Community Research and Development Information Service - CORDIS

Preparation of LTK63 adjuvanted influenza vaccines formulations for intranasal administration

The LTK63 adjuvanted influenza vaccines formulations, with and without delivery system, for intranasal administration, have been developed. Clinical grade lots the recombinant proteins LT-K63 and LT-R72 were produced.

Following a change in the study plans only LTK63 was used in intranasal formulations. Formulation studies were performed to devise a suitable way of preparing clinical vaccines containing the adjuvant as well as three influenza antigens. Flu antigens were of three following strains (H5N3, B, A/H3N2).Five different lots of vaccine (four nasal and 1 intramuscular) were formulated and extensively tested for immunogenicity and stability over time in different conditions.

Three of the nasal formulations contained the biopolymer SMBV (the Supramolecular Biovector), a new delivery system.

The clinical lots produced for the Phase I trial were the following:
- 3 µg/dose LTK63 + SMBV + HA (3X 7.5 mcg);
- 10 µg/dose LTK63 + SMBV + 3HA (3X 7.5 mcg);
- 30 µg/dose LTK63 + SMBV + 3HA (3X 7.5 mcg);
- 30 µg/dose LTK63 + 3HA (3X 7.5 mcg) ;
- IN placebo;
- IM adjuvanted flu vaccine (active control)Vaccine preparations for human use were packaged and labelled according to the study protocol and shipped to the clinical site in Leicester, UK.

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