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Impact of Human Papillomavirus (HPV) Vaccination on Burden of Disease in Patients With Actinic Keratosis (VAXAK)

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ClinicalTrials.gov Identifier: NCT05202860
Recruitment Status : Recruiting
First Posted : January 24, 2022
Last Update Posted : September 14, 2022
Information provided by (Responsible Party):
Merete Haedersdal, Bispebjerg Hospital

Brief Summary:
A double-blind, randomized, placebo controlled intervention trial on patients with actinic keratosis.

Condition or disease Intervention/treatment Phase
Actinic Keratoses Basal Cell Carcinoma Squamous Cell Carcinoma Biological: HPV Vaccine Biological: PLACEBO vaccine Phase 2

Detailed Description:

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.

Seventy 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Human Papillomavirus (HPV) Vaccination on Burden of Disease in Patients With Actinic Keratosis - a Double-blind Randomized Controlled Trial
Actual Study Start Date : May 9, 2022
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arm Intervention/treatment
Experimental: HPV vaccine
Commercially available nonavalent HPV vaccine (Gardasil(R) 9) given intramuscularly at baseline, month 2 and month 6
Biological: HPV Vaccine
(Gardasil 9 human papilloma vaccine)

Placebo Comparator: Isotonic Saltwater Vaccine
0.9% NaCl given intramuscularly at baseline, month 2 and month 6
Biological: PLACEBO vaccine
Isotonic saltwater sham vaccine

Primary Outcome Measures :
  1. Treatment response in HPV vaccinated versus control group [ Time Frame: Evaluated at month 2, 6, 9, and 12 ]
    Percentage change from baseline (%) in number of AK lesions (grades I and II-III) in the selected test area

Secondary Outcome Measures :
  1. New AK lesions [ Time Frame: Evaluated at month 2, 6, 9, 12 ]
    New AK lesions (n) arising in the test area since last visit

  2. Partial (≥75%) clearance [ Time Frame: Evaluated at month 12 ]
    Atleast 75 % reduction in total number of AK lesions compared to baseline

  3. Complete (100%) clearance [ Time Frame: Evaluated at month 12 ]
    100% reduction in total number of AK lesions compared to baseline

  4. Side Effects [ Time Frame: Evaluated over the course of 12 months ]
    Occurence of local and systemic side effects in HPV vaccinated versus control group

  5. New Keratinocyte Carcinomas (KCs) [ Time Frame: Evaluated at month 2, 6, 9, and 12 ]
    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Subjects who meet all the following criteria are eligible to participate in this study:

  1. High AK burden, defined as ≥15 AK lesions in the included test area (50-100 cm2) at baseline
  2. Test area does not involve the ala nasi, eyelids, nasolabial folds, or periauricular skin
  3. >18 years of age at baseline
  4. Fitzpatrick skin phototype I-IV
  5. Legally competent, able to give verbal and written informed consent
  6. 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.
  7. 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.

1Female 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.

2Intrauterine device or hormonal contraception (oral, implant, patch, vaginal ring, injection).

Exclusion Criteria:

Subjects meeting any of the following criteria are not eligible to participate in this study:

  1. Known or suspected immunosuppression (by disease or immunosuppressive drug)
  2. History of vaccine-related allergic reactions or known allergy to Gardasil®9 ingredients or yeast
  3. Previously vaccinated with any HPV vaccine
  4. History of keloids
  5. Other skin diseases present in the test area at baseline
  6. Lactating or pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05202860

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Contact: Emily Wenande, MD, PhD +4538636081 emily.cathrine.wenande@regionh.dk
Contact: Lene Rask lene.rask.01@regionh.dk

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Department of Dermatology, Bispebjerg Hospital Recruiting
Copenhagen, Hovedstaden, Denmark, 2400
Contact: Emily C Wenande, MD, PhD    +4540505590    emily.cathrine.wenande@regionh.dk   
Sponsors and Collaborators
Merete Haedersdal
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Principal Investigator: Merete Haedersdal, MD, PhD, DMSc Bispebjerg Hospital
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Responsible Party: Merete Haedersdal, Sponsor-Investigator, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT05202860    
Other Study ID Numbers: EudraCT 2021-003895-15
H-21047863 ( Other Identifier: National Committee on Health Research Ethics (NVK; Denmark) )
First Posted: January 24, 2022    Key Record Dates
Last Update Posted: September 14, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Keratosis, Actinic
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Skin Diseases
Precancerous Conditions
Neoplasms, Basal Cell
Immunologic Factors
Physiological Effects of Drugs