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

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ClinicalTrials.gov Identifier: NCT01037114
Recruitment Status : Completed
First Posted : December 21, 2009
Results First Posted : April 27, 2011
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hepatitis A Hepatitis B Procedure: Blood sampling Biological: Engerix-B Biological: Havrix Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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.
Actual Study Start Date : January 27, 2010
Actual Primary Completion Date : February 28, 2014
Actual Study Completion Date : February 28, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Twinrix Group

Subjects who received 2 doses of Twinrix (lot A, B or C) in the primary study.

As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.

A challenge dose of the Havrix or Engerix-B vaccines can be administered in this study based on serology results at each time point.

Procedure: Blood sampling
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).

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037114


Locations
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Belgium
GSK Investigational Site
Gent, Belgium, 9000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 112266
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 112266
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 112266
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 112266
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 112266
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 112266
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 112266
For additional information about this study please refer to the GSK Clinical Study Register

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01037114     History of Changes
Other Study ID Numbers: 112266
First Posted: December 21, 2009    Key Record Dates
Results First Posted: April 27, 2011
Last Update Posted: February 1, 2019
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Hepatitis A and hepatitis B
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections