Correlates of Protection in Ghana

August 26, 2010 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Immunological Correlates of Protection Against Clinical Malaria in a Cohort of Young Children in the Kassena Nankana District of Ghana

Malaria is a sickness passed from one person to the other by the bite of a mosquito. In areas of frequent malaria infection, children may develop natural protection against malaria and they are less likely to become sick or die from it as they age. The purpose of this study is to investigate the body's natural protection against malaria in children by testing their blood. This information may help investigators develop a malaria vaccine. The Navrongo Health Research Centre is conducting this study in Ghana. Three hundred healthy children between the ages of 1 and 5 years will participate in the study for 12 months. Study procedures will include 7 field worker visits to check on the child's health and obtain a blood sample. Every two months, a blood sample will be taken from each child to test it for strength against malaria. Whenever a child is sick, the child will be tested for malaria.

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

The principal aim of this study is to identify immunological correlates of naturally acquired immunity to malaria in young children in the process of acquiring clinical immunity. As a secondary aim, the investigators will study whether allele specific immune responses provide only allele-specific protection against symptomatic infection. Finally, the investigators will assess the baseline immune responses and the extent to which they are boosted during the malaria transmission season in a population likely to be involved in malaria vaccine trials in the near future. The overall study design is to enroll 300 healthy children, aged 1-5 years, located in the northern section of the Kassena-Nankana district and to follow them for twelve months, including the entire high malaria transmission season. They will be evaluated upon enrollment, bimonthly, and at the close of the study by physical examination, malaria smear, hemoglobin determination, and analysis of levels of specific antibody directed against a panel of candidate malaria vaccine antigens. Throughout the course of the study the children will be followed with passive case detection. In between the scheduled visits, parents will be encouraged to bring their children to the Paga Health Centre or Navrongo War Memorial Hospital or to a field worker anytime that they believe the child is not well. At such visits, the child will be evaluated with a morbidity questionnaire including a physical examination. A blood smear will be taken and a rapid malaria diagnostic test (DiaMed Optimal Rapid Malaria test) and hemoglobin measurement will be performed at the time of the visit. Treatment decisions will be based on clinical assessment and the result of the rapid malaria test. The smear result will not be available at the time initial treatment decisions are made. Children diagnosed with malaria will be treated with standard therapy per Ghana Ministry of Health policy by Ghana Health Service personnel. Children suffering from severe anemia or from any form of severe malaria will be referred to the Navrongo War Memorial Hospital for definitive treatment, including intravenous anti-malarial therapy and transfusion, if indicated, at no cost to the subject. At the time of discharge the subject will be evaluated by a study physician with a history and physical, malaria smear and hemoglobin determination. If in the clinical judgment of the study physician no further treatment is required, the subject will resume participation in the study.

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.
300

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

  • Ghana
      • Legon, Ghana
        • Noguchi Memorial Institute of Medical Research
      • Navrongo, Ghana
        • Navrongo Health Research Centre

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

1 year to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female children aged between 1-5 years.
  2. Willingness of parent or guardian to give and sign a consent form and have the child participate in this study.
  3. The expectation of continuous residency in the Kassena-Nankana District for the entire study period

Exclusion Criteria:

  1. Pre-existing chronic disease at the time of enrollment.
  2. Acute illness at the time of enrollment.
  3. Hemoglobin less than 6.0g/dL at the time of enrollment.
  4. Inability of the child's parent or guardian to give informed consent.
  5. Expectation of possible unavailability to continue participation 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

  • Time Perspectives: Prospective

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 Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2006

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).
August 26, 2005

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.
August 26, 2005

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.
August 30, 2005

Study Record Updates

Last Update Posted (Estimate)

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.
August 27, 2010

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.
August 26, 2010

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.
March 1, 2007

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.
  • 04-027

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.

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