Target species
Chickens and embryonated chicken eggs (broilers).
Indications for use, specifying the target species
For active immunisation of 18-day-old broiler embryos or day-old broiler chickens in order to reduce clinical signs, virus shedding and acute lesions of the bursa of Fabricius caused by very virulent Avian Infectious Bursal Disease (IBD) virus infection.
In laboratory studies, it was observed that the vaccination with Nextmune can reduce weight loss after infection with vvIBDV as observed 10 days after infection.
Onset of immunity is expected from 21 days of age onwards 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.
Laboratory and field trials have been carried out in birds with MDA titres of 2500-7900 ELISA Units
In vaccinated chicks the release of the vaccine virus (vaccine virus take) was observed between 14-35 days of age in clinical trials.
Duration of immunity: up to 7 weeks of age.
Contraindications
Do not use in embryos or chickens from non-vaccinated parent flocks or having no MDA against IBDV.
Special warnings for each target species
Vaccinate healthy chickens only.
Vaccinate only MDA positive chickens which have at least an average day-old MDA level of 3200 ELISA units.
Special precautions for use
Special precautions for use in animals
Vaccinated chickens may excrete the vaccine strain up to 21 days following the vaccine virus take.
During this time, contact between the vaccinated chickens and any immunosuppressed or unvaccinated birds 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.
This product should only be used after it has been demonstrated that very virulent IBDV strains are epidemiologically relevant in the area of vaccination.
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 further 7 days, this depletion decreases and is followed by lymphocyte repopulation and regeneration of the bursa of Fabricius.
Use during pregnancy, lactation or lay
Not applicable.
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 can be administered by in ovo or via subcutaneous routes.
Use sterile devices and equipment for reconstitution and for administration of the vaccine.
Match the dose size of the vaccine and the sterile solvent according to the tables below.
In ovo administration
One single dose of 0.05 ml is injected into each 18-day-old embryonated broiler chicken egg using in-ovo equipment. The vaccine is delivered to the amnion sac.
Proposed dilutions for in ovo administration:
Number of vaccine ampoules | Solvent | Volume of one dose |
4 *2,000 doses | 400 ml | 0.05 ml |
2 * 4,000 doses | 400 ml |
4 * 4,000 doses | 800 ml |
1 * 8,000 doses | 400 ml |
2 * 8,000 doses | 800 ml |
2 * 8,000 + 1 * 4,000 doses | 1000 ml |
3 * 8,000 doses | 1200 ml |
4 * 8,000 doses | 1600 ml |
Subcutaneous administration
One single injection of 0.2 ml per chick is applied at one day of age. Automatic syringe is recommended to use. The vaccine is delivered under the skin of the neck.
Proposed dilutions for subcutaneous administration:
Number of vaccine ampoules | Solvent | Volume of one dose |
1 * 2,000 doses | 400 ml | 0.2 ml |
2 * 2,000 doses | 800 ml |
1 * 4,000 doses | 800 ml |
3 * 2,000 doses | 1200 ml |
1 * 8,000 doses | 1600 ml |
Preparation of vaccine:
1. After matching the dose size of the vaccine with the solvent (Cevac Solvent Poultry) size, quickly remove from liquid nitrogen container the exact number of ampoules needed.
2. Draw up 2-5 ml of solvent into a 5-10 ml sterile syringe. Use at least 18 gauge needles.
3. Thaw rapidly the contents of the ampoules by gentle agitation in water at 27-39°C.
4. As 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.
5. Once the ampoule is open slowly draw up the content into the needle already containing 2-5 ml solvent.
6. Transfer the suspension into the solvent bag. The diluted vaccine prepared as described is mixed by gentle agitation.
7. Withdraw a portion of the diluted 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.
8. The diluted 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.
The reconstituted vaccine is orange to red, clear to opaque suspension. Insoluble particles may be present.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse reactions other than those mentioned in section 4.6 were observed after the administration of a ten dose of vaccine to chicks having MDA against IBDV.
Withdrawal period(s)
Zero days.