A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, British Columbia
Information provided by (Responsible Party):
Simon Dobson, University of British Columbia
ClinicalTrials.gov Identifier:
NCT00501137
First received: July 11, 2007
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

Primary objective is to determine if antibody responses to HPV types 16 & 18 are non-inferior after a 2-dose paediatric regimen as compared to a 3-dose adult regimen of Q-HPV vaccination, with responses measured at Month 7.


Condition Intervention Phase
Cervical Cancer
Genital Warts
Biological: HPV (Human Papillomavirus) Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Primary Objective Part 1 [ Time Frame: Measured after Month 7 ] [ Designated as safety issue: No ]
    To determine if antibody responses to HPV types 16 & 18 are non-inferior after a 2-dose paediatric regimen as compared to a 3-dose adult regimen of Q-HPV vaccination

  • Primary Objective Part 2 [ Time Frame: At 18, 24 and 36mths post dose 1 ] [ Designated as safety issue: No ]
    To compare the serum antibody responses to HPV 6, 11, 16 & 18 at months 18, 24 and 36 in 2-dose adolescent arm, 3-dose adolescent arm and 3-dose adult arm of the study.

  • Primary Objective Part 2 [ Time Frame: Measured at 36 mths ] [ Designated as safety issue: No ]
    To evaluate the memory B cell and T helper cell mediated immune response to Q-HPV vaccine in the 2-dose adolescent, 3-dose adolescent and 3-dose adult arms


Secondary Outcome Measures:
  • Secondary Objective Part 1 & 2 - Antibody responses 2 doses between 9-13 vs 16-26 [ Time Frame: Measured at 7, 18,24 and 36 mths ] [ Designated as safety issue: No ]
    To demonstrate that 2-doses of Q-HPV vaccine administered to 9-13 year old females produces a serum antibody response to HPV 6 and 11 that is similar to the response seen in 16-26 year olds

  • Secondary Objective Part 1 & 2 - HPV 16 and 18 2 doses versus 3 [ Time Frame: Measured at 7,18,24 and 36 mths ] [ Designated as safety issue: No ]
    To evaluate the antibody responses to HPV 16 and 18 in 9-13 year old females after a 2-dose versus a 3-dose Q-HPV regimen

  • Secondary Objective Part 1 seroconversion rates [ Time Frame: Measured at 7 mths ] [ Designated as safety issue: No ]
    To evaluate seroconversion rates to HPV 6, 11, 16, and 18

  • Secondary Objective Part 1 Memory Response [ Time Frame: Measured at 7 mths ] [ Designated as safety issue: No ]
    To evaluate the memory B cell and T helper cell mediated immune response to Q-HPV vaccine in the 2-dose adolescent, 3-dose adolescent and 3-dose adult arms


Enrollment: 830
Study Start Date: July 2007
Study Completion Date: December 2010
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 16-26 year olds 3 doses HPV Vaccine
Group 3 - 16-26 year olds receiving 3 doses HPV (Human Papillomavirus) Vaccine at 0, 2, 6 mths
Biological: HPV (Human Papillomavirus) Vaccine
HPV (Human Papillomavirus) Vaccine received by all participants in groups 1, 2 and 3 according to the arm
Other Names:
  • Gardasil
  • Q-HPV
  • HPV Vaccine
Active Comparator: 3 dose 9-13 HPV Vaccine
Group 2 - 9-13 year olds receiving 3 doses HPV (Human Papillomavirus) Vaccine at 0,2,6 mths
Biological: HPV (Human Papillomavirus) Vaccine
HPV (Human Papillomavirus) Vaccine received by all participants in groups 1, 2 and 3 according to the arm
Other Names:
  • Gardasil
  • Q-HPV
  • HPV Vaccine
Active Comparator: 2 dose 9-13 yrs HPV Vaccine
Group 1 9-13 year olds 2 doses HPV (Human Papillomavirus) Vaccine at 0 and 6 mths
Biological: HPV (Human Papillomavirus) Vaccine
HPV (Human Papillomavirus) Vaccine received by all participants in groups 1, 2 and 3 according to the arm
Other Names:
  • Gardasil
  • Q-HPV
  • HPV Vaccine

