Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine, Injected According to 0, 6-month Schedule

NCT00289757 | Completed Phase 4 Results

• 10 other identifiers: 100576 (Y11)100577 (Y12)100578 (Y13)100579 (Y14)100580 (Y15)111028 (Y16)111029 (Y17)111030 (Y18)111031 (Y19)111032 (Y20)
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the long-term persistence of hepatitis A antibodies at 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 years after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A vaccine.

Conditions

Hepatitis A

Keywords

Havrix™; Hepatitis A

Outcome Measures

Primary Outcomes (3)

• Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration

  Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL). The laboratory assay was changed at Year 11, thus the blood samples were with both the old and the new assay for the sake of bridging.

  At Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after the first vaccine dose of the 2-dose primary vaccination

• Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration

  Concentrations given as GMC expressed as mIU/mL.

  Before the additional dose, 14 days and 30 days after the additional dose

• Number of Seropositive Subjects for Anti-HAV Antibodies.

  Seropositivity for anti-HAV antibodies defined as antibody concentrations ≥ 15 mIU/mL for Year 11 to Year 20 time points. The laboratory assay was changed at Year 11, thus the blood samples were with both the old and the new assay for the sake of bridging.

  From Year 11 to Year 20

Secondary Outcomes (5)

• Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigators as Related to Vaccination or to Study Procedures or Lack of Efficacy

  Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after the first vaccine dose of the 2-dose primary vaccination

• Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms

  During the 4-day (Day 0-3) follow-up period after additional vaccination

• Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms

  During the 4-day (Day 0-3) follow-up period after additional vaccination

• Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AE)

  During the 30-day follow-up period after additional vaccination (for subjects who received the additional vaccine dose between Year 11 and 15)

• Number of Subjects Reporting Serious Adverse Events (SAE)

  During the follow-up period after additional vaccination up to Year 20

Study Arms (1)

Havrix Group

EXPERIMENTAL

Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study. As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up.

Biological: Havrix™

Interventions

Havrix™ BIOLOGICAL

2 doses at 6 months interval

Havrix Group

Eligibility Criteria

• Age: 29 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Wilrijk, 2610, Belgium

Location

Related Publications (10)

• Desombere I et al. (2000) Long-term persistence of cellular immunity towards hepatitis A vaccine (HAV) following HAV vaccination. J Antiviral Therapy. 5: 7.

  BACKGROUND

• Van Damme P, Mathei C, Thoelen S, Meheus A, Safary A, Andre FE. Single dose inactivated hepatitis A vaccine: rationale and clinical assessment of the safety and immunogenicity. J Med Virol. 1994 Dec;44(4):435-41. doi: 10.1002/jmv.1890440422.

  PMID: 7897376 BACKGROUND

• Van Damme P et al. (1998) Long-term immunogenicity of a high potency inactivated hepatitis A vaccine. J Hepatol. 28 (suppl.1): 113.

  BACKGROUND

• Van Herck K et al. (2000) Model-based estimates of long-term persistence of vaccine-induced hepatitis A antibodies. J Antiviral Therapy. 5:3-4.

  BACKGROUND

• Van Herck K, Van Damme P. Inactivated hepatitis A vaccine-induced antibodies: follow-up and estimates of long-term persistence. J Med Virol. 2001 Jan;63(1):1-7.

  PMID: 11130881 BACKGROUND

• 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.

  PMID: 21915861 BACKGROUND

• 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.

  PMID: 22327499 BACKGROUND

• 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.

  PMID: 32710245 DERIVED

• 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.

  PMID: 26190091 DERIVED

• 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.

  PMID: 24508042 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Hepatitis A

Interventions

Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2006
• First Posted: February 10, 2006
• Study Start: January 1, 2004
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 23, 2018
• Results First Posted: March 4, 2010

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)