Efficacy, immunogenicity, and safety of the 9vHPV vaccine in adult males 20 to 45 years of age
- Conditions
- Oral persistent infection caused by any of the human papillomavirus types 16, 18, 31, 33, 45, 52, and 58MedDRA version: 20.0Level: LLTClassification code 10006524Term: Buccal cavity papillomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2019-003236-23-IT
- Lead Sponsor
- MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 6000
1. Is healthy and is judged to be in good physical health based on medical history and physical examination
2. Is male, from 20 years to 45 years of age inclusive, at the time of signing the informed consent
3. Provides 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.
4. 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
5. Can read, understand, and complete the eVRC
6. Has had at least 1 lifetime sexual partner
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6000
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Has a history of HPV-related anal lesion (anal intraepithelial neoplasia or anal cancer) or HPV-related head and neck cancer
2.Has a history of or clinical evidence at the Day 1 external genital examination of HPV-related external lesion (condyloma acuminata, penile intraepithelial neoplasia or penile cancer)
3.Has clinical evidence at the Day 1 external genital examination of gross genital lesion suggesting sexually transmitted disease
4.Has a fever (defined as oral temperature >=100.0°F or >=37.8°C) within the 24-hour period prior to the Day 1 visit*
5.Has a history of severe allergic reaction (eg, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention
6.Is allergic to any vaccine component, including aluminum, yeast, or BENZONASE™ (nuclease, Nycomed [used to remove residual nucleic acids from this and other vaccines]). For this exclusion criterion, an allergy to vaccine components is defined as an allergic reaction that met
the criteria for severe AEs or SAEs
7.Has known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections
8.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
9.Has a history of splenectomy
10.Has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the
participant to participate by judgement of investigator
11.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
12.Has received within 12 months prior to enrollment, is receiving, or plans to receive during Day 1 through Month 7 of the study, the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (AravaTM), TNF-a antagonists, monoclonal antibody therapies (including rituximab [Rituxan™]), IVIG, antilymphocyte sera, or other therapy known to interfere with the be excluded if he is currently receiving steroid therapy, has recently (defined as within 2 weeks of Day 1 vaccination) 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 to Day 1 vaccination. Participants using inhaled, nasal, or topical steroids are considered eligible for the study.
....
17.Has engaged in sexual activity 48 hours prior to Day 1 (this may result in the detection of viral DNA that has been deposited in the oral cavity and is not the result of ongoing infection) *
Sexual activity is defined as:
•Penile penetrative vaginal intercourse with female partner
•Penile penetrative or receptive anal intercourse with male or female partner
•Oral sex involving any contact between participant's mouth with a female partner's vagina, g
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method