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
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
Treatments tested in this trial
- Hepatitis B Vaccine administered trans-dermally via Microneedle Array Patch (MAP)
- Active comparator vaccine via intramuscular injection
Treatment groups
40 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
International Vaccine Institute
Lead sponsor
QuadMedicine
Collaborator
Source ClinicalTrials.gov