WP6 - Work performed since the beginning of the project
Overview work package
WP6 is devoted to preparation, organization, and coordination of clinical trials with selected vaccine candidates.
Two vaccines have been identified to enter clinical Phase IIb trials: Flu-v (SEEK) and M-0100 (BiondVax).
Activities month 1-18
Since both vaccines aim primarily at induction of influenza-specific T cells, cell-mediated immunity (CMI), rather than antibody responses, was chosen as primary endpoint. Change of the primary endpoint allowed reduction of the number of participants without losing statistical power. Suppliers able to produce the vaccines under GMP conditions were identified and approached. Assays to be performed on the patient samples were selected in close collaboration with WP5. Six potential trial sites have been identified and audited and two clinics have been selected, one for the SEEK and one for the BiondVax trial. Generic protocols including subject information leaflets, informed consent forms and data forms have been developed for both trials and will be submitted to the Ethical Committees in due time. Both trials were registered in the European clinical trials database EudraCT and obtained registration numbers.
Activities month 18-36:
- SEEK protocol, ICF and other documentation is approved by CCMO (Dutch Central Committee on Research Involving Human Subjects) and the Dutch Minister of Health, Welfare and Sport.
- The first vaccination has given to 96 subjects at the end of September 2016. Subject recruitment is ongoing.
- Protocol (including subject information leaflet, ICF and data forms-) for BiondVax trial is approved by OGYÉI (Hungarian National Institute of Pharmacy and Nutrition) and KFEB.
- 245 subjects were recruited and 225 were randomized for the BiondVax trial. Among those randomized, 6 withdrew and 219 stayed in the trial. All subjects have received the study vaccines and have their blood sampled for immunogenicity tests. 219 subjects have completed the trial.
- Data cleaning for the BiondVax trial has started.
- Biological samples collected from the BiondVax trial are shipped to the analytical sites. RKI (Germany) and NCE (Hungary) have the PBMC samples. FACS assays will start as soon as possible. qRT-PCR assay has been started by NCE. NCE (Hungary) and BiondVax (Israel) have the serum samples are now performing the samples on HAI and SRH assays.
- Results from all immunological assays are expected in December 2016 for the BiondVax trial. After which the final data lock will take place. Analysis of the data and writing of a report is planned for January-March 2017.
- Together with WP5, protocols for clinical sample storage and multiparametric FACS analysis are validated.
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3/31/2016 2:06:17 PM
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