RH5.1/AS01 is a vaccine candidate that make many different types of antibodies against the same RH5 protein target.
The malaria parasite's protein, RH5, must bind to a human protein on red blood cells called basigin in order to infect them.
Human antibodies effectively block RH5 from binding with basigin, thus preventing the Malaria parasite from spreading to the blood.
Clinical Trial NCT02927145: A Phase I/IIa Clinical Trial to Assess the Safety, Immunogenicity, and Efficacy of the Blood-stage Plasmodium Falciparum Malaria Vaccine Candidate RH5.1/AS01
Challenge Study to Assess the Safety, Immunogenicity, and Efficacy of a Malaria Vaccine Candidate
This is a descriptive phase I trial to assess the safety and immunogenicity of the RH5.1/AS01 vaccine in healthy volunteers at different doses and to establish whether the RH5.1/AS01 vaccine can demonstrate a reduced parasite multiplication rate in vaccinated subjects compared to infectivity controls in a blood-stage controlled human malaria infection model.
There will be 6 study groups across two phases of the trial, with a total of 66 - 78 volunteers.
Vaccination of groups will be sequential from Group 1 to Group 3. Group 3 and 4 can be recruited simultaneously. Volunteers will be able to choose which group they are allocated to.
The vaccination dose for Group 5 has been decided following the analysis of safety and exploratory immunology assays from Groups 1, 2 and 4. They will undergo blood-stage CHMI 2 weeks after the final vaccination and will be followed up until approximately 6 months after the final vaccination.
Group 6 volunteers will be infectivity controls, so will not receive any vaccinations.
Volunteers will be recruited and undergo screening visits, vaccination and clinic visits post-vaccination at their local trial site. Procedures will be performed on the visit time points indicated in the schedule of attendances.. Additional procedures or laboratory tests may be performed, at the discretion of the Investigators.