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

NCT ID: NCT00501137

Last Updated: 2015-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 830 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2010-12-31

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.

Conditions

Cervical Cancer; Genital Warts

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

16-26 year olds 3 doses HPV Vaccine

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

Group Type: ACTIVE_COMPARATOR

HPV (Human Papillomavirus) Vaccine

Intervention Type: BIOLOGICAL

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

3 dose 9-13 HPV Vaccine

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

Group Type: ACTIVE_COMPARATOR

HPV (Human Papillomavirus) Vaccine

Intervention Type: BIOLOGICAL

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

2 dose 9-13 yrs HPV Vaccine

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

Group Type: ACTIVE_COMPARATOR

HPV (Human Papillomavirus) Vaccine

Intervention Type: BIOLOGICAL

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

Interventions

HPV (Human Papillomavirus) Vaccine

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Gardasil; Q-HPV; HPV Vaccine

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Health, British Columbia

OTHER_GOV

Sponsor Role: collaborator

Simon Dobson

OTHER

Sponsor Role: lead

Responsible Party

Simon Dobson

Associate Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Scott Halperin, MD

Role: STUDY_DIRECTOR

Centre for Vaccinology, Halifax

Joanne Langley, MD

Role: STUDY_DIRECTOR

Centre for Vaccinology, Halifax

Marc Dionne, MD

Role: STUDY_DIRECTOR

Centre de Recherche du CHUL (CHUQ), Quebec

Simon Dobson, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

David Scheifele, MD

Role: STUDY_DIRECTOR

Vaccine Evaluation Centre, Vancouver

Meena Dawar, MD

Role: STUDY_DIRECTOR

Vaccine Evaluation Centre, Vancouver

Tobias Kollman, MD

Role: STUDY_DIRECTOR

Vaccine Evaluation Centre, Vancouver

Shelly McNeil, MD

Role: STUDY_DIRECTOR

Centre for Vaccinology, Halifax

Locations

Vaccine Evaluation Centre

Vancouver, British Columbia, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 23632723 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24055350 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21248158 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22469863 (View on PubMed)

Related Links

http://www.vec.med.ubc.ca

click here for study details

Other Identifiers

H07-00928

Identifier Type: -

Identifier Source: org_study_id