Production Technologies, Regulatory Parameters, and Quality Control of Vaccine Vectors for Veterinary Use
Abstract
:1. Introduction
Platform | Characteristics | Restrictions | Refs |
---|---|---|---|
Whole virus | |||
Attenuated | Entire virus passed on in successive cultivations to lose infective capacity. | Production requires cell culture of the virus and exhaustive safety tests as they are more immunogenic. | [21] |
Inactivated | The intact virus is inactivated by chemical or physical methods. | Vaccines based on the inactivated virus require an initial high amount of virus. | |
Subunit | |||
Proteins | Proteins or their fragments are injected directly into the animal. | Generally, require adjuvants or multiple doses to achieve the desired immune response. | [21] |
Virus-like particle | Self-assembled viral structural proteins that resemble the virus, however, lack genetic material. | The biggest challenge of this platform is to ensure that the epitopes are in an adequate conformation after translation and that the expressed proteins are not allergenic. | [22] |
Nucleic acid | |||
DNA | Insertion of the DNA that encodes the viral antigen into a plasmid. | They are platforms under experimentation for animal purposes. | [23] |
RNA | Messenger RNA encapsulated in a lipid membrane. | ||
Vector encoding antigen | |||
Replicating and non-replicating | Non-infective pathogens are genetically modified with the insertion of one or more genes that express antigenic particles, which may or may not multiply in the animal organism. | Requires level 2 biosafety labs for production; it has reduced efficacy due to pre-existing immunity to selected vectors. | [24] |
Vaccine Strategy | Disease | Animal | Consequences | Refs |
---|---|---|---|---|
Bacterial ghost construction | Avian Colibacillosis | Avian | Mortality of poultry bacterial infections—it causes a variety of disease manifestations in poultry including yolk sac infection, omphalitis, respiratory tract infection, swollen head syndrome, septicemia, polyserositis, coligranuloma, enteritis, cellulitis and salpingitis | [30,31] |
Avirulent suspension of Salmonella typhimurium AWC 591 | Salmonellosis | Commercial poultry | Economic losses and risks to public health such as diarrhea, fever, and stomach cramps | [32] |
Modified live vaccine (MLV) infectious bovine rhinotracheitis | Rhinotracheitis | Cattle | Respiratory disease complex | [33] |
The gene for protein 2 (VP2) of infectious bursal disease virus was cloned into a Pichia pastoris expression system | Infectious bursal disease (also known as Gumboro disease) | Avian | Immunosuppressive viral disease due to widespread destruction of lymphocytes | [34] |
Replacement of the capsid-encoding gene (P1) from the vaccine strain O1 Manisa | Foot-and-mouth disease virus | Cattle, pigs, sheep, and many wildlife species | Economically devastating disease; reduced animal productivity and the restrictions on international trade in animal products | [35,36] |
Recombinant vaccines based on Brucella Outer Membrane Protein (OMP) antigens | Brucellosis | Calves, sheep, cattle, goats, pigs, and dogs, among others | High economic losses due to restrictions on international trade in animal products; the signs and symptoms include fever, joint pain (arthritis, spondylitis, sacroiliitis), endocarditis and fatigue. | [37] |
Recombinant vaccines based on their major toxins and their genetic origins (iota (ia), alpha (cpa), beta (cpb), and epsilon (etx), and toxoid vaccines, bacterin-toxoid vaccine | Clostridial diseases | Cattle, sheep, and goats | botulism, tetanus, enterotoxaemia, gas gangrene, necrotic enteritis, pseudomembranous colitis, blackleg, and black disease causing severe economic losses in livestock and poultry industries | [38] |
Disease | Example (Supplier)/Vaccine Strategy | Recommended Vaccination Schedule |
---|---|---|
Feline Panleukopenia/ Infectious Enteritis (Parvovirus) | Fevaxyn® Pentofel (Zoetis Belgium SA)/Fevaxyn Pentofel contains the following inactivated viruses: feline panleukopenia virus, feline rhinotracheitis virus, feline calicivirus, feline leukemia virus, and the inactivated bacterium feline Chlamydophila felis. | Cats of 9 weeks or older. Two doses at an interval of 3 to 4 weeks. |
Feline Calicivirus | Purevax RC (Boehringer Ingelheim, Ingelheim am Rhein, Germany)/Attenuated feline rhinotracheitis herpesvirus (FVH F2 strain) and inactivated feline calicivirus antigens (FCV 431 and G1 strains) | Only cats of 8 weeks or older receive the first injection; the second injection is 3 to 4 weeks later. Revaccination: the first revaccination should be carried out one year after the primary vaccination, and subsequent revaccinations: at intervals of up to three years. |
Feligen RCP (Virbac)/a modified live vaccine providing immunization of healthy cats against feline rhinotracheitis virus, feline calicivirus and feline panleucopaenia virus. | Cats from minimum 9 weeks of age. Two doses at an interval of 3 to 4 weeks. Annual boosters are recommended after that | |
Feline Leukaemia Virus | Purevax FeLV (Boehringer Ingelheim, Ingelheim am Rhein, Germany)/virus canaripox recombinante FeLV (vCP97). The vaccine strain is a recombinant canarypox virus that expresses the FeLV-A env and gag genes. Under natural conditions, only subgroup A is infectious and immunization against subgroup A induces total protection against subgroups A, B, and C. After inoculation, the virus expresses the protective proteins but does not replicate in the cat. Thus, the vaccine induces an immune state against the feline leukemia virus. | Cats of 8 weeks of age or older. Primary vaccination: first injection: from the age of 8 weeks. Second injection: 3 to 4 weeks later. Revaccination: annual |
