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.

Abstract

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.

• Authors: Ananda S Bandyopadhyay, Chris Gast, Elizabeth B Brickley, Ricardo Rüttimann, Ralf Clemens, M Steven Oberste, William C Weldon, Margaret E Ackerman, Ruth I Connor, Wendy F Wieland-Alter, Peter Wright, Vytautas Usonis
• Journal: The Journal of infectious diseases (J Infect Dis) Vol. 223 Issue 1 Pg. 119-127 (01 04 2021) ISSN: 1537-6613 [Electronic] United States
• PMID: 32621741 (Publication Type: Clinical Trial, Phase IV, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America.

Chemical References

• Antibodies, Neutralizing
• Poliovirus Vaccine, Inactivated
• Poliovirus Vaccine, Oral

Topics

• Antibodies, Neutralizing
• Child, Preschool
• Female
• Humans
• Immunogenicity, Vaccine
• Infant
• Intestines (immunology)
• Lithuania
• Male
• Poliomyelitis (immunology, prevention & control)
• Poliovirus Vaccine, Inactivated (administration & dosage)
• Poliovirus Vaccine, Oral (administration & dosage, adverse effects, immunology)
• Virus Shedding