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Completed

NCT Number: NCT00480116

Consistency Study of Three Lots of Henogen's Adjuvanted Hepatitis B Vaccine When Given in 0, 1 Month Schedule

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.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vaccination and Travel Medicine Centre Poliklinika II

Hradec Králové, 500 03, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adjuvanted Hepatitis B vaccine Lot 1

Biological

20 µg, IM, month 0 and 1

Adjuvanted Hepatitis B vaccine Lot 2

Biological

20µg, IM, month 0 and 1

Adjuvanted Hep B vaccine Lot 3

Biological

20µg, IM, month 0 and 1

Primary outcomes

  1. Anti-HBs seroprotection rates at Month 2.

    Time frame: Month 2

Secondary outcomes

  1. 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.

    Time frame: Month 0, 1 and 2

  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).

    Time frame: Month 0 and 1

  3. Occurrence, intensity and relationship to vaccination of unsolicited symptoms after administration of study vaccine (Day 0 to 30)

    Time frame: Month 0 and 1

  4. Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2.

    Time frame: Month 0 to 2

Sponsors and collaborators

Lead sponsor

Henogen

Industry

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 30, 2007
Registry last updated
Aug 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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