The EC FP7 funded portion of the HELICOVAXOR® consortium is now complete and the final report has been submitted. A number of the members of the consortium continue to work together to further research oral adjuvanted vaccines.
The critical needs for successful oral vaccine product development are to
1) find a broadly protective vaccine antigen
2) find or develop a useful, safe, yet effective, mucosal adjuvant
3) develop a useful formulation for oral use that would allow the vaccine-adjuvant mixture to be
a) combined in a single co-administration formulation
b) be protected against negative pH effects
c) allow effective intestinal-mucosal co-delivery of vaccine and adjuvant stimulating immune responses and immune protection in the stomach mucosa against challenge infection with virulent Helicobacter pylori bacteria.
The HELICOVAXOR® project achieved remarkable progress towards the set goal despite some scientific hurdles encountered in relation to the initially selected adjuvant(s).
1) identified a useful inactivated whole-cell vaccine formulation
2) identified a novel attractive adjuvant (as an alternative to the initially proposed adjuvant technology), which was able to potentiate intestinal-mucosal immune responses to the whole-cell vaccine and most importantly to significantly potentiate its protective efficacy against Helicobacter pylori infection when administered orally in the SmPill® formulation
3) co-incorporated the whole-cell vaccine and adjuvant in the SmPill® oral drug delivery system retaining immunological activities and retaining or enhancing immune-protective efficacy
4) assessed the toxicological impact of the developed vaccine prototype in mice
5) developed a scaled-up manufacturing process for the oral vaccine product
There are still some remaining activities to be completed before the prototype oral vaccine is ready to advance into first in human trials.
1) data providing evidence of protection against all or most “global” clinical H. pylori isolates
2) fully scaled-up production of some of the vaccine components;
3) further improving the immunogenicity and efficacy of the oral HELICOVAXOR® product by adding yet another mucosal adjuvant (here the SME partner Gotovax has done significant development in constructing and showing the potential of a novel enterotoxin-derived adjuvant) to the formulation.
The results achieved within the HELICOVAXOR® program lay the foundation for the proposed oral vaccine product development and contribute towards the promise of developing an effective vaccine against Helicobacter pylori infection. The HELICOVAXOR® system shows considerable promise to encapsulate an effective vaccine using an advanced nano-emulsion format that is stable at ambient temperature, allows controlled release and can be administered orally. Once the additional work has been completed, the long-term plan of the consortium members is to move to first in human clinical trials; the latter achievable once convincing promising data that the highlighted hurdles have been overcome. It is the intention of the relevant HELICOVAXOR® partners to seek further funding either from the European Community or from the pharma industry to progress the programme in due course.