Malaria future or investigational therapies
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Future or Investigational Therapies
RTS,S Anti-Malaria Vaccine
In October 2005, Malaria Vaccine Initiative PATH (MVI/PATH) partnered with Glaxosmithkline (GSK), a pharmaceutical company, to develop an anti-malaria vaccine, using a grant by Bill & Melinda Gates Foundation.[1]
The vaccine, called "GSK RTS,S/AS01" was administered with other vaccines included in Expanded Programme on Immunization (EPI). It includes 2 proteins: RTS and S. It is produced by S. cerevisiae species.[2] The project ended in December 2014 with the publishing of two phase 3 trial reports in 2011 and 2012. The "RTS,S/AS01" vaccine affects the pre-erythrocytic stage of "P. falciparum" in young (5-17 months old) African children.[3]
The authors concluded in 2011, after 12 months of follow-up, that the candidate vaccine has an efficacy against clinical and severe malaria of 55.8% and 47.3%, respectively.[3] In cases of severe malaria in children between 6 to 12 weeks of age, the efficacy was less obvious. In 2012, infants 6-12 weeks of age were enrolled. The study showed that the vaccine efficacy against all clinical malaria was approximately 37% and against severe malaria was approximately 31%.[3] The vaccine was considered safe in the phase 3 trials conducted. The study did not report any increase in the incidence of of serious adverse events following the use of the drug. Common side effects included local injection reaction and fever.
On July 24 2014, GSK submitted a regulatory application to the European Medicines Agency (EMA) for approval of the vaccine. If granted, the World Health Organization (WHO) intends to recommend the RTS,S malaria vaccine in 2015.
References
- ↑ "Vaccine candidates". malariavaccine.org. Malaria Vaccine Initiative. 2014. Retrieved Jul 24 2014. Check date values in:
|accessdate=(help) - ↑ "Vaccine candidates". malariavaccine.org. Malaria Vaccine Initiative. 2014. Retrieved Jul 24 2014. Check date values in:
|accessdate=(help) - ↑ 3.0 3.1 3.2 RTS,S Clinical Trials Partnership. Agnandji ST, Lell B, Fernandes JF, Abossolo BP, Methogo BG; et al. (2012). "A phase 3 trial of RTS,S/AS01 malaria vaccine in African infants". N Engl J Med. 367 (24): 2284–95. doi:10.1056/NEJMoa1208394. PMID 23136909.