Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138307
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2005-08-26
Brief Title:
Correlates of Protection in Ghana
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Immunological Correlates of Protection Against Clinical Malaria in a Cohort of Young Children in the Kassena Nankana District of Ghana
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 bodys 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 childs 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None