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Hepatitis B Vaccine Delivered Trans-dermally by MAP

NCT06800131 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-01-29

No results posted yet for this study

Summary

This is Phase I, randomized, open-label, active-controlled study to evaluate the safety, tolerability, and immunogenicity of a hepatitis B vaccine administered trans-dermally via microneedle array patch (MAP) compared to the intra-muscular (IM) hepatitis B vaccine (Euvax B™), administered at Day (D) 0, Week (W) 4, W26 among healthy adults aged 19 to 40 years in the Republic of Korea.

Conditions

  • Hepatitis B Vaccine

Interventions

DEVICE

Hepatitis B Vaccine administered trans-dermally via Microneedle Array Patch (MAP)

A total of 40 subjects will be enrolled, 30 subjects administered trans-dermally via Microneedle Array Patch (MAP).

BIOLOGICAL

Active comparator vaccine via intramuscular injection

10 subjects administered with active comparator vaccine via intramuscular injection.

Sponsors & Collaborators

  • QuadMedicine

    collaborator INDUSTRY

  • International Vaccine Institute

    lead OTHER

Principal Investigators

  • Hee Soo Kim · Non-governmental Organization

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-05
Primary Completion
2026-08-05
Completion
2026-11-05

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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 NCT06800131 on ClinicalTrials.gov