Hepatitis B Vaccine Delivered Trans-dermally by MAP

January 24, 2025 updated by: International Vaccine Institute

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Healthy adults between 19 to 40 years of age will be screened for eligibility criteria. A total of 40 subjects will be enrolled, 30 subjects administered trans-dermally via MAP and 10 subjects administered with active comparator vaccine via intramuscular injection. Subjects will be randomized to either transdermal MAP arm or IM Injection arm with ratio of 3:1. At D0, subject will receive 1st vaccination, followed by 2nd and 3rd vaccination at W4 and W26, respectively.

For the first five (5) subjects who completed Week 1 visit, all available clinical laboratory and adverse event data will be reviewed in a rolling manner by Study Medical Monitor and Site PI. Further enrollment will be paused during safety review by the independent data safety monitoring board (DSMB). If there are no safety findings judged to be of clinical concern and has not met the trial halting criteria specified in the protocol section 10.1.4, subsequent dosing (2nd dose) will be opened for the first 5 subjects and enrollment of the remaining 35 subjects will begin. If any of the halting rules are met, the study will be halted immediately for DSMB review/recommendation.

After all enrolled subjects complete Visit 6 (4 weeks after 3rd dose), the DSMB will be convened to review the safety and immunogenicity data once available to look at the sero-protection rates and titers to formulate further recommendations and be diligent in case there are non-responders to MAP Hep B vaccine. All SMC and DSMB meetings will be conducted per SMC and DSMB charter, respectively.

The solicited and unsolicited adverse events will be recorded up to 7 days and 28 days, respectively for each injection. Relatedness of all adverse events that occurred in the MAP arm will be assessed to biologics component (active ingredient; HBsAg) as well as medical device component (microneedle patch). Serious adverse events (SAEs) and adverse events of special interest (AESIs) will be collected throughout the study.

Should the criteria for any temporary pause of immunization rule be met, at any time, further enrollment and administration of investigational product will be paused for further evaluation. The Sponsor will consult the DSMB, if needed, to determine whether to enroll and/or continue enrollment and/or dosing of remainder of the subjects.

All subjects will be followed for 52 weeks following the 1st vaccination. Week 52 of the last subject enrolled will be the End of Study (EOS) visit.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sun Bean Kim, Project technical lead
  • Phone Number: 02-8811-098
  • Email: sunbean.kim@ivi.int

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Able to communicate with investigator, and to provide informed consent and have signed Informed Consent Form (ICF) prior to screening procedures
  2. Adults aged 19 to 40 years
  3. Judged to be healthy by the Investigator on the basis of medical history, physical examination, screening laboratory results and vital signs performed at screening visit
  4. Able and willing to comply with all study procedures during the study period
  5. Negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis B surface antibody (Anti-HBs), antibody to Hepatitis B core antibody (anti-HBc), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody at screening

Exclusion Criteria:

  1. Pregnant or breastfeeding, or intending to become pregnant or father children within the projected duration of the trial starting with the screening visit until 3 months following last dose
  2. Positive serum pregnancy test at screening or positive urine pregnancy test prior at dosing visit
  3. Self-reported history of Hepatitis B vaccination beyond childhood Hepatitis B immunization series
  4. Currently participating in or has participated in a study with an investigational product administered within 6 months preceding Day 0
  5. Body mass index (BMI) <18 or >30 kg/m²

  6. Current or history of the following medical conditions:

    • Diagnosis of malignancy within 5 years of screening
    • Diagnosis of diabetes mellitus or HbA1c ≥7%
    • Liver transaminases > 2 times the upper limit of the normal range
    • Impaired renal function as creatinine >120 mmol/L or calculated glomerular filtration rate <60mls/min
    • Use of immunoglobulin or blood products in last 3 months
    • History of severe allergic reaction or anaphylaxis after immunization or administration of any medical products that contain drug substances of investigational product

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vaccine administered trans-dermally via MAP

Manufacturer: QuadMedicine Inc. Form: Microarray needle patch Appearance: Patch Dose: one patch contains 20μg of HbsAg (drug substance manufactured by LG Chemical)

Route: Intra-dermal (Skin application)Each patch of vaccine contains the following components:

  • HBsAg 20μg (drug substance manufactured by LG Chemical)
  • Sodium carboxymethyl cellulose (CMC Na): 20μg
  • Trehalose: 400μg
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).
Active Comparator: Active comparator vaccine via intramuscular injection

Euvax B™ (LG Chemical) is a white, slightly opalescent suspension.1 ml of the above vaccine contains:

  • Active ingredient: Purified HBsAg 20µg
  • Adjuvant: Aluminum Hydroxide Gel 0.5 mg
  • Excipients: Potassium phosphate, Sodium phosphate, Sodium chloride
Biological: Active comparator vaccine via intramuscular injection
10 subjects administered with active comparator vaccine via intramuscular injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the safety and tolerability of investigational product (QMV-24KRP)
Time Frame: Within 52 weeks of the first IP administration
  • Occurrence of any SAEs from the time of the first vaccination through the final visit
  • Occurrence of immediate reaction (reactogenicity event) within 30 minutes post each vaccination.
  • Occurrence of solicited local and systemic reactions within 7 days post each vaccination
  • Occurrence of unsolicited AEs within 28 days post each vaccination
Within 52 weeks of the first IP administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess anti-HBs response before the first vaccination and after each injection of QMV-24KRP
Time Frame: Within 52 weeks of the first IP administration
  • Percentage of subjects achieving sero-protection level (defined as anti-HBs antibody titer ≥ 10 IU/L) at Week 30 (4 weeks post third-dose vaccination)
  • Percentage of subjects achieving sero-protection level (defined as anti-HBs antibody titer ≥10 IU/L) at Week 52 (26 weeks post third-dose vaccination)
  • Percentage of subjects considered as good responder (defined as anti-HBs ≥ 100 IU/L) at Week 30 or Week 52
Within 52 weeks of the first IP administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Vaccine Institute

Collaborators

QuadMedicine

Investigators

  • Principal Investigator: Hee Soo Kim, Non-governmental Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 5, 2025

Primary Completion (Estimated)

August 5, 2026

Study Completion (Estimated)

November 5, 2026

Study Registration Dates

First Submitted

January 2, 2025

First Submitted That Met QC Criteria

January 24, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 24, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVI QMHepB-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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