EMVI/WHO EURHAVAC Workshop: "Optimising Decision Making Processes In Malaria Vaccine Design".
In collaboration with WHO/IVR, this workshop was held at the Staten’s Serum Institute in Copenhagen from 5 - 6 February 2008. Transcription of the meeting minutes has been completed and we are now preparing a report which will soon be distributed to the attendees for review.
First Day
- Welcome by EMVI and WHO.
- Presentation of the objectives of the workshop.
- Presentation of the current selection criteria developed by EMVDA / AMANET.
- Update on the current global status of malaria vaccines.
- Presentation of the benchmarking of the different immunological criteria already selected by other groups for the development of sub-unit malaria vaccines based on the rainbow table:
- Asexual blood stage vaccines
- Pre-erythrocytic stage vaccine
- Transmission blocking vaccines
- Pregnancy-associated malaria vaccines
- Discussion of criteria and conceptualisation of how vaccine candidates may progress through the given criteria.
- Case study on AMA1 - MSP1 WHO, and general update on AMA1 candidate portfolio.
- Case study on GLURP EMVI.
- Case study on Monash MSP4 and MSP5.
- Discussion:
- What are the most relevant criteria for the selection of the antigen?
- What are the most relevant criteria for the selection of production / expression systems, including manufacturing considerations?
- What are the most relevant criteria for assessment of antigenicity?
- What are the most relevant criteria for the assessment of optimisation of the immune response (adjuvant / presentation system)?
Workshop Dinner.
Second Day
- Assessment of the predictability of different assays based on the comparison of pre-clinical data with the human data (two case study vaccines):
- Humoral response: ELISA, ELISPOT
- Functionality of the response: GIA
- Cellular immune response
- Assessment of the product specifications and quality controls with emphasis on purity and stability.
- Assessment of the production costs:
- · Expected yield
- · Current production cost
- · Industrial scale up cost
- Discussion:
- Development of the decision process algorithm for malaria vaccine pharmaceutical development.
- Recommendations and closure of the workshop.