Malaria future or investigational therapies
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Associate Editor(s)-In-Chief: Serge Korjian, Yazan Daaboul
Overview
RTS,S is considered the first anti-malaria vaccine candidate. The phase 3 trial for the vaccine involving young African children demonstrated significant efficacy beyond the efficacy observed by the use of conventional preventative measures, proving further benefit in preventing malaria. 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. Other vaccines are also in the making, but still require further validation of their clinical efficacy.
Future or Investigational Therapies
RTS,S: 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). The vaccine includes 2 proteins: RTS and S.[1] 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 African children.[2]
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.[2] 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%.[2] The vaccine was considered safe in the phase 3 trials conducted. The study did not report any increase in the incidence 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.
PfSPZ: Malaria Vaccine
In May 2009, Sanaria Inc. launched a phase 1/2a trial involving 80 healthy volunteers in collaboration with MVI to assess the safety of a newly developed vaccine for malaria, PfSPZ.[1] Although no safety concerns were raised in the initial reports, the protective efficacy of the drug may require further improvement.[1]
References
- ↑ 1.0 1.1 1.2 1.3 "Vaccine candidates". malariavaccine.org. Malaria Vaccine Initiative. 2014. Retrieved Jul 24 2014. Check date values in:
|accessdate=(help) - ↑ 2.0 2.1 2.2 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.