Differences in Antigenic Structure of Inactivated Polio Vaccines Made From Sabin Live-Attenuated and Wild-Type Poliovirus Strains: Impact on Vaccine Potency Assays.
Antibodies, Neutralizing
/ immunology
Antibodies, Viral
/ immunology
Antigens, Viral
/ immunology
Humans
Immunogenicity, Vaccine
/ immunology
Poliomyelitis
/ prevention & control
Poliovirus
/ immunology
Poliovirus Vaccine, Inactivated
/ immunology
Poliovirus Vaccine, Oral
/ immunology
Vaccine Potency
Vaccines, Attenuated
/ immunology
D-antigen
ELISA
Inactivated polio vaccine
antigenic structure
vaccine potency
Journal
The Journal of infectious diseases
ISSN: 1537-6613
Titre abrégé: J Infect Dis
Pays: United States
ID NLM: 0413675
Informations de publication
Date de publication:
03 02 2020
03 02 2020
Historique:
received:
08
11
2018
accepted:
15
02
2019
pubmed:
23
2
2019
medline:
22
9
2020
entrez:
22
2
2019
Statut:
ppublish
Résumé
Following the declaration of wild-type 2 poliovirus eradication in 2015, the type 2 component was removed from the live-attenuated oral polio vaccine (OPV). This change implies a need to improve global coverage through routine immunization with inactivated polio vaccine (IPV), to ensure type 2 immunity. Several manufacturers use Sabin OPV strains for IPV production (sIPV), rather than the usual wild-type strains used for conventional IPV (cIPV). However, in contrast to cIPV, potency assays for sIPV have not been standardized, no international references exist, and no antigen units have been defined for a sIPV human dose. Thus, sIPV products from different manufacturers cannot be compared, and the relationship between antigenicity and immunogenicity of sIPV is not well understood. A collaborative study was conducted in which laboratories used different methods to measure the antigen content of a set of sIPV and cIPV samples with an aim to identify a suitable reference for sIPV products. The study revealed differences in the reactivity of antibody reagents to cIPV and sIPV products. Homologous references are required to measure the antigen content of IPV products consistently. The first World Health Organization international standard for sIPV was established, with new, specific Sabin D-antigen units assigned.
Sections du résumé
BACKGROUND
Following the declaration of wild-type 2 poliovirus eradication in 2015, the type 2 component was removed from the live-attenuated oral polio vaccine (OPV). This change implies a need to improve global coverage through routine immunization with inactivated polio vaccine (IPV), to ensure type 2 immunity. Several manufacturers use Sabin OPV strains for IPV production (sIPV), rather than the usual wild-type strains used for conventional IPV (cIPV). However, in contrast to cIPV, potency assays for sIPV have not been standardized, no international references exist, and no antigen units have been defined for a sIPV human dose. Thus, sIPV products from different manufacturers cannot be compared, and the relationship between antigenicity and immunogenicity of sIPV is not well understood.
METHODS
A collaborative study was conducted in which laboratories used different methods to measure the antigen content of a set of sIPV and cIPV samples with an aim to identify a suitable reference for sIPV products.
RESULTS
The study revealed differences in the reactivity of antibody reagents to cIPV and sIPV products.
CONCLUSIONS
Homologous references are required to measure the antigen content of IPV products consistently. The first World Health Organization international standard for sIPV was established, with new, specific Sabin D-antigen units assigned.
Identifiants
pubmed: 30788503
pii: 5351027
doi: 10.1093/infdis/jiz076
doi:
Substances chimiques
Antibodies, Neutralizing
0
Antibodies, Viral
0
Antigens, Viral
0
Poliovirus Vaccine, Inactivated
0
Poliovirus Vaccine, Oral
0
Vaccines, Attenuated
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
544-552Subventions
Organisme : Department of Health
Pays : United Kingdom
Investigateurs
Alexandre Dobly
(A)
Cai Wei
(C)
Shi Lei
(S)
Ping Ling
(P)
Changgui Li
(C)
Jiang Zheng
(J)
Yijing Wang
(Y)
Huo Liqun
(H)
Sylvie Jorajuria
(S)
Gwenäelle Cozic
(G)
Dori Ugiyadi
(D)
Nia Kurniati
(N)
Susumu Ochiai
(S)
Miwako Miyazawa
(M)
Yuichi Someya
(Y)
Takeshi Nishihama
(T)
Misaki Masafumi
(M)
Janny Westdijk
(J)
Saskia Crowe
(S)
Michelle de Graaf
(M)
Diana Kouiavskaia
(D)
Konstantin Chumakov
(K)
Commentaires et corrections
Type : CommentIn
Informations de copyright
© The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America.