Immunogenicity of two-dose and three-dose vaccination schedules with Sabin inactivated poliovirus vaccine in China: An open-label, randomized, controlled trial.
Inactivated polio vaccine
Sabin Strain
Seroprevalence
Journal
The Lancet regional health. Western Pacific
ISSN: 2666-6065
Titre abrégé: Lancet Reg Health West Pac
Pays: England
ID NLM: 101774968
Informations de publication
Date de publication:
May 2021
May 2021
Historique:
received:
03
12
2020
revised:
22
02
2021
accepted:
04
03
2021
entrez:
30
7
2021
pubmed:
31
7
2021
medline:
31
7
2021
Statut:
epublish
Résumé
We assessed immunogenicity of three-dose and two-dose immunization schedules with a Sabin-strain inactivated poliovirus vaccine (sIPV) produced by one Chinese vaccine manufacturer. This was an open label, randomized, controlled trial conducted in 16 vaccination clinics in Shandong province. Infants were allocated randomly to either a 3-dose study arm (sIPV administered at 2, 3, and 4 months of age) or a 2-dose arm (sIPV administered at 4 and 8-11 months of age). Poliovirus neutralizing antibodies were measured in sera collected prior to the first sIPV dose and one month after the last dose. We enrolled 560 infants; 536 (95.7%) completed the study. Final seropositivity rates were >98% for all three serotypes in both study arms. There were no statistically significant differences in seropositivity between the 2-dose and the 3-dose schedule. Final median reciprocal titres of polio antibodies were high overall (>1:768 for all serotypes) and statistically significantly higher in 2-dose recipients compared with 3-dose recipients ( This study offers evidence that two doses of sIPV administered at 4 and 8-11 months of age and three doses of sIPV administered at 2, 3, and 4 months of age both provide serological protection against poliomyelitis. Median reciprocal titres of polio antibodies were high overall, and were more related to the interval between doses than the number of doses, with the longer interval of the 2-dose schedule producing higher reciprocal titres than the shorter-interval 3-dose schedule. The protection provided by the 3-dose schedule is achieved earlier in life than the protection with the 2-dose schedule. Countries planning to use an IPV-only schedule in the post-eradication era can consider this 2-dose sIPV option as an immunogenic and dose-sparing strategy. World Health Organization (from a grant from International PolioPlus Committee, Rotary International, Evanston, IL, USA).
Sections du résumé
BACKGROUND
BACKGROUND
We assessed immunogenicity of three-dose and two-dose immunization schedules with a Sabin-strain inactivated poliovirus vaccine (sIPV) produced by one Chinese vaccine manufacturer.
METHODS
METHODS
This was an open label, randomized, controlled trial conducted in 16 vaccination clinics in Shandong province. Infants were allocated randomly to either a 3-dose study arm (sIPV administered at 2, 3, and 4 months of age) or a 2-dose arm (sIPV administered at 4 and 8-11 months of age). Poliovirus neutralizing antibodies were measured in sera collected prior to the first sIPV dose and one month after the last dose.
FINDINGS
RESULTS
We enrolled 560 infants; 536 (95.7%) completed the study. Final seropositivity rates were >98% for all three serotypes in both study arms. There were no statistically significant differences in seropositivity between the 2-dose and the 3-dose schedule. Final median reciprocal titres of polio antibodies were high overall (>1:768 for all serotypes) and statistically significantly higher in 2-dose recipients compared with 3-dose recipients (
INTERPRETATION
CONCLUSIONS
This study offers evidence that two doses of sIPV administered at 4 and 8-11 months of age and three doses of sIPV administered at 2, 3, and 4 months of age both provide serological protection against poliomyelitis. Median reciprocal titres of polio antibodies were high overall, and were more related to the interval between doses than the number of doses, with the longer interval of the 2-dose schedule producing higher reciprocal titres than the shorter-interval 3-dose schedule. The protection provided by the 3-dose schedule is achieved earlier in life than the protection with the 2-dose schedule. Countries planning to use an IPV-only schedule in the post-eradication era can consider this 2-dose sIPV option as an immunogenic and dose-sparing strategy.
FUNDING
BACKGROUND
World Health Organization (from a grant from International PolioPlus Committee, Rotary International, Evanston, IL, USA).
Identifiants
pubmed: 34327346
doi: 10.1016/j.lanwpc.2021.100133
pii: S2666-6065(21)00042-0
pmc: PMC8315596
doi:
Types de publication
Journal Article
Langues
eng
Pagination
100133Subventions
Organisme : World Health Organization
ID : 001
Pays : International
Informations de copyright
© 2021 Published by Elsevier Ltd.
Déclaration de conflit d'intérêts
All authors of this manuscript have indicated that they have no conflicts of interest that relate to the content of this manuscript.
Références
J Pediatric Infect Dis Soc. 2016 Sep;5(3):287-96
pubmed: 26407255
Methods Mol Biol. 2016;1387:145-76
pubmed: 26983734
Lancet Infect Dis. 2012 Feb;12(2):128-35
pubmed: 22071249
Pharm Pat Anal. 2012 Nov;1(5):589-99
pubmed: 24236927
Lancet Infect Dis. 2020 Sep;20(9):1071-1079
pubmed: 32442523
Clin Infect Dis. 2018 Oct 30;67(suppl_1):S57-S65
pubmed: 30376095
PLoS Pathog. 2012;8(4):e1002599
pubmed: 22532797
Open Forum Infect Dis. 2019 Aug 26;6(10):ofz380
pubmed: 31660344
J Virol Methods. 2020 Feb;276:113785
pubmed: 31765719
Science. 2020 Apr 24;368(6489):401-405
pubmed: 32193361
J Infect Dis. 2019 Oct 8;220(10):1551-1557
pubmed: 30958543
Lancet. 2015 Dec 12;386(10011):2413-21
pubmed: 26388534
J Infect Dis. 2014 Nov 1;210 Suppl 1:S434-8
pubmed: 25316865