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Preventing the Spread of Malaria in Mali

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT01360112
First received: May 20, 2011
Last updated: November 11, 2014
Last verified: December 2013
  Purpose

A vaccine which interrupts malaria transmission is a critical tool to achieve the ultimate goal of eradication of this disease. Transmission blocking vaccines work by inducing antibody in vaccinated individuals that inhibits the development of malaria parasites in the mosquito, thus interrupting the cycle of transmission to the next human host. Efficacy of these vaccines may be estimated by in vitro membrane feeding assays using immune sera and laboratory strain mosquitoes, but these assays need to be qualified to determine to what extent they are predictive of transmission blocking in the field. Clinical trials of transmission blocking vaccines are also anticipated and have started in this community. This protocol will use a nested casecontrol cohort design to compare results of mosquito feeding assays in a malaria exposed population in Bancoumana and surrounding villages in Mali. Households will be identified using census data and individuals will be consented for participation. Malaria smears will be obtained at monthly visits, and gametocytemic individuals will be asked to participate in direct feed experiments using insectary-raised mosquitoes. Infectivity in these mosquitoes will be compared against those of mosquitoes fed in membrane feeding assays in Mali and the USA. Data will also be obtained on gametocyte and parasite carriage rates through the year. A total of 250 volunteers from Bancoumana, ages 3 months to 50 years, were initially enrolled in 2011. In 2012, an additional 250 adults from Bancoumana were enrolled and participants older than 5 years of age who were enrolled in 2011 and wanted to continue participation were re-enrolled into the study. A transmission blocking vaccine trial started in May 2013, and has enrolled participants from this adult cohort in that study. Up to 50 new adults from Bancoumana and surrounding villages will be enrolled in 2014 and those volunteers previously enrolled into the study over theage of 5 years old will be offered re-enrollment into the study.


Condition
Malaria

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Malaria Transmission Blocking Assay Development and Gametocyte Carriage in a Vaccine Testing Site in Mali

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1000
Study Start Date: April 2011
Detailed Description:

A vaccine which interrupts malaria transmission is a critical tool to achieve the ultimate goal of eradication of this disease. Transmission blocking vaccines work by inducing antibody in vaccinated individuals that inhibits the development of malaria parasites in the mosquito, thus interrupting the cycle of transmission to the next human host. Efficacy of these vaccines may be estimated by in vitro membrane feeding assays using immune sera and laboratory strain mosquitoes, but these assays need to be qualified to determine to what extent they are predictive of transmission blocking in the field. Clinical trials of transmission blocking vaccines are also anticipated and have started in this community. This protocol will use a nested casecontrol cohort design to compare results of mosquito feeding assays in a malaria exposed population in Bancoumana and surrounding villages in Mali. Households will be identified using census data and individuals will be consented for participation. Malaria smears will be obtained at monthly visits, and gametocytemic individuals will be asked to participate in direct feed experiments using insectary-raised mosquitoes. Infectivity in these mosquitoes will be compared against those of mosquitoes fed in membrane feeding assays in Mali and the USA. Data will also be obtained on gametocyte and parasite carriage rates through the year. A total of 250 volunteers from Bancoumana, ages 3 months to 50 years, were initially enrolled in 2011. In 2012, an additional 250 adults from Bancoumana were enrolled and participants older than 5 years of age who were enrolled in 2011 and wanted to continue participation were re-enrolled into the study. A transmission blocking vaccine trial started in May 2013, and has enrolled participants from this adult cohort in that study. Up to 50 new adults from Bancoumana and surrounding villages will be enrolled in 2014 and those volunteers previously enrolled into the study over theage of 5 years old will be offered re-enrollment into the study.

  Eligibility

Ages Eligible for Study:   3 Months to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

All of the following criteria must be fulfilled for a volunteer to participate in the study:

  1. Age between 3 months and 50 years, inclusive
  2. Good general health as a result of review of medical history and/or clinical testing at the time of screening
  3. Available for the duration of the study (1 year)
  4. 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
  5. Known resident of the village of the study
  6. Willingness to allow stored laboratory specimens to be used for future research.
  7. 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:

  1. Pregnancy as determined by history or a positive urine Beta-hCG test at any point during the study.
  2. 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.
  3. 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.
  4. Participation in another investigational vaccine or drug trial while this study is ongoing.
  5. Previous receipt of experimental malaria vaccine.
  6. 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:

  7. History of reactions to mosquito bites with severe itching or swelling, or lasting longer than 3 days
  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: NCT01360112

Locations
Mali
University of Bamako, Faculty of Medicine, Pharmacy and Odontostomatology
Bamako, Mali
Sponsors and Collaborators
Investigators
Principal Investigator: Yimin Wu, Ph.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT01360112     History of Changes
Other Study ID Numbers: 999911143, 11-I-N143
Study First Received: May 20, 2011
Last Updated: November 11, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Mosquito
Membrane
Feeding
Parasites
Infection
Malaria

Additional relevant MeSH terms:
Malaria
Parasitic Diseases
Protozoan Infections

ClinicalTrials.gov processed this record on November 20, 2014