By Isaiah Esipisu - Kenya

Even before work is completed on the promising RTS,S vaccine for children, scientists in  Kenya have taken another big step towards developing a vaccine to protect adults from the deleterious effects of malaria.

Researchers at the Kenya Medical Research Institute (KEMRI) are for the first time engaging in clinical trials for malaria vaccine using adults as participants. The KEMRI headquarters in Nairobi has therefore upgraded its facility for the phase I clinical trials for
malaria vaccines, thanks to support from the Malaria Clinical Trials Alliance (MCTA).

The research institute is already conducting phase III trials on the RTS,S malaria vaccine in the Nyanza and Coastal regions, where participants are strictly children.

“The phase I clinical trial of any nature is the most critical stage because it is the very first time the substance being tried is introduced into a body of a human being, thus good clinical practice must be observed,” said Dr Bernhards R. Ogutu, a Clinical Trialist at KEMRI.

Generally, phase I clinical trials are designed to assess the safety and tolerability, among others, of a drug or the substance on trial. These trials are often conducted in an In-Patient Clinic, where the subject can be observed by full-time staff.

So far, the MCTA has donated over $280,000 for refurbishing the facility at KEMRI in order to conform to the good clinical practice of the global standard, in preparation of phase I clinical trial activities.

“We have already purchased the necessary equipment. Some have already been installed while others are yet to be installed by the end of the year,” said Rispah Nyangweso, the Administrative Officer at the Centre for Clinical Research (CCR) at KEMRI.

This is the first time the CCR facility is being refurbished since it was built by Japanese philanthropies in 1979, when KEMRI was established.

“The facility has been painted, the laboratory is refurbished, special Intensive Care Unit  (ICU) beds have been installed, fridges and all necessary equipment procured,” Nyangweso added.

Though the nursing station at the facility has a 50 bed capacity, only eight beds have been set aside for the research purpose.

“In the beginning, we will have to admit only six patients on the clinical trial program before expanding the capacity in the near future,” said the Administrative Officer.

The clinical trials into the malaria vaccine began in several African countries after scientists developed a vaccine known as RTS,S – or Mosquirix.

According to the GlaxoSmithKline, a drug manufacturing company which developed the Mosquirix, the vaccine reduced cases of life-threatening malaria by 49 percent and all clinical cases by 35 percent in a group of Mozambican children treated in 2003.

The Malaria Vaccine Initiative, (MVI) which is working with Glaxo and the Bill & Melinda Gates Foundation on the project, has set a target of getting a malaria vaccine that is at least 50 percent effective by 2015 and one that is 80 percent effective by 2025.

To ensure that this works effectively, the MCTA, which is an outfit of the INDEPTH Network, has taken the challenge to ensure that all sites in Africa, which have the capacity to conduct clinical trials of malaria vaccines and drugs work under conditions of good clinical practice. The programme supports, strengthens and mentors the research centres in alliance to facilitate their progression  into self-sustaining clinical research institutions.