Genital WartsPhase 3NCT01651949

Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)

A Phase 3 study testing 9vHPV Vaccine in people with Genital Warts and Anal Cancer, run by Merck Sharp & Dohme LLC.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 16 to 26 yearsHealthy volunteers can take part
Conditions the study is for: Genital Warts, Anal Cancer, Anal Intraepithelial Neoplasia
What is being tested?: 9vHPV Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,520 participants
Where: No sites listed yet
Study dates: 29 Oct 2012to 4 Aug 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 16 to 26 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Good physical health
Has never had Papanicolaou testing (Pap, cervical or anal) or has only had normal Pap test results
Other inclusion criteria will be discussed with the investigator

Who cannot join

History of severe allergic reaction that required medical intervention
Currently enrolled in a clinical trial
If participant is female, pregnant
Currently immunocompromised or having received immunosuppressive therapy in the last year
Positive test for HPV
History of HPV-related external genital lesions or HPV-related anal lesions or anal cancer
If participant is female, history of abnormal cervical biopsy results
Other exclusion criteria will be discussed with the investigator

About this study

Official title: A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of 9vHPV (V503), a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, in 16- to 26-Year-Old Men and 16- to 26-Year-Old Women

This study is designed to evaluate the immunogenicity and tolerability of 9vHPV (9-valent HPV vaccine, V503) in 16- to 26-year old men and women. The overall goal is to bridge 9vHPV efficacy findings in young women to young men based on the demonstration of similar immunogenicity and safety profiles. The primary hypothesis is that 9vHPV induces antibody responses at 4 weeks postdose 3 in heterosexual males that are non-inferior to antibody responses in young women.

Read the detailed description

Study participants will be administered a 3-dose regimen of 9vHPV. They will be assessed for immunogenicity 1 month following completion of vaccination. All participants will be followed for safety for a total of 12 months.

Conditions: Genital Warts, Anal Cancer, Anal Intraepithelial Neoplasia
Being tested: 9vHPV Vaccine
Medical subject headings: Condylomata Acuminata, Anus Neoplasms

What participants receive

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

9vHPV VaccineBiological
9vHPV, V503 (9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine), 0.5 mL injection in 3-dose regimen

Study groups in NCT01651949
Study group	Role	What they receive
Females	Active comparator	Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6 Receives: Biological: 9vHPV Vaccine
Heterosexual Males	Experimental	Healthy heterosexual males 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6 Receives: Biological: 9vHPV Vaccine
Men who have Sex with Men	Experimental	Healthy MSM 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6 Receives: Biological: 9vHPV Vaccine

What is being measured

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

Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine
Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL
Measured: Four weeks post vaccination 3 (Month 7)
Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling. Participants were instructed to use the Vaccination Report Card to record AEs daily after each study vaccination.
Measured: Up to 5 days after any vaccination
Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F)
Participants were instructed by the investigator to use the Vaccination Report Card to document evening oral temperature daily after each study vaccination
Measured: Up to 5 days after any vaccination
Percentage of Participants With an Adverse Event
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.
Measured: Up to Month 12
Percentage of Participants Who Had Study Vaccine Discontinued Due to an Adverse Event
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.
Measured: Up to Month 12

Secondary outcomes (1)

Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine
Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24; HPV Type 31: ≥10; HPV Types 33, 45, 52, and 58: ≥8.
Measured: Four weeks post vaccination 3 (Month 7)

Timeline

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

29 Oct 20124 Aug 2014

First posted27 Jul 2012 (estimated)
Study start29 Oct 2012
Primary completion4 Aug 2014
Study completion4 Aug 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Genital WartsStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 2,520 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01651949
Sponsor's protocol ID: V503-003
Other IDs: 2012-002758-22
Status last verified: Oct 2018
First submitted: 25 Jul 2012
Last updated: 27 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Castellsague X, Giuliano AR, Goldstone S, Guevara A, Mogensen O, Palefsky JM, Group T, Shields C, Liu K, Maansson R, Luxembourg A, Kaplan SS. Immunogenicity and safety of the 9-valent HPV vaccine in men. Vaccine. 2015 Nov 27;33(48):6892-901. doi: 10.1016/j.vaccine.2015.06.088. Epub 2015 Jul 2.
PubMed 26144901
Moreira ED Jr, Block SL, Ferris D, Giuliano AR, Iversen OE, Joura EA, Kosalaraksa P, Schilling A, Van Damme P, Bornstein J, Bosch FX, Pils S, Cuzick J, Garland SM, Huh W, Kjaer SK, Qi H, Hyatt D, Martin J, Moeller E, Ritter M, Baudin M, Luxembourg A. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Pediatrics. 2016 Aug;138(2):e20154387. doi: 10.1542/peds.2015-4387. Epub 2016 Jul 15.
PubMed 27422279

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?

