NCT00480116

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 30, 2007

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

August 25, 2008

Status Verified

August 1, 2008

Enrollment Period

3 months

First QC Date

May 29, 2007

Last Update Submit

August 22, 2008

Conditions

Hepatitis B

Keywords

ConsistencyImmunogenicity

Outcome Measures

Primary Outcomes (1)

  • Anti-HBs seroprotection rates at Month 2.

    Month 2

Secondary Outcomes (4)

  • 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

Study Arms (3)

1

ACTIVE COMPARATOR
Biological: Adjuvanted Hepatitis B vaccine Lot 1

2

ACTIVE COMPARATOR
Biological: Adjuvanted Hepatitis B vaccine Lot 2

3

ACTIVE COMPARATOR
Biological: Adjuvanted Hep B vaccine Lot 3

Interventions

Adjuvanted Hepatitis B vaccine Lot 1BIOLOGICAL

20 µg, IM, month 0 and 1

1
Adjuvanted Hepatitis B vaccine Lot 2BIOLOGICAL

20µg, IM, month 0 and 1

2
Adjuvanted Hep B vaccine Lot 3BIOLOGICAL

20µg, IM, month 0 and 1

3

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • A healthy male or female adult aged between 18 and 40 years.
  • Written informed consent obtained from the subject

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vaccination and Travel Medicine Centre Poliklinika II

Hradec Králové, 500 03, Czechia

Location

Related Publications (1)

  • 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.

    PMID: 20523113DERIVED

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Jiri Beran, MD

    Vaccination and Travel Medicine Centre Poliklinika II

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 29, 2007

First Posted

May 30, 2007

Study Start

January 1, 2008

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

August 25, 2008

Record last verified: 2008-08

Locations

CZ(1)