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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

506 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-26

Study Completion Date

2008-11-03

Brief Summary

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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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Detailed Description

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Conditions

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Hepatitis A Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Twinrix Group

Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).

Group Type EXPERIMENTAL

Twinrix

Intervention Type BIOLOGICAL

Intramuscular injection, single dose in left deltoid.

Engerix + Havrix Group

Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).

Group Type ACTIVE_COMPARATOR

Engerix-B

Intervention Type BIOLOGICAL

Intramuscular injection, single dose in left deltoid.

Havrix

Intervention Type BIOLOGICAL

Intramuscular injection, single dose in right deltoid.

HB VAX PRO + Vaqta Group

Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).

Group Type ACTIVE_COMPARATOR

HBVAXPRO

Intervention Type BIOLOGICAL

Intramuscular injection, single dose in the left deltoid.

Vaqta

Intervention Type BIOLOGICAL

Intramuscular injection, single dose in right deltoid.

Interventions

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Twinrix

Intramuscular injection, single dose in left deltoid.

Intervention Type BIOLOGICAL

Engerix-B

Intramuscular injection, single dose in left deltoid.

Intervention Type BIOLOGICAL

Havrix

Intramuscular injection, single dose in right deltoid.

Intervention Type BIOLOGICAL

HBVAXPRO

Intramuscular injection, single dose in the left deltoid.

Intervention Type BIOLOGICAL

Vaqta

Intramuscular injection, single dose in right deltoid.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

41 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Wilrijk, , Belgium

Site Status

GSK Investigational Site

Hradec Králové, , Czechia

Site Status

Countries

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Belgium Czechia

References

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Chlibek R, von Sonnenburg F, Van Damme P, Smetana J, Tichy P, Gunapalaiah B, Leyssen M, Jacquet JM. Antibody persistence and immune memory 4 years post-vaccination with combined hepatitis A and B vaccine in adults aged over 40 years. J Travel Med. 2011 Mar-Apr;18(2):145-8. doi: 10.1111/j.1708-8305.2010.00499.x. Epub 2011 Feb 7.

Reference Type DERIVED

PMID: 21366801 (View on PubMed)

Study Documents

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