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Completed

NCT Number: NCT00684671

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

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.

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Key information

Conditions

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

Age range

41 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Wilrijk, Belgium

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Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Twinrix

Biological

Intramuscular injection, single dose in left deltoid.

Engerix-B

Biological

Intramuscular injection, single dose in left deltoid.

Havrix

Biological

Intramuscular injection, single dose in right deltoid.

HBVAXPRO

Biological

Intramuscular injection, single dose in the left deltoid.

Vaqta

Biological

Intramuscular injection, single dose in right deltoid.

Primary outcomes

  1. 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.

    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.

  2. 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.

    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 outcomes

  1. Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations

    Time frame: Prior to administration of challenge dose

    Concentrations are given as geometric mean concentration (GMCs) expressed as mIU/mL.

  2. 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

    Concentrations are given as geometric mean concentration (GMCs) expressed as mIU/mL.

  3. Number of Subjects Reporting Solicited Symptoms

    Time frame: During the 4-day follow-up period after the challenge dose.

    Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache and temperature (above 37 degree Celsius).

  4. Number of Subjects Reporting Unsolicited Symptoms

    Time frame: During the 31-day follow-up period after the challenge dose.

    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.

  5. 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)

    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.

  6. Number of Subjects Reporting Serious Adverse Events (SAEs)

    Time frame: During one month following the administration of the challenge dose

    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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Challenge Dose Administration of Twinrix™ or Comparator 4 Years After Primary Vaccination.

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 28, 2008
Registry last updated
Aug 17, 2018

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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