EMA to Scrutinize Trial Results for Malaria Vaccine

The first malaria vaccine candidate (RTS,S/AS01) to reach Phase 3 trials is partially effective against clinical disease in young African children up to four years after vaccination, according to final trial data published in The Lancet, which will now be evaluated by the European Medicines Agency (EMA).

The results suggest the vaccine may prevent many cases of clinical malaria, especially in areas of high transmission. Also, they reveal that vaccine efficacy against clinical and severe malaria was better in children than in young infants, but waned over time in both groups. However, protection was prolonged by a booster dose, increasing the average number of cases prevented in both children and young infants.

“Despite the falling efficacy over time, there is still a clear benefit from RTS,S/AS01. An average 1363 cases of clinical malaria were prevented over 4 years of follow-up for every 1000 children vaccinated, and 1774 cases in those who also received a booster shot. Over 3 years of follow-up, an average 558 cases were averted for every 1000 infants vaccinated, and 983 cases in those also given a booster dose,” noted Prof. Brian Greenwood, corresponding author and Professor of Clinical Tropical Medicine at London School of Hygiene & Tropical Medicine, U.K. “Given that there were an estimated 198 million malaria cases in 2013, this level of efficacy potentially translates into millions of cases of malaria in children being prevented.”
 
The RTS,S/AS01 vaccine was developed for use in sub-Saharan Africa where malaria still kills around 1300 children every day. There is currently no licensed vaccine against malaria anywhere in the world.
 
The Phase 3 randomized trial enrolled 15459 young infants (aged 6 to 12 weeks at first vaccination) and children (5 to 17 months at first vaccination) from 11 sites across seven sub-Saharan African countries (Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania) with varying levels of malaria transmission. In 2014, initial phase 3 results at 18 months showed vaccine efficacy of about 46% against clinical malaria in children and around 27% among young infants.

In this study, which was funded by GlaxoSmithKline Biologicals SA and the PATH Malaria Vaccine Initiative, members of the RTS,S Clinical Trials Partnership followed up the infants and children for a further 20 to 30 months, respectively, and assessed the impact of a fourth booster dose. Participants were each vaccinated three times with RTS,S/AS01 with or without a booster dose 18 months later, or given four doses of a comparator vaccine (control group).
  
“The EMA will assess the quality, safety, and efficacy of the vaccine based on these final data,” said Greenwood. “If the EMA gives a favorable opinion, WHO could recommend the use of RTS,S/AS01 as early as October this year. If licensed, RTS,S/AS01 would be the first licensed human vaccine against a parasitic disease.”
   

Read the full release.