Trial Of New Malaria Vaccine Begins

By Stephen K. Effah, Kintampo   

Tuesday, 11 December 2007

 Clinical trials aimed at ascertaining the safety of a malaria vaccine when given alongside polio and tuberculosis vaccines, have begun here.

In all, 170 babies, between six and 10 weeks are involved in the trials.

The vaccine was developed by GlaxoSmithKline Biologicals, of Belgirus in partnership with Walter Reed Army Institute of Research in the U.S., for use in places where malaria is common.

The current malaria vaccine trials, started last week when a team of journalists from the Africa Media and Malaria Research Network visited the Kintampo Health Research Centre to acquire first hand information on the final stage of the Phase Two of the clinical trials.

Dr. Seth Owusu-Agyei, Director of the Kintampo Health Research Centre, the body conducting the trials, explained that only half of the babies would be given the malaria vaccine alongside the polio and tuberculosis vaccines that are given children from the age of six weeks.

The other babies, he said, would be given only the normal routine vaccinations, adding that the two groups will be evaluated later to determine the level of protection that they would have from the malaria vaccine and the level of protection they would have from the routine vaccination.

He said the trial of the vaccine in babies follows the approval by the various ethical committees in the Ghana Health Service, Food and Drugs Board and two other international institutions in the U.S and U.K

"Apart from the safety and protection we look for, we will assess the interference of the malaria vaccine on the routine vaccines," Dr. Owusu-Agyei told the team.

He said that five blood samples will be taken from the babies during the study, and "spaced out such that it will not affect the participants".

He said that similar trials are being carried out in Gabon and Tanzania.

Dr. Owusu-Agyei told the team that the results of the first stage of the phase two, which started in September 2006, and involved children aged between five and 17 months is expected to be ready in mid next year.

The children participating in the first stage trial are being visited by field workers at their various homes at monthly intervals until March 2008, adding "the trial is going on smoothly."

He pointed out that the results of the first and that of the second stages which is expected to be ready by the end of next year would be analysed "to see which of the two age groups will be the best schedule to use to administer the vaccine."

Dr. Owusu-Agyei, an epidemiologist, said that there are no licensed vaccines to prevent malaria infection at the moment, and if the vaccine is found to be safe and effective, it will complement other malaria control measures in reducing the burden of malaria in endemic countries.

He said the third phase, which is the last in the trial and is expected to start next year, would look at the efficacy of the vaccine, how the vaccine is able to protect the kids from getting malaria, "and if, he gets it, how severe it will be."

Dr. Kwaku P. Asante, a Clinical Research Fellow at the KHRC, said the trial team is committed to ensuring the safety of the trial participants, noting that field workers who live in the communities with the participants visit them on daily basis to ensure that the child is well.

 

 

Source: The Ghanaian Times,