Detailed Description:

Human Papillomavirus (HPV) infection is a cause of cervical cancer. Immunogenicity, safety and efficacy in the prevention of persistent infection from HPV 16 and 18 has been proven using a 3-dose regimen in adolescent and adult females using the Quadrivalent Human Papillomavirus (Q-HPV) vaccine. The intensity of the immune response is inversely proportional to age. Immunogenicity in adolescents 9-15 years of age is 1.7 - 2 times greater than in 16-26 year old vaccine recipients. Paediatric dosing studies are necessary and prudent given limited provincial funding for new biologics acquisition and programme service delivery. A reduction from an adult 3-dose HPV vaccine regimen to a pediatric 2-dose regimen will result in increased compliance to the full vaccine series and in significant savings to the health care system both in the cost of biologics and of program delivery and administration.

  Eligibility

Ages Eligible for Study:   9 Years to 26 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A female between, and including, 9-13 years (before 14th birthday) and 16-26 years of age (before 27th birthday) at the time of the first vaccination.
  • Healthy
  • Not pregnant
  • Four or less sexual partners over lifetime as reported by subject. (Sexual activity is defined as intercourse)
  • Not planning to become pregnant or likely to become pregnant
  • No reported history of genital warts
  • No laboratory confirmed history of cervical intraepithelial neoplasia
  • No previous vaccination against HPV
  • No administration of immunoglobulin and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period
  • No previous anaphylactic reaction to HPV vaccine or any vaccine related component including aluminum hydroxyphosphate sulfate and polysorbate 80
  • No confirmed or suspected immunosuppressive or immunodeficient condition based on medical history
  • No bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  • Cannot be already enrolled in any clinical trial in which investigational vaccine or drug are being administered

Exclusion

  • Pregnant
  • Female planning to become pregnant or likely to become pregnant (as determined by the investigator) during the study duration Part 1 (0-7 months)
  • Reported history of genital warts
  • Laboratory confirmed history of cervical intraepithelial neoplasia
  • Greater than four lifetime sexual partners involving sexual intercourse
  • Previous vaccination against HPV
  • Administration of immunoglobulin and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period
  • A previous anaphylactic reaction to HPV vaccine or any vaccine related component including aluminum hydroxyphosphate sulfate and polysorbate 80
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history (e.g. HIV infection, genetic defect, immunosuppressive therapy). *Chronic administration (defined as more than 14 days) of immune-modifying drugs within 6 months prior to the first vaccine dose or planned use during the study period is exclusionary (corticosteroid use - immune-modifying level is ≥0.5 mg/kg/day; inhaled or topical steroids are acceptable).
  • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection (thrombocytopaenia, coagulation disorder, anti-coagulant therapy).
  • Enrollment in any clinical trial in which investigational vaccine or drug are being administered
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00501137

Locations
Canada, British Columbia
Vaccine Evaluation Centre
Vancouver, British Columbia, Canada
Sponsors and Collaborators
Simon Dobson
Ministry of Health, British Columbia
Investigators
Principal Investigator: Simon Dobson, MD University of British Columbia
Study Director: David Scheifele, MD Vaccine Evaluation Centre, Vancouver
Study Director: Meena Dawar, MD Vaccine Evaluation Centre, Vancouver
Study Director: Tobias Kollman, MD Vaccine Evaluation Centre, Vancouver
Study Director: Shelly McNeil, MD Centre for Vaccinology, Halifax
Study Director: Scott Halperin, MD Centre for Vaccinology, Halifax
Study Director: Joanne Langley, MD Centre for Vaccinology, Halifax
Study Director: Marc Dionne, MD Centre de Recherche du CHUL (CHUQ), Quebec
  More Information

Additional Information:
Publications:

Responsible Party: Simon Dobson, Associate Clinical Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT00501137     History of Changes
Other Study ID Numbers: H07-00928, BCGov-01
Study First Received: July 11, 2007
Last Updated: April 16, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
HPV
HPV vaccine
Gardasil
Human Papillomavirus
vaccine
2 dose versus 3

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Condylomata Acuminata
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on April 16, 2014