Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Injected According to a 0, 12-month Schedule
Double-blind Randomized Study to Evaluate the Immunogenicity and Reactogenicity of Two Different Lots of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Containing 1440 EL.U of Antigen Per mL and Injected According to a 0, 12 Month Schedule in Healthy Adult Volunteers
The aim of this study is to evaluate the persistence of hepatitis A antibodies at 138, 150, 162, 174,186, 198, 210, 222, 234 and 246 months after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A vaccine.
This protocol posting deals with objectives & outcome measures of the extension phase at year 11 to 20.
No additional subjects will be recruited during this long-term follow-up.
Přehled studie
Detailní popis
This is a long-term follow-up study at Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after primary vaccination with GSK Biologicals' hepatitis A vaccine (two-dose schedule). To evaluate the long-term antibody persistence, volunteers will donate a blood sample at Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after the first vaccine dose of the primary vaccination course to determine their anti-hepatitis A (anti-HAV) antibody concentrations.
If a subject has become seronegative for anti-HAV antibodies during any of the long-term blood sampling time point (i.e. Months 138, 150, 162, 174,186, 198, 210, 222, 234 and 246), he/ she will be offered an additional vaccine dose. A blood sample will be taken on the day of the additional vaccination 14 days and one month after additional vaccination to evaluate the immune response following this vaccination.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007 and to extend the follow up until Year 20.
The study has 10 phases: 100571, 100572, 100573, 100574, 100575, 110677, 110678, 110679, 110680, 110681.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 4
Kontakty a umístění
Studijní místa
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Wilrijk, Belgie, 2610
- GSK Investigational Site
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Subjects who had received at least one dose of the study vaccine in the primary study
- Written informed consent will have been obtained from the subjects before the blood sampling visit of each year.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Havrix Group
Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
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2 doses at 12 months interval
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
Časové okno: At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
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Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL).
** = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed.
Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234.
$ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory.
Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.
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At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
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Number of Seropositive Subjects Against Hepatitis A Virus
Časové okno: At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
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A seropositive subject was a vaccinated subject whose concentrations for antibodies against hepatitis A virus (anti-HAV) were equal or above (>=) the assay cut-off for seropositivity of 15 milli-international units per milliliter (mIU/mL).
** = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed.
Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234.
$ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory.
Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.
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At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
Časové okno: Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination
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Concentrations given as GMC expressed as mIU/mL. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198. Please note that value 14.9 means <15. |
Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination
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Number of Subjects Reporting Solicited Local Symptoms
Časové okno: During the 4-day (Days 0-3) follow-up period after additional vaccination
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Solicited local symptoms assessed include pain, redness and swelling.
Additional vaccination was given to 4 subjects at the Month 186 timepoint and to 1 subject at the Month 198 timepoint.
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During the 4-day (Days 0-3) follow-up period after additional vaccination
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Number of Subjects Reporting Solicited General Symptoms
Časové okno: During the 4-day (Days 0-3) follow-up period after additional vaccination
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Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198. |
During the 4-day (Days 0-3) follow-up period after additional vaccination
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Number of Subjects Reporting Unsolicited Adverse Events (AE)
Časové okno: During the 30-day follow-up period after additional vaccination
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An AE is 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. 4 subjects received additional vaccination at Month 186 and 1 at Month 198. |
During the 30-day follow-up period after additional vaccination
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Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigator as Related to Primary Study Vaccination, Procedures or Lack of Vaccine Efficacy
Časové okno: At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
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An 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
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At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
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Number of Subjects Reporting Serious Adverse Events (SAE) After Additional Vaccination
Časové okno: During the 30-day follow-up period after additional vaccination
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An 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. 4 subjects received additional vaccination at Month 186 and 1 at Month 198. |
During the 30-day follow-up period after additional vaccination
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Number of Subjects Reporting Pregnancies After Additional Vaccination
Časové okno: At Months 186 and 198
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The number of subjects with outcome of pregnancies reported among subjects who had received the additional vaccination was tabulated.
4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.
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At Months 186 and 198
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Van Herck K, Jacquet JM, Van Damme P. Antibody persistence and immune memory in healthy adults following vaccination with a two-dose inactivated hepatitis A vaccine: long-term follow-up at 15 years. J Med Virol. 2011 Nov;83(11):1885-91. doi: 10.1002/jmv.22200. Epub 2011 Aug 23.
- Van Herck K, Crasta PD, Messier M, Hardt K, Van Damme P. Seventeen-year antibody persistence in adults primed with two doses of an inactivated hepatitis A vaccine. Hum Vaccin Immunother. 2012 Mar;8(3):323-7. doi: 10.4161/hv.18617. Epub 2012 Feb 13.
- Agrawal A, Kolhapure S, Andani A, Ota MOC, Badur S, Karkada N, Mitra M. Long-Term Persistence of Antibody Response with Two Doses of Inactivated Hepatitis A Vaccine in Children. Infect Dis Ther. 2020 Dec;9(4):785-796. doi: 10.1007/s40121-020-00311-8. Epub 2020 Jul 24.
- Theeten H, Van Herck K, Van Der Meeren O, Crasta P, Van Damme P, Hens N. Long-term antibody persistence after vaccination with a 2-dose Havrix (inactivated hepatitis A vaccine): 20 years of observed data, and long-term model-based predictions. Vaccine. 2015 Oct 13;33(42):5723-5727. doi: 10.1016/j.vaccine.2015.07.008. Epub 2015 Jul 16.
- Hens N, Habteab Ghebretinsae A, Hardt K, Van Damme P, Van Herck K. Model based estimates of long-term persistence of inactivated hepatitis A vaccine-induced antibodies in adults. Vaccine. 2014 Mar 14;32(13):1507-13. doi: 10.1016/j.vaccine.2013.10.088. Epub 2014 Feb 7.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 100571 (M138)
- 100572 (M150) (Jiný identifikátor: GSK)
- 100573 (M162) (Jiný identifikátor: GSK)
- 100574 (M174) (Jiný identifikátor: GSK)
- 100575 (M186) (Jiný identifikátor: GSK)
- 110677 (M198) (Jiný identifikátor: GSK)
- 110678 (M210) (Jiný identifikátor: GSK)
- 110679 (Jiný identifikátor: GSK)
- 110680 (Jiný identifikátor: GSK)
- 110681 (Jiný identifikátor: GSK)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Studijní data/dokumenty
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Soubor dat jednotlivých účastníků
Identifikátor informace: 100571 (M138)Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 100571 are summarised with studies 100572, 100573, 100574, 100575, 110677, 110678, 110679, 110680, and 110681 on the GSK Clinical Study
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Formulář informovaného souhlasu
Identifikátor informace: 100571 (M138)Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Protokol studie
Identifikátor informace: 100571 (M138)Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Specifikace datové sady
Identifikátor informace: 100571 (M138)Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Zpráva o klinické studii
Identifikátor informace: 100571 (M138)Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Plán statistické analýzy
Identifikátor informace: 100571 (M138)Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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