Cervical Cancer, Genital Warts
Conditions
Keywords
HPV, HPV vaccine, Gardasil, Human Papillomavirus, vaccine, 2 dose versus 3
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.
Interventions
BIOLOGICALHPV (Human Papillomavirus) Vaccine
HPV (Human Papillomavirus) Vaccine received by all participants in groups 1, 2 and 3 according to the arm
Sponsors
Ministry of Health, British Columbia
Simon Dobson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
9 Years to 26 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objective Part 1 | Measured after Month 7 | 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 | At 18, 24 and 36mths post dose 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Objective Part 1 & 2 - Antibody responses 2 doses between 9-13 vs 16-26 | Measured at 7, 18,24 and 36 mths | 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 | Measured at 7,18,24 and 36 mths | 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 | Measured at 7 mths | To evaluate seroconversion rates to HPV 6, 11, 16, and 18 |
| Secondary Objective Part 1 Memory Response | Measured at 7 mths | 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 |
Countries
Canada
Outcome results
None listed