Last updated: 07/17/2024 15:21:45
Long-term persistence study in healthy adults previously vaccinated with Twinrix Adult
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
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)
Timeframe: At Years 16, 17, 18, 19 and 20.
Anti-HAV and anti-HBs Geometric Mean Concentrations (GMCs)
Timeframe: At Years 16, 17, 18, 19 and 20.
Secondary outcomes:
Anti-HBs concentrations after the challenge dose of Engerix-B
Timeframe: Before, 14 days and one month (30 days) after the challenge dose of Engerix-B.
Anti-HAV concentrations after the challenge dose of Havrix
Timeframe: Before, 14 days and one month (30 days) after the challenge dose of Havrix.
Number of subjects with anamnestic response to the challenge dose of Engerix-B
Timeframe: 30 days after the challenge dose of Engerix-B.
Number of Subjects With Anamnestic Response to the Challenge Dose of Havrix
Timeframe: 30 days after the challenge dose of Havrix.
Number of subjects reporting Unsolicited Adverse Events (AEs)
Timeframe: 31 days (Days 0-30) after the challenge dose of Engerix-B and Havrix.
Number of subjects with serious adverse events (SAEs)
Timeframe: During the 31-day (Days 0-30) follow-up period after the Engerix-B challenge dose.
Number of subjects with serious adverse events (SAEs)
Timeframe: During the 31-day (Days 0-30) follow-up period after the Havrix challenge dose.
Number of subjects reporting SAEs related to study participation or a concurrent GSK medication
Timeframe: Up to Year 20.
Interventions:
Procedure/surgery: Blood sampling
Biological/vaccine: Engerix-B
Biological/vaccine: Havrix
Enrollment:
50
Observational study model:
Not applicable
Primary completion date:
2014-28-02
Time perspective:
Not applicable
Clinical publications:
Van Damme P et al. (2017) Persistence of antibodies 20 y after vaccination with a combined hepatitis A and B vaccine. Hum Vaccin Immunother. 1-9. doi: 10.1080/21645515.2016.1274473. [Epub ahead of print].
Medical condition
Hepatitis A
Product
SB208109, SB208127, SKF103860
Collaborators
Not applicable
Study date(s)
January 2010 to February 2014
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
All subjects must satisfy the following criteria at entry into each of the long-term follow-up visits:
Exclusion criteria:
- 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.
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:
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2014-28-02
Actual study completion date
2014-28-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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