiopia, Bangladesh, Indonesia
-
Medicines for Malaria VentureAsociacion Civil Selva AmazonicaCompletedPlasmodium Falciparum Malaria | Plasmodium Vivax MalariaPeru
-
Gadjah Mada UniversityMenzies School of Health Research; Eijkman Institute for Molecular Biology; Timika...Completed
-
Menzies School of Health ResearchNational Health and Medical Research Council, Australia; Wellcome Trust; National...CompletedVivax Malaria | Falciparum MalariaIndonesia
-
London School of Hygiene and Tropical MedicineWorld Health Organization; United Nations High Commissioner for Refugees; HealthNet... and other collaboratorsCompletedMalaria | Vivax Malaria | Falciparum MalariaPakistan
-
Menzies School of Health ResearchNational Health and Medical Research Council, Australia; Wellcome Trust; National...CompletedVivax Malaria | Falciparum MalariaIndonesia
-
Research Institute for Tropical Medicine, PhilippinesWorld Health OrganizationCompletedTES of Artemether-lumefantrine for Pf and Chloroquine for Pv in the Philippines From 2013-2014 (TES)Malaria | Vivax Malaria | Falciparum Malaria | Malaria Recrudescence
-
University of IbadanShin Poong Pharm Co Ltd 161 yoksam-ro, Gangnam-Gu Seoul 135-925, Korea; Institute...CompletedPlasmodium Falciparum Malaria | Uncomplicated Malaria | Malaria FeverNigeria