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

NCT00169858 | Completed Phase 4

• 2 other identifiers: HBV-257 ext. HBV-278103860/257 ext. 278
• Study Type: interventional
• Target: 1,129
• Locations: 1 country
• Sites: 1

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).

Conditions

Hepatitis B; Vaccination

Keywords

Hepatitis B; Vaccination; Engerix-B; Immunogenicity; Long-term immunity; Booster dose; Safety

Outcome Measures

Primary Outcomes (1)

• 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.

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

  1995 - 2011

Secondary Outcomes (8)

• - To determine the antibody levels obtained following primary vaccination and the proportion of children who seroconvert

  1 month post primary vaccination

• - To determine the antibody levels of one third of subjects at age 15, 5 years after primary vaccination (Group A)

  2001

• - To determine the effect on antibody levels of a booster injection at age 15 years given to one third of the subjects (Group A)

  2001

• - 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)

  2006

• - To determine the effect on antibody levels of a booster injection at age 20 years given to one third of the subjects (Group B)

  2006

Interventions

Engerix-B BIOLOGICAL

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

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• \- Not applicable

Sponsors & Collaborators

• Laval University: lead
• Institut National en Santé Publique du Québec: collaborator
• Centre de Recheche du Centre Hospitalier Université Laval: collaborator
• SmithKlinBeecham Biologicals: collaborator

Study Sites (1)

Vladimir Gilca

Québec, Quebec, G1E 7G9, Canada

Location

Related Publications (4)

• 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.

  PMID: 15750456 RESULT

• 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.

  PMID: 10618544 RESULT

• 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.

  PMID: 19683086 RESULT

• 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.

  PMID: 23206974 RESULT

MeSH Terms

Conditions

Hepatitis B

Interventions

Engerix-B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Bernard Duval, MD

  Laval University Hospital Center, Public Health Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: September 1, 1995
• Primary Completion: October 1, 2011
• Study Completion: May 1, 2012
• Last Updated: May 29, 2013

Record last verified: 2013-05

Locations

CA (1)