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

NCT00501137 | Completed Phase 3 DMC

• 1 other identifier: H07-00928
• Study Type: interventional
• Target: 830
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer; Genital Warts

Keywords

HPV; HPV vaccine; Gardasil; Human Papillomavirus; vaccine; 2 dose versus 3

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (4)

• Secondary Objective Part 1 & 2 - Antibody responses 2 doses between 9-13 vs 16-26

  Measured at 7, 18,24 and 36 mths

• Secondary Objective Part 1 & 2 - HPV 16 and 18 2 doses versus 3

  Measured at 7,18,24 and 36 mths

• Secondary Objective Part 1 seroconversion rates

  Measured at 7 mths

• Secondary Objective Part 1 Memory Response

  Measured at 7 mths

Study Arms (3)

16-26 year olds 3 doses HPV Vaccine

ACTIVE COMPARATOR

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

Biological: HPV (Human Papillomavirus) Vaccine

3 dose 9-13 HPV Vaccine

ACTIVE COMPARATOR

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

Biological: HPV (Human Papillomavirus) Vaccine

2 dose 9-13 yrs HPV Vaccine

ACTIVE COMPARATOR

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

Biological: HPV (Human Papillomavirus) Vaccine

Interventions

HPV (Human Papillomavirus) Vaccine BIOLOGICAL

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

Also known as: Gardasil, Q-HPV, HPV Vaccine

16-26 year olds 3 doses HPV Vaccine; 2 dose 9-13 yrs HPV Vaccine; 3 dose 9-13 HPV Vaccine

Eligibility Criteria

• Age: 9 Years - 26 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Simon Dobson: lead
• Ministry of Health, British Columbia: collaborator

Study Sites (1)

Vaccine Evaluation Centre

Vancouver, British Columbia, Canada

Location

Related Publications (5)

• 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.

  PMID: 23632723 RESULT

• 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.

  PMID: 24055350 RESULT

• 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.

  PMID: 21248158 RESULT

• 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.

  PMID: 22469863 RESULT

• Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.

  PMID: 41276263 DERIVED

Related Links

• click here for study details

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Condylomata Acuminata

Interventions

Papillomavirus Vaccines; Vaccines; Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Study Officials

• Simon Dobson, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• David Scheifele, MD

  Vaccine Evaluation Centre, Vancouver

  STUDY DIRECTOR

• Meena Dawar, MD

  Vaccine Evaluation Centre, Vancouver

  STUDY DIRECTOR

• Tobias Kollman, MD

  Vaccine Evaluation Centre, Vancouver

  STUDY DIRECTOR

• Shelly McNeil, MD

  Centre for Vaccinology, Halifax

  STUDY DIRECTOR

• Scott Halperin, MD

  Centre for Vaccinology, Halifax

  STUDY DIRECTOR

• Joanne Langley, MD

  Centre for Vaccinology, Halifax

  STUDY DIRECTOR

• Marc Dionne, MD

  Centre de Recherche du CHUL (CHUQ), Quebec

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Clinical Professor

Study Record Dates

• First Submitted: July 11, 2007
• First Posted: July 13, 2007
• Study Start: July 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: December 1, 2010
• Last Updated: April 10, 2015

Record last verified: 2015-04

Locations

CA (1)