NCT01862874

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

Completed Phase 3 Results posted Last updated 2 April 2019

What this trial tests

Phase 3 trial testing V501 in Anogenital Human Papilloma Virus Infection in 1,124 participants. Completed in 30 August 2017.

Timeline

27 June 2013

Primary endpoint
30 August 2017

30 August 2017

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	1,124
Start date	27 June 2013
Primary completion	30 August 2017
Estimated completion	30 August 2017

Drugs / interventions tested

• V501 — full drug profile →
• Placebo

Conditions studied

• Anogenital Human Papilloma Virus Infection — all drugs for Anogenital Human Papilloma Virus Infection →
• Condyloma Acuminata — all drugs for Condyloma Acuminata →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 16 to 26, male only, with Anogenital Human Papilloma Virus Infection or Condyloma Acuminata. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
V501	0.3
Placebo	1.9

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

Group	Value	95% CI
V501	2.7
Placebo	3.9

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

Injection-site erythema

Group	Value	95% CI
V501	24.5
Placebo	21.6

Injection-site pain

Group	Value	95% CI
V501	54.9
Placebo	48.5

Injection-site swelling

Group	Value	95% CI
V501	21.3
Placebo	14.5

Percentage of Participants With a Systemic Adverse Event Primary · 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 su

Group	Value	95% CI
V501	14.4
Placebo	15.4

Percentage of Participants With a Vaccine-related Systemic Adverse Event Primary · 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,

Group	Value	95% CI
V501	3.4
Placebo	5.0

Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection or Disease Secondary · 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 incidence of persistent infection detected in samples from ≥2 consecutive visits ≥6 months apart was assessed. Dis

Group	Value	95% CI
V501	0.3
Placebo	1.9

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 36 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

V501

Serious: 0/554 (0%)

Deaths: 0/554

Placebo

Serious: 1/559 (0%)

Deaths: 1/559

Serious adverse events (1 terms)

Reaction	System	V501	Placebo
Completed suicide	Psychiatric disorders	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	V501	Placebo
Injection-site pain	General disorders	—	—
Injection-site erythema	General disorders	—	—
Injection-site swelling	General disorders	—	—

Most-reported serious reactions: Completed suicide.

Data from ClinicalTrials.gov NCT01862874 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Comparison of different human papillomavirus (HPV) vaccine types and dose schedules for prevention of HPV-related disease in females and males.
   Bergman H, Buckley BS, Villanueva G, Petkovic J, et al · · 2019 · cited 90× · PMID 31755549 · DOI 10.1002/14651858.cd013479
2. Efficacy, safety, and immunogenicity of a quadrivalent HPV vaccine in Japanese men: A randomized, Phase 3, placebo-controlled study.
   Mikamo H, Yamagishi Y, Murata S, Yokokawa R, et al · · 2019 · cited 40× · PMID 30797638 · DOI 10.1016/j.vaccine.2019.01.069
3. Targeting lymph node delivery with nanovaccines for cancer immunotherapy: recent advances and future directions.
   Li Y, Li S, Jiang Z, Tan K, et al · · 2023 · cited 21× · PMID 37415161 · DOI 10.1186/s12951-023-01977-1
4. Comparative Effects of Bivalent, Quadrivalent, and Nonavalent Human Papillomavirus Vaccines in The Prevention of Genotype-Specific Infection: A Systematic Review and Network Meta-Analysis.
   Kim J, Choe YJ, Park J, Cho J, et al · · 2024 · cited 8× · PMID 38014729 · DOI 10.3947/ic.2023.0064