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Credit: St Jude Children’s
Research Hospital
First results from a phase 3 trial of the vaccine candidate RTS,S/AS01 indicate it provides young African children with protection against clinical and severe malaria.
The researchers also said RTS,S/AS01 has an acceptable safety and tolerability profile.
These results were announced October 19 at the Malaria Forum, hosted by the Bill & Melinda Gates Foundation in Seattle, Washington.
The findings were also published online in The New England Journal of Medicine.
“The publication of the first results in children aged 5 to 17 months marks an important milestone in the development of RTS,S/AS01,” said Irving Hoffman, PA, MPH, co-principal investigator at a study site in Lilongwe, Malawi.
The trial is still ongoing, being conducted at 11 sites in 7 countries across sub-Saharan Africa. But the researchers have performed an initial analysis of results in the first 6000 children enrolled, who were aged 5 months to 17 months at the time of enrollment.
The children received 3 doses of RTS,S/AS01 and were followed for a 12-month period. RTS,S/AS01 reduced the risk of clinical malaria in these children by 56% and the risk of severe malaria by 47%.
“These results confirm findings from previous phase 2 studies and support ongoing efforts to advance the development of this malaria vaccine candidate,” Hoffman said.
Efficacy and safety results in 6- to 12-week-old infants are expected by the end of 2012, according to the investigators. However, they have performed an analysis of severe malaria episodes reported thus far in all 15,460 children enrolled in the trial, ranging from 6 weeks to 17 months of age.
The analysis showed that RTS,S/AS01 had 35% efficacy over a follow-up period ranging between 0 months and 22 months (average, 11.5 months). Further information about the longer-term effects of RTS,S/AS01—30 months after the third dose—should be available by the end of 2014, the researchers said.
The overall incidence of serious adverse events in this trial was comparable between RTS,S/AS01 recipients (18%) and those receiving a control vaccine (22%)
There were differences in the rates of certain serious adverse events between the vaccine groups. Seizures and meningitis were both more frequent in the RTS,S/AS01 group. Seizures were linked to fever, and meningitis was considered unlikely to be vaccine-related.
RTS,S/AS01 is being developed by GlaxoSmithKline and the PATH Malaria Vaccine Initiative, together with African research centers. The partners are all represented on the Clinical Trials Partnership Committee, which is responsible for the conduct of the trial.
Major funding for clinical development comes from a grant by the Bill & Melinda Gates Foundation. 
Credit: St Jude Children’s
Research Hospital
First results from a phase 3 trial of the vaccine candidate RTS,S/AS01 indicate it provides young African children with protection against clinical and severe malaria.
The researchers also said RTS,S/AS01 has an acceptable safety and tolerability profile.
These results were announced October 19 at the Malaria Forum, hosted by the Bill & Melinda Gates Foundation in Seattle, Washington.
The findings were also published online in The New England Journal of Medicine.
“The publication of the first results in children aged 5 to 17 months marks an important milestone in the development of RTS,S/AS01,” said Irving Hoffman, PA, MPH, co-principal investigator at a study site in Lilongwe, Malawi.
The trial is still ongoing, being conducted at 11 sites in 7 countries across sub-Saharan Africa. But the researchers have performed an initial analysis of results in the first 6000 children enrolled, who were aged 5 months to 17 months at the time of enrollment.
The children received 3 doses of RTS,S/AS01 and were followed for a 12-month period. RTS,S/AS01 reduced the risk of clinical malaria in these children by 56% and the risk of severe malaria by 47%.
“These results confirm findings from previous phase 2 studies and support ongoing efforts to advance the development of this malaria vaccine candidate,” Hoffman said.
Efficacy and safety results in 6- to 12-week-old infants are expected by the end of 2012, according to the investigators. However, they have performed an analysis of severe malaria episodes reported thus far in all 15,460 children enrolled in the trial, ranging from 6 weeks to 17 months of age.
The analysis showed that RTS,S/AS01 had 35% efficacy over a follow-up period ranging between 0 months and 22 months (average, 11.5 months). Further information about the longer-term effects of RTS,S/AS01—30 months after the third dose—should be available by the end of 2014, the researchers said.
The overall incidence of serious adverse events in this trial was comparable between RTS,S/AS01 recipients (18%) and those receiving a control vaccine (22%)
There were differences in the rates of certain serious adverse events between the vaccine groups. Seizures and meningitis were both more frequent in the RTS,S/AS01 group. Seizures were linked to fever, and meningitis was considered unlikely to be vaccine-related.
RTS,S/AS01 is being developed by GlaxoSmithKline and the PATH Malaria Vaccine Initiative, together with African research centers. The partners are all represented on the Clinical Trials Partnership Committee, which is responsible for the conduct of the trial.
Major funding for clinical development comes from a grant by the Bill & Melinda Gates Foundation.
Credit: St Jude Children’s
Research Hospital
First results from a phase 3 trial of the vaccine candidate RTS,S/AS01 indicate it provides young African children with protection against clinical and severe malaria.
The researchers also said RTS,S/AS01 has an acceptable safety and tolerability profile.
These results were announced October 19 at the Malaria Forum, hosted by the Bill & Melinda Gates Foundation in Seattle, Washington.
The findings were also published online in The New England Journal of Medicine.
“The publication of the first results in children aged 5 to 17 months marks an important milestone in the development of RTS,S/AS01,” said Irving Hoffman, PA, MPH, co-principal investigator at a study site in Lilongwe, Malawi.
The trial is still ongoing, being conducted at 11 sites in 7 countries across sub-Saharan Africa. But the researchers have performed an initial analysis of results in the first 6000 children enrolled, who were aged 5 months to 17 months at the time of enrollment.
The children received 3 doses of RTS,S/AS01 and were followed for a 12-month period. RTS,S/AS01 reduced the risk of clinical malaria in these children by 56% and the risk of severe malaria by 47%.
“These results confirm findings from previous phase 2 studies and support ongoing efforts to advance the development of this malaria vaccine candidate,” Hoffman said.
Efficacy and safety results in 6- to 12-week-old infants are expected by the end of 2012, according to the investigators. However, they have performed an analysis of severe malaria episodes reported thus far in all 15,460 children enrolled in the trial, ranging from 6 weeks to 17 months of age.
The analysis showed that RTS,S/AS01 had 35% efficacy over a follow-up period ranging between 0 months and 22 months (average, 11.5 months). Further information about the longer-term effects of RTS,S/AS01—30 months after the third dose—should be available by the end of 2014, the researchers said.
The overall incidence of serious adverse events in this trial was comparable between RTS,S/AS01 recipients (18%) and those receiving a control vaccine (22%)
There were differences in the rates of certain serious adverse events between the vaccine groups. Seizures and meningitis were both more frequent in the RTS,S/AS01 group. Seizures were linked to fever, and meningitis was considered unlikely to be vaccine-related.
RTS,S/AS01 is being developed by GlaxoSmithKline and the PATH Malaria Vaccine Initiative, together with African research centers. The partners are all represented on the Clinical Trials Partnership Committee, which is responsible for the conduct of the trial.
Major funding for clinical development comes from a grant by the Bill & Melinda Gates Foundation.