Title A randomized phase 4 study of immunogenicity and safety after monovalent oral type 2 Sabin poliovirus vaccine challenge in children vaccinated with inactivated poliovirus vaccine in Lithuania /
Authors Bandyopadhyay, Ananda S ; Gast, Chris ; Brickley, Elizabeth B ; Rüttimann, Ricardo ; Clemens, Ralf ; Oberste, M. Steven ; Weldon, William C ; Ackerman, Margaret E ; Connor, Ruth I ; Wieland-Alter, Wendy F ; Wright, Peter ; Usonis, Vytautas
DOI 10.1093/infdis/jiaa390
Full Text Download
Is Part of Journal of infectious diseases.. Oxford : Oxford University Press. 2021, vol. 223, iss. 1, p. 119-127.. ISSN 0022-1899. eISSN 1537-6613
Keywords [eng] immunogenicity ; inactivated poliovirus vaccine ; oral poliovirus vaccine ; poliovirus ; vaccine ; viral shedding
Abstract [eng] Background: Understanding immunogenicity and safety of monovalent type 2 oral poliovirus vaccine (mOPV2) in inactivated poliovirus vaccine (IPV)-immunized children is of major importance in informing global policy to control circulating vaccine-derived poliovirus outbreaks. Methods: In this open-label, phase 4 study (NCT02582255) in 100 IPV-vaccinated Lithuanian 1-5-year-olds, we measured humoral and intestinal type 2 polio neutralizing antibodies before and 28 days after 1 or 2 mOPV2 doses given 28 days apart and measured stool viral shedding after each dose. Parents recorded solicited adverse events (AEs) for 7 days after each dose and unsolicited AEs for 6 weeks after vaccination. Results: After 1 mOPV2 challenge, the type 2 seroprotection rate increased from 98% to 100%. Approximately 28 days after mOPV2 challenge 34 of 68 children (50%; 95% confidence interval, 38%-62%) were shedding virus; 9 of 37 (24%; 12%-41%) were shedding 28 days after a second challenge. Before challenge, type 2 intestinal immunity was undetectable in IPV-primed children, but 28 of 87 (32%) had intestinal neutralizing titers ≥32 after 1 mOPV2 dose. No vaccine-related serious or severe AEs were reported. Conclusions: High viral excretion after mOPV2 among exclusively IPV-vaccinated children was substantially lower after a subsequent dose, indicating induction of intestinal immunity against type 2 poliovirus.
Published Oxford : Oxford University Press
Type Journal article
Language English
Publication date 2021
CC license CC license description