B/BE/99/VW8
| Company/Institution | Merial |
| Parental organism | Canarypoxvirus (ALVAC clone) |
| Transgene(s) | env and gag genes of the type A virus of feline leukemia (FELV) |
| Treated organism | cats |
| Title of the project | Development of a combined live vaccine against feline leukemia. Experiment outside containment (clinical trial) for the study of the safety of a sucutaneous administration of a recombinant canarypoxvirus expressing FELV genes. |
| Treatment indication | vaccination against feline leukemia virus (FELV) |
| Administration route(s) | subcutaneous |
| Total number of subjects foreseen | 800 |
| Foreseen duration of release | 8 months |
| Effective year(s) of release | not communicated |
| Current status | Trial completed |
| Locations | Heverlee, Deurne, Merksem, Tournai, Haine St Pierre, Ternat, Boncelles, Beaufays, Mechelen, Alleur |
| Number of sites | 10 |
| Monitoring | |
| Type of procedure | Classical procedure - Art. 9§1 of Royal Decree of 18 December 1998 |
| Notes | Same genetically modified virus as for dossier B/BE/97/VW9 authorized in 1998 |
| Other |
Information for the public
- B/BE/99/VW8 - Public information sheet (written by the notifier)
- B/BE/99/VW8 - Fiche d'information destinée au public (préparée par le notifiant)
- B/BE/99/VW8 – Informatie fiche bestemd voor het publiek (voorbereid door de kennisgever)
Information related to the decision procedure
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B/BE/99/VW8 – Advice of the Division Biosafety and Biotechnology (SBB)
6 October 2000: The SBB issues a positive advice for this trial (the advice is written in French)
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B/BE/99/VW8 – Advice of the Regional Competent Authority
17 October 2000: The Regional Competent Minister issues a positive advice
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B/BE/99/VW8 - Decision of the Federal Public Service (FINAL DECISION)
24 October 2000: The Federal Public Service Health, Food chain safety and Environment gives a final decision (positive with conditions) for this trial.
