Picture the scene: Kintampo has gone wild and there is great joy and excitement. Thousands are converging at Durbar grounds in Kintampo in the Brong Ahafo region of Ghana.  Research scientists, journalists, politicians, doctors, nurses, traditional rulers and ordinary people are anxious to find a seat before the ceremony kicks off.

The drumming and dancing, which started early in the morning, is now frenzied. The event should start any moment now.  The people have kept up to speed with vaccine research developments here right from the time officials from Kintampo Health Research Centre first visited to seek their consent and blessings as they began the long journey.

The waiting is finally over. Speaker after speaker mounts the podium to make brief speeches. The time is 1000 hours, the date some time in December 2012. The guest speaker, dressed in a white flowing traditional gown to signify victory, has mounted the podium to make the long awaited announcement.

The news is finally out: African research scientists in 11 trial sites on the continent have concluded a trial. They have produced the first malaria vaccine for Africa. The vaccine is to be added to other routine vaccines to protect children on the continent from the deadly malaria, a disease that has taken a toll on the continent’s human and financial riches.

The dream, that began in 1987, when the RTS,S experimental malaria vaccine was created, has become a reality in 2012.

It may be only 2009 now and African scientists are still a long way off from the vaccine, but they have their sleeves rolled up. They are determined to reach their goal: a malaria vaccine for the continent by 2012.

The phase three clinical trial into the malaria experimental vaccine, RTS,S, has kicked off across Africa this year.  Scientists at several trial sites are on the very last leg of the journey, a stage that will see the licensing and use of RTS,S.

The 11 trial sites are in Ghana, Tanzania, Mozambique, Kenya, Gabon, Burkina Faso and Malawi.

Some 16,000 children on the continent are being recruited for the phase three trials. Vaccination has begun under the trials that would determine the efficacy information required of RTS,S and its ability to prevent malaria, and especially the severe form in children.

A dress rehearsal, perhaps of what would happen in 2012 is what may have taken place on September 1, 2009, at Kintampo. Early that morning, there was a gathering of chiefs and health officials in Kintampo at an outdoor trial facility for vaccination. This was followed at noon by the official launch of the phase three trials at Kintampo Health Research Centre.

The vaccination of the first 20 children enrolled for phase three study begun on September 2, 2009. A small celebration among the staff continued after the successful vaccination of the first children at the Pentagon, located on the KHRC grounds. This is where KHRC staff troop to eat and relax after a hard day’s work. 

KHRC is overseeing the vaccination of some 1,200 children out of the 16,000 expected to take part in trials across Africa. In Ghana, the School of Medical Sciences and the Kumasi Centre for Collaborative Research of the Kwame Nkrumah University of Science and Technology, is the other site conducting the phase three trials, also involving 1,200 children. 

But before the big celebrations in 2012, when results are expected from the phase three study, it will be hard work and “behind the scenes activities”. 

On the sidelines, a lot of activities are taking place to ensure that as soon as the phase three trials are concluded and clearance is given by both local and international regulatory authorities, the vaccines will be ready and available for use as part of the Expanded Programme on Immunisation in child health programmes across the continent.

There is the scaling-up of a manufacturing facility by GlaxoSmithKline (GSK) Biologicals in Belgium for the production of the vaccines after licensing. GSK Biologicals and the Malaria Vaccine Initiative (MVI) are the vaccine producers.
A local and international taskforce has also been set up in preparation for the licensing and use of the vaccine.

In Ghana, for instance, the local task force is made up of the National Malaria Control Programme, the World Health Organisation, investigators working on the vaccine, epidemiologists and managers of the Expanded Programme on Immunisation.

“A similar task force has been set up internationally by the World Health Organisation,” says Dr Kweku Poku Asante, Principal Investigator of the RTS,S vaccine trials at Kintampo.

This is all to ensure that the time between the conclusion of the study, licensure and use of the vaccine is overly prolonged.

The Kombewa Clinical Research Centre, in Kenya, also began the phase three trial in July 2009.  Three sites across Kenya—Kilifi, Kombewa and Siaya—are part of the study.

Dr Bernhards Ogutu, a Senior Clinical trialist involved in the trial, says a regulatory strategy has been developed by GSK, MVI, the European regulatory authorities, WHO and Kenya’s national regulatory authorities.

Measures are being put in place to ensure that should the efficacy and safety of RTS,S prove positive, results are not left hanging after licensing. “Facilities should be ready for the commercial production of the vaccines for use on the continent,” he said. “Currently, there is some data available in bits and pieces to help the regulatory bodies review the product.”

Dr Walter Otieno, Principal Investigator at the Kombewa Research Centre, says that, as part of “behind the scenes” activities, GSK Biologicals is in talks with Kenya’s Ministry of Health, the Division of Vaccines/EPI and the national malaria control programme to ensure that the vaccines are available. “The understanding is that once the vaccine is rolled out it does not compromise with other vaccines in use.”

He adds: “The government is coordinating with GSK so that the vaccines are delivered in the cheapest way.  The Chief Executive Officer of GSK Biologicals official was in Kombewa in July this year.”

Meanwhile, the phase three trial across Africa being run under the Malaria Clinical Trials Alliance (MCTA), established with a $17 million facility from the Gates Foundation, has received an additional $150 million through MVI.

A lot of effort is going into ensuring that the trials meet international standards. Regulatory bodies such United States Food and Drugs Administration and the European Drugs regulators are working with the researchers in Africa to ensure that they conform to approved standards.  

Already, a phase two study which focused on the safety profile of the RTS,S vaccine among children aged 5-17 months and 6-12 weeks has ended successfully in the trial sites.

In earlier studies, the vaccine has been shown to be safe in adults in the United States, Belgium and Kenya and among children in Mozambique.

Africa is waiting and researchers are racing to deliver the first malaria vaccine that would wipe the tears off the faces of families that have had to bury their dead in the name of malaria.