Plasmodium Resistance in A. Gambiae

January 30, 2019 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Genetic Association Mapping of Malaria Resistance in Anopheles Gambiae

The purpose of this study is to find new ways to control malaria by looking at mosquitoes infected with the disease. Knowledge of the genetics that affect the spread of malaria by mosquitoes will help in developing control strategies. A small amount of blood from infected humans will be used to infect the mosquitoes. No contact will occur between the human subject and the mosquito. Study participants will be divided into 2 groups of 20, for a total of 40 children, ages 5-10, in Burkina Faso, West Africa. Each subject will be screened by finger-prick once per month, from June through October, until they reach a maximum age of 10. Two positive subjects of the 40 screened will be asked to donate about 1 teaspoon of blood, which will be used to feed and infect the mosquitoes. Study participants will be involved in study related procedures for a maximum of 5 years.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Malaria is a blood-borne human disease, and is transmitted to mosquitoes in the bloodmeal, an obligatory step in human malaria transmission. This is a study of malaria parasites in the major mosquito vector of human malaria in Africa, Anopheles gambiae. The intent of the study is to develop modern forms of vector control that would specifically decrease disease transmission by targeting the vector. Genetic linkage mapping of the mosquito vector (Anopheles gambiae) in Africa has identified a small genomic region in the mosquito that controls most of the natural genetic variation for resistance to mosquito infection with the human malaria parasite (Plasmodium falciparum). In order to study the influence of mosquito vector genetics on transmission of malaria parasites, mosquitoes are exposed to malaria parasites and then the efficiency of parasite development within the mosquito is measured. The goal of the study is to promote and expand this non-transmitting subset of the vector population in order to decrease or interrupt human malaria transmission. The study focuses on the mosquito vector, not the human subjects infected with malaria. The reason for the use of human subjects is that 5cc of blood from human subjects naturally infected with malaria will be used to infect the mosquitoes by an indirect feeding method that involves a membrane feeding device. There will be no contact of human subjects with the mosquitoes. The blood-fed mosquitoes are the primary focus of this study, not human subjects. DNA extracted from mosquitoes that fed on the blood of human study subjects will be analyzed genetically by microsatellites and single-nucleotide polymorphisms (SNPs) to identify mosquito genes that control mosquito resistance to malaria parasites. The genetic analysis is of mosquito DNA, not DNA of the human subjects. At the time mosquitoes are analyzed, one week after the bloodmeal, there is no residual genetic, DNA, cellular, or any material of the human subject remaining within the mosquito, and thus no genetic or other information can derive from the human source, even accidentally. A secondary objective will be to identify naturally-occurring mechanisms of mosquito resistance to malaria infection in Burkina Faso. Mosquitoes that are not infected by malaria parasites do not transmit malaria. Research that identifies these genes for resistance may lead to a method for blocking the transmission of malaria. A total enrollment of 40 healthy volunteers, 5-10 years old, is planned at one site in Burkina Faso, West Africa. Malaria transmission occurs during the rainy season (June through October). There will be 2 experimental cycles per month from June through October (10 cycles per year). There will be two such groups of 20, for a total study size of 40. Each group of 20 will be screened for malaria in an alternating pattern, so each group of 20 is screened no more frequently than once per month during the malaria transmission season, for a total study duration of 5 years. One human subject with mature malaria gametocytes (the transmission stage infective to mosquitoes) will be identified the day before the projected experimental infection of mosquitoes. Blood (5 cc) will be drawn from the subject, which will occur no more frequently than once per month. Twenty subjects are screened for malaria parasites (by standard diagnosis) to insure finding at least one positive donor per cycle. The 5cc of blood is used to feed and infect mosquitoes, which are the subject of this study. Subject participation is approximately 5 months per year, for the total study duration of 5 years. A target sample size of 200 mosquitoes with a set of 150 markers will be analyzed in this study. A successful outcome of this study is genetic identification of mosquito genes controlling resistance and susceptibility to P. falciparum infection of the mosquitoes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Burkina Faso
      • West Africa, Burkina Faso
        • Centre national de recherche et de formation sur le paludisme

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 10 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 5-10 years old
  2. No major diagnosable health problems (compared to local population)
  3. Willing to participate in the study
  4. Identified as having a malaria infection by blood film examination

Exclusion Criteria:

  1. Outside the inclusion age group
  2. Specific major diagnosable health problems
  3. Not willing to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Allergy and Infectious Diseases (NIAID)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2007

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2007

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2007

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 06-0084

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