Cervical Cancer Clinical Trial
— BCGov-01Official title:
A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine
Verified date | April 2015 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 830 |
Est. completion date | December 2010 |
Est. primary completion date | February 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 9 Years to 26 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Canada | Vaccine Evaluation Centre | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Simon Dobson | Ministry of Health, British Columbia |
Canada,
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 adolesc — View 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 — View 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 I — View 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):35 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Measured after Month 7 | No |
Primary | 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. | At 18, 24 and 36mths post dose 1 | No |
Primary | 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 | Measured at 36 mths | No |
Secondary | 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 | Measured at 7, 18,24 and 36 mths | No |
Secondary | 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 | Measured at 7,18,24 and 36 mths | No |
Secondary | Secondary Objective Part 1 seroconversion rates | To evaluate seroconversion rates to HPV 6, 11, 16, and 18 | Measured at 7 mths | No |
Secondary | 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 | Measured at 7 mths | No |
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