PMID- 32621741
OWN - NLM
STAT- MEDLINE
DCOM- 20210610
LR  - 20210610
IS  - 1537-6613 (Electronic)
IS  - 0022-1899 (Print)
IS  - 0022-1899 (Linking)
VI  - 223
IP  - 1
DP  - 2021 Jan 4
TI  - 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.
PG  - 119-127
LID - 10.1093/infdis/jiaa390 [doi]
AB  - 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.
CI  - (c) The Author(s) 2020. Published by Oxford University Press for the Infectious 
      Diseases Society of America.
FAU - Bandyopadhyay, Ananda S
AU  - Bandyopadhyay AS
AD  - Bill & Melinda Gates Foundation, Seattle, Washington, USA.
FAU - Gast, Chris
AU  - Gast C
AD  - Biostatistical Consulting, Washington, USA.
FAU - Brickley, Elizabeth B
AU  - Brickley EB
AD  - Department of Infectious Disease Epidemiology, London School of Hygiene & 
      Tropical Medicine, London, United Kingdom.
FAU - Ruttimann, Ricardo
AU  - Ruttimann R
AD  - Fighting Infectious Diseases in Emerging Countries, Miami, Florida, USA.
FAU - Clemens, Ralf
AU  - Clemens R
AD  - Global Research in Infectious Diseases, Rio de Janeiro, Brazil.
FAU - Oberste, M Steven
AU  - Oberste MS
AD  - Division of Viral Diseases, Centers for Disease Control and Prevention, Atlanta, 
      Georgia, USA.
FAU - Weldon, William C
AU  - Weldon WC
AD  - Division of Viral Diseases, Centers for Disease Control and Prevention, Atlanta, 
      Georgia, USA.
FAU - Ackerman, Margaret E
AU  - Ackerman ME
AD  - Thayer School of Engineering, Dartmouth College, Hanover, New Hampshire, USA.
FAU - Connor, Ruth I
AU  - Connor RI
AD  - Department of Pediatrics, Geisel School of Medicine at Dartmouth, 
      Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
FAU - Wieland-Alter, Wendy F
AU  - Wieland-Alter WF
AD  - Department of Pediatrics, Geisel School of Medicine at Dartmouth, 
      Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
FAU - Wright, Peter
AU  - Wright P
AD  - Department of Pediatrics, Geisel School of Medicine at Dartmouth, 
      Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
FAU - Usonis, Vytautas
AU  - Usonis V
AD  - Clinic of Children's Diseases, Institute of Clinical Medicine, Faculty of 
      Medicine, Vilnius University, Lithuania.
LA  - eng
SI  - ClinicalTrials.gov/NCT02582255
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Infect Dis
JT  - The Journal of infectious diseases
JID - 0413675
RN  - 0 (Antibodies, Neutralizing)
RN  - 0 (Poliovirus Vaccine, Inactivated)
RN  - 0 (Poliovirus Vaccine, Oral)
SB  - IM
CIN - J Infect Dis. 2021 Jan 4;223(1):7-9. PMID: 32621744
MH  - Antibodies, Neutralizing
MH  - Child, Preschool
MH  - Female
MH  - Humans
MH  - Immunogenicity, Vaccine
MH  - Infant
MH  - Intestines/immunology
MH  - Lithuania
MH  - Male
MH  - Poliomyelitis/*immunology/prevention & control
MH  - Poliovirus Vaccine, Inactivated/administration & dosage
MH  - Poliovirus Vaccine, Oral/administration & dosage/adverse effects/*immunology
MH  - Virus Shedding
PMC - PMC7781454
OTO - NOTNLM
OT  - immunogenicity
OT  - inactivated poliovirus vaccine
OT  - oral poliovirus vaccine
OT  - poliovirus
OT  - vaccine
OT  - viral shedding
EDAT- 2020/07/06 06:00
MHDA- 2021/06/11 06:00
PMCR- 2020/07/04
CRDT- 2020/07/05 06:00
PHST- 2020/04/14 00:00 [received]
PHST- 2020/06/25 00:00 [accepted]
PHST- 2020/07/06 06:00 [pubmed]
PHST- 2021/06/11 06:00 [medline]
PHST- 2020/07/05 06:00 [entrez]
PHST- 2020/07/04 00:00 [pmc-release]
AID - 5867494 [pii]
AID - jiaa390 [pii]
AID - 10.1093/infdis/jiaa390 [doi]
PST - ppublish
SO  - J Infect Dis. 2021 Jan 4;223(1):119-127. doi: 10.1093/infdis/jiaa390.