Anogenital Human Papilloma Virus InfectionPhase 3NCT01862874

Efficacy and Tolerability Study of V501 in Japanese Males (V501-122)

A Phase 3 study testing V501 in people with Anogenital Human Papilloma Virus Infection and Condyloma Acuminata, 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

Search all trials

Trial summary

Who is it for?: Ages 16 to 26 years, men onlyHealthy volunteers can take part
Conditions the study is for: Anogenital Human Papilloma Virus Infection, Condyloma Acuminata
What is being tested?: V501
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,124 participants
Where: No sites listed yet
Study dates: 27 Jun 2013to 30 Aug 2017
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
Men only
Healthy volunteers accepted
Child, Adult

Who may be able to join

Japanese
No clinical evidence of gross genital lesion suggesting sexually-transmitted disease and no clinically present external genital warts
Other inclusion criteria will be discussed with the investigator during screening

Who cannot join

History of known prior vaccination with an HPV vaccine or plans to receive one outside the study
History of external genital warts
History of severe allergic reaction that required medical intervention
Received immune globulin or blood-derived products in the past 6 months or plan to receive any before Month 7 of the study
History of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, Human Immunodeficiency Virus (HIV), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition
Received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids
Known thrombocytopenia or coagulation disorder that would contraindicate intramuscular injections
Ongoing alcohol or drug abuse within the past 12 months

About this study

Official title: A Phase III Placebo-controlled Clinical Trial to Study the Tolerability, Immunogenicity and Efficacy of V501 in 16- to 26-year-old Japanese Men

A study to evaluate the efficacy and tolerability of V501 (quadrivalent Human Papilloma Virus [HPV] [Type 6, 11, 16 and 18] L1 Virus-Like Particle vaccine, GARDASIL™) in healthy, 16- to 26-year old Japanese males. The hypotheses tested are: 1) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection compared with placebo, and 2) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection, condyloma acuminata, penile/perianal/perineal intraepithelial neoplasia, or penile, perianal, or perineal cancer compared with placebo.

Conditions: Anogenital Human Papilloma Virus Infection, Condyloma Acuminata
Being tested: V501, Placebo

What participants receive

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

V501Biological
Also called GARDASIL™, Quadrivalent HPV (Type 6, 11, 16 and 18) L1 Virus-Like Particle vaccine
Formulated with aluminum hydroxyphosphate sulfate (AAHS) adjuvant
PlaceboBiological
Formulated with AAHS adjuvant

Study groups in NCT01862874
Study group	Role	What they receive
V501	Experimental	Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36. Receives: Biological: V501
Placebo	Placebo comparator	Participants received placebo 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36. Receives: Biological: Placebo

What is being measured

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

Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection
Persistent infection was defined as 1) polymerase chain reaction (PCR) positive to HPV Type 6, 11, 16, or 18 in 2 consecutive anogenital or biopsy samples collected ≥4 months apart, or 2) Pathology Panel consensus diagnosis of condyloma acuminate, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal, or perineal cancer and PCR detection of HPV Type 6, 11, 16, or 18 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit. The combined incidence of HPV Type 6, 11, 16, or 18 persistent infection detected in samples from ≥2 consecutive visits ≥6 months apart was assessed.
Measured: Up to Month 36
Percentage of Participants With Maximum Temperature ≥37.5°C Reported on the Vaccination Report Card
Body temperature (oral or oral equivalent) was recorded on the Vaccination Report Card (VRC). The percentage of participants with a maximum temperature ≥37.5°C was summarized.
Measured: Up to 5 days after any vaccination
Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, and swelling) was summarized.
Measured: Up to 5 days after any vaccination
Percentage of Participants With a Systemic Adverse Event
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The percentage of participants with a systemic AE was summarized.
Measured: Up to 15 days after any vaccination
Percentage of Participants With a Vaccine-related Systemic Adverse Event
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. Vaccine-related AEs are those that were deemed possibly, probably, or definitely related to vaccine administration by the investigator. The percentage of participants with a vaccine-related systemic AE was summarized.
Measured: Up to 15 days after any vaccination

Secondary outcomes (1)

Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection or Disease
Persistent infection was defined as 1) polymerase chain reaction (PCR) positive to HPV Type 6, 11, 16, or 18 in 2 consecutive anogenital or biopsy samples collected ≥4 months apart, or 2) Pathology Panel consensus diagnosis of condyloma acuminate, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal, or perineal cancer and PCR detection of HPV Type 6, 11, 16, or 18 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit. The incidence of persistent infection detected in samples from ≥2 consecutive visits ≥6 months apart was assessed. Disease was defined as HPV Type 6, 11, 16, or 18-related condyloma acuminate, PIN, penile, perianal, or perineal cancer. The combined incidence of HPV Type 6, 11, 16, or 18 persistent infection or disease was assessed.
Measured: Up to Month 36

