NCT06800131Not yet recruitingPhase 1
Hepatitis B Vaccine Delivered Trans-dermally by MAP
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
Source: ClinicalTrials.gov · Last updated 29 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 2 Jan 2025
- Start date
- 5 Feb 2025
- Primary completion date
- 5 Aug 2026
- Lead sponsor
- International Vaccine Institute
- Diseases
- Hepatitis B
- NCT number
- NCT06800131
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 40
- From 5 Feb 2025 to the primary completion date, 5 Aug 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently participating in or has participated in a study with an investigational product administered within 6 months preceding Day 0
Other illness
- Self-reported history of Hepatitis B vaccination beyond childhood Hepatitis B immunization series
Lab values
- Positive serum pregnancy test at screening or positive urine pregnancy test prior at dosing visit
- 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
Other
- 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
- Body mass index (BMI) \<18 or \>30 kg/m²
Who the study is looking for
- 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
Age in the registry: 19 years to 40 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.