Target species
Chickens
Indications for use, specifying the target species
For active immunisation of day-old future layer chickens in order to reduce clinical signs and acute lesions of bursa of Fabricius caused by very virulent Avian Infectious Bursal Disease (IBD) virus infection.
Onset of immunity is expected from 30 days depending on the initial MDA level.
The immunisation is influenced by the natural decline of maternally derived antibodies (MDA), and has been found to occur when MDA have reached appropriate release level. The onset of clinical protection depends on the initial MDA level. In vaccinated day old future layer chicks the release of the vaccine virus (vaccine virus take) was observed between 21-42 days after vaccination.
Duration of immunity: 9 weeks.
The virulent challenge tests conducted to support the claim were carried out on day old future layer chicks having MDA ELISA titre of 3,000 to 5,700 (average Day 0 MDA levels).
Field trials carried out showed that vaccine virus replication in the bursa of Fabricius occurs in day old future layer chicks having average MDA titre levels of 6,000 ELISA units.
Contraindications
Do not vaccinate chickens from non-vaccinated parent flocks or having no MDA against IBDV as vaccination of such birds may cause immunosuppression.
Special warnings for each target species
Vaccinate healthy birds only.
Vaccinate only MDA positive birds which have at least an average day-old MDA level of 2500 ELISA units (this MDA level was determined from studies which used a commercially available ELISA kit from BioCheck).
Special precautions for use
Special precautions for use in animals
Vaccinated chickens may excrete the vaccine strain up to 14 days following the vaccine virus take. During this time, the contact of immunosuppressed and unvaccinated chickens with vaccinated chickens should be avoided.
Appropriate veterinary and husbandry measures should be taken to avoid spread of the vaccine strain to susceptible birds. Vaccinate all the birds in a flock at the same time.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Liquid nitrogen containers and vaccine should be handled by properly trained personnel only.
Personal protective equipment consisting of protective gloves, spectacles and boots should be worn when handling the veterinary medicinal product, before withdrawing from liquid nitrogen, during the ampoule thawing and opening operations.
Frozen glass ampoules can explode during sudden temperature changes. Store and use liquid nitrogen only in a dry and well-ventilated place. Inhalation of the liquid nitrogen is dangerous.
Personnel involved in the treatment of vaccinated birds should use hygiene principles and take particular care in handling litter from vaccinated chickens.
Adverse reactions (frequency and seriousness)
In vaccinated chickens, mild to moderate lymphocyte depletion is very common, which is maximal at around 7 days after vaccine take. After 7 days, this depletion decreases and is followed by lymphocyte repopulation and regeneration of the bursa of Fabricius.
Use during pregnancy, lactation or lay
Laying birds:
Do not use in birds in lay and within 4 weeks before the start of the laying period.
Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Amounts to be administered and administration route
The vaccine must be administered by subcutaneous route
The vaccine is to be administered once at 1 day of age. Automatic syringe may be used. The injection volume is 0.2 ml per dose. The vaccine is delivered under the skin of the neck.
Use sterile devices and equipment for reconstitution and for administration of the vaccine.
Proposed dilutions for subcutaneous administration:
Number of vaccine ampoules | Solvent | Volume of one dose |
2 x 500 doses | 200 ml | 0.2 ml |
4 x 500 doses | 400 ml | 0.2 ml |
8 x 500 doses | 800 ml | 0.2 ml |
1 x 1000 doses | 200 ml | 0.2 ml |
2 x 1000 doses | 400 ml | 0.2 ml |
4 x 1000 doses | 800 ml | 0.2 ml |
1 x 2000 doses | 400 ml | 0.2 ml |
2 x 2000 doses | 800 ml | 0.2 ml |
2 x 2000 + 1 x 1000 doses | 1000 ml | 0.2 ml |
3 x 2000 doses | 1200ml | 0.2ml |
4 x 2000 doses | 1600 ml | 0.2ml |
Preparation of vaccine:
1After matching the dose size of the vaccine ampoule(s) with the solvent size, quickly remove from liquid nitrogen container the exact number of ampoules needed.
2Draw up 2-5 ml of solvent into a 5-10 ml sterile syringe. Use at least 18 gauge needles.
3Thaw rapidly the contents of the ampoules by gentle agitation in water at 27-39°C.
4As soon as they are completely thawed, open ampoules holding them at arm’s length in order to prevent any risk of injury should the ampoule break.
5Once the ampoule is open slowly draw up the content into the needle already containing 2-5 ml solvent.
6Transfer the suspension into the solvent bag. The diluted vaccine prepared as described is mixed by gentle agitation.
7Withdraw a portion of the vaccine into the syringe to rinse ampoule. Remove the washing from the ampoule and inject it gently into the solvent bag. Repeat it one or two times.
8The vaccine prepared as described is mixed by gentle agitation so as to be ready for use.
Repeat the operations in point 2-7 for the appropriate number of ampoules to be thawed.
Do not use Novamune if you notice visible signs of unacceptable decolourisation in the vials.
The reconstituted vaccine is orange to red, clear to opaque suspension. Insoluble particles may be present.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Ten times the maximum dose was shown to be safe for commercial layer chicks having MDA against IBDV.
Withdrawal period(s)
Zero days.