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

NCT05202860 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: EudraCT 2021-003895-15H-21047863
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Actinic Keratoses; Basal Cell Carcinoma; Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Treatment response in HPV vaccinated versus control group

  Percentage change from baseline (%) in number of AK lesions (grades I and II-III) in the selected test area

  Evaluated at month 2, 6, 9, and 12

Secondary Outcomes (6)

• New AK lesions

  Evaluated at month 2, 6, 9, 12

• Partial (≥75%) clearance

  Evaluated at month 12

• Complete (100%) clearance

  Evaluated at month 12

• Side Effects

  Evaluated over the course of 12 months

• New Keratinocyte Carcinomas (KCs)

  Evaluated at month 2, 6, 9, and 12

Study Arms (2)

HPV vaccine

EXPERIMENTAL

Commercially available nonavalent HPV vaccine (Gardasil(R) 9) given intramuscularly at baseline, month 2 and month 6

Biological: HPV Vaccine

Isotonic Saltwater Vaccine

PLACEBO COMPARATOR

0.9% NaCl given intramuscularly at baseline, month 2 and month 6

Biological: PLACEBO vaccine

Interventions

HPV Vaccine BIOLOGICAL

(Gardasil 9 human papilloma vaccine)

HPV vaccine

PLACEBO vaccine BIOLOGICAL

Isotonic saltwater sham vaccine

Isotonic Saltwater Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who meet all the following criteria are eligible to participate in this study:
• High AK burden, defined as ≥15 AK lesions in the included test area (50-100 cm2) at baseline
• Test area does not involve the ala nasi, eyelids, nasolabial folds, or periauricular skin
• \>18 years of age at baseline
• Fitzpatrick skin phototype I-IV
• Legally competent, able to give verbal and written informed consent
• 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.
• 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.
• Female 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.
• Intrauterine device or hormonal contraception (oral, implant, patch, vaginal ring, injection).

You may not qualify if:

• Subjects meeting any of the following criteria are not eligible to participate in this study:
• Known or suspected immunosuppression (by disease or immunosuppressive drug)
• History of vaccine-related allergic reactions or known allergy to Gardasil®9 ingredients or yeast
• Previously vaccinated with any HPV vaccine
• History of keloids
• Other skin diseases present in the test area at baseline
• Lactating or pregnant women

Sponsors & Collaborators

• Merete Haedersdal: lead

Study Sites (1)

Department of Dermatology, Bispebjerg Hospital

Copenhagen, Capital Region, 2400, Denmark

Location

Related Publications (1)

• 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.

  PMID: 40047786 DERIVED

MeSH Terms

Conditions

Keratosis, Actinic; Carcinoma, Basal Cell; Carcinoma, Squamous Cell

Interventions

Papillomavirus Vaccines

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Basal Cell; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Merete Haedersdal, MD, PhD, DMSc

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

• Emily Wenande, MD, PhD

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 24, 2022
• Study Start: May 9, 2022
• Primary Completion: June 19, 2024
• Study Completion (Estimated): June 19, 2034
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)