MALARIA STUDIES-NATIONAL INSTITUTES OF HEALTH (NIH)
Malaria Vaccines: Clinical Research and Trial Sites in Endemic Areas
A new collaboration between the Noguchi Memorial Institute for Medical Research (NMIMR), University Of Ghana and the National Institutes of Health (NIH) was developed in 2007. This collaboration seeks to develop the Kintampo North and South districts for malaria intervention studies such as vaccine trials. Four (4) research proposals were developed in 2007 to be implemented in 2008.
Below is a summary of each proposal.
1. Determination of Baseline Malaria Epidemiology among a Birth Cohort of Children in the Middle Belt of Ghana for Malaria Interventions.
In 2003 and 2004, the Kintampo Health Research Centre (KHRC) conducted malaria epidemiological studies among the local population with the aim of providing data that can be used as end points for malaria drug and vaccine evaluation. However, since 2004, several public health interventions to reduce malaria such as education and treated bed-net distribution have been undertaken in the whole country including the study area. These may have affected the epidemiology of malaria in the study area. The available data needs to be updated to include immunological correlates of malaria prior to any evaluation of novel malaria interventions such as vaccines.
A prospective cohort study is planned to determine relevant malaria epidemiological and immunological data among a cohort of about 800 children from birth until 2 years of age in the Kintampo North and South Districts of Ghana to inform the design in testing new malaria vaccines.
Data to be determined will include incidence of clinical malaria in the first two years of life, attributable fraction of fevers due to malaria in the birth cohort, the effect of maternal malaria on the risk of malaria during infancy, immunological correlates of clinical immunity to malaria in children aged 0-2 years hemoglobin levels and pattern of change in the hemoglobin levels among the cohort of young children, host genetic factors associated with resistance or susceptibility to severe malaria and immunological correlates of clinical immunity to malaria in children aged 0-2 years.
Time lines.
The duration of the study is expected to be four (4) years.
Contact: Dr. Kwaku Poku Asante
E-mail :kwakupoku.asante @ ghana-khrc.org
2. Establishment of Laboratory Reference Values for the Population of Kintampo North and South Districts in the Middle Belt of Ghana
Hematological and biochemical laboratory results, used together with clinical examination provide useful information for screening, diagnosis and monitoring of diseases. Interpretation of these laboratory results depends on the laboratory reference values for the tests in the population. Reference values are known to vary among different populations (gender and age groups). However, hematological and biochemical reference values have not been established for the Kintampo North and South Districts in the middle belt of Ghana, where the Kintampo Health Research Centre is located.
This study has been designed to establish age and gender-specific hematological (hemoglobin levels and cell counts) and biochemical (including liver and kidney function tests) reference values that will be used in assessing the safety of subjects participating in drug and vaccine trials. It will also determine the prevalence of hemoglobinopathies (such as sickle cell disease, thalassemias, Glucose-6-phosphate dehydrogenase deficiency) and viral antibodies (e.g. adenovirus). The study will involve a minimum of 2,340 subjects stratified into different gender and age groups (<6 months, 6-23 months, 2-4, 5-9, 10-14, 15-19, 20-39, 40-59 and >50 years).
Time lines
The study duration is one (1) year, but the expected duration of subject participation in the study will be one day for screening, enrolment and sample collection.
Contact: David Kwame Dosoo
E-mail: david.dosoo @ ghana-khrc.org
3. Severe malaria and bacterial co-infections in children in the Kintampo district of Ghana.
The study is a descriptive study of severe malaria and bacterial co-infections and a case-control
study of host (socio-demographic, genetic and nutritional) risk factors and parasite genetic risk
factors for the development of severe malaria in children aged 0 months to 59 months.
Epidemiological studies done to characterize the malaria epidemiology of the study area have mainly
been in the area of uncomplicated malaria. The Kintampo Health Research Centre is interested in
carrying out interventional trials in the management of severe malaria as well as in participating in
large phase three (3) malaria vaccine trials and has set out to characterize the epidemiology of severe
malaria in the district.
This study will partly fulfill this purpose and will help to improve clinical
management of acutely ill children with severe malaria and other infections in health facilities in
the district, suggest new targets for anti-malarial drug and vaccines and refine case definitions
for severe malaria which can be used as an end-point for large phase 3 vaccine trials.
Time lines
The duration of the study will be three (3) years.
Contact: Dr. Ruth Owusu-Ofori
E-mail:ruth.owusu @ ghana-khrc.org
4. Passive Case Detection of Malaria among children under five in Health Facilities in the Kintampo North and South Districts: Any Implications for Current Practices?
Strategies aimed at eradicating malaria have largely proved unsuccessful. As a result, the current trend is towards the control of the disease, for example through interventions like the use of insecticide treated bed-nets (ITBN), prompt and appropriate treatment with anti-malaria drugs, intermittent preventive treatment (IPT) of pregnant women and hopefully soon, infants and young children. It is also hoped that malaria vaccines will become available in the near future to augment malaria control. The appropriate or inappropriate use of currently available efficacious antimalarials will determine how long these antimalarials will last before the malaria parasite begins to develop resistance to them.
Over diagnosis and treatment of malaria is a common feature in most settings including hospitals in sub-Saharan Africa. However, with increasing drug resistance to chloroquine and SP and the introduction of artemesinin based combination therapy (ACT), clinical judgment based diagnosis of malaria is no longer sensible or sustainable. The diagnosis of malaria using malaria Rapid Diagnostic tests (RDT) or the conventional microscopy has the potential to improve diagnosis of malaria and thereby reduce the wastage of antimalarial drugs.
This study aims at determining the benefit (or otherwise) of basing the management of cases of suspected malaria solely on laboratory confirmation (microscopically and/or by RDT) as compared to presumptive management, on the incidence of malaria in children under five years reporting to the Kintampo District Hospital (KDH) as well as comparing the cost effectiveness of case management in the two scenarios. It is expected to last for 20 months.
Contact: Dr. Kingsley Osei Kwakye
E-mail:kingsley.osei-kwakye @ ghana-khrc.org
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