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

NCT ID: NCT05202860

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-09
• Study Completion Date: 2034-06-19

Brief Summary

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

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.

Conditions

Actinic Keratoses; Basal Cell Carcinoma; Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HPV vaccine

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

Group Type: EXPERIMENTAL

HPV Vaccine

Intervention Type: BIOLOGICAL

(Gardasil 9 human papilloma vaccine)

Isotonic Saltwater Vaccine

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

Group Type: PLACEBO_COMPARATOR

PLACEBO vaccine

Intervention Type: BIOLOGICAL

Isotonic saltwater sham vaccine

Interventions

HPV Vaccine

(Gardasil 9 human papilloma vaccine)

Intervention Type: BIOLOGICAL

PLACEBO vaccine

Isotonic saltwater sham vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merete Haedersdal

OTHER

Sponsor Role: lead

Responsible Party

Merete Haedersdal

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Merete Haedersdal, MD, PhD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Emily Wenande, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

Department of Dermatology, Bispebjerg Hospital

Copenhagen, Capital Region, Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 40047786 (View on PubMed)

Other Identifiers

H-21047863

Identifier Type: OTHER

Identifier Source: secondary_id

EudraCT 2021-003895-15

Identifier Type: -

Identifier Source: org_study_id