According to two studies, a vaccine against the parasitic disease Malaria, is entering into its’ third and final phase of clinical trials, after two successful trials.
Malaria kills nearly 1 million people each year and sickens about 2 million others, according to estimates from the World Health Organization. Most of the deaths are among children younger than 5 in sub-Saharan Africa, the population that the vaccine targets.
The vaccine RTS,S was developed by Belgium-basedGlaxoSmithKline Biologicals with support from the PATH Malaria Vaccine Initiative, a global nonprofit consortium that works with pharmaceutical companies.
In the first study, conducted in Kenya and Tanzania, 894 children ages 5 months to 17 months were inoculated either with the three-dose experimental malaria vaccine or a rabies vaccine as a control group. In the eight-month follow-up period, researchers found that children receiving RTS,S had 53% fewer diagnosed cases of malaria — 38 episodes compared with 86 among recipients of the control rabies vaccine.
In the other study, conducted in Tanzania, the vaccine was given to 340 infants at 8, 12 and 16 weeks old, along with vaccines against polio, diphtheria, tetanus, pertussis (whooping cough) and Haemophilus influenzae B without lessening the safety or effectiveness of the vaccines. The ability to administer the vaccine as part of already established immunization programs is important for countries where health workers, clinics and roads are in such shortage that delivering a drug can be almost as challenging as developing one, researchers say.
Again, the trial was randomized and double-blinded — considered the scientific gold standard — with half the infants receiving the malaria vaccine and the other half receiving a hepatitis B vaccine as a control. Although it was not the main object of the study, the researchers found that infants who received the malaria vaccine had 65% fewer infections, as measured by the presence of parasite in the bloodstream, over a six-month period than those who did not, confirming the findings from an earlier, smaller study.
If all goes as planned, the final trials will end in 2011, and should then be prepared for licensure at that time. It would then be available for use in 2012.
Dr. Carlos C. “Kent” Campbell called the findings impressive. He led the malaria program at the national Centers for Disease Control and Prevention for almost 20 years and was not involved in the research.
-via L.A. Times