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NOT YET RECRUITING
NCT06800131
PHASE1

Hepatitis B Vaccine Delivered Trans-dermally by MAP

Sponsor: International Vaccine Institute

View on ClinicalTrials.gov

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.

Official title: A Phase I, Randomized, Open-Label, Active-Control Study to Evaluate Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Delivered Trans-dermally by Microneedle Array Patch (MAP) in Healthy Adults

Key Details

Gender

All

Age Range

19 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-02-05

Completion Date

2026-11-05

Last Updated

2025-01-29

Healthy Volunteers

Yes

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.