Long Term Immunogenicity Study of Engerix-B Vaccine in 10 Year Old Children and the Effect of Booster Injections

This study has been completed.

Sponsor:

Collaborators:

Institut National en Santé Publique du Québec

Centre de Recheche du Centre Hospitalier Université Laval

SmithKlinBeecham Biologicals

Information provided by (Responsible Party):

Vladimir Gilca, Laval University

ClinicalTrials.gov Identifier:

NCT00169858

First received: September 13, 2005

Last updated: May 9, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

May 9, 2013

Start Date ^ICMJE

September 1995

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To evaluate the persistence of antibodies to Engerix-B in all subjects at age 25 and to compare the levels obtained in those given a booster injection at age 15 or 20 with those receiving no booster injection. [ Time Frame: 1995 - 2011 ] [ Designated as safety issue: Yes ]

Long term persistence of anti-HBs and the effect of a booster dose given 5, 10 or 15 years post-primary vaccination.

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00169858 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

- To determine the antibody levels obtained following primary vaccination and the proportion of children who seroconvert [ Time Frame: 1 month post primary vaccination ] [ Designated as safety issue: Yes ]
Anti-HBs titers were measured 1 months post-primary vaccination
- To determine the antibody levels of one third of subjects at age 15, 5 years after primary vaccination (Group A) [ Time Frame: 2001 ] [ Designated as safety issue: Yes ]
Anti-HBs titers were measured 5 years post primary vaccination.
- To determine the effect on antibody levels of a booster injection at age 15 years given to one third of the subjects (Group A) [ Time Frame: 2001 ] [ Designated as safety issue: Yes ]
The effect of a booster dose was measured
- To determine the antibody levels of subjects in groups A and B at age 20, 5 years after booster (Group A), 10 years after primary vaccination (Group B) [ Time Frame: 2006 ] [ Designated as safety issue: Yes ]
Anti-HBs titers were measured 10 years post primary vaccination (Group B) and 5 years post booster dose (Group A)
- To determine the effect on antibody levels of a booster injection at age 20 years given to one third of the subjects (Group B) [ Time Frame: 2006 ] [ Designated as safety issue: Yes ]
Anti-HBs titers were measured 1 month post booster dose given 10 years post-primary vaccination
- To determine the persistence of antibody 15 years after primary vaccination (Group C) [ Time Frame: 2011 ] [ Designated as safety issue: Yes ]
Anti-HBs titers will be measured
- To determine the antibody levels of subjects in Group A and Group B one year after their 5 or 10 year booster [ Time Frame: 2011 ] [ Designated as safety issue: Yes ]
anti-HBs titers will be measured 10 years post booster dose (Group A) and 5 years post booster dose (Group B)
- To evaluate the effect of a booster dose given 15 years post primary vaccination (Group C) [ Time Frame: 2011 ] [ Designated as safety issue: Yes ]
Anti-HBs titers will be measured one month post booster dose (Group C)

Original Secondary Outcome Measures ^ICMJE

- To determine the antibody levels obtained following primary vaccination and the proportion of children who seroconvert
- To determine the antibody levels of one third of subjects at age 15, 5 years after primary vaccination (Group A)
- To determine the effect on antibody levels of a booster injection at age 15 years given to one third of the subjects (Group A)
- To determine the antibody levels of subjects in groups A and B at age 20, 5 years after booster (Group A), 10 years after primary vaccination (Group B)
- To determine the effect on antibody levels of a booster injection at age 20 years given to one third of the subjects (Group B)
- To determine the effect on antibody levels of a booster injection at age 25 years given to one third of the subjects (Group C)
- To determine the antibody levels of subjects in Group A and Group B one year after their 5 or 10 year booster
- To evaluate safety

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Long Term Immunogenicity Study of Engerix-B Vaccine in 10 Year Old Children and the Effect of Booster Injections

Official Title ^ICMJE

Open Randomised Clinical Study of the Long Term Immunogenicity of Engerix-B in 10 Year Old Children and of the Effect of Booster Injections Given 5, 10 or 15 Years After Primary Vaccination

Brief Summary

Hepatitis B immunization has been offered to all grade 4 students (age 9-10) in the province of Quebec, using Engerix-B at a dose of 10 mkg. The peak incidence of hepatitis B occurs between age 15 and 35; the proportion of vaccinated children who will still be protected at this age is currently unknown. This study is designed to determine:

persistence of immunity until age 25
persistence of immunological memory as demonstrated by an anamnestic response following a booster dose
the effect of a booster dose on immunogenicity at either 5, 10 or 15 years after the primary vaccination course (at age (15, 20 or 25).

