Clinical trial NCT00291876: Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Injected According to a 0, 12-month Schedule
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis A
Keywords: HAVRIX™
Hepatitis A
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-02-15
Enrollment: 135
Sex: ALL
Minimum age (years): 29
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
timeFrame: At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
measure: Number of Seropositive Subjects Against Hepatitis A Virus
timeFrame: At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
Secondary outcomes:
measure: Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
timeFrame: Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination
measure: Number of Subjects Reporting Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) follow-up period after additional vaccination
measure: Number of Subjects Reporting Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) follow-up period after additional vaccination
measure: Number of Subjects Reporting Unsolicited Adverse Events (AE)
timeFrame: During the 30-day follow-up period after additional vaccination
measure: Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigator as Related to Primary Study Vaccination, Procedures or Lack of Vaccine Efficacy
timeFrame: At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
measure: Number of Subjects Reporting Serious Adverse Events (SAE) After Additional Vaccination
timeFrame: During the 30-day follow-up period after additional vaccination
measure: Number of Subjects Reporting Pregnancies After Additional Vaccination
timeFrame: At Months 186 and 198
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.