Scientists Say The Clinical Trial Of RTSS/AS Is Effective
A vaccine against malaria, the world’s most notorious vectorborne disease, is finally in sight and could become a reality in four years time. Two separate trials of the promising candidate vaccine RTSS/AS on children as young as eight weeks old in Africa, have found that it reduced clinical malaria incidents by nearly 65%.
Also, the children in Tanzania and Kenya, who were administered the vaccine as part of an advanced Phase-II trial, did not report any major sideeffects. Scientists who published this finding in Monday’s edition of “The New England Journal of Medicine” say that this vaccine once available, could dramatically reduce malarial infections in children 5 to 17 months of age.
The vaccine, that protects against the most deadly form of malaria — Plasmodium Falciparum — was found to be equally effective when co-administered with other childhood vaccines such as polio, diphtheria and tetanus, paving its way for use in national immunisation programmes across the world.
The Phase-III trial — the final hurdle before marketing approval for the vaccine can be sought — for which 12,000 to 16,000 children will be enrolled across Africa, is set to begin early 2009. Babies vaccinated during this trial will be monitored for at least three years afterwards.
Christian Loucq, director of PATH’s Malaria Vaccine Initiative, said, “We
are closer than ever before to developing a malaria vaccine for children in Africa. History has shown that vaccines are the most powerful tool to control and eliminate infectious diseases. Clearly, the world urgently needs a safe and effective vaccine against malaria.”
Dr A P Dash, director of ICMR’s Malaria Research Centre, said: “This looks most promising till now. We have to wait for the large scale human Phase-III trial results.” Joe Cohen, coinventor of the vaccine at Glaxo-SmithKline Biologicals (GSK), said, “The vaccine works alongside standard infant vaccines, has a favourable safety profile and has consistently shown a significant efficacy level.”
In the first study, the vaccine when co-administered at 8, 12, and 16 weeks of age on 340 infants in Tanzania with commonly used childhood vaccine, did not interfere with the protective immune responses to each of the vaccine components. The study reported 65% reduction against first infection from malaria in those infants who received three doses of the vaccine and were followed over a six-month period.
The second study, which enrolled 894 children 5-17 months old in both Kenya and Tanzania, was designed to evaluate the safety and efficacy of RTSS/AS. The study was a randomised clinical trial in which children received either three doses of the RTSS vaccine candidate or a rabies vaccine. It found that RTSS reduced clinical malaria episodes by 53% for up to an average of eight months. During this period, 32 of those who received malaria vaccine got infected as against 66 who got the rabies vaccine.
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