Hepatitis B Vaccine Delivered Trans-dermally by MAP

ConditionHepatitis B Vaccine

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age19-40

SponsorInternational Vaccine Institute

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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 injection
Biological/Vaccine
10 subjects administered with active comparator vaccine via intramuscular injection.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Vaccine administered trans-dermally via MAPExperimental treatment 1 intervention

Group B: Active comparator vaccine via intramuscular injectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

Within 52 weeks of the first IP administration

Secondary outcomes

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

Time frame

Within 52 weeks of the first IP administration

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

International Vaccine Institute

Lead sponsor

QuadMedicine

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: