Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-28 @ 12:03 AM
Study NCT ID:
NCT05202860
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-22
First Post:
2022-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Human Papillomavirus (HPV) Vaccination on Burden of Disease in Patients with Actinic Keratosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055623', 'term': 'Keratosis, Actinic'}, {'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053918', 'term': 'Papillomavirus Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2034-06-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-20', 'studyFirstSubmitDate': '2022-01-10', 'studyFirstSubmitQcDate': '2022-01-10', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment response in HPV vaccinated versus control group', 'timeFrame': 'Evaluated at month 2, 6, 9, and 12', 'description': 'Percentage change from baseline (%) in number of AK lesions (grades I and II-III) in the selected test area'}], 'secondaryOutcomes': [{'measure': 'New AK lesions', 'timeFrame': 'Evaluated at month 2, 6, 9, 12', 'description': 'New AK lesions (n) arising in the test area since last visit'}, {'measure': 'Partial (≥75%) clearance', 'timeFrame': 'Evaluated at month 12', 'description': 'Atleast 75 % reduction in total number of AK lesions compared to baseline'}, {'measure': 'Complete (100%) clearance', 'timeFrame': 'Evaluated at month 12', 'description': '100% reduction in total number of AK lesions compared to baseline'}, {'measure': 'Side Effects', 'timeFrame': 'Evaluated over the course of 12 months', 'description': 'Occurence of local and systemic side effects in HPV vaccinated versus control group'}, {'measure': 'New Keratinocyte Carcinomas (KCs)', 'timeFrame': 'Evaluated at month 2, 6, 9, and 12', 'description': 'New KCs (basal or squamous cell carcinoma) identified anywhere on the body of participants in HPV vaccinated versus control group registered over the course of the 12-month trial, compared to average yearly whole-body KC rate (determined by assessment of electronic medical record/patobank results) up to 3 years prior to baseline.'}, {'measure': 'Long term Keratinocyte Carcinoma (KC) rates', 'timeFrame': '10 years', 'description': 'Annual rate and total number of histologically confirmed KC lesions determined by assessment of electronic medical record/patobank results assessed 3, 5 and 10 years after vaccination compared to KC rates up to 5 years prior to vaccination'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Actinic Keratoses', 'Basal Cell Carcinoma', 'Squamous Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '40047786', 'type': 'DERIVED', 'citation': 'Wenande E, Hastrup A, Wiegell S, Philipsen PA, Thomsen NB, Demehri S, Kjaer SK, Haedersdal M. Human Papillomavirus Vaccination and Actinic Keratosis Burden: The VAXAK Randomized Clinical Trial. JAMA Dermatol. 2025 Jun 1;161(6):605-614. doi: 10.1001/jamadermatol.2025.0531.'}]}, 'descriptionModule': {'briefSummary': 'A double-blind, randomized, placebo controlled intervention trial on patients with actinic keratosis.', 'detailedDescription': 'Endeavoring to develop a new therapeutic and preventative strategy for patients with AK, this study aims to investigate the impact of 9-valent HPV vaccination on AK burden and -development over the course of 12 months.\n\nSeventy actinic keratosis (AK) patients are randomized 1:1 to two parallel groups that receive blinded HPV vaccination or sham placebo (isotonic NaCl) vaccination at baseline (day 0), month 2 and month 6. At month 6 and 9, both groups undergo lesion-directed cryotherapy of Olsen grade II-III AKs. Treatment response, based on percentage change (%) in baseline number of AK lesions in a predefined test area (primary outcome), is evaluated at months 2, 6, 9, and 12.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects who meet all the following criteria are eligible to participate in this study:\n\n1. High AK burden, defined as ≥15 AK lesions in the included test area (50-100 cm2) at baseline\n2. Test area does not involve the ala nasi, eyelids, nasolabial folds, or periauricular skin\n3. \\>18 years of age at baseline\n4. Fitzpatrick skin phototype I-IV\n5. Legally competent, able to give verbal and written informed consent\n6. Subject is willing to participate and can comply with protocol requirements including the refraining from other therapy (with the exception of KC treatment) in the test area for the duration of the trial.\n7. Women of childbearing potential1 must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment and be on effective contraception2 until discontinuation of the vaccine therapy. Additional pregnancy testing will not be conducted unless pregnancy is suspected.\n\n1Female subjects are considered of childbearing potential unless they have been hysterectomized or have undergone tubal ligation or have been post-menopausal for at least one year prior to first visit.\n\n2Intrauterine device or hormonal contraception (oral, implant, patch, vaginal ring, injection).\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria are not eligible to participate in this study:\n\n1. Known or suspected immunosuppression (by disease or immunosuppressive drug)\n2. History of vaccine-related allergic reactions or known allergy to Gardasil®9 ingredients or yeast\n3. Previously vaccinated with any HPV vaccine\n4. History of keloids\n5. Other skin diseases present in the test area at baseline\n6. Lactating or pregnant women'}, 'identificationModule': {'nctId': 'NCT05202860', 'acronym': 'VAXAK', 'briefTitle': 'Impact of Human Papillomavirus (HPV) Vaccination on Burden of Disease in Patients with Actinic Keratosis', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Impact of Human Papillomavirus (HPV) Vaccination on Burden of Disease in Patients with Actinic Keratosis - a Double-blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'EudraCT 2021-003895-15'}, 'secondaryIdInfos': [{'id': 'H-21047863', 'type': 'OTHER', 'domain': 'National Committee on Health Research Ethics (NVK; Denmark)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HPV vaccine', 'description': 'Commercially available nonavalent HPV vaccine (Gardasil(R) 9) given intramuscularly at baseline, month 2 and month 6', 'interventionNames': ['Biological: HPV Vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Isotonic Saltwater Vaccine', 'description': '0.9% NaCl given intramuscularly at baseline, month 2 and month 6', 'interventionNames': ['Biological: PLACEBO vaccine']}], 'interventions': [{'name': 'HPV Vaccine', 'type': 'BIOLOGICAL', 'description': '(Gardasil 9 human papilloma vaccine)', 'armGroupLabels': ['HPV vaccine']}, {'name': 'PLACEBO vaccine', 'type': 'BIOLOGICAL', 'description': 'Isotonic saltwater sham vaccine', 'armGroupLabels': ['Isotonic Saltwater Vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'state': 'Capital Region', 'country': 'Denmark', 'facility': 'Department of Dermatology, Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Merete Haedersdal, MD, PhD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bispebjerg Hospital'}, {'name': 'Emily Wenande, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bispebjerg Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merete Haedersdal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sponsor-Investigator', 'investigatorFullName': 'Merete Haedersdal', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}