ClinicalTrials.gov

History of Changes for Study: NCT04199689
Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)
Latest version (submitted August 17, 2022) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 December 12, 2019 None (earliest Version on record)
2 January 9, 2020 Study Status, Contacts/Locations and Oversight
3 January 19, 2020 Study Status
4 February 18, 2020 Study Status
5 March 9, 2020 Recruitment Status, Study Status and Contacts/Locations
6 March 24, 2020 Study Status
7 March 31, 2020 Contacts/Locations, Eligibility and Study Status
8 April 3, 2020 Study Status
9 April 9, 2020 Contacts/Locations and Study Status
10 April 17, 2020 Contacts/Locations and Study Status
11 April 29, 2020 Contacts/Locations and Study Status
12 May 5, 2020 Study Status and Contacts/Locations
13 May 15, 2020 Contacts/Locations and Study Status
14 May 22, 2020 Contacts/Locations and Study Status
15 June 12, 2020 Study Status and Contacts/Locations
16 June 19, 2020 Contacts/Locations and Study Status
17 June 29, 2020 Contacts/Locations and Study Status
18 July 2, 2020 Study Status, Contacts/Locations and Study Identification
19 July 10, 2020 Contacts/Locations and Study Status
20 July 17, 2020 Contacts/Locations and Study Status
21 July 24, 2020 Contacts/Locations and Study Status
22 July 31, 2020 Contacts/Locations and Study Status
23 August 7, 2020 Study Status and Contacts/Locations
24 August 13, 2020 Contacts/Locations and Study Status
25 August 21, 2020 Contacts/Locations and Study Status
26 August 28, 2020 Contacts/Locations and Study Status
27 September 4, 2020 Contacts/Locations and Study Status
28 September 11, 2020 Contacts/Locations and Study Status
29 September 18, 2020 Contacts/Locations and Study Status
30 October 8, 2020 Study Status and Contacts/Locations
31 October 16, 2020 Contacts/Locations and Study Status
32 October 21, 2020 Contacts/Locations and Study Status
33 November 5, 2020 Study Status and Contacts/Locations
34 November 11, 2020 Contacts/Locations and Study Status
35 November 20, 2020 Contacts/Locations and Study Status
36 November 25, 2020 Contacts/Locations and Study Status
37 December 4, 2020 Contacts/Locations and Study Status
38 December 8, 2020 Contacts/Locations and Study Status
39 December 18, 2020 Contacts/Locations and Study Status
40 December 24, 2020 Contacts/Locations and Study Status
41 December 31, 2020 Contacts/Locations and Study Status
42 January 7, 2021 Study Status and Contacts/Locations
43 January 13, 2021 Contacts/Locations and Study Status
44 January 20, 2021 Contacts/Locations and Study Status
45 January 22, 2021 Study Status
46 January 29, 2021 Contacts/Locations and Study Status
47 February 4, 2021 Contacts/Locations and Study Status
48 February 11, 2021 Contacts/Locations and Study Status
49 February 19, 2021 Recruitment Status, Contacts/Locations and Study Status
50 August 17, 2022 Study Status
Comparison Format:

Scroll up to access the controls

Study NCT04199689
Submitted Date:  December 12, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: V503-049
Brief Title: Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)
Official 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
Secondary IDs: 2019-003236-23 [EudraCT Number]
V503-049 [Merck]
Open or close this module Study Status
Record Verification: December 2019
Overall Status: Not yet recruiting
Study Start: February 25, 2020
Primary Completion: December 20, 2025 [Anticipated]
Study Completion: December 20, 2025 [Anticipated]
First Submitted: December 12, 2019
First Submitted that
Met QC Criteria:
December 12, 2019
First Posted: December 16, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
December 12, 2019
Last Update Posted: December 16, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Merck Sharp & Dohme LLC
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief 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.
Detailed Description:
Open or close this module Conditions
Conditions: Papillomavirus Infections
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 6000 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: 9vHPV vaccine
Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6
Biological: 9vHPV Vaccine
9-valent human papillomavirus vaccine (9vHPV) is an aluminum-adjuvanted recombinant protein vaccine prepared from the highly purified virus-like particles (VLPs) of the recombinant major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 given as a 0.5 mL intramuscular injection.
Other Names:
  • GARDASIL®9
  • V503
Placebo Comparator: Placebo
Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6
Placebo (Saline for Injection)
0.9% sodium chloride given as a 0.5-mL intramuscular injection
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Incidence of Human Papillomavirus (HPV)16/18/31/33/45/52/58-related 6-month Persistent Oral Infection
[ Time Frame: Up to Month 42 ]

