TOPLINE:
Standard human papillomavirus (HPV) vaccination reduced actinic keratosis (AK) burden in immunocompetent individuals with multiple lesions, with effects observed in both the total number of lesions and the number of thick lesions.
METHODOLOGY:
- Researchers conducted the VAXAK trial, enrolling 70 immunocompetent adults with ≥ 15 clinical AK lesions within a 50 cm² to 100 cm² test area on the head, trunk, or extremities.
- Participants received intramuscular injections of either the 9-valent alphapapillomavirus vaccine or a sham vaccine (isotonic sodium chloride solution) at baseline, 2 months, and 6 months. Additionally, thick lesions were treated with cryotherapy at 6 and 9 months.
- The primary outcome measure was the percentage reduction in baseline AKs, assessed at 2, 6, 9, and 12 months after the first vaccination. Secondary outcomes included the total AK lesion count, number of thick lesions, number of new lesions, and rate of incident keratinocyte carcinomas over 12 months.
TAKEAWAY:
- At 12 months, total AK counts were significantly lower in the HPV-vaccinated group than in the sham group (median, 10 vs 16; P = .02). Similarly, fewer thick AKs were observed in the HPV-vaccinated group (median, 3 vs 5; P = .049).
- No significant differences were found in the number of new AKs (1-2 lesions per month) or the rate of keratinocyte carcinomas during the 12-month trial period.
- Rates of adverse events (AEs) and serious AEs were not significantly different between the groups. Soreness at the vaccination site, headache, and dizziness were the common AEs associated with HPV vaccination.
IN PRACTICE:
"In this RCT [randomised clinical trial], standard alpha-HPV vaccination was shown to reduce AK burden in immunocompetent individuals with multiple lesions. Although the effect on skin cancer development remains uncertain, HPV-targeted vaccines might prove useful in the management of AK, a chronic, relapsing disease and the most common precancer in fair-skinned populations," the authors concluded.
SOURCE:
The study was led by Emily Wenande, MD, PhD, Department of Dermatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Denmark. It was published online on March 6, 2025, in JAMA Dermatology.
LIMITATIONS:
Monitoring of multiple individual lesions was challenging due to changing morphological characteristics, clustering, and difficulty distinguishing similarly appearing lesions. Histological confirmation of lesional clearance was not performed due to feasibility constraints. Additionally, the presence of an increased proportion of fair-skinned patients with Fitzpatrick skin type I in the HPV-vaccinated group may have influenced outcomes. The study also did not assess participants' sun protection practices or HPV presence in their skin.
DISCLOSURES:
The study received support from Region Hovedstadens Forskningsfond til Sundhedsforskning, Bispebjerg og Frederiksberg Hospitaler Frie Forskningsmidler 2021, and Fonden af Fam Kjaersgaard, Sunds. Additional funding came from the Danish Research Center for Skin Cancer. Several authors reported receiving grants or personal fees or having other ties with various sources.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
