Phase 4
N=49
Long-term Persistence Study in Healthy Adults Previously Vaccinated With Twinrix Adult
Hepatitis A · Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT01037114 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcome: Primary: 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) — 28; 27; 27; 26 Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Blood sampling (Procedure); Engerix-B (Biological); Havrix (Biological)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
28; 27; 27; 26; 25; 25 | — |
| PRIMARY Anti-HAV and Anti-HBs Geometric Mean Concentrations (GMCs) |
262.5; 79.9; 369.4; 71.7; 237.7; 61.3 | — |
| SECONDARY Anti-HBs Concentrations After the Challenge Dose of Engerix-B |
7.86; 50640.0; 31442.0 | — |
| SECONDARY Anti-HAV Concentrations After the Challenge Dose of Havrix |
25; 3421; 3389; 19; 1096; 1060 | — |
| SECONDARY Number of Subjects With Anamnestic Response to the Challenge Dose of Engerix-B |
1 | — |
| SECONDARY Number of Subjects With Anamnestic Response to the Challenge Dose of Havrix |
2 | — |
| SECONDARY Number of Subjects Reporting Unsolicited Adverse Events (AEs) |
1 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
— | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
— | — |
| SECONDARY Number of Subjects Reporting SAEs Related to Study Participation or a Concurrent GSK Medication |
— | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01037114). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.