Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-02-20 @ 10:46 PM
Study NCT ID:
NCT06688058
Status:
RECRUITING
Last Update Posted:
2025-10-06
First Post:
2024-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Evaluate Tolerability and Immunogenicity of V540D in Healthy Adults (V540D-004)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C110128', 'term': 'Neu1 protein, mouse'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-02', 'studyFirstSubmitDate': '2024-11-12', 'studyFirstSubmitQcDate': '2024-11-12', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experience a Solicited Injection-Site Adverse Event (AE)', 'timeFrame': 'Up to approximately 6 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.'}, {'measure': 'Number of Participants Who Experience a Solicited Systemic AE', 'timeFrame': 'Up to approximately 6 months', 'description': 'Solicited systemic AEs include headache, fatigue, nausea, dizziness, muscle aches, joint pain.'}, {'measure': 'Number of Participants Who Experience Immediate Reactions Occurring Within 30 Minutes After Any Vaccination', 'timeFrame': 'Up to approximately 6 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.'}, {'measure': 'Number of Participants Who Experience Unsolicited AEs', 'timeFrame': 'Up to approximately 7 months', 'description': 'An unsolicited AE is an event that is not predefined as a solicited AE or is predefined as a solicited AE but reported at any time outside the solicited time period.'}, {'measure': 'Number of Participants Who Experience a Serious Adverse Event (SAE)', 'timeFrame': 'Up to approximately 18 months', 'description': 'SAEs include AEs that result in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect.'}, {'measure': 'Number of Participants Who Experience a Medically-Attended AE (MAAE)', 'timeFrame': 'Up to approximately 18 months', 'description': 'AEs in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Routine visits are not considered MAAEs. Examples of routine visits include physical examination, wellness visits, or vaccinations.'}, {'measure': 'Number of Participants Who Experience an Event of Clinical Interest (ECI)', 'timeFrame': 'Up to approximately 18 months', 'description': "ECIs are defined as an overdose of Sponsor's product, drug-induced liver injury events, or potential immune-mediated diseases (pIMDs)."}], 'secondaryOutcomes': [{'measure': 'Total Immunoglobulin G (IgG) Geometric Mean Ratios (GMRs) for anti-HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58', 'timeFrame': 'Up to approximately 7 months', 'description': 'GMR of titers for participants vaccinated with V540D versus those who received GARDASIL®9 alone will be calculated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': "Researchers are looking for new ways to prevent cancers related to human papillomavirus (HPV). HPV is a common virus that can cause an infection. There are many different types of HPV. Most people's immune system can fight HPV infection and it goes away without treatment. For some people, HPV infections can last longer and may cause cancer years later.\n\nA standard vaccine to prevent HPV-related cancers is GARDASIL®9 (G9). G9 protects against 9 types of HPV but it does not protect against other types of HPV. The study vaccine (called V540D) is designed to protect against the same HPV types that G9 protects against plus other HPV types. The main goal of this study is to learn about the safety of V540D in healthy adults and if people tolerate it."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe key inclusion criteria include but are not limited to the following:\n\n* Is in good health based on medical history, physical examination, vital sign (VS) measurements and electrocardiograms (ECGs) performed before randomization\n\nExclusion Criteria:\n\nThe key exclusion criteria include but are not limited to the following:\n\n* Has a history of abnormal Pap smears, HPV- related external genital lesions (eg, condyloma acuminate, vulval intraepithelial neoplasia (VIN), or prostatic intraepithelial neoplasia (PIN)) or external genital cancer (eg, penile cancer), HPV-related vaginal or anal lesions (eg, condyloma acuminata or vaginal intraepithelial neoplasia (VaIN)) or vaginal or anal cancer\n* Has a history of cancer (malignancy)\n* Has received any HPV vaccine or is expected to receive any HPV vaccine during the study, outside the protocol'}, 'identificationModule': {'nctId': 'NCT06688058', 'briefTitle': 'A Trial to Evaluate Tolerability and Immunogenicity of V540D in Healthy Adults (V540D-004)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 1, Randomized, Double-Blind, Comparator-Controlled, Dose-Escalation Trial to Evaluate, Tolerability, and Immunogenicity of V540D in Healthy Adults.', 'orgStudyIdInfo': {'id': 'V540D-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'V540D', 'description': 'Participants will receive vaccinations with V540D.', 'interventionNames': ['Biological: V540D']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GARDASIL®9', 'description': 'Participants will receive vaccinations with GARDASIL®9.', 'interventionNames': ['Biological: GARDASIL®9']}], 'interventions': [{'name': 'V540D', 'type': 'BIOLOGICAL', 'description': 'Experimental vaccine and adjuvant administered via intramuscular (IM) injection', 'armGroupLabels': ['V540D']}, {'name': 'GARDASIL®9', 'type': 'BIOLOGICAL', 'otherNames': ['G9', 'V503'], 'description': 'Suspension administered via IM injection', 'armGroupLabels': ['GARDASIL®9']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Research Centers of America ( Hollywood ) ( Site 0001)', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Velocity Clinical Research, Savannah ( Site 0005)', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '64114', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Alliance for Multispecialty Research, LLC ( Site 0003)', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Alliance for Multispecialty Research, LLC ( Site 0004)', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}], 'centralContacts': [{'name': 'Toll Free Number', 'role': 'CONTACT', 'email': 'Trialsites@msd.com', 'phone': '1-888-577-8839'}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'https://externaldatasharing-msd.com/', 'ipdSharing': 'YES', 'description': 'https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}