Antibody Persistence & Immune Memory in Healthy Adults Previously Vaccinated With Twinrix™ Adult
|ClinicalTrials.gov Identifier: NCT01000324|
Recruitment Status : Completed
First Posted : October 23, 2009
Results First Posted : January 13, 2011
Last Update Posted : November 20, 2015
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 GlaxoSmithKline (GSK) Biologicals' Twinrix™ 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 (Havrix™ and/or Engerix™-B) at the next planned visit.
No new subjects will be recruited during this study.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis A Hepatitis B||Procedure: Blood sampling Biological: Engerix™-B Biological: Havrix||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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-028 (208127/021) in Which Healthy Adults Were Vaccinated With Twinrix Adult Following a Three-dose Schedule.|
|Study Start Date :||November 2009|
|Primary Completion Date :||July 2014|
|Study Completion Date :||July 2014|
Experimental: Twinrix Group
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
Procedure: 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).Biological: Engerix™-B
Engerix-B will be administered to subjects who are not seroprotected against hepatitis BBiological: Havrix
Havrix will be administered to subjects who are seronegative for anti-HAV antibodies
- 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). [ Time Frame: At Years 16, 17, 18, 19 and 20. ]Seropositivity for anti-HAV antibodies is defined as antibody concentrations >= 15 milliinternational units per milliliter (mIU/mL). Seropositivity for anti-HBs antibodies is defined as antibody concentrations >= 6.2 mIU/mL.
- Anti-HAV and Anti-HBs Geometric Mean Concentrations (GMCs) [ Time Frame: At Years 16, 17, 18, 19 and 20. ]Concentrations were expressed as GMCs in mIU/mL.
- 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. ]None of the subjects received a challenge dose at Years 16, 17, 18 and 20 while, one subject received the challenge dose at Year 19.
- Anti-hepatitis B Virus (Anti-HBs) Antibody Concentration [ Time Frame: At Year 18, 14 days and 30 days post challenge dose (Year 19) ]Concentrations are given as Geometric Mean Concentrations (GMCs) expressed as mIU/mL.
- 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. ]An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
- 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. ]A serious adverse event was any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
- Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: Up to Year 20. ]A serious adverse event is any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, or was a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01000324
|GSK Investigational Site|
|Wilrijk, Belgium, 2610|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|