This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Veterinary Vaccine In Vivo Safety Assays
The in vivo safety assays of veterinary vaccine development aim to evaluate the safety and adverse reactions of these vaccines in host animals. BioVenic provides in vivo safety assessment services for veterinary vaccines, including administering vaccines at different doses and circumstances to assess their impact on the animals. We also offer specialized testing services for reproductive safety and live vaccines. Throughout the evaluation process, we adhere to ethical and regulatory standards to ensure the well-being of experimental animals and ethical treatment.
Fig.1 Mice that develop an inflammatory response to injection of a vaccine based on LNP containing mRNA. 1
Our Services
Single, Repeat, and Overdose Safety Assessment
- Safety of the Single Dose
BioVenic administers one dose of the product for each administration route and target species suitable for your veterinary vaccine to determine the safety of a single dose. We also offer testing on animals of the minimum recommended age and pregnant animals to encompass special scenarios.
Following administration, our team of professionals examines the animals daily for any signs of abnormal local and systemic reactions and also measures their body temperature, typically for up to 14 days post-administration. After completing the observation records, we will conduct a detailed molecular biology and histology examination of the vaccine injection sites in the experimental animals.
| Clinical Symptoms |
Observe whether the animal exhibits normal behaviors such as appetite and mobility. Check the respiratory rate and whether abnormal respiration occurs. Observe whether the animal shows abnormal mental status, such as sullenness, dullness, etc. |
| Body Temperature | Different animals have different normal body temperature ranges, check whether the body temperature is within the normal range. |
| Local Inflammation |
Observe the injection site for signs of inflammation such as redness, bruising, and swelling. Technical means like PCR, ELISA, IHC are used to detect pro-inflammatory cytokines such as IL-2, IL-6, IFN-γ, and TNF-α. |
| Tissue Lesions | Comprehensive histologic examination of major organs such as heart, lungs, liver, etc. |
- Safety of the Repeated Dose
If the veterinary vaccine requires a single initial dose followed by a repeated dose, BioVenic provides repeated dose studies. In such cases, the dosing interval can be shortened to 14 days. Similarly, these tests should be conducted using the recommended route of administration in the most sensitive target animal category, with animals observed for at least 14 days after the final dosing.
- Safety of the Overdose
BioVenic administers excessive quantities of products via the recommended administration routes for the anticipated most sensitive target animal category (e.g., animals of the minimum age). Overdosing typically involves 10 doses of live vaccine.
Reproductive Safety Assessment
If your veterinary vaccine is intended for use in pregnant animals or egg-laying poultry, BioVenic conducts safety assessments in accordance with requirements. In appropriate situations, we perform assessments for reproductive toxicity and potential adverse effects on offspring, such as teratogenicity or abortion, using the recommended route of administration for each type of veterinary vaccine. When evaluating the safety of pregnant animals, we administer the recommended vaccine dose to each animal, with a second dose, if required, given 14 days after the initial vaccination. We then monitor the animals daily for any abnormalities until one day after parturition.
Production Performance Impact Test
BioVenic evaluates effects of vaccines on production performances of farmed animals for meat, milk, and egg production through the following aspects.
| The growth and development of animals | Weight gain | Feed reward | Stocking rate |
Adjuvant Residue Detection
Some non-biological substances used in the preparation of veterinary vaccines, such as mineral oil adjuvants and aluminum gel adjuvants, may pose risks to human life and health when consumed in food animals. BioVenic provides residue testing of adjuvants in target animals, specifically examining the vaccine injection site.
Special Assessment for Live Vaccines
- Test for Reversion to Virulence
If your veterinary vaccine is of the live vaccine type, to prevent the occurrence of virulence reversion, BioVenic offers virulence reversion testing. We use the antigen with the passage level closest to the vaccine master seed and, therefore, with the least attenuation, to study the potential for virulence reversion. This material is administered through the recommended or anticipated vaccine administration route that is most likely to lead to virulence reversion We pass the target vaccine through this route in the target species for five generations and observe the animals from the final generation for 21 days, monitoring clinical signs and other relevant parameters. We then compare the data obtained with observations made in animals used in a single-dose safety test.
- Dissemination Detection in Vaccinated Animal
For live vaccines against zoonotic diseases identified for use in food animals, BioVenic gives special consideration to the persistence of the strain at the injection site.
| Feces | Urine | Milk | Eggs |
| Oral, nasal, and other secretions | Predilection sites for replication of the organism | ||
Why Choose Us?
- We provide customized and reliable in vivo safety assay program for veterinary vaccine development.
- For vaccines for pregnant animals or egg-laying birds, we offer appropriate safety assessment solutions.
- For live vaccines, which are more likely to cause adverse reactions in vaccinated animals, BioVenic offers specific assays to deal with possible problems.
- Considering adjuvant residues and production performance in vaccinated animals.
BioVenic's in vivo safety assay services for veterinary vaccines are instrumental in helping you accurately evaluate the vaccine's safety and monitor potential side effects. Our commitment to animal welfare highlights our dedication to assisting you in veterinary vaccine development, so please feel free to contact us now!
Reference
- Ndeupen, Sonia, et al. "The mRNA-LNP platform's lipid nanoparticle component used in preclinical vaccine studies is highly inflammatory." Iscience 24.12 (2021).