Major achievements to date

At the end of its first year of activity, the Child-Innovac consortium has obtained some major results in each arm of the programme, allowing to progress towards the launch of the Phase I trial planned during Summer 2010. 

WP2: Preclinical Safety studies on B. pertussis BPZE1

     • Preclinical studies demonstrated the excellent biological and genetic stability of the BPZE, both in vitro and in vivo.

     • BPZE1 was shown to be safe also in immunodepressed mouse model (e.g. SCID, IFN-gR-/- mice).

     • GMP production process of BPZE1 is fully operational and GMP-grade toxicology/safety studies have started in Sweden (VISIONAR). They will be finalised before this summer.

     • It was shown that BPZE1 does not exacerbate asthma in mice, contrary to wild-type B. pertussis, and even has a protective effect against asthma.

     • Analysis of immune responses to BPZE1, in mice and human cells, is ongoing.

WP3: Immune responses to B. pertussis antigens in children

     • Techniques for the in vitro characterization of antigen-specific memory B & T cells have been harmonized between the countries participating in our clinical study.

     • Same for measuring anti-FHA, anti-PT, and anti-Pertactin Ab titres in human cells.
 

 WP4: Construction and evaluation of recombinant B. pertussis/RSV

     • A universal vector has been constructed to insert foreign epitopes into B. pertussis fused to selected carrier proteins .

     • M2 and F RSV-G recombinants have been made and tested.

     • The epitope expression by recombinants was demonstrated by Western blot.

WP5: Phase I clinical trial on B. pertussis BPZE1

     • The study protocol and study organization for the Phase I trial, including monitoring procedures, is being finalized thanks to WP2 and WP3 outputs.

     • Phase I trial should start in Summer 2010 in Sweden.