Feline Rhinotracheitis (Herpesvirus) | Purevax RC (Boehringer Ingelheim, Ingelheim am Rhein, Germany)/Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) and inactivated feline calicivirus (FCV 431 and G1 strains) antigens | Cats of 8 weeks of age or older. Against feline viral rhinotracheitis, for the reduction in clinical signs and against calicivirus infection for the reduction in clinical signs. Primary vaccination: first injection: from 8 weeks. Second injection: 3 to 4 weeks later. Revaccination: the first revaccination should be carried out one year after the primary vaccination, subsequent revaccinations at intervals of up to three years. |
Feline Rabies | Purevax Rabies (Boehringer Ingelheim, Ingelheim am Rhein, Germany)/Contains rabies recombinant canarypox virus (vCP65); Rabisin (Boehringer Ingelheim, Ingelheim am Rhein, Germany)/inactivated rabies antigen (viral glycoproteins) | Cats 12 weeks of age and older. The cats should be revaccinated every year |
Canine Rabies | Rabvac 1 (Boehringer Ingelheim Ingelheim am Rhein, Germany)/a inactivated virus vaccine; Defensor (Zoetis, Belgium SA)/ Rabico virus strain PV-Paris (Pasteur) replicated in a stable cell line, chemically inactivated; Rabisin (Boehringer Ingelheim, Ingelheim am Rhein, Germany)/inactivated rabies antigen (viral glycoproteins). | Rabvac 1:3 months of age or older. Revaccinate one year later and annually thereafter. Defensor: heath dogs and cats: a single dose at 3 months of age or older. Annual revaccination with a single dose is recommended. Rabisin: inactivated rabies antigen (viral glycoproteins) |
Canine distemper virus, Canine Adenovirus Type 2, infectious hepatitis, Canine Parvovirus (modified live viruses), Coronavirose canina, and Leptospira Canicola-Icterohaemorrhagiae (L. canicola and L. icterohaemorrhagiae) | V8 Nobivac® Canine (MSD, NJ, USA)/vaccine combination—modified live virus vaccine and a live attenuated vaccine | Puppies from 45 days of age, there are 3 or 4 doses in a row with intervals of 21 to 30 days between them |
Canine distemper, infectious hepatitis, parainfluenza, parvovirus, coronavirus, and leptospirosis (Canicola and Icterohaemorrhagiae serovars), leptospirosis (Grippotyphosa and Pomona) | V10 Vanguard Plus (Zoetis, Belgium SA)/live attenuated vaccine | After V8 applications, the adult dog must be vaccinated with V10 from 6 weeks of age or older. |
2. Production of Vaccines
2.1. Bacteria Seed
2.2. Virus Seed
2.3. Computational Based Vaccine
2.4. Challenges in Vaccine Production
2.5. Production Methods
3. Inactivation
3.1. Bacterial Vaccines
3.2. Bacterial Toxoids
3.3. Viral Vaccines
4. Choice of Composition and Strain of Vaccines
5. Final Bulk and Final Batch
6. Vaccines Assays and Quality Control
- Test for the detection of Mycoplasma contamination
- ii
- Test of residual moisture (RM)
- iii
- Test of residual formaldehyde
7. Vaccines’ Labeling
8. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Issue | Test | Guideline | Refs | |
---|---|---|---|---|
Quality | Impurities | Test for the detection of Mycoplasma contamination | VICH GL34 | [112] |
Test of residual moisture | VICH GL26 | [113] | ||
Test of residual formaldehyde | VICH GL25 | [114] | ||
Stability | Stability testing of new biotechnological/biological veterinary medicinal products | VICH GL17 | [115] | |
Specification | Test procedures and acceptance criteria for new biotechnological/biological veterinary medicinal products | VICH GL40 | [116] | |
Safety | Target animal batch safety | Harmonization of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use | VICH GL50 (R) | [117] |
Harmonization of criteria to waive target animal batch safety testing for live vaccines for veterinary use | VICH GL55 | [118] | ||
Harmonization of criteria to waive laboratory animal batch safety testing for vaccines for veterinary use | VICH GL 59 | [119] | ||
Target animal safety | Examination of live veterinary vaccines in target animals for absence of reversion to virulence | VICH GL41 | [120] | |
Target animal safety for veterinary live and inactivated vaccines | VICH GL44 | [121] |
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Barbosa, R.d.M.; Silva, A.M.; Silva, C.F.d.; Cardoso, J.C.; Severino, P.; Meirelles, L.M.A.; Silva-Junior, A.A.d.; Viseras, C.; Fonseca, J.; Souto, E.B. Production Technologies, Regulatory Parameters, and Quality Control of Vaccine Vectors for Veterinary Use. Technologies 2022, 10, 109. https://doi.org/10.3390/technologies10050109
Barbosa RdM, Silva AM, Silva CFd, Cardoso JC, Severino P, Meirelles LMA, Silva-Junior AAd, Viseras C, Fonseca J, Souto EB. Production Technologies, Regulatory Parameters, and Quality Control of Vaccine Vectors for Veterinary Use. Technologies. 2022; 10(5):109. https://doi.org/10.3390/technologies10050109
Chicago/Turabian StyleBarbosa, Raquel de M., Amélia M. Silva, Classius F. da Silva, Juliana C. Cardoso, Patricia Severino, Lyghia M. A. Meirelles, Arnobio A. da Silva-Junior, César Viseras, Joel Fonseca, and Eliana B. Souto. 2022. "Production Technologies, Regulatory Parameters, and Quality Control of Vaccine Vectors for Veterinary Use" Technologies 10, no. 5: 109. https://doi.org/10.3390/technologies10050109