Efficacy Against Oral Persistent Infection Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)

  • STATUS
    Recruiting
  • End date
    Jul 15, 2024
  • participants needed
    6000
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 27 November 2020
Investigator
Toll Free Number
Primary Contact
Diablo Clinical Research, Inc ( Site 0042) (4.7 mi away) Contact
+105 other location
dose regimen
vaccination
human papillomavirus
hpv vaccine
v503
persistent infection

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.

Details
Treatment 9vHPV Vaccine, Placebo (Saline for Injection)
Clinical Study IdentifierNCT04199689
SponsorMerck Sharp & Dohme Corp.
Last Modified on27 November 2020

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Eligibility

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Inclusion Criteria

Is your age between 20 yrs and 45 yrs?
Are you male?
Do you have Papillomavirus Infections?
Do you have any of these conditions: Papillomavirus Infections or HPV Infection or Human Papillomavirus Infection?
Do you have any of these conditions: Human Papillomavirus Infection or Papillomavirus Infections or HPV Infection?
Do you have any of these conditions: Papillomavirus Infections or Human Papillomavirus Infection or HPV Infection?
Do you have any of these conditions: Human Papillomavirus Infection or HPV Infection or Papillomavirus Infections?
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 lifetime sexual partner

Exclusion Criteria

Has a history of human papillomavirus (HPV)-related anal lesion (anal intraepithelial neoplasia or anal cancer) or HPV related head and neck cancer
Has a history of or clinical evidence at the Day 1 external genital examination of HPV-related external lesion
Has clinical evidence at the Day 1 external genital examination of gross genital lesion suggesting sexually transmitted disease
Has a fever (defined as oral temperature 100.0F or 37.8C)
Has a history of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention
Is allergic to any vaccine component, including aluminum, yeast, or BENZONASE
Has known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections
Is 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
Has a 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- 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, genital or anal area or male partner's penis or genital or anal area. This also includes any contact between participant's partner's mouth with participant's penis, genital or anal 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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