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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00169858
• Other study ID #: HBV-257 ext. HBV-278
• Secondary ID: 103860/257 ext.
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: May 24, 2013
• Start date: September 1995
• Est. completion date: May 2012

Study information

• Verified date: May 2013
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1129
• Est. completion date: May 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 10 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hepatitis B
• Vaccination

Intervention

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.

Locations

Country	Name	City	State
Canada	Vladimir Gilca	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
Laval University	Centre de Recheche du Centre Hospitalier Université Laval, Institut National en Santé Publique du Québec, SmithKlinBeecham Biologicals

Country where clinical trial is conducted

Canada, 

References & Publications (4)

Duval B, Boulianne N, De Serres G, Laflamme N, De Wals P, Massé 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. — View Citation

Duval B, Gîlca V, Boulianne N, De Wals P, Massé 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 — View Citation

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 — View Citation

Gilca V, De Serres G, Boulianne N, Murphy D, De Wals P, Ouakki M, Trudeau G, Massé 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. — View Citation

Outcome

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