NCT05327426View on ClinicalTrials.gov

Intradermal Fractional Dose IPV (fIPV) in Combination With dmLT

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

April 1, 2022

Primary Completion Date

October 10, 2023

Study Completion Date

August 25, 2024

Conditions
Poliomyelitis
Interventions
BIOLOGICAL

Intradermal fractional dose inactivated polio vaccine (fIPV) in combination with recombinant double mutant heat labile toxin, LT(R192G/L211A), (dmLT)

Sanofi's licensed IPOL trivalent inactivated polio vaccine (NDC 49281-860-78) delivered at the dose-sparing fractional volume of 1/5 the full dose (0.1mL) admixed with 0.47µg of recombinant double mutant \[LT(R192G/L211A)\] Enterotoxigenic Escherichia coli heat labile toxin (dmLT) adjuvant.

BIOLOGICAL

Intradermal fractional dose inactivated polio vaccine (fIPV)

Sanofi's licensed IPOL trivalent inactivated polio vaccine (NDC 49281-860-78) delivered at the dose-sparing fractional volume of 1/5 the full dose (0.1mL).

BIOLOGICAL

Monovalent oral poliomyelitis vaccine (mOPV), Sabin strain

Monovalent oral polio vaccine (OPV) challenge administered as a test of mucosal immunity.

Trial Locations (1)

05401

University of Vermont Vaccine Testing Center at the Larner College of Medicine, Burlington

All Listed Sponsors
collaborator

World Health Organization

OTHER

lead

University of Vermont

OTHER