Official record

Not yet recruiting
Efficacy and Safety of Oral Ivermectin for Genital Warts
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Treatment of Recurrent Genital Warts by Combination of CO2 Laser and Geniwa Gel
HPV (Human Papillomavirus)-Associated, Genital Warts
RecruitingPhase 2
To Evaluate the Safety and Immunogenicity of 15-valent HPV Recombinant Vaccine in Chinese People Aged 9-45 Years
HPV Infection, HPV-Related Carcinoma
Active, not recruitingPhase 3
A Phase III Trial to Evaluate the Efficacy, Immunogenicity and Safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.Coli) in Chinese Males
Penile/Perineal /Perianal Intraepithelial Neoplasia, Anal Intraepithelial Neoplasia
Active, not recruitingPhase 3
A Phase III Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent HPV Vaccine in Chinese Males
Genital Wart, Penile Cancer

All Genital Warts trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of 9vHPV (V503), a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, in 16- to 26-Year-Old Men and 16- to 26-Year-Old Women
ClinicalTrials.gov ID: NCT01651949
Acronym / sponsor ID: V503-003
Conditions: Genital Warts, Anal Cancer, Anal Intraepithelial Neoplasia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,520 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 29 Oct 2012 (actual)
Primary completion: 4 Aug 2014 (actual)
Study completion: 4 Aug 2014 (actual)
First posted: 27 Jul 2012 (estimated)
Results: Posted 9 Mar 2015

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Females	Active comparator	Biological: 9vHPV VaccineHealthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
Heterosexual Males	Experimental	Biological: 9vHPV VaccineHealthy heterosexual males 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
Men who have Sex with Men	Experimental	Biological: 9vHPV VaccineHealthy MSM 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6

Who may qualify

Ages: 16 to 26 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Good physical health
Has never had Papanicolaou testing (Pap, cervical or anal) or has only had normal Pap test results
Other inclusion criteria will be discussed with the investigator

Key exclusion criteria (8 listed)

History of severe allergic reaction that required medical intervention
Currently enrolled in a clinical trial
If participant is female, pregnant
Currently immunocompromised or having received immunosuppressive therapy in the last year
Positive test for HPV

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
9vHPV Vaccine9vHPV, V503 (9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine), 0.5 mL injection in 3-dose regimen	Biological	Females, Heterosexual Males, Men who have Sex with Men

Primary outcome

Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine
Time frame: Four weeks post vaccination 3 (Month 7)
Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL
Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card
Time frame: Up to 5 days after any vaccination
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling. Participants were instructed to use the Vaccination Report Card to record AEs daily after each study vaccination.
Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F)
Time frame: Up to 5 days after any vaccination
Participants were instructed by the investigator to use the Vaccination Report Card to document evening oral temperature daily after each study vaccination
Percentage of Participants With an Adverse Event
Time frame: Up to Month 12
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.
Percentage of Participants Who Had Study Vaccine Discontinued Due to an Adverse Event
Time frame: Up to Month 12
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.

1 secondary outcome

Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine
Time frame: Four weeks post vaccination 3 (Month 7)

Results and safety

Results posted to the registry on 9 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Heterosexual Males	1,106	1,053
Females	1,101	1,015
Men Who Have Sex With Men (MSM)	313	282

Primary outcome: Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine

Time frame: Four weeks post vaccination 3 (Month 7). Geometric mean (95% Confidence Interval). Unit: milli Merck Units/mL

Measure	Heterosexual Males n = 914	Females n = 884	Men Who Have Sex With Men n = 239
Anti-HPV Type 6 (n=847, 708, 164)	782.0 (738.0 to 828.7)	703.9 (660.6 to 749.9)	568.9 (498.7 to 649.0)
Anti-HPV Type 11 (n=851, 712, 165)	616.7 (582.4 to 653.0)	564.9 (530.6 to 601.3)	437.7 (384.4 to 498.5)
Anti-HPV Type 16 (n=899, 781, 212)	3346.0 (3158.9 to 3544.1)	2788.3 (2621.4 to 2965.8)	2294.0 (2037.8 to 2582.5)
Anti-HPV Type 18 (n=906, 831, 220)	808.2 (754.9 to 865.4)	679.8 (633.1 to 730.1)	608.1 (529.4 to 698.5)
Anti-HPV Type 31 (n=908, 826, 227)	708.5 (662.7 to 757.6)	570.1 (531.5 to 611.5)	420.7 (368.0 to 480.9)
Anti-HPV Type 33 (n=901, 853, 230)	384.8 (362.5 to 408.4)	322.0 (302.9 to 342.3)	252.3 (224.2 to 283.8)
Anti-HPV Type 45 (n=909, 871, 232)	235.6 (219.0 to 253.6)	185.7 (172.3 to 200.2)	157.5 (136.2 to 182.2)
Anti-HPV Type 52 (n=907, 849, 232)	386.8 (363.4 to 411.6)	335.2 (314.3 to 357.6)	233.1 (206.0 to 263.7)

