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Develeopment and technology-transfer of a reduced-dose injectable polio vaccine containing adjuvants.

Funder: Wellcome TrustProject code: 090311
Funded under: Innovations Funder Contribution: 722,174 GBP

Develeopment and technology-transfer of a reduced-dose injectable polio vaccine containing adjuvants.

Description

As polio eradication is entering its final phase, the planning for the final push to eradicate polio and the cessation of OPV use is assuming a high priority. Continued immunization against polio during and after this time will require that affordable IPV is available in adequate quantities. One potential strategy to stretch the available production capacity, and to make IPV affordable for developing countries, is dose reduction by the addition of adjuvants to the vaccine. This project aims to develop a low-dose IPV vaccine by evaluating the ability of oil-in-water emulsions, already known for their ability to permit dose-reduction of other vaccines, to permit dose-reduction of an existing approved IPV vaccine. We plan to establish the production and characterization of a generic form of the MF59 emulsion adjuvant, perform preclinical immunogenicity and toxicology studies of this with an approved IPV vaccine, undertake technology transfer of adjuvant production to the Serum Institute of India, and to perform age de-escalation safety studies and then a paediatric safety/immunogenicity trial in infants in India. This will be undertaken by the Global Adjuvant Development Initiative (GADI) laboratory at the University of Lausanne which was established by WHO and which brings together experts with significant industrial experience in adjuvant production and evaluation, technology transfer and clinical trial conduct in developing countries. In parallel with clinical evaluation and technology transfer support, a small research activity will evaluate alternative adjuvant formulations to: provide a stable preformulated product; provide better dose-reduction capacity, and evaluate low-dose formulations more suitable to post-eradication era routine immunization. The formulation systems we plan to evaluate have already been used by the investigators in preclinical settings for other vaccines and are selected because of their freedom from intellectual property barriers

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