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Completed

NCT Number: NCT00169858

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

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).

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Key information

Conditions

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

Age range

8 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vladimir Gilca

Québec, Quebec, G1E 7G9, Canada

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

    Time frame: 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 outcomes

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

    Time frame: 1 month post primary vaccination

    Anti-HBs titers were measured 1 months post-primary vaccination

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

    Time frame: 2001

    Anti-HBs titers were measured 5 years post primary vaccination.

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

    Time frame: 2001

    The effect of a booster dose was measured

  4. - 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)

    Time frame: 2006

    Anti-HBs titers were measured 10 years post primary vaccination (Group B) and 5 years post booster dose (Group A)

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

    Time frame: 2006

    Anti-HBs titers were measured 1 month post booster dose given 10 years post-primary vaccination

  6. - To determine the persistence of antibody 15 years after primary vaccination (Group C)

    Time frame: 2011

    Anti-HBs titers will be measured

  7. - To determine the antibody levels of subjects in Group A and Group B one year after their 5 or 10 year booster

    Time frame: 2011

    anti-HBs titers will be measured 10 years post booster dose (Group A) and 5 years post booster dose (Group B)

  8. - To evaluate the effect of a booster dose given 15 years post primary vaccination (Group C)

    Time frame: 2011

    Anti-HBs titers will be measured one month post booster dose (Group C)

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
1995
Primary completion
2011
Study completion
2012
First posted
Sep 15, 2005
Registry last updated
May 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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