Actinic KeratosesPhase 2VAXAKNCT05202860
Impact of Human Papillomavirus (HPV) Vaccination on Burden of Disease in Patients with Actinic Keratosis
A Phase 2 study testing HPV Vaccine in people with Actinic Keratoses and Basal Cell Carcinoma, run by Merete Haedersdal at 1 site in Denmark.
Trial summary
A double-blind, randomized, placebo controlled intervention trial on patients with actinic keratosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratoses, Basal Cell Carcinoma, Squamous Cell Carcinoma
- What is being tested?
- HPV Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- 9 May 2022to 19 Jun 2034
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Dermatology, Bispebjerg Hospital
Copenhagen, Capital Region, 2400
About this study
Official title: Impact of Human Papillomavirus (HPV) Vaccination on Burden of Disease in Patients with Actinic Keratosis - a Double-blind Randomized Controlled Trial
A double-blind, randomized, placebo controlled intervention trial on patients with actinic keratosis.
Read the 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.
- Being tested
- HPV Vaccine, PLACEBO vaccine
- Medical subject headings
- Keratosis, Actinic, Carcinoma, Basal Cell, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV VaccineBiological
(Gardasil 9 human papilloma vaccine)
PLACEBO vaccineBiological
Isotonic saltwater sham vaccine
| Study group | Role | What they receive |
|---|---|---|
| HPV vaccine | Experimental | Commercially available nonavalent HPV vaccine (Gardasil(R) 9) given intramuscularly at baseline, month 2 and month 6 Receives: Biological: HPV Vaccine |
| Isotonic Saltwater Vaccine | Placebo comparator | 0.9% NaCl given intramuscularly at baseline, month 2 and month 6 Receives: Biological: PLACEBO vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Evaluated at month 2, 6, 9, and 12
Secondary outcomes (6)
New AK lesions
New AK lesions (n) arising in the test area since last visit
Measured: Evaluated at month 2, 6, 9, 12
Partial (≥75%) clearance
Atleast 75 % reduction in total number of AK lesions compared to baseline
Measured: Evaluated at month 12
Complete (100%) clearance
100% reduction in total number of AK lesions compared to baseline
Measured: Evaluated at month 12
Side Effects
Occurence of local and systemic side effects in HPV vaccinated versus control group
Measured: Evaluated over the course of 12 months
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.
Measured: Evaluated at month 2, 6, 9, and 12
Long term Keratinocyte Carcinoma (KC) rates
Annual rate and total number of histologically confirmed KC lesions determined by assessment of electronic medical record/patobank results assessed 3, 5 and 10 years after vaccination compared to KC rates up to 5 years prior to vaccination
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start9 May 2022
- Primary completion19 Jun 2024
- Study completion19 Jun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Actinic KeratosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merete Haedersdal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Merete Haedersdal, Bispebjerg Hospital
- Investigators
- Merete Haedersdal, MD, PhD, DMSc, Principal investigator, Bispebjerg HospitalEmily Wenande, MD, PhD, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202860
- Sponsor's protocol ID
- EudraCT 2021-003895-15
- Other IDs
- H-21047863
- Acronym
- VAXAK
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2022
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40047786
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Human Papillomavirus (HPV) Vaccination on Burden of Disease in Patients with Actinic Keratosis - a Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05202860
- Acronym / sponsor ID
- VAXAK / EudraCT 2021-003895-15
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Merete HaedersdalUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 19 Jun 2034 (estimated)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPV vaccine | Experimental | Biological: HPV VaccineCommercially available nonavalent HPV vaccine (Gardasil(R) 9) given intramuscularly at baseline, month 2 and month 6 |
| Isotonic Saltwater Vaccine | Placebo comparator | Biological: PLACEBO vaccine0.9% NaCl given intramuscularly at baseline, month 2 and month 6 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV Vaccine(Gardasil 9 human papilloma vaccine) | Biological | HPV vaccine |
| PLACEBO vaccineIsotonic saltwater sham vaccine | Biological | Isotonic Saltwater Vaccine |
Primary outcome
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
6 secondary outcomes
New AK lesions
Time frame: Evaluated at month 2, 6, 9, 12
Partial (≥75%) clearance
Time frame: Evaluated at month 12
Complete (100%) clearance
Time frame: Evaluated at month 12
Side Effects
Time frame: Evaluated over the course of 12 months
New Keratinocyte Carcinomas (KCs)
Time frame: Evaluated at month 2, 6, 9, and 12
Long term Keratinocyte Carcinoma (KC) rates
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Derived from this study: PubMed 40047786Wenande 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merete Haedersdal, MD, PhD, DMSc principal investigator
Bispebjerg Hospital
Emily Wenande, MD, PhD principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HPV Vaccine in people with Actinic Keratoses and Basal Cell Carcinoma, run by Merete Haedersdal at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response in HPV vaccinated versus control group (time frame: Evaluated at month 2, 6, 9, and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05202860, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.