Phase 1
N=34
Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders
Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT02540538 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Subjects With Local and/or General Adverse Events Irrespective of Severity — 8; 9; 7; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- HBVaxPro (Biological); HBAI20 (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Maastricht University Medical Center
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects With Local and/or General Adverse Events Irrespective of Severity |
8; 9; 7; 7; 8; 4 | — |
| PRIMARY Subjects With Local and/or General SEVERE Adverse Events |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Seroprotection |
0; 0; 3; 1; 2; 1 | — |
Summary
The purpose of this study is to determine whether the HBAI20 vaccine is safe and more immunogenic than the HBVaxPro-10µg in people who have never been vaccinated with a hepatitis B vaccine and in people who have been vaccinated 6 times with hepatitis B vaccine but do not have a protective anti hepatitis B antibody titer.
Eligibility Criteria
Inclusion Criteria
- In good health as determined by the outcome of medical history, physical examination screening/baseline labs and clinical judgment of the clinical investigator
- Age 18 to 59 years, inclusive at the time of enrolment
- Willing and able to adhere to the study regimen
- Having a signed informed consent form
Non-responders:
- Documented non-responders: Subjects with documented two cycles of Hepatitis B vaccination (total of 6 vaccinations) and titer analysis that show that they have not developed the Hepatitis B antibody titer recommended after standard vaccination: anti-HBsAg antibody titer higher to 10mIU/ml.
Exclusion Criteria
- Any infectious disease at the time of screening and/or enrolment
- Positive HIV, Hepatitis B virus or Hepatitis C virus serology
- Positive anti-IL-2 antibody titer
- Known or suspected immune deficiency
- Known or suspected disease that influences the immune system including chronic allergies that require frequent anti-allergy medication, cancer and transplantation recipients
- Known or suspected allergy to any of the vaccine components.
- Dialysis patient
- History of unusual or severe reactions to any previous vaccination
- History of any neurologic disorder, including epilepsy and autism
- Use of medication that influences the immune system (immune suppressive treatment)
- Any vaccination within 3 months before screening
- Blood donation within 1 month before screening
- Administration of plasma (incl. immunoglobulins) or blood products within 12 months before screening
- Participation in another clinical trial within 3 months before screening
- Abnormal pre-treatment laboratory parameters which are clinically relevant according to the investigator
- Bleeding disorders, or use of medication for bleeding disorders, and use of anti-coagulants
- Female subjects planning to become pregnant or breastfeeding babies until visit 7
- Females: positive urine pregnancy test. Urine test positive at screening date or positive urine pregnancy test on the day of vaccination
- Excessive alcohol or controlled drug use - More than 2 alcohol measures per day (one alcohol measure is a beer (250ml) or one glass of wine (125ml) or one strong measure (35ml) or one port/sherry (75ml)). Regular use of controlled drugs
Exclusion criterion for Hepatitis B naïve subjects (groups 1 and 2):
- Previous vaccination with Hepatitis B vaccine
Exclusion criterion for non-responders (group 3):
- Any Hepatitis B vaccination in the last 6 months
Temporary exclusion criterion for vaccination
- Ear temperature > 38.4°C will lead to postponement of participation and vaccination. Screening may continue when the temperature has normalized.
Data sourced from ClinicalTrials.gov (NCT02540538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.