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Published on: July 17, 2014
RTS,S/AS01, a vaccine targeting pre-erythrocytic stages of Plasmodium falciparum
Lorenz von Seidlein1,2, Borimas Hanboonkunupakarn1,2, Podjanee Jittmala1,2
1Mahidol-Oxford Research Unity, Bangkok, Thailand.
Insights
The RTS,S/AS01 malaria vaccine is safe and moderately effective, protecting about a third of young children. Further studies and novel strategies are exploring its use in different age groups and combined with other interventions.
Area of Science:
- Malariology
- Vaccinology
- Public Health
Background:
- The RTS,S/AS01 vaccine represents a significant advancement in malaria prevention.
- It has demonstrated moderate efficacy and a favorable safety profile in large-scale trials.
Purpose of the Study:
- To summarize the efficacy and regulatory status of the RTS,S/AS01 malaria vaccine.
- To explore novel strategies for optimizing the use of RTS,S/AS01 in malaria control and elimination efforts.
Main Methods:
- Review of pivotal phase III trial data in young children in sub-Saharan Africa.
- Analysis of European Medicines Agency licensing and WHO implementation plans.
- Consideration of ongoing phase II trials evaluating combination strategies.
Main Results:
- Phase III trials showed RTS,S/AS01 protected approximately one-third of children (5-17 months) and one-fourth of infants (6-12 weeks) against uncomplicated falciparum malaria.
- The vaccine has received approval for rollout in malaria-endemic countries.
- Further studies are planned, including a large implementation program involving over 400,000 children.
Conclusions:
- RTS,S/AS01 is a valuable tool for malaria prevention, with ongoing efforts to maximize its impact.
- Alternative deployment strategies, such as use in older children or combination with mass drug administration, are under investigation to address evolving malaria epidemiology and enhance protection.
Abstract:
RTS,S/AS01 is the most advanced vaccine to prevent malaria. It is safe and moderately effective. A large pivotal phase III trial in over 15 000 young children in sub-Saharan Africa completed in 2014 showed that the vaccine could protect around one-third of children (aged 5-17 months) and one-fourth of infants (aged 6-12 weeks) from uncomplicated falciparum malaria. The European Medicines Agency approved licensing and programmatic roll-out of the RTSS vaccine in malaria endemic countries in sub-Saharan Africa. WHO is planning further studies in a large Malaria Vaccine Implementation Programme, in more than 400 000 young African children. With the changing malaria epidemiology in Africa resulting in older children at risk, alternative modes of employment are under evaluation, for example the use of RTS,S/AS01 in older children as part of seasonal malaria prophylaxis. Another strategy is combining mass drug administrations with mass vaccine campaigns for all age groups in regional malaria elimination campaigns. A phase II trial is ongoing to evaluate the safety and immunogenicity of the RTSS in combination with antimalarial drugs in Thailand. Such novel approaches aim to extract the maximum benefit from the well-documented, short-lasting protective efficacy of RTS,S/AS01.
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