Detailed Description

Three doses of Engerix-B vaccine (10 mkg) were administered according to 0, 1, 6 month schedule to 1126 9-10 year-old children.

The primary objective of the study is to evaluate the persistence of antibodies to Engerix-B in all subjects at age 25 and to compare the levels obtained in those given a booster injection at age 15 or 20 with those receiving no booster injection.

Secondary objectives

To determine the antibody levels obtained following primary vaccination and the proportion of children who seroconvert
To determine the antibody levels of one third of subjects at age 15, 5 years after primary vaccination (Group A)
To determine the effect on antibody levels of a booster injection at age 15 years given to one third of the subjects (Group A)
To determine the antibody levels of subjects in groups A and B at age 20, 5 years after booster (Group A), 10 years after primary vaccination (Group B)
To determine the effect on antibody levels of a booster injection at age 20 years given to one third of the subjects (Group B)
To determine the effect on antibody levels of a booster injection at age 25 years given to one third of the subjects (Group C)
To determine the antibody levels of subjects in Group A and Group B one year after their 5 or 10 year booster
To evaluate safety

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Hepatitis B
Vaccination

Intervention ^ICMJE

Biological: Engerix-B

10 mkg per dose; 3 doses according to 0, 1, 6 month schedule; booster doses 5, 10 or 15 years post-primary vaccination.

Study Arm (s)

Not Provided

Publications *

Duval B, Gilca V, Boulianne N, De Wals P, Masse R, Trudeau G, De Serres G. Comparative long term immunogenicity of two recombinant hepatitis B vaccines and the effect of a booster dose given after five years in a low endemicity country. Pediatr Infect Dis J. 2005 Mar;24(3):213-8.
Duval B, Boulianne N, De Serres G, Laflamme N, De Wals P, Masse R, Trudeau G, Delage G, Desjardins L. Comparative immunogenicity under field conditions of two recombinant hepatitis B vaccines in 8-10-year-old children. Vaccine. 2000 Feb 14;18(15):1467-72.
Gilca V, De Serres G, Boulianne N, De Wals P, Murphy D, Trudeau G, Massé R, Duval B. Antibody kinetics among 8-10 years old respondents to hepatitis B vaccination in a low endemic country and the effect of a booster dose given 5 or 10 years later. Vaccine. 2009 Oct 9;27(43):6048-53. Epub 2009 Aug 13.
Antibody persistence and the effect of a booster dose given 5, 10 or 15 years after vaccinating preadolescents with a recombinant hepatitis B vaccine. Gilca V, De Serres G, Boulianne N, Murphy D, De Wals P, Ouakki M, Trudeau G, Massé R, Dionne M. Vaccine. 2013 Jan 7;31(3):448-51. doi: 10.1016/j.vaccine.2012.11.037. Epub 2012 Dec 1

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1129

Completion Date

May 2012

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Previously completed the 1995 to 1996 Hepatitis B vaccination program vaccinations (Primary study) to the best of his/her knowledge and already enrolled and followed in the long term study
Must be HBc negative
Required standard interval between last dose of primary immunization and booster vaccination
Written informed consent obtained from the subject
Free of obvious health problems as established by medical history and clinical examination before entering into the study
Previously completed routine childhood vaccination to the best of his/her knowledge
If the subject is female, and the potential of pregnancy exists, it must be asked prior to immunization by the study nurse. According to the protocol d'immunisation du Québec, Engerix-B is not contra-indicated during pregnancy. However, if a participant thinks she could be pregnant (sexually active and no oral contraception or intra uterine device), a pregnancy test will be carried out. In case of pregnancy, the booster vaccination will be performed after delivery.

Exclusion Criteria:

- Not applicable

Gender

Both

Ages

8 Years to 10 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00169858

Other Study ID Numbers ^ICMJE

HBV-257 ext. HBV-278, 103860/257 ext. 278

Has Data Monitoring Committee

Responsible Party

Vladimir Gilca, Laval University

Study Sponsor ^ICMJE

Laval University

Collaborators ^ICMJE

Institut National en Santé Publique du Québec
Centre de Recheche du Centre Hospitalier Université Laval
SmithKlinBeecham Biologicals

Investigators ^ICMJE

Principal Investigator:

Bernard Duval, MD

Laval University Hospital Center, Public Health Research Unit

Information Provided By

Laval University

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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