John Lusingu, a Tanzanian general practitioner, contracted malaria when he was 16 and battled the disease on and off for a decade. In 2000, after a 5-year stint at Mbeya Consultant Hospital in Tanzania, he decided to return to school to study the disease that changed his life and plagues millions of people in his home country and throughout the world. Though he left Africa to earn a PhD from the University of Copenhagen in Denmark, his heart remained at home, and he decided to focus his graduate research on malaria morbidity and immunity in the Korogwe region of northeast Tanzania. But his research required a well-equipped hospital, and the region simply had no science infrastructure to speak of. “There was no building or laboratory or offices to conduct research in the Korogwe area,” Lusingu says.
Undeterred, he helped convert a former kitchen in the Korogwe District Hospital into a small malaria research laboratory in 2004, and launched a study of the infection in children. The efforts soon caught the attention of the PATH Malaria Vaccine Initiative (MVI), which had partnered with pharmaceutical giant GlaxoSmithKline to initiate a Phase IIB trial of its RTS,S malaria vaccine candidate.
To convince the government to [devote] money to connect a small village because of one project, for me, this was the greatest achievement of this challenge.—Tinto Halidou, PI, phase III malaria clinical trailLusingu’s cramped kitchen lab was sufficient for his graduate work, but it wasn’t suitable for a large-scale trial. MVI, along with the Joint Malaria Programme and the Malaria Clinical Trial Alliance (MCTA), equipped the lab with tools for hematology, biochemistry, and parasitology experiments, as well as vaccine fridges, new computers, and additional office, storage, and data management space.
After the Phase IIB data demonstrated a 53 percent efficacy in children, the RTS,S vaccine entered a larger Phase III trial at 11 sites in seven African countries, each of which needed to be upgraded to bring the facilities to a level that would meet international standards, says MVI director Christian Loucq. “It’s the first vaccine against malaria—there’s no room for any compromise. [The trial] had to be very high quality.”
Trial organizers had to first install bacteriology and radiology labs—sometimes even erecting entirely new buildings—and train staff so that infections could be accurately characterized as malaria. All of the trial sites also had to be equipped with Internet satellite connections for uploading and sharing data among researchers and to allow for regular quality assessments. All told, MVI and the Malaria Clinical Trial Alliance spent two years and an estimated $8 million—much of it provided by the Bill & Melinda Gates Foundation—preparing the 11 sites for the Phase III trial. “It’s a huge enterprise,” Loucq says.
And some sites required more than just equipment and training. Medical facilities in the town of Nanoro in Burkina Faso, for example, had only unreliable access to electricity through a solar system and fuel-powered generators prior to the start of the trial. After a hospital in Nanoro was selected to take part in the Phase III trial, the village chief persuaded the country’s minister of energy to extend the national grid from the capital city to the small village—a distance of about 100 kilometers.
“I couldn’t believe [it],” recalls Tinto Halidou, the Nanoro site PI for the Phase III trial. “To convince the government to [devote] money to connect a small village because of one project, for me, this was the greatest achievement of this challenge.”
In addition to improving living and working conditions in the village, including powering more than 200 households, the connection has allowed Halidou and his colleagues to launch other research projects: investigations into the adverse effects of antimalarial treatments, the safety and effectiveness of such treatments for pregnant women, and the effects on maternal and infant health of iron and folic acid supplements. This has put the researchers in a better position to compete for grants, Halidou says. Prior to the renovation, they received only a handful of research grants; in the last two years, they have secured about 20.
The Phase III trial is well on its way, having recently completed the enrollment of more than 15,000 infants and children. Preliminary results for the 5–17-month-old group are expected later this year, and in late 2012 the researchers hope to have initial results for the 6–12-week-old group. The final analysis is expected in late 2014. “There’s still some time to go before the end of the trial, but one of the biggest hurdles has been overcome—we have enrolled all the kids,” says Loucq. “And I think that, considering the quality of the data that we see coming in, we will confirm that we can do a high quality trial in Africa.”