Clinical trialNCT04529538CompletedPhase 1Interventional

Study of Novel Types 1 and 3 Oral Poliomyelitis Vaccines

SponsorPATHEnrollment226Poliomyelitis

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this study is to assess the safety (primary objective), the ability to trigger the production of antibodies (immunogenicity; a secondary objective) and presence of vaccine virus in the stool (fecal shedding; a secondary objective) of two novel oral polio vaccines (nOPV), novel oral poliomyelitis vaccine type 1 (nOPV1) and novel oral poliomyelitis vaccine type 3 (nOPV3), as compared to Sabin strain monovalent oral poliomyelitis vaccine (mOPV) controls, in healthy adults.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Arlene Sena, MD
University of North Carolina
Principal Investigator
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Jessica Crothers, MD
University of Vermont
Principal Investigator
clinicaltrials.gov ↗
Mohamed Al-Ibrahim, MB CHB, FACP
Pharmaron CPC, Inc.
Principal Investigator
clinicaltrials.gov ↗
Peter Wright, MD
Dartmouth-Hitchcock Medical Center
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

4 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Pharmaron Cpc, Inc.
Baltimore, Maryland, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
University of North Carolina Institute for Global Health and Infectious Diseases (ighid)
Chapel Hill, North Carolina, United States
University of Vermont Vaccine Testing Center
Burlington, Vermont, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Novel Oral Polio Vaccine Type 1Novel Oral Polio Vaccine Type 3Sabin Monovalent Oral Polio Vaccine Type 1Sabin Monovalent Oral Polio Vaccine Type 3

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 26 Mar 2021
Primary completion: 17 Feb 2023
Completion: 17 Feb 2023
Last update posted: 20 Nov 2024
Registered enrollment: 226
Registry id: NCT04529538

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.