Trial reportThe Journal of infectious diseases2021
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.
Trial report in The Journal of infectious diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02582255 (A Phase 4 Study to Evaluate the Safety and Immunogenicity of Monovalent Oral Polio Vaccine Type 2 in Healthy IPV-vaccinated Children Aged 1 to 5 Years in Lithuania), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 4 Study to Evaluate the Safety and Immunogenicity of Monovalent Oral Polio Vaccine Type 2 in Healthy IPV-vaccinated Children Aged 1 to 5 Years in Lithuania
Who cites it
16 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Intestinal mucosal immune responses induced by novel oral poliovirus vaccine type 2 and Sabin monovalent oral poliovirus vaccine type 2: an analysis of data from four clinical trials.The Lancet. Microbe · 2025Pooled it
- Review of Poliovirus Transmission and Economic Modeling to Support Global Polio Eradication: 2020-2024.Pathogens (Basel, Switzerland) · 2024Pooled it
- Safety and immunogenicity of novel live attenuated type 1 and type 3 oral poliomyelitis vaccines in healthy adults in the USA: a first-in-human, observer-masked, multicentre, phase 1 randomised controlled trial.The Lancet. Infectious diseases · 2025Trial
- Immunogenicity of Reduced-Dose Monovalent Type 2 Oral Poliovirus Vaccine in Mocuba, Mozambique.The Journal of infectious diseases · 2022Trial
- Safety and immunogenicity of two novel type 2 oral poliovirus vaccine candidates compared with a monovalent type 2 oral poliovirus vaccine in children and infants: two clinical trials.Lancet (London, England) · 2021Trial
- Safety and immunogenicity of two novel type 2 oral poliovirus vaccine candidates compared with a monovalent type 2 oral poliovirus vaccine in healthy adults: two clinical trials.Lancet (London, England) · 2021Trial
- Immune and Safety Analysis ofViruses · 2025Article
- A highly immunogenic UVC inactivated Sabin based polio vaccine.NPJ vaccines · 2024Article
- Tolerability, safety, and immunogenicity of the novel oral polio vaccine type 2 in children aged 6 weeks to 59 months in an outbreak response campaign in The Gambia: an observational cohort study.The Lancet. Infectious diseases · 2024Observational
- Positive-unlabeled learning to infer protection status and identify correlates in vaccine efficacy field trials.iScience · 2024Article
- Fecal Shedding of 2 Novel Live Attenuated Oral Poliovirus Type 2 Vaccine Candidates by Healthy Infants Administered Bivalent Oral Poliovirus Vaccine/Inactivated Poliovirus Vaccine: 2 Randomized Clinical Trials.The Journal of infectious diseases · 2022Article
- Intestinal Antibody Responses to 2 Novel Live Attenuated Type 2 Oral Poliovirus Vaccines in Healthy Adults in Belgium.The Journal of infectious diseases · 2022Article
- Evaluating stability of attenuated Sabin and two novel type 2 oral poliovirus vaccines in children.NPJ vaccines · 2022Article
- Mucosal immunity to poliovirus.Mucosal immunology · 2022Review
- Assessment of genetic changes and neurovirulence of shed Sabin and novel type 2 oral polio vaccine viruses.NPJ vaccines · 2021Article
- The Long and Winding Road to Eradicate Vaccine-Related Polioviruses.The Journal of infectious diseases · 2021Article
Corrections and comments
- Commented on by
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundUnderstanding 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.
methodsIn 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.
resultsAfter 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.
conclusionsHigh 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.