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Clinical Trial 20362

Cancer Type: Healthy Subjects
Study Type: Prevention
NCT#: NCT04199689

Phase: Phase III
Prinicipal Investigator:

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Overview

Study Title

A Phase 3, International, Multi-center, Randomized, Double-blind, Placebo- controlled Clinical Trial to Study the Efficacy, Immunogenicity, and Safety of the 9vHPV Vaccine, a Multivalent L1 Virus-like Particle Vaccine, in the Prevention of Oral Persistent Infection with HPV Types 16, 18, 31, 33, 45, 52, or 58 in Adult Males, 20 to 45 Years of Age

Summary

The purpose of this study is to evaluate the efficacy, immunogenicity and safety of the 9-valent human papillomavirus (9vHPV) vaccine in men 20 to 45 years of age. The primary hypothesis tested in this study is that administration of a 3-dose regimen of 9vHPV vaccine will reduce the incidence of HPV 16/18/31/33/45/52/58-related oral persistent infection (6 months or longer) compared with placebo.

Objective

Primary - Objective: To demonstrate that a 3-dose regimen of the 9vHPV vaccine will reduce the incidence of HPV 16/18/31/33/45/52/58-related oral persistent infection 6 months (± 1-month window) or longer compared with placebo in males 20 to 45 years of age Secondary - Objective: To demonstrate that a 3-dose regimen of the 9vHPV vaccine will reduce the incidence of HPV 6/11-related oral persistent infection 6 months (± 1-month window) or longer compared with placebo in males 20 to 45 years of age - Objective: To summarize antibody responses (GMT and seroconversion percentages) to each of HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7 - Objective: To evaluate the safety and tolerability of the 9vHPV vaccine when administered to males 20 to 45 years of age Tertiary/Exploratory - Objective: To assess the persistence of anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 antibody responses at Months 12, 24, 36, and 42 - Objective: To summarize the efficacy of the 9vHPV vaccine against HPV 6/11/16/18/31/33/45/52/58-related oral persistent infection 6 months (± 1-month window) or longer compared with placebo in males 20 to 45 years of age - Objective: To summarize the efficacy of 9vHPV vaccine to reduce the incidence of HPV 6/11/16/18/31/33/45/52/58-related oral persistent infection 12 months or longer compared with placebo in males 20 to 45 years of age - Objective: To summarize the efficacy of the 9vHPV vaccine against HPV 6/11/16/18/31/33/45/52/58-related oral persistent infection 6 months (± 1-month window) or longer compared with placebo in males 20 to 45 years of age who at baseline have genital HPV infection and no oral HPV infection

Treatments

Therapies

Medications

9vHPV Vaccine/Placebo ()

Inclusion Criteria

Inclusion Criteria:

  • Has provided written informed consent for the study. The participant may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research.
  • Agrees to provide study personnel with a primary telephone number as well as an alternate means of contact, if available (such as an alternate telephone number or email) for follow-up purposes
  • Can read, understand, and complete the electronic vaccination report card (eVRC)
  • Has had at least 1 sexual partner

  • Exclusion Criteria

    Exclusion Criteria:

  • History of human papillomavirus (HPV)-related anal lesion (anal intraepithelial neoplasia or anal cancer) or HPV related head and neck cancer
  • History of or clinical evidence at the Day 1 external genital examination of HPV-related external lesion
  • Clinical evidence at the Day 1 external genital examination of gross genital lesion suggesting sexually transmitted disease
  • Fever (defined as oral temperature ≥100.0°F or ≥37.8°C)
  • History of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention
  • Allergic to any vaccine component, including aluminum, yeast, or BENZONASE®
  • Known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections
  • Currently immunocompromised or has been diagnosed as having congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition
  • History of splenectomy
  • Is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence at the discretion of the investigator. Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems because of alcohol use.
  • Has received within 12 months prior to enrollment, is receiving, or plans to receive during the study, the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (ARAVA®), TNF-α antagonists, monoclonal antibody therapies (including rituximab [RITUXAN®]), intravenous immunoglobulin (IVIG), anti-lymphocyte sera, or other therapy known to interfere with the immune response. Regarding systemic corticosteroids, a participant will be excluded if he is currently receiving steroid therapy, has recently received such therapy, or has received 2 or more courses of high-dose corticosteroids (≥20 mg/day of prednisone [or equivalent] orally or parenterally) lasting at least 1 week in duration in the year prior. Participants using inhaled, nasal, or topical steroids are considered eligible for the study.
  • Has received within the 3 months prior to vaccination, is receiving, or plans to receive during the study, any immune globulin product (including RhoGAM™) or blood-derived product other than IVIG
  • Has received inactivated or recombinant vaccines within 14 days prior to vaccination or receipt of live vaccines within 21 days prior to vaccination
  • Is concurrently enrolled in other clinical studies of investigational agents
  • Has previously received a marketed HPV vaccine, or has participated in a clinical trial for any HPV vaccine (receiving either active agent or placebo)
  • Has engaged in sexual activity 48 hours prior to vaccination. Sexual activity is defined as: penile penetrative vaginal intercourse with female partner; penile penetrative or receptive anal intercourse with male or female partner; or oral sex involving any contact between participant's mouth with a female partner's vagina or genital area or male partner's penis or genital area.
  • Is unlikely to adhere to the study procedures, keep appointments, or is planning to permanently relocate from the area prior to the completion of the study or to leave for an extended period when study visits would need to be scheduled
  • Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study

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