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A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine (BCGov-01)

Primary Purpose

Cervical Cancer, Genital Warts

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
HPV (Human Papillomavirus) Vaccine
Sponsored by
Simon Dobson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer focused on measuring HPV, HPV vaccine, Gardasil, Human Papillomavirus, vaccine, 2 dose versus 3

Eligibility Criteria

9 Years - 26 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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 Criteria

  • 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

Sites / Locations

  • Vaccine Evaluation Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

16-26 year olds 3 doses HPV Vaccine

3 dose 9-13 HPV Vaccine

2 dose 9-13 yrs HPV Vaccine

Arm Description

Group 3 - 16-26 year olds receiving 3 doses HPV (Human Papillomavirus) Vaccine at 0, 2, 6 mths

Group 2 - 9-13 year olds receiving 3 doses HPV (Human Papillomavirus) Vaccine at 0,2,6 mths

Group 1 9-13 year olds 2 doses HPV (Human Papillomavirus) Vaccine at 0 and 6 mths

Outcomes

Primary Outcome Measures

Primary Objective Part 1
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
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
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
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
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
To evaluate seroconversion rates to HPV 6, 11, 16, and 18
Secondary Objective Part 1 Memory Response
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

Full Information

First Posted
July 11, 2007
Last Updated
April 8, 2015
Sponsor
Simon Dobson
Collaborators
Ministry of Health, British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT00501137
Brief Title
A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine
Acronym
BCGov-01
Official Title
A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Simon Dobson
Collaborators
Ministry of Health, British Columbia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Genital Warts
Keywords
HPV, HPV vaccine, Gardasil, Human Papillomavirus, vaccine, 2 dose versus 3

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
830 (Actual)

8. Arms, Groups, and Interventions

Arm Title
16-26 year olds 3 doses HPV Vaccine
Arm Type
Active Comparator
Arm Description
Group 3 - 16-26 year olds receiving 3 doses HPV (Human Papillomavirus) Vaccine at 0, 2, 6 mths
Arm Title
3 dose 9-13 HPV Vaccine
Arm Type
Active Comparator
Arm Description
Group 2 - 9-13 year olds receiving 3 doses HPV (Human Papillomavirus) Vaccine at 0,2,6 mths
Arm Title
2 dose 9-13 yrs HPV Vaccine
Arm Type
Active Comparator
Arm Description
Group 1 9-13 year olds 2 doses HPV (Human Papillomavirus) Vaccine at 0 and 6 mths
Intervention Type
Biological
Intervention Name(s)
HPV (Human Papillomavirus) Vaccine
Other Intervention Name(s)
Gardasil, Q-HPV, HPV Vaccine
Intervention Description
HPV (Human Papillomavirus) Vaccine received by all participants in groups 1, 2 and 3 according to the arm
Primary Outcome Measure Information:
Title
Primary Objective Part 1
Description
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
Time Frame
Measured after Month 7
Title
Primary Objective Part 2
Description
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.
Time Frame
At 18, 24 and 36mths post dose 1
Title
Primary Objective Part 2
Description
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
Time Frame
Measured at 36 mths
Secondary Outcome Measure Information:
Title
Secondary Objective Part 1 & 2 - Antibody responses 2 doses between 9-13 vs 16-26
Description
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
Time Frame
Measured at 7, 18,24 and 36 mths
Title
Secondary Objective Part 1 & 2 - HPV 16 and 18 2 doses versus 3
Description
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
Time Frame
Measured at 7,18,24 and 36 mths
Title
Secondary Objective Part 1 seroconversion rates
Description
To evaluate seroconversion rates to HPV 6, 11, 16, and 18
Time Frame
Measured at 7 mths
Title
Secondary Objective Part 1 Memory Response
Description
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
Time Frame
Measured at 7 mths

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 Criteria 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Dobson, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Scheifele, MD
Organizational Affiliation
Vaccine Evaluation Centre, Vancouver
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Meena Dawar, MD
Organizational Affiliation
Vaccine Evaluation Centre, Vancouver
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tobias Kollman, MD
Organizational Affiliation
Vaccine Evaluation Centre, Vancouver
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shelly McNeil, MD
Organizational Affiliation
Centre for Vaccinology, Halifax
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Scott Halperin, MD
Organizational Affiliation
Centre for Vaccinology, Halifax
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joanne Langley, MD
Organizational Affiliation
Centre for Vaccinology, Halifax
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marc Dionne, MD
Organizational Affiliation
Centre de Recherche du CHUL (CHUQ), Quebec
Official's Role
Study Director
Facility Information:
Facility Name
Vaccine Evaluation Centre
City
Vancouver
State/Province
British Columbia
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23632723
Citation
Dobson SR, McNeil S, Dionne M, Dawar M, Ogilvie G, Krajden M, Sauvageau C, Scheifele DW, Kollmann TR, Halperin SA, Langley JM, Bettinger JA, Singer J, Money D, Miller D, Naus M, Marra F, Young E. Immunogenicity of 2 doses of HPV vaccine in younger adolescents vs 3 doses in young women: a randomized clinical trial. JAMA. 2013 May 1;309(17):1793-802. doi: 10.1001/jama.2013.1625.
Results Reference
result
PubMed Identifier
24055350
Citation
Krajden M, Cook D, Yu A, Chow R, Su Q, Mei W, McNeil S, Money D, Dionne M, Palefsky J, Karunakaran K, Kollmann T, Ogilvie G, Petric M, Dobson S. Assessment of HPV 16 and HPV 18 antibody responses by pseudovirus neutralization, Merck cLIA and Merck total IgG LIA immunoassays in a reduced dosage quadrivalent HPV vaccine trial. Vaccine. 2014 Jan 23;32(5):624-30. doi: 10.1016/j.vaccine.2013.09.007. Epub 2013 Sep 19.
Results Reference
result
PubMed Identifier
21248158
Citation
Krajden M, Cook D, Yu A, Chow R, Mei W, McNeil S, Money D, Dionne M, Karunakaran KP, Palefsky JM, Dobson S, Ogilvie G, Petric M. Human papillomavirus 16 (HPV 16) and HPV 18 antibody responses measured by pseudovirus neutralization and competitive Luminex assays in a two- versus three-dose HPV vaccine trial. Clin Vaccine Immunol. 2011 Mar;18(3):418-23. doi: 10.1128/CVI.00489-10. Epub 2011 Jan 19.
Results Reference
result
PubMed Identifier
22469863
Citation
Smolen KK, Gelinas L, Franzen L, Dobson S, Dawar M, Ogilvie G, Krajden M, Fortuno ES 3rd, Kollmann TR. Age of recipient and number of doses differentially impact human B and T cell immune memory responses to HPV vaccination. Vaccine. 2012 May 21;30(24):3572-9. doi: 10.1016/j.vaccine.2012.03.051. Epub 2012 Mar 31.
Results Reference
result
Links:
URL
http://www.vec.med.ubc.ca
Description
click here for study details

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

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