The recent phase four trials for a malaria vaccine by GlaxoSmithKline Biologicals called RTS,S/AS01E has generated a lot of news about the possibility of dealing with malaria once and for all. A blog post by one of our friends, the link for it is here, made me look into what exactly the fuss was about. So I decided to look into the vaccine and the Random Control Trials performed by the company in Sub-Saharan Africa. Turns out the vaccine are not a one for all cures for malaria. It is more like a vaccine that deals with the severe cases of malaria as through the RCT the subjects who were administered the vaccine reported cases of clinical malaria. The complete report for the RCT’s can be found here.
The Randomized Control Trial was performed in Africa for 3 months on babies between the ages of 5 months and 17 months. The children were randomly administered three doses of the malaria vaccine or three doses of rabies vaccine and were randomly administered among 1600 kids. The trail conductors agreed an analysis plan on before the data was unblinded. It was agreed that the primary analysis would be an estimate of the hazard ratio for the first episode of malaria involving fever and a parasite density above 2500 per microliter for the group given the vaccine compared with the control group. The secondary analysis included episodes of malaria involving fever. The results according to me are pretty astonishing.
In the first or only episode of malaria, 8% of those who were given the vaccine reported cases of malaria as opposed to 17% of those who were given the rabies vaccine. There were also kids who were not given the vaccine and this around the end of the transmission season so that’s a great plus for the vaccine makers. Another interesting analysis of the study was the happening of clinical malaria. While a number of kids reported clinical malaria for the first time, the number of kids reporting clinical malaria for the second time was 1% and 3% for the groups respectively. It shows that the vaccine is one that works because after the malaria parasite hit the body for the first time, the pathogens in the body developed immunity them come second time and that’s a big positive. 82 of the 447 children receiving the rabies vaccine had one or more serious adverse events, whereas only 42 of the 447 children receiving the RTS,S/AS01E vaccine reported adverse events. This is most important part of the study as the vaccine deals very well with severe cases of malaria including cerebral malaria and anemia because these severe cases are much lower in children given the vaccine as a percentage. This clearly makes the vaccine really promising in dealing with severe cases of malaria and is something from where further work for complete eradication of malaria can be done.