A novel P. vivax pre-erythrocytic malaria vaccine for broad coverage: Progression to GMP manufacture of a clinical vaccine lot

Objectives

With this project, it is proposed to manufacture the Rv21 candidate vaccine to GMP standards. Our pre-clinical results indicate that this could be the most effective P. vivax vaccine yet developed with additional potential to prevent hypnozoite and relapse, while offering the possibility of medium term licensure and deployment. This project will take 30 months to complete and will involve GMP production of a vaccine lot, as well as ethics and regulatory approvals for a first-in-human clinical trial.

The primary objectives of this proposal are to:

1. produce Rv21 to GMP standards and we will deliver a product suitable for a future phase I clinical trial in quantity and quality. We will rely on the Jenner’s clinical biomanufacturing facility (CBF) to produce the vaccine, which has recently succeeded in producing a similar VLP for falciparum: R21.
2. perform toxicology and stability testing.
3. apply for ethics and regulatory approvals for a future clinical trial.

Therefore, pre-erythrocytic vaccines such as the one proposed here, could make P. vivax elimination economically feasible or even possible, by preventing hypnozoite formation or by eliminating such structure.