Overview

This trial is active, not recruiting.

Conditions hepatitis a, hepatitis b
Treatments blood sampling, engerixtm-b, havrix
Phase phase 4
Sponsor GlaxoSmithKline
Start date November 2009
End date March 2013
Trial size 40 participants
Trial identifier NCT01000324, 112267

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 GSK Biologicals' TwinrixTM Adult. The subjects will be invited for blood sampling 16, 17, 18, 19 and 20 years after 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 (HavrixTM and/or EngerixTM-B) at the next planned visit. No new subjects will be recruited during this study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
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).
engerixtm-b
Engerix-B will be administered to subjects who are not seroprotected against hepatitis B
havrix
Havrix will be administered to subjects who are seronegative for anti-HAV antibodies

Primary Outcomes

Measure
Number of Subjects With Anti-hepatitis A (Anti-HAV) Antibody Concentration Equal to or Above 15 Milli-international Units Per Milliliter (mIU/mL)
time frame: At Year 16
Number of Subjects With Anti-hepatitis A (Anti-HAV) Antibody Concentration Equal to or Above 15 Milli-international Units Per Milliliter (mIU/mL)
time frame: At Year 17
Number of Subjects With Anti-hepatitis A (Anti-HAV) Antibody Concentration Equal to or Above 15 Milli-international Units Per Milliliter (mIU/mL)
time frame: At Year 18
Number of Subjects With Anti-hepatitis A (Anti-HAV) Antibody Concentration Equal to or Above 15 Milli-international Units Per Milliliter (mIU/mL)
time frame: At Year 19
Number of Subjects With Anti-hepatitis A (Anti-HAV) Antibody Concentration Equal to or Above 15 Milli-international Units Per Milliliter (mIU/mL)
time frame: At Year 20
Concentration of Anti-hepatitis A (Anti-HAV) Antibodies
time frame: At Year 16
Concentration of Anti-hepatitis A (Anti-HAV) Antibodies
time frame: At Year 17
Concentration of Anti-hepatitis A (Anti-HAV) Antibodies
time frame: At Year 18
Concentration of Anti-hepatitis A (Anti-HAV) Antibodies
time frame: At Year 19
Concentration of Anti-hepatitis A (Anti-HAV) Antibodies
time frame: At Year 20
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above the Cut-off Values
time frame: At Year 16
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above the Cut-off Values
time frame: At Year 17
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above the Cut-off Values
time frame: At Year 18
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above the Cut-off Values
time frame: At Year 19
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above the Cut-off Values
time frame: At Year 20
Concentration of Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies
time frame: At Year 16
Concentration of Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies
time frame: At Year 17
Concentration of Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies
time frame: At Year 18
Concentration of Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies
time frame: At Year 19
Concentration of Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies
time frame: At Year 20

Secondary Outcomes

Measure
Number of Subjects With Immune Response to the Challenge Vaccine Antigen
time frame: Before, 14 days and one month after the challenge dose at Year 19.
Number of Subjects With an Anamnestic Response to the Challenge Dose
time frame: One month after the challenge dose at Years 16, 17, 18 and 19
Anti-hepatitis B Virus (Anti-HBs) Antibody Concentration
time frame: At Year 18, 14 days and 30 days post challenge dose (Year 19)
Number of Subjects Reporting Unsolicited Adverse Events (AE).
time frame: During the 31-day (Day 0 to 30) period after administration of the challenge dose at Years 16, 17 and 18
Number of Subjects Reporting Serious Adverse Events (SAEs)
time frame: During the 31-day (Day 0 to 30) period after administration of the challenge dose at Years 16, 17 and 18
Number of Subjects Reporting Unsolicited Adverse Events (AE).
time frame: During the 31-day (Day 0 to 30) period after administration of the challenge dose at Year 19.
Number of Subjects Reporting Serious Adverse Events (SAEs)
time frame: During the 31-day (Day 0 to 30) period after administration of the challenge dose at Year 19.

Eligibility Criteria

Male or female participants of any age.

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 HAB-028 (208127/021).• 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 HAB-028 (208127/021).• Written informed consent obtained from the subject.• Subjects who participated in the long-term follow-up (LTFU) phase of the HAB-028 (208127/021) 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 HAB-028 (208127/021).• History of hepatitis A or hepatitis B infection since the primary study HAB-028 (208127/021).• 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.

Additional Information

Official title Antibody Persistence and Immune Memory in Healthy Adults Previously Vaccinated With Twinrix™ Adult
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.