A 6-month persistent infection is defined to have occurred if a participant, after completion of the Month 7 visit, is positive for the same human papillomavirus (HPV) type by the HPV polymerase chain reaction (PCR) assay to at least 1 common gene in Oral Rinse and Gargle (ORG) samples obtained at 2 or more consecutive visits at 6 months (+/-1 month visit window) apart.
Secondary Outcome Measures:
1. Incidence of Human Papillomavirus (HPV) 6/11-related 6-month Persistent Oral Infection
[ Time Frame: Up to Month 42 ]

A 6-month persistent infection is defined to have occurred if a participant, after completion of the Month 7 visit, is positive for the same human papillomavirus (HPV) type by the HPV polymerase chain reaction (PCR) assay to at least 1 common gene in Oral Rinse and Gargle (ORG) samples obtained at 2 or more consecutive visits at 6 months (+/-1 month visit window) apart.
2. Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 Antibodies
[ Time Frame: 1 month postdose 3 (Month 7) ]

Serum antibodies to HPV types are measured with competitive Luminex immunoassay (cLIA). Geometric mean titers of antibodies to HPV types will be calculated by exponentiating the mean estimates of natural logarithm of the anti-HPV titers.
3. Percentage of Participants who Seroconvert to Human Papillomavirus (HPV) Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
[ Time Frame: 1 month postdose 3 (Month 7) ]

Seroconversion is defined as changing a participant's serostatus from seronegative at Day 1 to seropositive by 4 weeks postdose 3. A participant with anti-HPV competitive Luminex immunoassay (cLIA) titer at or above the serostatus cutoff of the cLIA for a given HPV type is considered seropositive for that HPV type.
4. Percentage of Participants with at Least 1 Solicited Injection-site Adverse Event (AE)
[ Time Frame: 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 the study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Solicited injection-site AEs such as redness/erythema, swelling, and tenderness/pain at the injection site will be recorded.
5. Percentage of Participants with Elevated Temperature (Fever)
[ Time Frame: Up to 5 days after any vaccination ]

Participants are asked to record oral body temperatures. The percentage of participants with elevated temperature (≥37.8°C or 100.0°F) will be assessed.
6. Percentage of Participants Who Report at Least 1 Systemic Adverse Event
[ Time Frame: Up to 15 days after any vaccination ]

An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Systemic AEs are those not categorized as injection-site AEs.
7. Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)
[ Time Frame: Up to 15 days after any vaccination ]

A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is another important medical event deemed such by medical or scientific judgment.
8. Percentage of Participants who Experience at Least 1 Serious Vaccine-Related Adverse Event
[ Time Frame: Up to Month 42 ]

A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is another important medical event deemed such by medical or scientific judgment. An SAE that is considered by an investigator (a qualified physician) to be vaccine-related will be reported during entire study period.
Open or close this module Eligibility
Minimum Age: 20 Years
Maximum Age: 45 Years
Sex: Male
Gender Based: Yes
Healthy male participants between the ages of 20 and 45 years (inclusive)
Accepts Healthy Volunteers: Yes
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 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 ≥100.0°F or ≥37.8°C)
  • 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-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
Open or close this module Contacts/Locations
Study Officials: Medical Director
Study Director
Merck Sharp & Dohme LLC
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Yes
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Supporting Information:
Time Frame:
Access Criteria:
URL: http://engagezone.msd.com/ds_documentation.php
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services