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

NCT ID: NCT00169858

Last Updated: 2013-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-09-30
• Study Completion Date: 2012-05-31

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

Conditions

Hepatitis B; Vaccination

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut National en Santé Publique du Québec

OTHER

Sponsor Role: collaborator

Centre de Recheche du Centre Hospitalier Université Laval

OTHER

Sponsor Role: collaborator

SmithKlinBeecham Biologicals

UNKNOWN

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Vladimir Gilca

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bernard Duval, MD

Role: PRINCIPAL_INVESTIGATOR

Laval University Hospital Center, Public Health Research Unit

Locations

Vladimir Gilca

Québec, Quebec, Canada

Countries

Canada

References

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. doi: 10.1097/01.inf.0000154329.00361.39.

Reference Type: RESULT

PMID: 15750456 (View on PubMed)

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. doi: 10.1016/s0264-410x(99)00422-3.

Reference Type: RESULT

PMID: 10618544 (View on PubMed)

Gilca V, De Serres G, Boulianne N, De Wals P, Murphy D, Trudeau G, Masse 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. doi: 10.1016/j.vaccine.2009.07.100. Epub 2009 Aug 13.

Reference Type: RESULT

PMID: 19683086 (View on PubMed)

Gilca V, De Serres G, Boulianne N, Murphy D, De Wals P, Ouakki M, Trudeau G, Masse R, Dionne M. Antibody persistence and the effect of a booster dose given 5, 10 or 15 years after vaccinating preadolescents with a recombinant hepatitis B vaccine. Vaccine. 2013 Jan 7;31(3):448-51. doi: 10.1016/j.vaccine.2012.11.037. Epub 2012 Dec 1.

Reference Type: RESULT

PMID: 23206974 (View on PubMed)

Other Identifiers

103860/257 ext. 278

Identifier Type: -

Identifier Source: secondary_id

HBV-257 ext. HBV-278

Identifier Type: -

Identifier Source: org_study_id