Timeline

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

27 Jun 201330 Aug 2017

First posted27 May 2013 (estimated)
Study start27 Jun 2013
Primary completion30 Aug 2017
Study completion30 Aug 2017

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 (1)Papers the sponsor has linked to this study.
Other trials for Anogenital Human Papilloma Virus InfectionStudies 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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 1,124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01862874
Sponsor's protocol ID: V501-122
Other IDs: 132237, 2015-002931-16, V501-122, 2015
Status last verified: Mar 2019
First submitted: 22 May 2013
Last updated: 2 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Mikamo H, Yamagishi Y, Murata S, Yokokawa R, Han SR, Wakana A, Sawata M, Tanaka Y. Efficacy, safety, and immunogenicity of a quadrivalent HPV vaccine in Japanese men: A randomized, Phase 3, placebo-controlled study. Vaccine. 2019 Mar 14;37(12):1651-1658. doi: 10.1016/j.vaccine.2019.01.069. Epub 2019 Feb 20.
PubMed 30797638

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

Recruiting
Comparative Self-collection for Cervical Cancer Screening Pivotal Study
HPV, HPV - Anogenital Human Papilloma Virus Infection
Not yet recruiting
The Effect of the Health Belief Model-Based Education Given to Mothers of Children Aged 9-15 on HPV Knowledge Level and Child Vaccination
Cancer , Healthy, HPV - Anogenital Human Papilloma Virus Infection
Not yet recruiting
Effect of a Dietary Supplement Containing EGCG, Folic Acid, Vitamin B12 and Hyaluronic Acid in Supporting Male Genital Balance in Subjects Exposed to HPV Risk
HPV - Anogenital Human Papilloma Virus Infection, Infertilities
Active, not recruitingPhase 1
A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors
Head and Neck Cancer, Cervical Cancer
Not yet recruitingPhase 2
Comparison Between Efficacy of Topical 25%Podophyllin and Cryotherapy on Genital Warts
Anogenital Human Papilloma Virus Infection

All Anogenital Human Papilloma Virus Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Placebo-controlled Clinical Trial to Study the Tolerability, Immunogenicity and Efficacy of V501 in 16- to 26-year-old Japanese Men
ClinicalTrials.gov ID: NCT01862874
Acronym / sponsor ID: V501-122
Conditions: Anogenital Human Papilloma Virus Infection, Condyloma Acuminata
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,124 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 27 Jun 2013 (actual)
Primary completion: 30 Aug 2017 (actual)
Study completion: 30 Aug 2017 (actual)
First posted: 27 May 2013 (estimated)
Results: Posted 31 Aug 2018

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
V501	Experimental	Biological: V501Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36.
Placebo	Placebo comparator	Biological: PlaceboParticipants received placebo 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36.

Who may qualify

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

Key inclusion criteria (3 listed)

Japanese
No clinical evidence of gross genital lesion suggesting sexually-transmitted disease and no clinically present external genital warts
Other inclusion criteria will be discussed with the investigator during screening

Key exclusion criteria (8 listed)

History of known prior vaccination with an HPV vaccine or plans to receive one outside the study
History of external genital warts
History of severe allergic reaction that required medical intervention
Received immune globulin or blood-derived products in the past 6 months or plan to receive any before Month 7 of the study
History of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, Human Immunodeficiency Virus (HIV), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition

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
V501Also: GARDASIL™, Quadrivalent HPV (Type 6, 11, 16 and 18) L1 Virus-Like Particle vaccineFormulated with aluminum hydroxyphosphate sulfate (AAHS) adjuvant	Biological	V501
PlaceboFormulated with AAHS adjuvant	Biological	Placebo

Primary outcome

Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection
Time frame: Up to Month 36
Persistent infection was defined as 1) polymerase chain reaction (PCR) positive to HPV Type 6, 11, 16, or 18 in 2 consecutive anogenital or biopsy samples collected ≥4 months apart, or 2) Pathology Panel consensus diagnosis of condyloma acuminate, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal, or perineal cancer and PCR detection of HPV Type 6, 11, 16, or 18 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit. The combined incidence of HPV Type 6, 11, 16, or 18 persistent infection detected in samples from ≥2 consecutive visits ≥6 months apart was assessed.
Percentage of Participants With Maximum Temperature ≥37.5°C Reported on the Vaccination Report Card
Time frame: Up to 5 days after any vaccination
Body temperature (oral or oral equivalent) was recorded on the Vaccination Report Card (VRC). The percentage of participants with a maximum temperature ≥37.5°C was summarized.
Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card
Time frame: Up to 5 days after any vaccination
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, and swelling) was summarized.
Percentage of Participants With a Systemic Adverse Event
Time frame: Up to 15 days after any vaccination
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The percentage of participants with a systemic AE was summarized.
Percentage of Participants With a Vaccine-related Systemic Adverse Event
Time frame: Up to 15 days after any vaccination
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. Vaccine-related AEs are those that were deemed possibly, probably, or definitely related to vaccine administration by the investigator. The percentage of participants with a vaccine-related systemic AE was summarized.

