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

Sponsor:	Laval University
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

Purpose

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).

Condition	Intervention	Phase
Hepatitis B Vaccination	Biological: Engerix-B	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

U.S. FDA Resources

Further study details as provided by Laval University:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

- 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)

Enrollment:	1129
Study Start Date:	September 1995
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

Eligibility

Ages Eligible for Study:	8 Years to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169858

Locations

Canada
Research Center of Laval University Hospital Center, Public Health Research Unit
Quebec, Canada, G1E 7G9

Sponsors and Collaborators

Laval University

Institut National en Santé Publique du Québec

Centre de Recheche du Centre Hospitalier Université Laval

SmithKlinBeecham Biologicals

Investigators

Principal Investigator:

Bernard Duval, MD

Laval University Hospital Center, Public Health Research Unit

More Information

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.

Responsible Party:	Vladimir Gilca, PhD, Laval University
ClinicalTrials.gov Identifier:	NCT00169858 History of Changes
Other Study ID Numbers:	HBV-257 ext. HBV-278, 103860/257 ext. 278
Study First Received:	September 13, 2005
Last Updated:	September 29, 2011
Health Authority:	Canada: Health Canada

Keywords provided by Laval University:

Hepatitis B
Vaccination
Engerix-B
Immunogenicity

Long-term immunity
Booster dose
Safety

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human

Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on February 09, 2012