Assessment of laboratory reference values and seroprevalence of antibodies against candidate malaria vaccine viral vectors in the Kassena-Nankana district of northern Ghana as part of our field characterisation for future malaria vaccine trials

Location          :Kassena-Nankana district

Coordinator    :

Investigators  :

Collaboration   : Navrongo Health Research Centre, Noguchi Memorial Institute for Medical Research and the Naval Medical Research Center, USA.

Funding             :The National Institute of Allergy and Infectious Diseases (NIAID/NIH), USA

Period Covered:

Size                    :

PROJECT SUMMARY

The future trial of any potential malaria candidate vaccine will require strict compliance with established guidelines and regulations. The primary objective of Phase I trials will be to demonstrate the safety and tolerability of the investigational product. This will require strict clinical observations, and haematological and biochemical laboratory tests.

In order to accurately assess vaccine safety and efficacy in the people of the Kassena-Nankana district it is only prudent to establish laboratory reference ranges of biochemical and haematological parameters such as the concentration of serum creatinine and hepatic transaminases, white blood cell (WBC) count, red blood cell (RBC) count and platelet count among others. However, standard local values for use as reference values are non-existent at the moment.

Also, viral vectors are being incorporated into newly developed vaccines. Pre-existing antibodies may interfere with the immunogenicity of such vaccines. We therefore plan to establish antibody responses against these vectors and the haematological and biochemical profile of the population. This will guide us in the screening of potential study participants and in assessing vaccine safety and efficacy.

This study is therefore aimed at characterizing the Kassena-Nankana population with respect to haematological and biochemical parameters that could be used to establish inclusion/exclusion criteria for participation in future malaria vaccine trials as well as for assessing vaccine safety.

The primary objective of the study is to determine the distribution of values for specific haematological and biochemical parameters in the general population of the Kassena-Nankana district We shall also collect and store serum specimens from an age-stratified sample of the general population for the future determination of the prevalence of antibodies to specific putative viral vectors of malaria vaccines

We shall enroll approximately 1900 individuals selected to include at least 130 males and 130 females from Ages: <6 months, 6 – 23 months, 2 – 4 years, 5 – 9 years, 10 – 19 years, 20 – 39 years and >= 40 years.

Ethics approval has been obtained from

The NHRC-Institutional Review Board and GHS-Ethical Review Committee.

Person to whom correspondence should be addressed:

Mr. Thomas Anyorigiya

Navrongo Health Research Centre

Ministry of Health

PO Box 114

Navrongo, Ghana,

Phone: +233 74 22310, Fax: +233 742 22320

          tanyorigiya@navrongo.mimcom.net