Correlates of Protection in Ghana

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00138307
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : August 27, 2010
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
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.

Condition or disease

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 : Observational
Enrollment : 300 participants
Time Perspective: Prospective
Official Title: Immunological Correlates of Protection Against Clinical Malaria in a Cohort of Young Children in the Kassena Nankana District of Ghana
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00138307

Noguchi Memorial Institute of Medical Research
Legon, Ghana
Navrongo Health Research Centre
Navrongo, Ghana
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00138307     History of Changes
Other Study ID Numbers: 04-027
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: August 27, 2010
Last Verified: March 2007

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
malaria, children, naturally acquired immunity, Ghana

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases