Hepatitis B VaccinePhase 1NCT06800131
Hepatitis B Vaccine Delivered Trans-dermally by MAP
A Phase 1 study testing Hepatitis B Vaccine administered trans-dermally via Microneedle Array Patch (MAP) and Active comparator vaccine via intramuscular injection in people with Hepatitis B Vaccine, run by International Vaccine Institute.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B Vaccine
- What is being tested?
- Hepatitis B Vaccine administered trans-dermally via Microneedle Array Patch (MAP) and Active comparator vaccine via intramuscular injection
- Type of treatment
- Vaccines, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 5 Feb 2025to 5 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 12Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Hepatitis B Vaccine
- Being tested
- Hepatitis B Vaccine administered trans-dermally via Microneedle Array Patch (MAP), Active comparator vaccine via intramuscular injection
- Keywords
- Microneedle array patch
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
Active comparator vaccine via intramuscular injectionBiological
10 subjects administered with active comparator vaccine via intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Biological: Active comparator vaccine via intramuscular injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
- 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
Measured: Within 52 weeks of the first IP administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start5 Feb 2025 (estimated)
- Primary completion5 Aug 2026 (estimated)
- Study completion5 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Vaccine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- QuadMedicine
- Responsible party
- Sponsor
- Investigators
- Hee Soo Kim, Principal investigator, Non-governmental Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800131
- Sponsor's protocol ID
- IVI QMHepB-01
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06800131
- Acronym / sponsor ID
- IVI QMHepB-01
- Conditions
- Hepatitis B Vaccine
- Keywords
- Microneedle array patch
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- International Vaccine InstituteUniversity, hospital or other
- Collaborators
- QuadMedicine
- Study start
- 5 Feb 2025 (estimated)
- Primary completion
- 5 Aug 2026 (estimated)
- Study completion
- 5 Nov 2026 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Vaccine administered trans-dermally via MAP | Experimental | Device: Hepatitis B Vaccine administered trans-dermally via Microneedle Array Patch (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 |
| Active comparator vaccine via intramuscular injection | Active comparator | Biological: Active comparator vaccine via intramuscular injectionEuvax 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 |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Vaccine administered trans-dermally via MAP |
| Active comparator vaccine via intramuscular injection10 subjects administered with active comparator vaccine via intramuscular injection. | Biological | Active comparator vaccine via intramuscular injection |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hee Soo Kim principal investigator
Non-governmental Organization
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hepatitis B Vaccine administered trans-dermally via Microneedle Array Patch (MAP) and Active comparator vaccine via intramuscular injection in people with Hepatitis B Vaccine, run by International Vaccine Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sun Bean Kim, Project technical lead (02-8811-098, sunbean.kim@ivi.int), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and tolerability of investigational product (QMV-24KRP) (time frame: Within 52 weeks of the first IP administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.