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

NCT01862874 | Completed Phase 3 Results DMC

• 3 other identifiers: V501-1221322372015-002931-16
• Study Type: interventional
• Target: 1,124
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  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

  Up to Month 36

Study Arms (2)

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.

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.

Biological: Placebo

Interventions

V501 BIOLOGICAL

Formulated with aluminum hydroxyphosphate sulfate (AAHS) adjuvant

Also known as: GARDASIL™, Quadrivalent HPV (Type 6, 11, 16 and 18) L1 Virus-Like Particle vaccine

V501

Placebo BIOLOGICAL

Formulated with AAHS adjuvant

Placebo

Eligibility Criteria

• Age: 16 Years - 26 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Japanese
• No clinical evidence of gross genital lesion suggesting sexually-transmitted disease and no clinically present external genital warts

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 30797638 RESULT

MeSH Terms

Interventions

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: May 27, 2013
• Study Start: June 27, 2013
• Primary Completion: August 30, 2017
• Study Completion: August 30, 2017
• Last Updated: April 2, 2019
• Results First Posted: August 31, 2018

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share