Cluster 4 - Demonstration activities

WP4.1 GMP production

After the successful development of a detailed production process for the selected candidate vaccines this process is transferred to a GMP production contract manufacturer. GMP production may take place at an EMVDA member institution, or may be contracted to a Contract Manufacturing Organisation (CMO) depending on the availability of a slot and the ability to produce at the GMP unit of the EMVDA member.

Work Package Leader: EVI

WP 4.2 Phase I Clinical Trials

The safety, tolerance and immunogenicity of low and high doses of a recombinant vaccine and a single dose of a viral vaccine will be assessed in say 12 volunteers/dose. The harmonised immunisation protocol (see WPs 3.) will be utilised to compare the various vaccines. Immunogenecity tests will include IgG subclass determination, reactivity with parasite protein and reactivity in the Growth Inhibition Assay (GIA) standardised in this project. The follow-up of volunteers will extend to one year after the last dose administered. Safety of the formulations will be assessed through standard clinical and biological criteria.

Work Package Leader: EVI