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Evaluation of Antibody Persistence & Immune Memory in Subjects Vaccinated During Adolescence With Twinrix™

18. července 2018 aktualizováno: GlaxoSmithKline

An Open Multicentre, Multicountry Study to Evaluate Long-term Antibody Persistence and Immune Memory Between Years 11 and 15 After the Primary Study HAB-084 in Which Healthy Adolescents Were Vaccinated With Twinrix™ Adult Following a Two-dose Schedule or Twinrix™ Junior Following a Three-dose Schedule.

This study will evaluate the immune response against Hepatitis-A (HAV) and Hepatitis B surface (HBs) antigen in healthy subjects aged 12 to 15 years (at the time of primary vaccination), who received vaccination course with GSK Biologicals' Twinrix Adult and Twinrix Junior vaccine, approximately 10 years ago in the primary study. The subjects will be invited for blood sampling at 11, 12, 13, 14 and 15 years after primary vaccination to evaluate the persistence of immune response. For subjects detected with decreased immunity, the presence of immune memory against hepatitis A & B antigens will be investigated by the administration of a challenge dose of the appropriate vaccine 6 to 12 months after the Year 15 follow-up time-point.

No new subjects will be recruited during this booster phase of the study.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

210

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Belgie
      • Bruxelles, Belgie, 1200
        • GSK Investigational Site
  • Česko
      • Hradec Kralove, Česko, 500 03
        • GSK Investigational Site

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

12 let až 15 let (Dítě)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • 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 according to his/her group allocation in the primary study
  • Written informed consent obtained from the subject.

All subjects must satisfy the following criteria at entry into the challenge dose phase:

  • A male or female who received the complete primary vaccination course according to his/her group allocation in the primary study.
  • Subjects who participated in the long-term follow-up phase of the primary study and for whom the antibody concentrations were below specified value for anti-HAV antibodies and/ or for anti-HBs antibodies at the last available follow-up time-points.
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  • Written informed consent obtained from the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the challenge dose phase of this study.
  • If the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized; 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 each follow-up visit. If any apply at study entry, the subject must not be included at that long-term follow-up visit.

  • Use of any investigational or non-registered product (drug or vaccine) since the last blood sampling visit.
  • Administration of a hepatitis A, hepatitis B or hepatitis combination vaccine since the primary vaccination course of the primary study.
  • History of hepatitis A or hepatitis B infection.
  • Administration of hepatitis A or hepatitis B immunoglobulins and/or any blood products within 3 months prior to blood sampling.

The following criteria should be checked before the challenge dose phase. If any apply, the subject must not be included in the challenge dose phase:

  • Use of any investigational or non-registered product (drug or vaccine) within 30 days before the administration of the challenge dose or planned use during the study period outside the context of the study.
  • Administration of a hepatitis A, hepatitis B or hepatitis combination vaccine between the primary vaccination course of the primary study and the challenge dose visit.
  • History of hepatitis A or hepatitis B infection.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the challenge dose.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • Acute disease at the time of.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the challenge dose or planned administration before the final blood sampling point (one month after the challenge dose).
  • Pregnant or lactating female.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Twinrix Adult Group
Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
Postup: Blood sampling
Blood sampling at Years 11, 12, 13, 14, 15 and at the time of challenge dose administration and one month after challenge dose administration.
Biologický: Additional challenge dose
If a subject became seronegative for anti-HAV antibodies (< 15 mIU/mL) or if anti-HBs antibody concentrations decreased below 10 mIU/mL during the long-term follow-up, immune memory against the antigen was evaluated by administering a challenge dose of the appropriate antigen (vaccine) 6 to 12 months after the Year 15 follow-up time-point.
Experimentální: Twinrix Junior Group
Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
Postup: Blood sampling
Blood sampling at Years 11, 12, 13, 14, 15 and at the time of challenge dose administration and one month after challenge dose administration.
Biologický: Additional challenge dose
If a subject became seronegative for anti-HAV antibodies (< 15 mIU/mL) or if anti-HBs antibody concentrations decreased below 10 mIU/mL during the long-term follow-up, immune memory against the antigen was evaluated by administering a challenge dose of the appropriate antigen (vaccine) 6 to 12 months after the Year 15 follow-up time-point.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Anti-HAV Antibody Concentrations
Časové okno: At Year 11, 12, 13, 14 and 15 after the first vaccine dose of two-dose or three-dose primary vaccination in study HAB-084
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HAV seropositive subjects. Seropositive subjects are subjects with anti-HAV antibody concentrations >= 15 mIU/mL.
At Year 11, 12, 13, 14 and 15 after the first vaccine dose of two-dose or three-dose primary vaccination in study HAB-084
Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above the Cut-Off Values
Časové okno: At Year 11, 12, 13, 14 and 15 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084
Anti-HBs antibody cut-off values assessed were >= 6.2 mIU/mL and >= 10 mIU/mL. Note: A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following complete retesting and reanalysis for years 11 to 13. Results of year 14 and year 15 were only analysed by ChemiLuminescence ImmunoAssay (CLIA).
At Year 11, 12, 13, 14 and 15 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084
Anti-HBs Antibody Concentrations
Časové okno: At Year 11, 12, 13, 14 and 15 after the first vaccine dose of a two-dose or a three-dose primary vaccination in study HAB-084.

