The Use of Next-Generation Sequencing for the Quality Control of Live-Attenuated Polio Vaccines.
MAPREC
neurovirulence
next-generation sequencing
oral polio vaccine
vaccine quality control
vaccine safety
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:
09 11 2020
09 11 2020
Historique:
received:
20
03
2020
accepted:
28
05
2020
pubmed:
4
6
2020
medline:
26
3
2021
entrez:
4
6
2020
Statut:
ppublish
Résumé
Next-generation sequencing (NGS) analysis was compared to the current MAPREC (mutational analysis by polymerase chain reaction and restriction enzyme cleavage) assay for quality control of live-attenuated oral polio vaccine (OPV). MAPREC measures reversion of the main OPV attenuating mutations such as uracil (U) to cytosine (C) at nucleotide 472 in the 5' noncoding region of type 3 OPV. Eleven type 3 OPV samples were analyzed by 8 laboratories using their in-house NGS method. Intraassay, intralaboratory, and interlaboratory variability of NGS 472-C estimates across samples and laboratories were very low, leading to excellent agreement between laboratories. A high degree of correlation between %472-C results by MAPREC and NGS was observed in all laboratories (Pearson correlation coefficient r = 0.996). NGS estimates of sequences at nucleotide 2493 with known polymorphism among type 3 OPV lots also produced low assay variability and excellent between-laboratory agreement. The high consistency of NGS data demonstrates that NGS analysis can be used as high-resolution test alternative to MAPREC, producing whole-genome profiles to evaluate OPV production consistency, possibly eliminating the need for tests in animals. This would be very beneficial for the quality assessment of next-generation polio vaccines and, eventually, for other live-attenuated viral vaccines.
Sections du résumé
BACKGROUND
Next-generation sequencing (NGS) analysis was compared to the current MAPREC (mutational analysis by polymerase chain reaction and restriction enzyme cleavage) assay for quality control of live-attenuated oral polio vaccine (OPV).
METHODS
MAPREC measures reversion of the main OPV attenuating mutations such as uracil (U) to cytosine (C) at nucleotide 472 in the 5' noncoding region of type 3 OPV. Eleven type 3 OPV samples were analyzed by 8 laboratories using their in-house NGS method.
RESULTS
Intraassay, intralaboratory, and interlaboratory variability of NGS 472-C estimates across samples and laboratories were very low, leading to excellent agreement between laboratories. A high degree of correlation between %472-C results by MAPREC and NGS was observed in all laboratories (Pearson correlation coefficient r = 0.996). NGS estimates of sequences at nucleotide 2493 with known polymorphism among type 3 OPV lots also produced low assay variability and excellent between-laboratory agreement.
CONCLUSIONS
The high consistency of NGS data demonstrates that NGS analysis can be used as high-resolution test alternative to MAPREC, producing whole-genome profiles to evaluate OPV production consistency, possibly eliminating the need for tests in animals. This would be very beneficial for the quality assessment of next-generation polio vaccines and, eventually, for other live-attenuated viral vaccines.
Identifiants
pubmed: 32492703
pii: 5850979
doi: 10.1093/infdis/jiaa299
doi:
Substances chimiques
Poliovirus Vaccine, Oral
0
Vaccines, Attenuated
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1920-1927Investigateurs
Jean-Pol Cassart
(JP)
Ahmed Essaghir
(A)
Olivier Vandeputte
(O)
Christophe Lambert
(C)
Mathias Janssen
(M)
Lucas Preux
(L)
Murielle Andre
(M)
Eric Sarcey
(E)
Isabelle Perret
(I)
Fabrice Tindy
(F)
Laurent Mallet
(L)
Steffen Matthijn de Boer
(SM)
Tomofumi Nakamura
(T)
Susumu Ochiai
(S)
Martin Fritzsche
(M)
Nadine Holmes
(N)
Manasi Majumdar
(M)
Edward Mee
(E)
Begona Valdazo-Gonzalez
(B)
Majid Laassri
(M)
Konstantin Chumakov
(K)
Informations de copyright
© Crown copyright 2020.