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Hepatitis B Vaccine Delivered Trans-dermally by MAP
Sponsor: International Vaccine Institute
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
Conditions
Interventions
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).
Active comparator vaccine via intramuscular injection
10 subjects administered with active comparator vaccine via intramuscular injection.