Dr Pedro Alonso of the Manhica Health Research Centre in Mozambique and colleagues, did a double-blind trial of 214 infants in Mozambique to test the safety, immunogenicity, and efficacy of the malaria vaccine RTS,S/AS02D.
Children were randomly assigned to receive three doses of the vaccine or hepatitis B vaccine Energix-B (as a control) at ages 10 weeks, 14 weeks and 18 weeks, as well as routine immunisation vaccines given at eight, 12, and 16 weeks of age.
They found that the vaccine was safe (the primary purpose of the trial), since there were no vaccine-related serious adverse events in either the vaccine or control groups, nor an imbalance in unsolicited adverse events between the two groups.
They also found that for children vaccinated the risk of contracting new malaria infections was reduced by 65%’compared with a previous efficacy of 45% reported in a trial of children aged one to four years.
The authors, who are also attached to the Hospital Clinic of the Universitat de Barcelona in Spain, pointed out that all study participants were provided with free-insecticide-treated bednets and their homes were twice sprayed with insecticide.
‘The trial was undertaken in an area of high transmission, but in the context of renewed and intense malaria control activities…the future use and deployment of a malaria vaccine should be seen in the context of comprehensive malaria control programmes,’ they said.
The authors concluded that the study provided evidence of a strong association between vaccine induced antibodies and reduction of risk of malaria infection. ‘This is of great significance because up until now, immunogenicity was a marker of response with no clearly proven relation to protection, which in turn could only be established with a clinical trial.
‘This finding needs to be corroborated further in other trials, but this observation might be important in the clinical development plan of this vaccine,’ the authors said. ‘ Health-e News Service.
