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

Cervical Cancer Clinical Trial

— BCGov-01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00501137
• Other study ID #: H07-00928
• Status: Completed
• Phase: Phase 3
• First received: July 11, 2007
• Last updated: April 8, 2015
• Start date: July 2007
• Est. completion date: December 2010

Study information

• Verified date: April 2015
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cervical Cancer
• Genital Warts
• Uterine Cervical Neoplasms

Intervention

Biological:
• HPV (Human Papillomavirus) Vaccine
HPV (Human Papillomavirus) Vaccine received by all participants in groups 1, 2 and 3 according to the arm

Locations

Country	Name	City	State
Canada	Vaccine Evaluation Centre	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Simon Dobson	Ministry of Health, British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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

Outcome

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

External Links

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