B/BE/11/V3

Company/Institution	Laboratorios Hipra S.A.
Parental organism	Actinobacillus pleuropneumoniae strain HP-3179
Transgene(s)	no new genes but deletion of a segment of gene A from which depends the haemolytic activity of the pathogen
Treated organism	pigs
Title of the project	Evaluation of the safety and efficacy of the vaccine PB-116 in the control of porcine pleuropneumonia caused by Actinobacillus pleuropneumoniae
Treatment indication	Active immunisation of fattening pigs for the prevention of the mortality, clinical signs and pulmonary lesions of the respiratory processes produced by Actinobacillus pleuropneumoniae
Administration route(s)	intramuscular
Total number of subjects foreseen	2400 pigs but about 1200 in Belgium
Foreseen duration of release	to be defined
Effective year(s) of release
Current status	Waiting final decision
Locations	To be defined
Number of sites	multicentric study in different European countries; 3 farms in Flanders - the farms have still to be selected
Monitoring
Type of procedure	Notification for deliberate release of GMO's other than higher plants for any other purpose than for placing on the market - submitted under the Royal Decree of 21 February 2005 on Deliberate release of genetically modified organisms - part B
Notes
Other

Information for the public

B/BE/11/V3 - Advice Biosafety Advisory Council
16 April 2012: The Biosafety Advisory Council issues a positive advice (with conditions) for this trial.