Kenya is set to start phase III of a malaria vaccine trial, the country’s premier medical research institute said in a statement released in the capital, Nairobi on Wednesday.
The trial, which is being led by the head of clinical research at Kenya Medical Research Institute (KEMRI)-Wellcome Trust research program Manga Hamaluba, seeks to assess the malaria vaccine, efficacy, its safety, and tolerability among infants and young children.
“This phase III trial builds on previous work done in two clinical trials in Kenya and Burkina Faso where 371 children were involved,” said KEMRI.
The trial is recruiting a total of 4,800 children aged between 5-36 months, with a total of 600 children being recruited in Kenya, most of who have recently been vaccinated is also taking place in Burkina Faso, Mali, and Tanzania.
KEMRI said the current phase III trial is a safety and efficacy trial aiming for licensure and rapid large-scale deployment by 2023.
Once parents of participating children provide informed consent, the children will be screened to ensure they are healthy. After screening, those found eligible for vaccination will be assigned randomly to either receive the R21/Matrix-M 9 (scientific name of the vaccine under trial) or a control vaccine (Rabies).
According to KEMRI, there will be four vaccinations in total – three primary vaccinations in one month apart then a booster, 12 months after the 3rd dose.
The medical research institute said that blood samples will be taken to assess immune responses around the time of vaccination. Researchers will also be checking for malaria regularly throughout the study or when any child becomes unwell.
Recruitment of research candidates will be focused in the coastal county of Kilifi where children are disproportionately affected by malaria due to higher transmission.
Malaria remains one of the leading causes of infectious diseases and death worldwide and it is increasingly affecting children of school-going age in Sub-Saharan Africa.
According to WHO, the most recent World malaria report found that over the last four years progress in reducing malaria has hit a plateau. In 2019, there were an estimated 229 million malaria episodes and 400,000 deaths from the disease. Over 90 percent of malaria deaths occur in Africa, the majority-more than 265,000-in young children.
The vaccine trial is being undertaken in collaboration with the University of Oxford, Serum Institute of India and partners across Africa. Enditem