Heterosexual Males vs Females: GMT Ratio: 1.11 (95% CI 1.02 to 1.21), p <0.001, ANOVA
Heterosexual Males vs Females: GMT Ratio: 1.09 (95% CI 1.00 to 1.19), p <0.001, ANOVA
Heterosexual Males vs Females: GMT Ratio: 1.20 (95% CI 1.10 to 1.30), p <0.001, ANOVA

Population analysed: The analysis set includes heterosexual male and female participants who received the 3 vaccinations, were seronegative to the appropriate HPV type at baseline, and had Month 7 immunogenicity results for the appropriate HPV type. Per-protocol non-inferiority analysis compared heterosexual males and females only.

Primary outcome: Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card

Time frame: Up to 5 days after any vaccination. Number. Unit: Percentage of Participants

Measure	Heterosexual and MSM Males n = 1394	Females n = 1075
Overall injection-site AEs	66.7	84.0
Injection-site Erythema	20.7	32.2
Injection-site Pain	63.4	82.5
Injection-site Swelling	20.2	37.5

Heterosexual and MSM Males vs Females: Risk Difference (RD): -11.5 (95% CI -15.0 to -8.0), p <0.001, Miettinen & Nurminen
Heterosexual and MSM Males vs Females: Risk Difference (RD): -19.1 (95% CI -22.5 to -15.7), p <0.001, Miettinen & Nurminen
Heterosexual and MSM Males vs Females: Risk Difference (RD): -17.3 (95% CI -20.8 to -13.7), p <0.001, Miettinen & Nurminen

Population analysed: The analysis set includes all participants who received \>=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes.

Primary outcome: Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F)

Time frame: Up to 5 days after any vaccination. Number. Unit: Percentage of Participants

Measure	Heterosexual and MSM Males n = 1386	Females n = 1066
Value	4.4	5.9

Heterosexual and MSM Males vs Females: Risk Difference (RD): -1.5 (95% CI -3.4 to 0.2), p = 0.091, Miettinen & Nurminen

Population analysed: The analysis set includes all participants who received \>=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes.

Primary outcome: Percentage of Participants With an Adverse Event

Time frame: Up to Month 12. Number. Unit: Percentage of Participants

Measure	Heterosexual and MSM Males n = 1394	Females n = 1075
Value	76.2	89.4

Population analysed: The analysis set includes all participants who received \>=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to Month 12. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Heterosexual and MSM Males	23 of 1,394 (1.6%)	976 of 1,394 (70%)	Not reported
Females	26 of 1,075 (2.4%)	924 of 1,075 (86%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26144901Castellsague X, Giuliano AR, Goldstone S, Guevara A, Mogensen O, Palefsky JM, Group T, Shields C, Liu K, Maansson R, Luxembourg A, Kaplan SS. Immunogenicity and safety of the 9-valent HPV vaccine in men. Vaccine. 2015 Nov 27;33(48):6892-901. doi: 10.1016/j.vaccine.2015.06.088. Epub 2015 Jul 2.
Derived from this study: PubMed 27422279Moreira ED Jr, Block SL, Ferris D, Giuliano AR, Iversen OE, Joura EA, Kosalaraksa P, Schilling A, Van Damme P, Bornstein J, Bosch FX, Pils S, Cuzick J, Garland SM, Huh W, Kjaer SK, Qi H, Hyatt D, Martin J, Moeller E, Ritter M, Baudin M, Luxembourg A. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Pediatrics. 2016 Aug;138(2):e20154387. doi: 10.1542/peds.2015-4387. Epub 2016 Jul 15.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 9vHPV Vaccine in people with Genital Warts and Anal Cancer, run by Merck Sharp & Dohme LLC.

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 3 inclusion and 8 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 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 9 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine (time frame: Four weeks post vaccination 3 (Month 7)). The study lists 5 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 NCT01651949, which also lists 2 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 27 Nov 2018; AzTrials last refreshed its copy on 6 Nov 2026.