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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
- Source :
- The Journal of Infectious Diseases, Journal of infectious diseases, Oxford : Oxford University Press, 2021, vol. 223, iss. 1, p. 119-127
- Publication Year :
- 2020
-
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.
- Subjects :
- 0301 basic medicine
Male
viral shedding
inactivated poliovirus vaccine
030106 microbiology
immunogenicity
oral poliovirus vaccine
poliovirus
vaccine
medicine.disease_cause
03 medical and health sciences
Major Articles and Brief Reports
0302 clinical medicine
Immunogenicity, Vaccine
Immunity
medicine
Immunology and Allergy
Humans
AcademicSubjects/MED00860
030212 general & internal medicine
Viral shedding
business.industry
Immunogenicity
Poliovirus
Infant
Lithuania
medicine.disease
Virology
Antibodies, Neutralizing
Poliomyelitis
Virus Shedding
Vaccination
Intestines
Poliovirus Vaccine, Inactivated
Infectious Diseases
AcademicSubjects/MED00290
Immunization
Child, Preschool
Poliovirus Vaccine, Oral
Viruses
Inactivated Poliovirus Vaccine
Female
business
Subjects
Details
- ISSN :
- 15376613 and 00221899
- Volume :
- 223
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- The Journal of infectious diseases
- Accession number :
- edsair.doi.dedup.....bb94882f8bd5c1c2d43210b794d5660c