Safety and Immunogenicity of a New Inactivated Polio Vaccine Made From Sabin Strains: A Randomized, Double-Blind, Active-Controlled, Phase 2/3 Seamless Study.
Sabin vaccine
health
inactivated poliovirus vaccine
infant
safety
vaccine immunogenicity
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:
24 08 2022
24 08 2022
Historique:
received:
08
11
2020
accepted:
20
12
2020
pubmed:
23
12
2020
medline:
27
8
2022
entrez:
22
12
2020
Statut:
ppublish
Résumé
A new inactivated polio vaccine made from Sabin strains (sIPV) was developed as part of the global polio eradication initiative. This randomized, double-blind, active-controlled, phase 2/3 seamless study was conducted in 2 stages. Healthy infants aged 6 weeks were randomly assigned to receive 3 doses of 1 of 4 study vaccines at 6, 10, and 14 weeks of age (336 received low-, middle-, or high-dose sIPV, or conventional IPV [cIPV] in stage I, and 1086 received lot A, B, or C of the selected sIPV dose, or cIPV in stage II). The primary outcome was the seroconversion rate 4 weeks after the third vaccination. In stage I, low-dose sIPV was selected as the optimal dose. In stage II, consistency among the 3 manufacturing lots of sIPV was demonstrated. The seroconversion rates for Sabin and wild strains of the 3 serotypes after the 3-dose primary series were 95.8% to 99.2% in the lot-combined sIPV group and 94.8% to 100% in the cIPV group, proving the noninferiority of sIPV compared to cIPV. No notable safety risks associated with sIPV were observed. Low-dose sIPV administered as a 3-dose vaccination was safe and immunogenic compared to cIPV. NCT03169725.
Sections du résumé
BACKGROUND
A new inactivated polio vaccine made from Sabin strains (sIPV) was developed as part of the global polio eradication initiative.
METHODS
This randomized, double-blind, active-controlled, phase 2/3 seamless study was conducted in 2 stages. Healthy infants aged 6 weeks were randomly assigned to receive 3 doses of 1 of 4 study vaccines at 6, 10, and 14 weeks of age (336 received low-, middle-, or high-dose sIPV, or conventional IPV [cIPV] in stage I, and 1086 received lot A, B, or C of the selected sIPV dose, or cIPV in stage II). The primary outcome was the seroconversion rate 4 weeks after the third vaccination.
RESULTS
In stage I, low-dose sIPV was selected as the optimal dose. In stage II, consistency among the 3 manufacturing lots of sIPV was demonstrated. The seroconversion rates for Sabin and wild strains of the 3 serotypes after the 3-dose primary series were 95.8% to 99.2% in the lot-combined sIPV group and 94.8% to 100% in the cIPV group, proving the noninferiority of sIPV compared to cIPV. No notable safety risks associated with sIPV were observed.
CONCLUSIONS
Low-dose sIPV administered as a 3-dose vaccination was safe and immunogenic compared to cIPV.
CLINICAL TRIALS REGISTRATION
NCT03169725.
Identifiants
pubmed: 33351072
pii: 6044221
doi: 10.1093/infdis/jiaa770
pmc: PMC9400411
doi:
Substances chimiques
Poliovirus Vaccine, Inactivated
0
Banques de données
ClinicalTrials.gov
['NCT03169725']
Types de publication
Clinical Trial, Phase II
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
308-318Informations de copyright
© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America.
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