Cervical CancerPhase 3BCGov-01NCT00501137

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

A Phase 3 study testing HPV (Human Papillomavirus) Vaccine in people with Cervical Cancer and Genital Warts, run by Simon Dobson at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 9 to 26 years, women onlyHealthy volunteers can take part
Conditions the study is for: Cervical Cancer, Genital Warts
What is being tested?: HPV (Human Papillomavirus) Vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 830 participants
Where: 1 siteCanada
Study dates: Jul 2007to Dec 2010
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 9 to 26 years
Women only
Healthy volunteers accepted
Child, Adult

Who may be able to join

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

Show all 13Show fewer

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

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

Vaccine Evaluation Centre
Vancouver, British Columbia

Other trials in Canada

About this study

Read the 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
Being tested: HPV (Human Papillomavirus) Vaccine
Keywords: HPV, HPV vaccine, Gardasil, Human Papillomavirus, vaccine, 2 dose versus 3
Medical subject headings: Uterine Cervical Neoplasms, Condylomata Acuminata

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HPV (Human Papillomavirus) VaccineBiological
Also called Gardasil, Q-HPV, HPV Vaccine
HPV (Human Papillomavirus) Vaccine received by all participants in groups 1, 2 and 3 according to the arm

Study groups in NCT00501137
Study group	Role	What they receive
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 Receives: 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 Receives: 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 Receives: Biological: HPV (Human Papillomavirus) Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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: 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.
Measured: 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: Measured at 36 mths

Secondary outcomes (4)

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: 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
Measured: 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
Measured: Measured at 7 mths
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: Measured at 7 mths

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2007Dec 2010

First posted13 Jul 2007 (estimated)
Study startJul 2007
Primary completionFeb 2008
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Cervical CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 830 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00501137
Sponsor's protocol ID: H07-00928
Acronym: BCGov-01
Status last verified: Apr 2015
First submitted: 11 Jul 2007
Last updated: 10 Apr 2015
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 23632723
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.
PubMed 24055350
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.
PubMed 21248158
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.
PubMed 22469863
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.
PubMed 41276263

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine
ClinicalTrials.gov ID: NCT00501137
Acronym / sponsor ID: BCGov-01 / H07-00928
Conditions: Cervical Cancer, Genital Warts
Keywords: HPV, HPV vaccine, Gardasil, Human Papillomavirus, vaccine, 2 dose versus 3
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 830 participants (actual)
Lead sponsor: Simon DobsonUniversity, hospital or other
Collaborators: Ministry of Health, British Columbia
Study start: Jul 2007
Primary completion: Feb 2008 (actual)
Study completion: Dec 2010 (actual)
First posted: 13 Jul 2007 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
16-26 year olds 3 doses HPV Vaccine	Active comparator	Biological: HPV (Human Papillomavirus) VaccineGroup 3 - 16-26 year olds receiving 3 doses HPV (Human Papillomavirus) Vaccine at 0, 2, 6 mths
3 dose 9-13 HPV Vaccine	Active comparator	Biological: HPV (Human Papillomavirus) VaccineGroup 2 - 9-13 year olds receiving 3 doses HPV (Human Papillomavirus) Vaccine at 0,2,6 mths
2 dose 9-13 yrs HPV Vaccine	Active comparator	Biological: HPV (Human Papillomavirus) VaccineGroup 1 9-13 year olds 2 doses HPV (Human Papillomavirus) Vaccine at 0 and 6 mths

Who may qualify

Ages: 9 to 26 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (13 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HPV (Human Papillomavirus) VaccineAlso: Gardasil, Q-HPV, HPV VaccineHPV (Human Papillomavirus) Vaccine received by all participants in groups 1, 2 and 3 according to the arm	Biological	16-26 year olds 3 doses HPV Vaccine, 2 dose 9-13 yrs HPV Vaccine, 3 dose 9-13 HPV Vaccine

Primary outcome

Primary Objective Part 1
Time frame: 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
Time frame: 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.
Primary Objective Part 2
Time frame: Measured at 36 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

4 secondary outcomes

Secondary Objective Part 1 & 2 - Antibody responses 2 doses between 9-13 vs 16-26
Time frame: Measured at 7, 18,24 and 36 mths
Secondary Objective Part 1 & 2 - HPV 16 and 18 2 doses versus 3
Time frame: Measured at 7,18,24 and 36 mths
Secondary Objective Part 1 seroconversion rates
Time frame: Measured at 7 mths
Secondary Objective Part 1 Memory Response
Time frame: Measured at 7 mths

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
Results publication: PubMed 23632723Dobson 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.
Results publication: PubMed 24055350Krajden 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.
Results publication: PubMed 21248158Krajden 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.
Results publication: PubMed 22469863Smolen 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.
Derived from this study: PubMed 41276263Bergman 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.
click here for study detailsLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Simon Dobson, MD principal investigator

University of British Columbia

David Scheifele, MD study director

Vaccine Evaluation Centre, Vancouver

Meena Dawar, MD study director

Vaccine Evaluation Centre, Vancouver

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HPV (Human Papillomavirus) Vaccine in people with Cervical Cancer and Genital Warts, run by Simon Dobson at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Objective Part 1 (time frame: Measured after Month 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00501137, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2015.