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

July 11, 2007
April 16, 2014
July 2007
February 2008   (final data collection date for primary outcome measure)
  • 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
Not Provided
Complete list of historical versions of study NCT00501137 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine
A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Cervical Cancer
  • Genital Warts
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: 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
    Intervention: Biological: HPV (Human Papillomavirus) 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
    Intervention: Biological: HPV (Human Papillomavirus) 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
    Intervention: Biological: HPV (Human Papillomavirus) Vaccine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
830
December 2010
February 2008   (final data collection date for primary outcome measure)

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
Female
9 Years to 26 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00501137
H07-00928, BCGov-01
Yes
Simon Dobson, University of British Columbia
Simon Dobson
Ministry of Health, British Columbia
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
University of British Columbia
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP