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

Squamous Cell Carcinoma Clinical Trial

— VAXAK  

Official title:

Impact of Human Papillomavirus (HPV) Vaccination on Burden of Disease in Patients With Actinic Keratosis - a Double-blind Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05202860
• Other study ID #: EudraCT 2021-003895-15
• Secondary ID: H-21047863
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 9, 2022
• Est. completion date: June 2035

Study information

• Verified date: February 2024
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: June 2035
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Actinic Keratoses
• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Keratosis
• Keratosis, Actinic
• Squamous Cell Carcinoma

Intervention

Biological:
• HPV Vaccine
(Gardasil 9 human papilloma vaccine)
• PLACEBO vaccine
Isotonic saltwater sham vaccine

Locations

Country	Name	City	State
Denmark	Department of Dermatology, Bispebjerg Hospital	Copenhagen	Hovedstaden

Sponsors (1)

Lead Sponsor	Collaborator
Merete Haedersdal

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	New AK lesions	New AK lesions (n) arising in the test area since last visit	Evaluated at month 2, 6, 9, 12
Secondary	Partial (=75%) clearance	Atleast 75 % reduction in total number of AK lesions compared to baseline	Evaluated at month 12
Secondary	Complete (100%) clearance	100% reduction in total number of AK lesions compared to baseline	Evaluated at month 12
Secondary	Side Effects	Occurence of local and systemic side effects in HPV vaccinated versus control group	Evaluated over the course of 12 months
Secondary	New Keratinocyte Carcinomas (KCs)	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.	Evaluated at month 2, 6, 9, and 12