Hepatitis B, Vaccination
Conditions
Keywords
Hepatitis B, Vaccination, Engerix-B, Immunogenicity, Long-term immunity, Booster dose, Safety
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
Interventions
BIOLOGICALEngerix-B
10 mkg per dose; 3 doses according to 0, 1, 6 month schedule; booster doses 5, 10 or 15 years post-primary vaccination.
Sponsors
Institut National en Santé Publique du Québec
Centre de Recheche du Centre Hospitalier Université Laval
SmithKlinBeecham Biologicals
Laval University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 10 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 1995 - 2011 | Long term persistence of anti-HBs and the effect of a booster dose given 5, 10 or 15 years post-primary vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| - To determine the antibody levels of one third of subjects at age 15, 5 years after primary vaccination (Group A) | 2001 | 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) | 2001 | 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) | 2006 | Anti-HBs titers were measured 10 years post primary vaccination (Group B) and 5 years post booster dose (Group A) |
| - To determine the antibody levels obtained following primary vaccination and the proportion of children who seroconvert | 1 month post primary vaccination | Anti-HBs titers were measured 1 months post-primary vaccination |
| - To determine the persistence of antibody 15 years after primary vaccination (Group C) | 2011 | 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 | 2011 | 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) | 2011 | Anti-HBs titers will be measured one month post booster dose (Group C) |
| - 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 | Anti-HBs titers were measured 1 month post booster dose given 10 years post-primary vaccination |
Countries
Canada
Outcome results
None listed