Text Size

Evaluation of Immune Memory to Twinrix or Comparator by Challenge Dose Administration 4 Years After Primary Vaccination

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00684671
First received: May 23, 2008
Last updated: June 14, 2012
Last verified: June 2012
History of Changes
  Purpose

Only subjects who participated in the primary study will be invited to participate in the extension phase and the challenge dose phase of this study.


Condition Intervention Phase
Viral Hepatitis Vaccines
Hepatitis B
Hepatitis A
 Biological: Twinrix
Biological: Engerix-B
Biological: Havrix
Biological: HBVAXPRO
Biological: Vaqta
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Challenge Dose Administration of Twinrix™ or Comparator 4 Years After Primary Vaccination.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis A (Anti-HAV) Antibodies [ Time Frame: One month after the challenge dose. ] [ Designated as safety issue: No ]

    Anamnestic response was defined as:

    • for initially seronegative subjects, antibody concentration greater than or equal the cut-off [≥ 15 Milli-International Units per Milliliter (mIU/mL)],
    • for initially seropositive subjects with pre-vaccination antibody, concentration < 100 mIU/mL: antibody concentration at least four times the pre-vaccination antibody concentration,
    • for initially seropositive subjects with pre-vaccination antibody concentration ≥ 100 mIU/mL: antibody concentration at least two times the pre-vaccination antibody concentration.

  • Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies [ Time Frame: One month after the challenge dose. ] [ Designated as safety issue: No ]

    Anamnestic response was defined as :

    • for initially seronegative subjects, antibody concentration ≥ 10 Milli-International Units per Milliliter (mIU/mL),
    • for initially seropositive subjects: antibody concentration at ≥ 4 fold the pre-vaccination antibody concentration.


Secondary Outcome Measures:
  • Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations [ Time Frame: Prior to administration of challenge dose ] [ Designated as safety issue: No ]
    Concentrations are given as geometric mean concentration (GMCs) expressed as mIU/mL.

  • Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations [ Time Frame: Two weeks and one month after the challenge dose ] [ Designated as safety issue: No ]
    Concentrations are given as geometric mean concentration (GMCs) expressed as mIU/mL.

  • Number of Subjects Reporting Solicited Symptoms [ Time Frame: During the 4-day follow-up period after the challenge dose. ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache and temperature (above 37 degree Celsius).

  • Number of Subjects Reporting Unsolicited Symptoms [ Time Frame: During the 31-day follow-up period after the challenge dose. ] [ Designated as safety issue: No ]
    Unsolicited symptoms = any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

  • Number of Subjects With Serious Adverse Events (SAEs) Since the Last Study Visit of the HAB-160 (NCT00603252) Long-term Follow-up Study Considered by the Investigator to Have a Causal Relationship to Primary Vaccination [ Time Frame: Since the last study visit of the primary study long-term follow-up study up to challenge dose administration (1 year) ] [ Designated as safety issue: No ]
    A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or is a sign of suspected or confirmed hepatitis A or hepatitis B.

  • Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: During one month following the administration of the challenge dose ] [ Designated as safety issue: No ]
    A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or is a sign of suspected or confirmed hepatitis A or hepatitis B.


Enrollment: 506
Study Start Date: May 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Twinrix Group
Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
 Biological: Twinrix
Intramuscular injection, single dose in left deltoid.
Active Comparator: Engerix + Havrix Group
Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
 Biological: Engerix-B
Intramuscular injection, single dose in left deltoid.
Biological: Havrix
Intramuscular injection, single dose in right deltoid.
Active Comparator: HB VAX PRO + Vaqta Group
Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
 Biological: HBVAXPRO
Intramuscular injection, single dose in the left deltoid.
Biological: Vaqta
Intramuscular injection, single dose in right deltoid.

  Eligibility

Ages Eligible for Study:   41 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • A male or female who completed the primary vaccination phase of the HAB-160 study (NCT 00603252).
  • Written informed consent obtained from the subject.
  • If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after the vaccination.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the challenge dose, or planned use during the study period.
  • History of any hepatitis A or hepatitis B vaccination or infection since the primary vaccination study.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Acute disease at the time of enrolment.
  • Pregnant or lactating female.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684671

Locations
Belgium
GSK Investigational Site
Wilrijk, Belgium, 2610
Czech Republic
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 01
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00684671     History of Changes
Other Study ID Numbers: 111572
Study First Received: May 23, 2008
Results First Received: October 29, 2009
Last Updated: June 14, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by GlaxoSmithKline:
Immune memory
Combined hepatitis A and B vaccine
> 41 years old

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 19, 2013