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A novel approach for preparation of the antisera reagent for potency determination of inactivated H7N9 influenza vaccines
- Source :
- Influenza and Other Respiratory Viruses
- Publication Year :
- 2016
- Publisher :
- Wiley, 2016.
-
Abstract
- Background The potency of inactivated influenza vaccines is determined using a single‐radial immunodiffusion (SRID) assay and requires standardized reagents consisting of a Reference Antigen and an influenza strain‐specific antiserum. Timely availability of reagents is a critical step in influenza vaccine production, and the need for backup approaches for reagent preparation is an important component of pandemic preparedness. Objectives When novel H7N9 viruses emerged in China in 2013, candidate inactivated H7N9 influenza vaccines were developed for evaluation in clinical trials, and reagents were needed to measure vaccine potency. Methods We previously described an alternative approach for generating strain‐specific potency antisera, utilizing modified vaccinia virus Ankara vectors to produce influenza hemagglutinin (HA)‐containing virus‐like particles (VLPs) for immunization. Vector‐produced HA antigen is not dependent upon the success of the traditional bromelain‐digestion and HA purification. Results Antiserum for H7N9 vaccines, produced after immunization of sheep with preparations of bromelain‐HA (br‐HA), was not optimal for the SRID assay, and the supply of antiserum was limited. However, antiserum obtained from sheep boosted with VLPs containing H7 HA greatly improved the ring quality in the SRID assay. Importantly, this antiserum worked well with both egg‐ and cell‐derived antigen and was distributed to vaccine manufacturers. Conclusions Utilizing a previously developed approach for preparing vaccine potency antiserum, we have addressed a major bottleneck encountered in preparation of H7N9 vaccine reagents. The combination of br‐HA and mammalian VLPs for sequential immunization represents the first use of an alternative approach for producing an influenza vaccine potency antiserum.
- Subjects :
- 0301 basic medicine
Pulmonary and Respiratory Medicine
China
Immunodiffusion
Epidemiology
Influenza vaccine
Hemagglutinin Glycoproteins, Influenza Virus
Antibodies, Viral
Influenza A Virus, H7N9 Subtype
03 medical and health sciences
Influenza A Virus, H1N1 Subtype
0302 clinical medicine
Antigen
Influenza, Human
Pandemic
Animals
Humans
Potency
Vaccines, Virus-Like Particle
030212 general & internal medicine
Pandemics
Vaccine Potency
Antiserum
Sheep
Influenza A Virus, H5N1 Subtype
Chemistry
Immune Sera
single‐radial immunodiffusion assay
Public Health, Environmental and Occupational Health
Original Articles
vaccine potency assay
030112 virology
Virology
Influenza vaccine reagents
Infectious Diseases
Vaccines, Inactivated
Influenza Vaccines
Reagent
Original Article
Subjects
Details
- ISSN :
- 17502659 and 17502640
- Volume :
- 10
- Database :
- OpenAIRE
- Journal :
- Influenza and Other Respiratory Viruses
- Accession number :
- edsair.doi.dedup.....bd977b3689d0a4a4d36c2e10e07e455e