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Intradermal Fractional Dose IPV (fIPV) in Combination With dmLT

NCT05327426 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2023-11-29

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Jessica W Crothers, MD · UVM Vaccine Testing Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2023-10-10
Completion
2024-08-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05327426 on ClinicalTrials.gov