Mosquirix (RTS,S/AS01) is a recombinant vaccine candidate consisting of the P. falciparum circumsporozoite protein (CSP) from the pre-erythrocytic stage.
Mosquirix has been developed for use in preventing malaria in young children living in malaria-endemic regions.
Mosquirix is currently indicated for children aged 5 to 17 months and infants aged 6 to 12 weeks at the time of the first vaccination, to help protect against malaria caused by the parasite Plasmodium falciparum.
Mosquirix is not approved for older children, teens, nor adults.
Mosquirix is administered as an intramuscular injection.
The vaccine should only be used in areas of the world where malaria caused by Plasmodium falciparum is prevalent, and according to official recommendations in those areas.
Mosquirix does not provide complete protection against malaria caused by P. falciparum.
Mosquirix aims to trigger the immune system to defend against the first stages when the Plasmodium falciparum malaria parasite enters the human host’s bloodstream through a mosquito bite and infects liver cells.
The vaccine is designed to prevent the parasite from infecting the liver, where it can mature, multiply, re-enter the bloodstream, and infect red blood cells, which can lead to disease symptoms.
Clinical Trial NCT03806465: An Evaluation of the Cluster-randomised Pilot Implementation of RTS,S/AS01 Through Routine Health Systems in Moderate to High Malaria Transmission Settings in Africa
- Ministries of Health in the three countries will introduce the malaria vaccine (RTS,S/AS01) in a phased fashion (with some areas introducing the malaria vaccine first and the latter half, after the evaluation period) building on the national immunization programmes which routinely deliver vaccines and expanding the schedule of their routine EPI contacts.
- The evaluation of the pilot implementation will run for a total of about 46 months in each country.
- This will focus on the three main primary objectives of feasibility, safety, and impact. The data for this will be collected in the following ways.
- Three household surveys will be conducted to evaluate the programmatic feasibility to deliver a 4 dose schedule at baseline (before vaccination starts), 18 months and 30 months after the start of vaccination.
- Four to eight sentinel hospitals will be identified in each country to collect information on a larger scale on the safety of the malaria vaccine in children aged less than 5 years admitted with a focus on cases of cerebral malaria and meningitis.
- Community-based mortality surveillance will be established in the areas to facilitate the evaluation of the impact of the malaria vaccine on all-cause mortality.