Vaccine monitor says no adverse report on vaccine trial on children

Kintampo, (B/A), Jan. 8, GNA- Dr Sam Newton, the local expert monitoring the safety of the vaccine administration in Ghana, gave the assurance that there has been no life-threatening report on the phase two malaria vaccine trials on 540 children, taking place in the country.

He also said there was no violation of protocol or rules formulated to guide persons involved in the clinical trials and that both local and international monitoring was ongoing to protect the children.

Dr Newton, a Clinical Research Fellow, at the Kintampo Health Research Centre, was speaking to journalists from the African Media and Malaria Research Network, at Brong Ahafo region at the weekend. The journalists were on a study tour, to be acquainted with the malaria clinical trial taking place at the Kintampo Health Research Centre.

Dr Newton said local monitoring of the trials was important to ensure that researchers and scientists adhere to an outlined before the start of the trials, which began last September. The expert said as the Local Safety Monitor, he could stop the trial and inform the Data Safety Monitoring Board, which was in charge of ensuring efficiency in securing the safety of the children being used for the trials.

Dr Newton said all the monitors met regularly to also discuss ways of ensuring that trail rules were being followed. Ghana was one of the six African countries participating in the clinical trial aimed at assessing the safety of a malaria candidate vaccine, RTS,S (rpt. RTS,S), which was expected to help control malaria in Africa.

Senegal, Gabon, Tanzania, Kenya, Mozambique are the other African countries taking part in the second phase of the malaria. The project was being funded with a 17-million dollar grant from the Bill and Melinda Gates Foundation, under the Malaria Clinical Trials Alliance.

If the tests prove successful after further research into the efficacy of the vaccine and clearance from the appropriate drugs regulatory bodies, it will lead to the licensing and introduction of the vaccine for use in 2011.