A GNA Feature by Eunice Menka

Accra, Jan. 16, GNA - Dorcas Agyei, Hafizu Haruna and Rachael Asantewaa are ordinary children growing up in the Brong Ahafo Region, but their lives may very soon significantly impact on the destinies of other children in the country and across Africa.

These children are part of 270 children, all below two years, being used in an experiment likely to change the public health landscape and relieve Africa of a major developmental problem.

The children are participating in an experiment the Kintampo Health Research Centre in the Brong Ahafo Region is conducting on a candidate malaria vaccine.

The children have started receiving the vaccine, technically known as RTS,S. This clinical trial is aimed primarily at testing the safety of the vaccine.

Barring any set back, scientists in Africa have targeted 2011, for the introduction of the RTS,S vaccine for use in Ghana and across Africa to control malaria. This would, however, depend on further trials, including a phase three clinical trial, and licensing by the regulatory bodies.

But why would any mother or parent in Ghana offer the child to be used in these clinical tests?

A 27 year old trader in Kintampo, Dinah Konadu, whose child, Rachael is participating in the trials, said: "I was always taking my child to the hospital but since my child started receiving the vaccines I now have the peace to concentrate on my work."

Mr Lot Gyamfi, her husband, said they agreed as a couple to offer their child for the project.

Parents in Kintampo told journalists from the Africa Media and Malaria Research Network, visiting the trial site, that they were not coerced or given money to persuade them to allow their children to be used in the experiment as study children.

They said they voluntarily handed over their children for the trial because of their battles with malaria. The parents said they had since seen tremendous improvement in the health status of their children. A satisfied Haruna Musah, a parent, said he was now the envy of his friends because of the good health his child, Hafisu, was enjoying.

Kintampo has a high malaria transmission rate. Some active malaria surveillance done in the area showed that on average, a child in the area could get about six to seven malaria attacks within a year. As part of the experiment, not all the 270 children are on the vaccine. Until the trial is over and a code broken, neither parents nor scientists would know which child is on the vaccine and how those on the vaccines fared or reacted.

Regular checks are conducted on all the children. Blood samples are analyzed and checks conducted on their liver and kidney to see the effects of the vaccine on these organs.

During the trial period, field workers who live in the communities with the children, visit them on a daily basis to ensure that the children are well. If a child is unwell, the fieldworker calls a study ambulance and the child is sent to the hospital for treatment. According to researchers, a version of RTS,S vaccine was tested on 100 adult volunteers in the United States and 85 adults in Kenya and found to be safe.

Dr Seth Owusu-Agyei, Director of the Kintampo Health Research Centre, said the RTS,S vaccine has already been administered on about 2,000 children aged one to four years in Mozambique.

He said results indicated that 18 months after the children were vaccinated; the risk of getting malaria was lowered by one third, and the risk of severe malaria reduced by about one half.

Results also showed that the protective effect of the malaria vaccine did not wane 24 months after the vaccine was administered. Scientists conducting the trials said it is to be expected that some children, who receive these vaccines would have some reactions, as was the case for most vaccines.

For instance, about half of the children, who received the RTS,S vaccine in Mozambique, had pain and swelling at the site where they were injected in the days after the injection. About a quarter of the children had fever. Dr Owusu-Agyei said in most cases children recovered from these problems within a few days.

There are paediatrics trained doctors on site during vaccination sessions in Ghana to check on all children before they are given vaccines and observed afterwards. The children are visited everyday after vaccination by a study team.

Dr Sam Newton, a Local Safety Monitor, overseeing safety and ethical issues, said scientific principles were considered before the trials took off in Ghana.

Among some of the considerations that informed the initiation of the vaccine trial was to find out if the trial was scientifically sound?

Was trial relevant to the needs of Ghanaians? Are subjects being protected? Are the participating children well taken of? Will it cause any harm to participating children?

These, Dr Newton said, were some of the questions that informed the trial.

He said a Data Safety Monitoring Board, under the chairmanship of a revered minister, reviews everything including ethical issues related to the trials.

The plans and conduct of the trial in Ghana were reviewed and authorized by a number of regulatory authorities to ensure the safety of participating children.

The trials are being conducted under the Malaria Clinical Trials Alliance, (MCTA) an African-led institution set up to conduct research into malaria, with funding from the Bill and Melinda Gates Foundation. Eight MCTA sites in six African countries are involved in the Phase Two Trials. The countries are Ghana, Mozambique, Gabon, Kenya, Senegal and Tanzania.

The Kintampo Health Centre is one of eight sites in Africa researching into the Phase Two stage of the vaccine. The experiment started in Ghana in September 2006 and would last for 20 months. The Health Centre incidentally, is strategically positioned geographically to share its success with the whole Ghana. The Centre is near the spot said to be the geographic centre of Ghana. Should the Phase Two trials prove successful, a Phase Three stage would see about a thousand more Ghanaian children being recruited to now test the efficacy of the vaccine.

The Centre is also finalizing arrangement to recruit about 170 children aged between six weeks to nine months to participate in a trial, which would see how a mix of other vaccines would combine successfully with the malaria RTS,S vaccine. This experiment would serve as a basis for introducing the malaria vaccine into the Expanded Programme on Immunization, (EPI) a programme, where children are protected against major childhood killer diseases such as polio, whooping cough and tuberculosis.

The RTS,S vaccine was created in 1987 and GlaxoSmithKline, Biologicals in Belgium developed the vaccine.

Malaria is the single biggest killer of children under five. The resolve of African leaders to initiate various actions, including the strengthening of health systems, to deal with malaria, remains a dream as children continue to die of the disease, a preventable condition. African Heads of State are nowhere near cutting down malaria deaths by half by 2010. A dream they had settled on in 2000 at Abuja, Nigeria. It appears Africa's children and scientists participating in the vaccine trials may soon prove to be the true stars of Africa by providing the Continent with an answer to malaria. 16 Jan. 07