Two Clinical Research Associates (CRAs), Mr. Cosmos Ndeti from Kenya and Ms. Nora Mbinglo from Cameroon both working with PHARMALYS together with the Malaria Vaccine Pilot Implementation Project (MVIP) coordinator from WHO, Dr. Patricia Njuguna and the Director of the Kintampo Health Research Centre (KHRC) who is also the Lead Investigator of the MVPE project in Ghana, Dr. Kwaku Poku Asante, paid a monitoring visit to NHRC from 19th to 21st September 2019. PHARMALYS is a Contract Research Organization (CRO) engaged by WHO to monitor the implementation of the Malaria Vaccine Pilot Evaluation project in Ghana, Kenya and Malawi. The purpose of the visit was to review project files to ensure that the project is conducted in accordance with the approved protocol, the sponsor’s requirements and all other regulatory requirements.
At a meeting with Management of the Centre to kick start the visit, Dr. Asante gave a brief overview of the MVPE project in Ghana stating that, the project is made up of a consortium of partners to evaluate the implementation of the new malaria vaccine. He explained that, whiles Ghana Health Service is the implementing agency for the vaccine, the consortium is tasked to evaluate the implementation of the vaccine. He further explained that, the evaluation component has three main modules, which are Feasibility, Safety and Impact. Dr. Asante also indicated that, whiles some other institutions are conducting the Feasibility and Safety modules of the evaluation, NHRC is charged with conducting the Impact module which seeks to ascertain the impact of the vaccine on mortality among children under five years.
The MVPE Coordinator for the WHO, Dr. Njuguna also spoke on the global perspective of the MVPE project, indicating that, the vaccine is being implemented in Ghana, Kenya and Malawi. She said, similar evaluations are taking place in Kenya and Malawi just as is happening in Ghana. Dr. Njuguna further stated that, WHO contracted PHARMALYS as CRA to monitor the MVPE.
In line with progress of the Impact Module, Mr. Kampim, (the MVPE Impact Project Manager) at the NHRC gave a brief overview explaining the approach being used for evaluating the Impact of the vaccine. He explained that the approach is Community Mortality Surveillance, where deaths of children under five years are identified and verbal autopsies conducted on them to ascertain the cause of death. Mr. Kampim also stated that, the surveillance is being conducted in six regions (Volta, Oti, Bono, Ahafo, Bono East and Central regions) where the vaccine is being implemented. In outlining the key persons involved in the surveillance and their roles, Mr. Kampim explained that, 6 regional coordinators, 66 district coordinators and 6993 Community Key Informants (CKIs) are engaged on the project.
Management members present at the meeting were Dr. Victor Asoala and Mrs. Andriana Sumboh, Ag Director and Administrator of the Centre respectively, who took turns to warmly welcome the visiting team to the Centre and wished them well and a fruitful visit.
After a successful reception meeting, the CRAs spent the rest of the visiting period reviewing project files after which the CRAs gave a debriefing to the rest of the team. The debriefing was interactive as the team focused on best ways of ensuring the success of the project whiles ensuring compliance to regulations, protocols and proper documentation.
Overall, the monitoring visit was a success and the visiting team departed on the 21st September 2019.
Other members on the MVPE Impact project are Dr. Paul Welaga (Statistician and Technical Advisor to the project), Dr. George Wak (Demographer and Technical Advisor to the project) and Dr. Abraham Oduro, Head of the MVPE Impact Project who was on an official trip outside the Centre at the time of the visit.