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Completed

NCT Number: NCT01037114

Long-term Persistence Study in Healthy Adults Previously Vaccinated With Twinrix Adult

This study will evaluate the persistence of the immune response to HAV (hepatitis A virus) antigens and HBs (hepatitis B surface) antigens in healthy adults previously vaccinated with Twinrix Adult in the primary study, HAB-032 (208127/022). The subjects will be invited for blood sampling 16, 17, 18, 19 and 20 years after the primary vaccination to evaluate the antibody persistence. For subjects in whom low circulating antibodies are detected, the presence of immune memory against hepatitis A & B antigens will be investigated by the administration of a challenge dose of the appropriate vaccine (Havrix and/or Engerix-B) at the next planned visit.

No new subjects will be recruited during 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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

All subjects must satisfy the following criteria at entry into each of the long-term follow-up visits:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female who received the complete primary vaccination course in the primary study 208127/022.
  • Written informed consent obtained from the subject.

All subjects must satisfy the following criteria at entry into the challenge dose phase:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • A male or female who received the complete primary vaccination course in the primary study 208127/022.
  • Written informed consent obtained from the subject.
  • Subjects who participated in the LTFU phase of the 208127/022 study and for whom the antibody concentrations were below the cut-off at the last available follow-up time-point.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:
  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test on the day of vaccination, and
  • has agreed to continue adequate contraception for two months after the administration of the challenge dose.

Exclusion criteria

The following criteria should be checked before entry into each of the long-term follow-up visits. If any exclusion criterion applies, the subject must not be included in the study:

  • Use of any investigational or non-registered product within 30 days prior to blood sampling.
  • Administration of a hepatitis A, hepatitis B or combined hepatitis A and B vaccine outside the study procedures, since the primary study 208127/022.
  • History of hepatitis A or hepatitis B infection since the primary study 208127/022.
  • Administration of hepatitis A or hepatitis B immunoglobulins and/or any blood products within three months prior to blood sampling.

The following criteria should be checked before the challenge dose is administered. If any apply, the subject must not be included in the challenge dose phase:

  • Use of any investigational or non-registered product within 30 days prior to study start or planned use during the study.
  • Administration of a hepatitis A, hepatitis B or combined hepatitis A and B vaccine between the last LTFU visit and the challenge dose visit.
  • History of hepatitis A or hepatitis B infection between the last LTFU visit and the challenge dose visit.
  • History of anaphylactic reactions following the administration of vaccines.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
  • Acute disease and/or fever at the time of enrolment.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.

Treatment and study plan

blood sampling

Procedure

Blood sampling at Year 16, 17, 18, 19 and 20 and at the time of challenge dose administration and 14 days and one month after challenge dose administration (if challenge dose needed).

Engerix-B

Biological

Engerix-B will be administered to subjects who are not seroprotected against hepatitis B.

Havrix

Biological

Havrix will be administered to subjects who are seronegative for anti-HAV antibodies.

Primary outcomes

  1. Number of Subjects Seropositive for Anti-hepatitis A Virus Antibodies (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies and With Anti-HBs Antibody Concentrations >= 10 Milliinternational Units Per Milliliter (mIU/mL)

    Time frame: At Years 16, 17, 18, 19 and 20.

    Seropositivity for anti-HAV antibodies is defined as antibody concentrations >= 15 milliinternational units per milliliter (mIU/mL). Seropositivity for anti-HBs antibodies is defined as antibody concentrations >= 6.2 mIU/mL.

  2. Anti-HAV and Anti-HBs Geometric Mean Concentrations (GMCs)

    Time frame: At Years 16, 17, 18, 19 and 20.

    Concentrations were expressed as GMCs in mIU/mL.

Secondary outcomes

  1. Anti-HBs Concentrations After the Challenge Dose of Engerix-B

    Time frame: Before, 14 days and one month (30 days) after the challenge dose of Engerix-B.

    Concentration was given in mIU/mL.

    Only 1 subject was eligible for the challenge dose of Engerix-B at the Year 16 time point. Therefore the values for this subject are given without a measure of dispersion.

  2. Anti-HAV Concentrations After the Challenge Dose of Havrix

    Time frame: Before, 14 days and one month (30 days) after the challenge dose of Havrix.

    Concentration was given in mIU/mL. Only 2 subjects were eligible for the challenge dose of Havrix, one at Year 18 and another at Year 20 time point. Therefore the values for these subject are given without a measure of dispersion.

  3. Number of Subjects With Anamnestic Response to the Challenge Dose of Engerix-B

    Time frame: 30 days after the challenge dose of Engerix-B.

    At Year 16 only 1 subject was eligible for the challenge dose of Engerix-B.

    Anti-HBs anamnestic response to the challenge dose was defined as:

    • Anti-HBs antibody concentrations >= 10 mIU/mL at one month post-challenge dose in subjects seronegative at the pre-challenge time point.
    • At least a 4-fold increase in anti-HBs antibody concentrations, at one month post-challenge dose in subjects seropositive at the pre-challenge time point.

  4. Number of Subjects With Anamnestic Response to the Challenge Dose of Havrix

    Time frame: 30 days after the challenge dose of Havrix.

    Anti-HAV anamnestic response to the challenge dose was defined as:

    • Anti-HAV antibody concentrations ≥ 15 mIU/mL at one month post-challenge dose, in subjects seronegative at the pre-challenge time point.
    • At least a 2-fold increase in anti-HAV antibody concentrations one month after the challenge dose, in subjects having anti-HAV antibody concentrations ≥ 100 mIU/mL at the pre-challenge time point.
    • Or at least a 4-fold increase in anti-HAV antibody concentrations one month after the challenge dose, in seropositive subjects having anti-HAV antibody concentrations < 100 mIU/mL at the pre-challenge time-point.

  5. Number of Subjects Reporting Unsolicited Adverse Events (AEs)

    Time frame: 31 days (Days 0-30) after the challenge dose of Engerix-B and Havrix.

    At Year 16, 1 subject was administered a challenge dose of Engerix-B and at Y18 and Y20, 2 subjects were administered a challenge dose of Havrix.

    An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

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

    Time frame: During the 31-day (Days 0-30) follow-up period after the Engerix-B challenge dose.

    Only 1 subject received a challenge dose at Year 16 of Engerix-B.

    An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

  7. Number of Subjects With Serious Adverse Events (SAEs)

    Time frame: During the 31-day (Days 0-30) follow-up period after the Havrix challenge dose.

    One subject received a challenge dose of Havrix at Year 18 and another at Year 20.

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  8. Number of Subjects Reporting SAEs Related to Study Participation or a Concurrent GSK Medication

    Time frame: Up to Year 20.

    An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Open Single Centre Study to Evaluate the Long-term Antibody Persistence and Immune Memory Between 16 and 20 Years After the Primary Study HAB-032 (208127/022) in Which Healthy Adults Were Vaccinated With Twinrix Adult Following a Three-dose Schedule.

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 21, 2009
Registry last updated
Feb 1, 2019

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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