Antibodys concentrations are expressed as Geometric Mean concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HBs seropositive subjects. Seropositive subjects are subjects with anti-HBs antibody concentrations >= 6.2 mIU/mL.

Note: A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following complete retesting and reanalysis for years 11 to 13. Results of year 14 and year 15 were only analysed by CLIA.
At Year 11, 12, 13, 14 and 15 after the first vaccine dose of a two-dose or a three-dose primary vaccination in study HAB-084.
Anti-HBs Anamnestic Response.
Časové okno: One month after the challenge dose.

Anamnestic response was defined as:

Anti-HBs antibody concentrations ≥ 10 mIU/mL at one month post-challenge dose in subjects seronegative at the pre-challenge time-points.

At least a 4-fold increase in anti-HBs antibody concentrations, at one month post-challenge dose in subjects seropositive at the pre-challenge time-points.
One month after the challenge dose.
Number of Subjects With Anti-Hepatitis A (HAV) Antibody Concentrations Equal to or Above the Cut-Off Value.
Časové okno: At Year 11, 12, 13, 14 and 15 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084.
Anti-HAV antibody cut-off value assessed was >= 15 milli-International Units per milliliter (mIU/mL).
At Year 11, 12, 13, 14 and 15 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.
Časové okno: Since the last long-term follow-up visit up to Year 11.
SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Since the last long-term follow-up visit up to Year 11.
Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.
Časové okno: Since the last long-term follow-up visit up to Year 12.
SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Since the last long-term follow-up visit up to Year 12.
Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.
Časové okno: Since the last long-term follow-up visit up to Year 13.
SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Since the last long-term follow-up visit up to Year 13.
Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.
Časové okno: Since the last long-term follow-up visit up to Year 14.
SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Since the last long-term follow-up visit up to Year 14.
Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.
Časové okno: Since the last long-term follow-up visit up to Year 15.
SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Since the last long-term follow-up visit up to Year 15.
Number of Subjects With Anti-hepatitis A (HAV) Antibody Concentrations Equal to or Above the Cut-off Value.
Časové okno: Before (PRE) the challenge dose

Anti-HAV antibody cut-off value assessed was >= 15 milli-International Units per milliliter (mIU/mL).

Note: Since none of the subjects were seronegative for anti-HAV antibody concentration at the pre-challenge time point, subjects received only the HBV vaccine as the challenge dose.
Before (PRE) the challenge dose
Anti-HAV Antibody Concentrations
Časové okno: Before (PRE) the challenge dose
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HAV seropositive subjects. Seropositive subjects are subjects with anti-HAV antibody concentrations >= 15 mIU/mL.
Before (PRE) the challenge dose
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events.
Časové okno: During the 4-day (Day 0 to Day 3) follow-up period after the challenge dose
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
During the 4-day (Day 0 to Day 3) follow-up period after the challenge dose
Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above the Cut-off Values
Časové okno: Before (PRE) and one month after (POST) the challenge dose
Anti-HBs antibody cut-off values assessed were >= 6.2 mIU/mL and >= 10 mIU/mL
Before (PRE) and one month after (POST) the challenge dose
Anti-HBs Antibody Concentrations
Časové okno: Before (PRE) and one month after (POST) the challenge dose
Antibody concentrations are expressed as Geometric Mean concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HBs seropositive subjects. Seropositive subjects are subjects with anti-HBs antibody concentrations >= 6.2 mIU/mL.
Before (PRE) and one month after (POST) the challenge dose
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Časové okno: During the 4-day (Day 0 to Day 3) follow-up period after the challenge dose.
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever (axillary temperature). Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature > 39.5°C. Related = general symptoms which were assessed by the investigator as causally related to vaccination.
During the 4-day (Day 0 to Day 3) follow-up period after the challenge dose.
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms.
Časové okno: During the 31-day (Day 0 to 30) follow-up period after the challenge dose.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 = AE that prevented normal activity. Related = AE assessed by the investigator as causally related to the study vaccination.
During the 31-day (Day 0 to 30) follow-up period after the challenge dose.
Number of Subjects With Serious Adverse Events (SAEs).
Časové okno: One month after the administration of the challenge dose (Month 0 to Month 1)
Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were 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.
One month after the administration of the challenge dose (Month 0 to Month 1)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

GlaxoSmithKline

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. května 2009

Primární dokončení (Aktuální)

1. července 2014

Dokončení studie (Aktuální)

1. července 2014

Termíny zápisu do studia

První předloženo

2. dubna 2009

První předloženo, které splnilo kritéria kontroly kvality

2. dubna 2009

První zveřejněno (Odhad)

3. dubna 2009

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

20. srpna 2018

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

18. července 2018

Naposledy ověřeno

1. července 2018

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 110699
  • 110700 (Jiný identifikátor: GSK)
  • 110701 (Jiný identifikátor: GSK)
  • 110702 (Jiný identifikátor: GSK)
  • 110703 (Jiný identifikátor: GSK)
  • 110704 (Jiný identifikátor: GSK)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Studijní data/dokumenty

  1. Protokol studie
    Identifikátor informace: 110699
    Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
  2. Soubor dat jednotlivých účastníků
    Identifikátor informace: 110699
    Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
  3. Zpráva o klinické studii
    Identifikátor informace: 110699
    Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
  4. Specifikace datové sady
    Identifikátor informace: 110699
    Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
  5. Formulář informovaného souhlasu
    Identifikátor informace: 110699
    Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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