Long Term Immunogenicity Study of Engerix-B Vaccine in 10 Year Old Children and the Effect of Booster Injections
- Conditions
- Hepatitis BVaccination
- Registration Number
- NCT00169858
- Lead Sponsor
- Laval University
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1129
- 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.
- Not applicable
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method - 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 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 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
- 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)
Trial Locations
- Locations (1)
Vladimir Gilca
🇨🇦Quebec, Canada