NCT05327426

Intradermal Fractional Dose IPV (fIPV) in Combination With dmLT

Evaluating the Safety, Reactogenicity, and Immunogenicity of Intradermal Fractional Dose IPV (fIPV) in Combination With the Novel Mucosal Adjuvant, dmLT

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Vermont · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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).

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-10-10
• Completion: 2024-08-25
• First posted: 2022-04-14
• Last updated: 2023-11-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study