Back to results

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

Primary Purpose

Actinic Keratoses, Basal Cell Carcinoma, Squamous Cell Carcinoma

Status

Active

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

HPV Vaccine

PLACEBO vaccine

About this trial

This is an interventional treatment trial for Actinic Keratoses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

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:

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

Sites / Locations

Department of Dermatology, Bispebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HPV vaccine

Isotonic Saltwater Vaccine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

New AK lesions

New AK lesions (n) arising in the test area since last visit

Partial (≥75%) clearance

Atleast 75 % reduction in total number of AK lesions compared to baseline

Complete (100%) clearance

100% reduction in total number of AK lesions compared to baseline

Side Effects

Occurence of local and systemic side effects in HPV vaccinated versus control group

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.

Full Information

NCT ID

NCT05202860

First Posted

January 10, 2022

Last Updated

July 12, 2023

Sponsor

Merete Haedersdal

1. Study Identification

Unique Protocol Identification Number

NCT05202860

Brief Title

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

Acronym

VAXAK

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 9, 2022 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Merete Haedersdal

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Actinic Keratoses, Basal Cell Carcinoma, Squamous Cell Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HPV vaccine

Arm Type

Experimental

Arm Description

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

Arm Title

Isotonic Saltwater Vaccine

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

HPV Vaccine

Intervention Description

(Gardasil 9 human papilloma vaccine)

Intervention Type

Biological

Intervention Name(s)

PLACEBO vaccine

Intervention Description

Isotonic saltwater sham vaccine

Primary Outcome Measure Information:

Title

Treatment response in HPV vaccinated versus control group

Description

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

Time Frame

Evaluated at month 2, 6, 9, and 12

Secondary Outcome Measure Information:

Title

New AK lesions

Description

New AK lesions (n) arising in the test area since last visit

Time Frame

Evaluated at month 2, 6, 9, 12

Title

Partial (≥75%) clearance

Description

Atleast 75 % reduction in total number of AK lesions compared to baseline

Time Frame

Evaluated at month 12

Title

Complete (100%) clearance

Description

100% reduction in total number of AK lesions compared to baseline

Time Frame

Evaluated at month 12

Title

Side Effects

Description

Occurence of local and systemic side effects in HPV vaccinated versus control group

Time Frame

Evaluated over the course of 12 months

Title

New Keratinocyte Carcinomas (KCs)

Description

Time Frame

Evaluated at month 2, 6, 9, and 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Merete Haedersdal, MD, PhD, DMSc

Organizational Affiliation

Bispebjerg Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Dermatology, Bispebjerg Hospital

City

Copenhagen

State/Province

Hovedstaden

ZIP/Postal Code

2400

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs