Clinical trial NCT00480116: Consistency Study of Three Lots of Henogen's Adjuvanted Hepatitis B Vaccine When Given in 0, 1 Month Schedule
Official title: Phase III, Single Centre, Double Blind, Randomised Study Evaluating the Consistency of Three Lots of Henogen's New Adjuvanted Hepatitis B Vaccine, When Given at 0, 1 Month Schedule in Healthy Volunteers Aged 18 Years to 40 Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Keywords: Consistency
Immunogenicity
Lead sponsor: Henogen
Sponsor class: INDUSTRY
First posted: 2007-05-30
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anti-HBs seroprotection rates at Month 2.
timeFrame: Month 2
Secondary outcomes:
measure: 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.
timeFrame: Month 0, 1 and 2
measure: 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).
timeFrame: Month 0 and 1
measure: Occurrence, intensity and relationship to vaccination of unsolicited symptoms after administration of study vaccine (Day 0 to 30)
timeFrame: Month 0 and 1
measure: Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2.
timeFrame: Month 0 to 2
Other outcomes:
Locations:
city: Hradec Kralove
country: Czech Republic
facility: Vaccination and Travel Medicine Centre Poliklinika II
Study officials:
affiliation: Vaccination and Travel Medicine Centre Poliklinika II
name: Jiri Beran, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beran J, Hobzova L, Wertzova V, Kuriyakose S, Leyssen M, Surquin M, Houard S. Safety and immunogenicity of an investigational adjuvanted hepatitis B vaccine (HB-AS02V) in healthy adults. Hum Vaccin. 2010 Jul;6(7):578-84. doi: 10.4161/hv.6.7.11883. Epub 2010 Jul 1.