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Determination of influenza B identity and potency in quadrivalent inactivated influenza vaccines using lineage-specific monoclonal antibodies
- Source :
- PLoS ONE, Vol 12, Iss 4, p e0175733 (2017), PLoS ONE
- Publication Year :
- 2017
- Publisher :
- Public Library of Science (PLoS), 2017.
-
Abstract
- Co-circulation of two antigenically and genetically distinct lineages of influenza B virus, represented by prototype viruses B/Victoria/2/1987 and B/Yamagata/16/1988, has led to the development of quadrivalent influenza vaccines that contain two influenza B antigens. The inclusion of two influenza B antigens presents challenges for the production and regulation of inactivated quadrivalent vaccines, including the potential for cross-reactivity of the reagents used in identity and potency assays because of the relative close relatedness of the hemagglutinin (HA) from the two virus lineages. Monoclonal antibodies (mAbs) specific for the two lineages of influenza B HA were generated and characterized and used to set-up simple identity tests that distinguish the influenza B antigens in inactivated trivalent and quadrivalent vaccines. The lineage-specific mAbs bound well to the HA of influenza B strains included in influenza vaccines over a period of more than 10 years, suggesting that identity tests using such lineage-specific mAbs would not necessarily have to be updated with every influenza B vaccine strain change. These lineage-specific mAbs were also used in an antibody capture ELISA format to quantify HA in vaccine samples, including monovalent, trivalent, and quadrivalent vaccine samples from various manufacturers. The results demonstrated correlation with HA values determined by the traditional single radial immunodiffusion (SRID) assay. Further, the antibody-capture ELISA was able to distinguish heat-stressed vaccine from unstressed vaccine, and was similar to the SRID in quantifying the resultant loss of potency. These mAb reagents should be useful for further development of antibody-based alternative influenza B identity and potency assays.
- Subjects :
- RNA viruses
0301 basic medicine
Viral Diseases
Zygote
Physiology
lcsh:Medicine
Hemagglutinin Glycoproteins, Influenza Virus
Antibodies, Viral
medicine.disease_cause
Biochemistry
Madin Darby Canine Kidney Cells
Mice
Immunogenicity, Vaccine
0302 clinical medicine
Immune Physiology
Medicine and Health Sciences
Influenza A virus
Public and Occupational Health
030212 general & internal medicine
Enzyme-Linked Immunoassays
lcsh:Science
Antigens, Viral
Pathology and laboratory medicine
Vaccines
Immune System Proteins
Multidisciplinary
biology
Viral Vaccine
Immunogenicity
Antibodies, Monoclonal
Medical microbiology
Vaccination and Immunization
Infectious Diseases
Influenza Vaccines
Vaccines, Subunit
Viruses
Pathogens
Antibody
Protein Binding
Research Article
Immunodiffusion
Infectious Disease Control
medicine.drug_class
Immunology
Hemagglutinin (influenza)
Enzyme-Linked Immunosorbent Assay
Research and Analysis Methods
Monoclonal antibody
Microbiology
Antibodies
Virus
03 medical and health sciences
Dogs
Antigen
Virology
Influenza, Human
Vaccine Development
medicine
Animals
Humans
Influenza viruses
Immunoassays
Biology and life sciences
lcsh:R
Organisms
Viral pathogens
Proteins
Viral Vaccines
Hemagglutination Inhibition Tests
030112 virology
Influenza
Microbial pathogens
Influenza B virus
Vaccines, Inactivated
Immunologic Techniques
biology.protein
lcsh:Q
Preventive Medicine
Chickens
Orthomyxoviruses
Subjects
Details
- Language :
- English
- ISSN :
- 19326203
- Volume :
- 12
- Issue :
- 4
- Database :
- OpenAIRE
- Journal :
- PLoS ONE
- Accession number :
- edsair.doi.dedup.....72b154007354c3a13ae533d0a6896f17