Clinical trialNCT05327426UnknownPhase 1Interventional

Intradermal Fractional Dose IPV (fIPV) in Combination With dmLT

SponsorUniversity of VermontEnrollment19Poliomyelitis

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is a single site, phase 1 study of dmLT as a mucosal adjuvant to control fecal viral shedding when used in combination with intradermally administered fractional dose trivalent IPV (fIPV). It will be a 2-arm, randomized, double-blind controlled trial of intradermal fIPV versus fIPV+dmLT in healthy adults with a monovalent oral polio vaccine (OPV) challenge administered as a test of mucosal immunity. A maximum of 30 healthy subjects will be recruited, all of whom will have received IPV only as part of their primary childhood immunization series (cohort 1); they will be randomized 2:1 to receive fIPV-dmLT or fIPV alone. A maximum of 27 participants will be recruited from an earlier pilot study population exposed to fIPV+/-dmLT and will provide follow-up samples for immunologic studies only (cohort 2).

clinicaltrials.gov ↗

Investigators

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

Jessica W Crothers, MD
UVM Vaccine Testing 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

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

United States

University of Vermont Vaccine Testing Center at the Larner College of Medicine
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.

Intradermal fractional dose inactivated polio vaccineIntradermal fractional dose inactivated polio vaccine in combination with recombinant double mutant heat labile toxin, LTMonovalent oral poliomyelitis vaccine, Sabin strain

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: 1 Apr 2022
Primary completion: 10 Oct 2023
Completion: 25 Aug 2024
Last update posted: 29 Nov 2023
Registered enrollment: 19
Registry id: NCT05327426

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.