1 secondary outcome

Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection or Disease
Time frame: Up to Month 36

Results and safety

Results posted to the registry on 31 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
V501	562	483
Placebo	562	485

Primary outcome: Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection

Time frame: Up to Month 36. Number. Unit: Cases per 100 person-years of follow-up

Measure	V501 n = 497	Placebo n = 498
Value	0.3	1.9

V501 vs Placebo: Vaccine Efficacy: 85.9 (95% CI 52.7 to 97.3), p <0.001, One-sided exact test

Population analysed: Participants who were seronegative at Day 1 and PCR negative from Day 1 through Month 7 to the relevant HPV type, received all 3 vaccinations, did not deviate from the study protocol in ways that might interfere with vaccine efficacy, and had ≥1 follow-up visit after Month 7.

Primary outcome: Percentage of Participants With Maximum Temperature ≥37.5°C Reported on the Vaccination Report Card

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

Measure	V501 n = 551	Placebo n = 557
Value	2.7	3.9

V501 vs Placebo: Risk Difference (RD): -1.2 (95% CI -3.5 to 0.9), p = 0.256, Miettinen & Nurminen

Population analysed: Participants who received ≥1 study vaccination and had follow-up data available.

Primary outcome: Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card

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

Measure	V501 n = 554	Placebo n = 559
Injection-site erythema	24.5	21.6
Injection-site pain	54.9	48.5
Injection-site swelling	21.3	14.5

V501 vs Placebo: Risk Difference (RD): 2.9 (95% CI -2.1 to 7.9), p = 0.251, Miettinen & Nurminen
V501 vs Placebo: Risk Difference (RD): 6.4 (95% CI 0.5 to 12.2), p = 0.033, Miettinen & Nurminen
V501 vs Placebo: Risk Difference (RD): 6.8 (95% CI 2.3 to 11.3), p = 0.003, Miettinen & Nurminen

Population analysed: Participants who received ≥1 study vaccination and had follow-up data available.

Primary outcome: Percentage of Participants With a Systemic Adverse Event

Time frame: Up to 15 days after any vaccination. Number. Unit: Percentage of participants

Measure	V501 n = 554	Placebo n = 559
Value	14.4	15.4

V501 vs Placebo: Risk Difference (RD): -0.9 (95% CI -5.2 to 3.3)

Population analysed: Participants who received ≥1 study vaccination and had follow-up data available.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 36 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
V501	0 of 554 (0%)	329 of 554 (59.4%)	0 of 554
Placebo	1 of 559 (0.2%)	303 of 559 (54.2%)	1 of 559

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 30797638Mikamo H, Yamagishi Y, Murata S, Yokokawa R, Han SR, Wakana A, Sawata M, Tanaka Y. Efficacy, safety, and immunogenicity of a quadrivalent HPV vaccine in Japanese men: A randomized, Phase 3, placebo-controlled study. Vaccine. 2019 Mar 14;37(12):1651-1658. doi: 10.1016/j.vaccine.2019.01.069. Epub 2019 Feb 20.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Related trials for Anogenital Human Papilloma Virus Infection

Recruiting
Comparative Self-collection for Cervical Cancer Screening Pivotal Study
HPV, HPV - Anogenital Human Papilloma Virus Infection
Not yet recruiting
The Effect of the Health Belief Model-Based Education Given to Mothers of Children Aged 9-15 on HPV Knowledge Level and Child Vaccination
Cancer , Healthy, HPV - Anogenital Human Papilloma Virus Infection
Not yet recruiting
Effect of a Dietary Supplement Containing EGCG, Folic Acid, Vitamin B12 and Hyaluronic Acid in Supporting Male Genital Balance in Subjects Exposed to HPV Risk
HPV - Anogenital Human Papilloma Virus Infection, Infertilities
Active, not recruitingPhase 1
A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors
Head and Neck Cancer, Cervical Cancer
Not yet recruitingPhase 2
Comparison Between Efficacy of Topical 25%Podophyllin and Cryotherapy on Genital Warts
Anogenital Human Papilloma Virus Infection

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 V501 in people with Anogenital Human Papilloma Virus Infection and Condyloma Acuminata, 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 2 Apr 2019. 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. Some participants in this study may receive a placebo. 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 31 Aug 2018). 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?

Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection (time frame: Up to Month 36). 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 NCT01862874, which also lists 1 linked publication.

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 2 Apr 2019.