Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Injected According to a 0, 12-month Schedule

NCT00291876 | Completed Phase 4 Results

• 10 other identifiers: 100571 (M138)100572 (M150)100573 (M162)100574 (M174)100575 (M186)110677 (M198)110678 (M210)110679110680110681
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis A

Keywords

HAVRIX™; Hepatitis A

Outcome Measures

Primary Outcomes (2)

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

  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.

  At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246

• Number of Seropositive Subjects Against Hepatitis A Virus

  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.

  At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246

Secondary Outcomes (7)

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

  Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination

• Number of Subjects Reporting Solicited Local Symptoms

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

• Number of Subjects Reporting Solicited General Symptoms

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

• Number of Subjects Reporting Unsolicited Adverse Events (AE)

  During the 30-day follow-up period after additional vaccination

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

  At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246

Study Arms (1)

Havrix Group

EXPERIMENTAL

Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.

Biological: Havrix™

Interventions

Havrix™ BIOLOGICAL

2 doses at 12 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 (5)

• 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

Limitations and Caveats

For 5 subjects at Month 234, serum sample tubes were broken. Due to risk of contamination, anti-HAV concentrations analyses were not performed for these subjects, who were excluded in the LT-ATP cohort for immunogenicity analysis at Month 234.

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: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2006
• First Posted: February 15, 2006
• Study Start: January 1, 2004
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: November 29, 2017
• Results First Posted: March 8, 2010

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)