Hepatitis B
Conditions
Keywords
Consistency, Immunogenicity
Brief summary
The study vaccine has been developed for use in pre-dialysis/ haemodialysis patients and immuno-compromised individuals who could have or had a sub-optimal response following vaccination for hepatitis B with currently available commercial vaccines (target population). This study will aim to confirm in a clinical setting the consistency of production of three lots of the vaccine.
Detailed description
Double-blind, randomised, single centre study with three groups receiving three different lots of Henogen's adjuvanted hepatitis B vaccine according to 0, 1 months schedule. Blood samples will be taken at Month 0, Months 1 and 2.
Interventions
BIOLOGICALAdjuvanted Hepatitis B vaccine Lot 1
20 µg, IM, month 0 and 1
BIOLOGICALAdjuvanted Hepatitis B vaccine Lot 2
20µg, IM, month 0 and 1
BIOLOGICALAdjuvanted Hep B vaccine Lot 3
20µg, IM, month 0 and 1
Sponsors
Henogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* A healthy male or female adult aged between 18 and 40 years. * Written informed consent obtained from the subject
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Administration of a vaccine not foreseen by the study protocol within 14 days (killed vaccine) or 30 days (attenuated/ live vaccine) before the first vaccine dose. * Concurrently participating in another clinical study or exposure to an investigational or a non-investigational product (pharmaceutical product or device). * History of hepatitis B infection. * Known exposure to hepatitis B virus within 6 months. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-HBs seroprotection rates at Month 2. | Month 2 |
Secondary
| Measure | Time frame |
|---|---|
| Anti-HBs geometric mean concentration, seropositivity rates, seroprotection rates and the percentage of subjects with antibody concentrations superior or equal to 100 mIU/ml after HB-AS02V vaccination, at all time points. | Month 0, 1 and 2 |
| Occurrence and intensity of solicited local signs and symptoms, as well as occurrence, intensity and relationship to vaccination of solicited general signs and symptoms, within 4 days after administration of study vaccine (Day 0 to 3). | Month 0 and 1 |
| Occurrence, intensity and relationship to vaccination of unsolicited symptoms after administration of study vaccine (Day 0 to 30) | Month 0 and 1 |
| Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2. | Month 0 to 2 |
Countries
Czechia
Outcome results
None listed