Preclinical immunogenicity and safety of the cGMP-grade placental malaria vaccine PRIMVAC.

ABSTRACT:

Background

VAR2CSA is the lead antigen for developing a vaccine that would protect pregnant women against placental malaria. A multi-system feasibility study has identified E. coli as a suitable bacterial expression platform allowing the production of recombinant VAR2CSA-DBL1x-2x (PRIMVAC) to envisage a prompt transition to current Good Manufacturing Practice (cGMP) vaccine production.

Methods

Extensive process developments were undertaken to produce cGMP grade PRIMVAC to permit early phase clinical trials. PRIMVAC stability upon storage was assessed over up to 3 years. A broad toxicology investigation was carried out in rats allowing meanwhile the analysis of PRIMVAC immunogenicity.

Findings

We describe the successful cGMP production of 4. 65 g of PRIMVAC. PRIMVAC dr

SUBMITTER: Chene A 

PROVIDER: S-EPMC6491931 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature