Clinical trial NCT00684671: Evaluation of Immune Memory to Twinrix or Comparator by Challenge Dose Administration 4 Years After Primary Vaccination
Official title: Challenge Dose Administration of Twinrix™ or Comparator 4 Years After Primary Vaccination.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis A
Hepatitis B
Keywords: Immune memory
Combined hepatitis A and B vaccine
> 41 years old
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-05-28
Enrollment: 506
Sex: ALL
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis A (Anti-HAV) Antibodies
timeFrame: One month after the challenge dose.
measure: Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies
timeFrame: One month after the challenge dose.
Secondary outcomes:
measure: Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations
timeFrame: Prior to administration of challenge dose
measure: Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations
timeFrame: Two weeks and one month after the challenge dose
measure: Number of Subjects Reporting Solicited Symptoms
timeFrame: During the 4-day follow-up period after the challenge dose.
measure: Number of Subjects Reporting Unsolicited Symptoms
timeFrame: During the 31-day follow-up period after the challenge dose.
measure: Number of Subjects With Serious Adverse Events (SAEs) Since the Last Study Visit of the HAB-160 (NCT00603252) Long-term Follow-up Study Considered by the Investigator to Have a Causal Relationship to Primary Vaccination
timeFrame: Since the last study visit of the primary study long-term follow-up study up to challenge dose administration (1 year)
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: During one month following the administration of the challenge dose
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: GSK Investigational Site
city: Hradec Kralove
country: Czechia
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.