Hepatitis B Vaccine Delivered Trans-dermally by MAP

NCT06800131 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: IVI QMHepB-01
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Microneedle array patch

Outcome Measures

Primary Outcomes (1)

• To assess the safety and tolerability of investigational product (QMV-24KRP)

  * 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 Outcomes (1)

• To assess anti-HBs response before the first vaccination and after each injection of QMV-24KRP

  Within 52 weeks of the first IP administration

Study Arms (2)

Vaccine administered trans-dermally via MAP

EXPERIMENTAL

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)

Active comparator vaccine via intramuscular injection

ACTIVE COMPARATOR

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

Interventions

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

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

Vaccine administered trans-dermally via MAP

Active comparator vaccine via intramuscular injection BIOLOGICAL

10 subjects administered with active comparator vaccine via intramuscular injection.

Active comparator vaccine via intramuscular injection

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to communicate with investigator, and to provide informed consent and have signed Informed Consent Form (ICF) prior to screening procedures
• Adults aged 19 to 40 years
• 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
• Able and willing to comply with all study procedures during the study period
• 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

You may not qualify if:

• 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
• Positive serum pregnancy test at screening or positive urine pregnancy test prior at dosing visit
• Self-reported history of Hepatitis B vaccination beyond childhood Hepatitis B immunization series
• Currently participating in or has participated in a study with an investigational product administered within 6 months preceding Day 0
• Body mass index (BMI) \<18 or \>30 kg/m²
• 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

Sponsors & Collaborators

• International Vaccine Institute: lead
• QuadMedicine: collaborator

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Hee Soo Kim

  Non-governmental Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sun Bean Kim, Project technical lead

CONTACT

02-8811-098; sunbean.kim@ivi.int

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Day 0, subject will receive 1st vaccination, followed by 2nd and 3rd injection at W4 and W26, respectively.

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 29, 2025
• Study Start: February 5, 2025
• Primary Completion (Estimated): August 5, 2026
• Study Completion (Estimated): November 5, 2026
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share