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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
830
HPV (Human Papillomavirus) Vaccine received by all participants in groups 1, 2 and 3 according to the arm
Vaccine Evaluation Centre
Vancouver, British Columbia, Canada
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
Time frame: Measured after Month 7
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.
Time frame: At 18, 24 and 36mths post dose 1
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
Time frame: Measured at 36 mths
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
Time frame: Measured at 7, 18,24 and 36 mths
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
Time frame: Measured at 7,18,24 and 36 mths
Secondary Objective Part 1 seroconversion rates
To evaluate seroconversion rates to HPV 6, 11, 16, and 18
Time frame: Measured at 7 mths
Secondary Objective Part 1 Memory Response
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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