Safety and immunogenicity of HBAI20 adjuvanted Hepatitis B vaccine in naive adults and non-responders
- Conditions
- Hepatitis B vaccine for non-responders10047438
- Registration Number
- NL-OMON41999
- Lead Sponsor
- Cytuvax BV
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 59
Naive subjects must meet all of the following 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 superior to 10mIU/ml.
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Any infectious disease at the time of screening and/or enrolment
- Positive HIV, Hepatitis B virus or Hepatitis C virus serology
- 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: see IB, IMPD
- 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 and during the trial (until last visit)
- Administration of plasma (incl. immunoglobulins) or blood products within 3 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 negative at screening date and negative 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 criteria for vaccination
- Ear temperature > 38.4°C will lead to postponement of participation and vaccination. Screening may continue when the temperature has normalized.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study parameter is the number and intensity of local and systemic<br /><br>adverse reactions (redness, swelling, impaired movement). </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary study parameter is the HBAI20 vaccine immunogenicity as measured<br /><br>by the median titer, GMT, GMT increase, proportion of subjects with a virus<br /><br>specific antibody titer measure by the COBAS system of * 10 mIU/ml,<br /><br>seroconversion rate, and cellular immunogenicity. Seroconversion is defined as<br /><br>a four-fold increase in titer or a conversion from seronegative to a virus<br /><br>antibody titer of 10 mIU/ml after two vaccinations. </p><br>