Journal article
Assessing the potency and immunogenicity of inactivated poliovirus vaccine after exposure to freezing temperatures
According to manufacturers, inactivated poliovirus vaccines (IPVs) are freeze sensitive and require storage between 2°C and 8°C, whereas oral poliovirus vaccine requires storage at -20 °C. Introducing IPV into ongoing immunization services might result in accidental exposure to freezing temperatures and potential loss of vaccine potency. To better understand the effect of freezing IPVs, samples of single-dose vaccine vials from Statens Serum Institut (VeroPol) and multi-dose vaccine vials from Sanofi Pasteur (IPOL) were exposed to freezing temperatures mimicking what a vaccine vial might encounter in the field. D-antigen content was measured to determine the in vitro potency by ELISA. Immunogenicity testing was conducted for a subset of exposed IPVs using the rat model. Freezing VeroPol had no detectable effect on in vitro potency (D-antigen content) in all exposures tested. Freezing of the IPOL vaccine for 7 days at -20 °C showed statistically significant decreases in D-antigen content by ELISA in poliovirus type 1 (p < 0.0001) and type 3 (p = 0.048). Reduction of poliovirus type 2 potency also approached significance (p = 0.062). The observed loss in D-antigen content did not affect immunogenicity in the rat model. Further work is required to determine the significance of the loss observed and the implications for vaccine handling policies and practices.
Authors
Languages
- English
Journal
Biologicals
Volume
53
Type
Journal article
Categories
- Vaccines & delivery devices
Topic references
FREEZE-PREVENTION-POTENCY
Title | Author | Year | Type | Language |
---|---|---|---|---|
Assessing the potency and immunogenicity of inactivated poliovirus vaccine after exposure to freezing temperatures | Abhijeet Anand, Cynthia J. Snider, Dexiang Chen, Diana Kouiavskaia, Edmond F. Maes, Eric Stevens, Howard E. Gary Jr., Jacqueline Fournier-Caruana, Jessica A. White, Konstantin Chumakov, M. Steven Oberste, Marcus Estrada, William C. Weldon | Journal article | English | |
Cold chain study: danger of freezing vaccines | P. Milhomme | Journal article | English | |
Comparison of hepatitis B vaccine coverage and effectiveness among urban and rural Mongolian 2-year-olds | Ann Marie Kimball, Arslan Rinchin, J. Khulan, James S. Edstam, Nyamkhuu Dulmaa, Pagbajabyn Nymadawa | Journal article | English | |
Effects of freezing on DPT and DPT-IPV vaccines, adsorbed | A. Bell, D. Scheifele, R. Dimayuga | Journal article | English, French | |
Factors affecting the immunogenicity and potency of tetanus toxoid: implications for the elimination of neonatal and non-neonatal tetanus as public health problems | A. Galazka, F. van Loon, S. Cochi, V. Dietz | Journal article | English | |
Hepatitis B vaccine | Arlene A. McLean, Raymond Shaw Jr. | Journal article | English | |
Hepatitis B vaccine in healthy hospital employees | R. Normand, R. Silberman, S. A. Klotz | Journal article | English | |
Performance and potency of tetanus toxoid: implications for eliminating neonatal tetanus | F. van Loon, J. B. Milstien, J. Bennett, S. Cochi, V. Dietz | Journal article | English | |
Physical, chemical and immunological stability of CHO-derived hepatitis B surface antigen (HBsAg) particles | Dvorah Diminsky, Marian Gorecki, Neomi Moav, Yechezkel Barenholz | Journal article | English | |
Storage at -3 degrees C for 24 h alters the immunogenicity of pertussis vaccines | Christina Ann Boros, D. M. Roberton, M. Hanlon, Michael Steven Gold | Journal article | English |