VAXAK
Trial question
What is the effect of HPV vaccination in immunocompetent patients with high numbers of actinic keratosis?
Study design
Single center
Double blinded
RCT
Population
Characteristics of study participants
33.0% female
67.0% male
N = 70
70 patients (23 female, 47 male).
Inclusion criteria: immunocompetent adult patients with high numbers of actinic keratosis.
Key exclusion criteria: immunosuppression due to disease or medication; other dermatological disease in the skin area at baseline; history of HPV vaccination; keloids; any vaccine-related allergy; known allergy to yeast; pregnancy or lactation.
Interventions
N=35 HPV vaccination (IM administration of 9-valent alphapapillomavirus vaccine at 0, 2, and 6 months).
N=35 sham vaccination (IM administration of isotonic sodium chloride solution at 0, 2, and 6 months).
Primary outcome
Reduction in actinic keratosis at 6 months
47%
29%
47.0 %
35.3 %
23.5 %
11.8 %
0.0 %
Human papillomavirus
vaccination
Sham
vaccination
Significant
increase ▲
NNT = 5
Significantly greater reduction in actinic keratosis at 6 months (47% vs. 29%; AD 18%, 95% CI 4.3 to 31.7).
Secondary outcomes
Significant decrease in total actinic keratosis numbers at 6 months (14 lesions vs. 17 lesions; AD -3 lesions, 95% CI -5.28 to -0.72).
Significant decrease in total thick actinic keratosis at 6 months (5 lesions vs. 6.5 lesions; AD -1.5 lesions, 95% CI -2.77 to -0.23).
No significant difference in total actinic keratosis that received cryotherapy at 9 months (4 lesions vs. 5 lesions; AD -1 lesions, 95% CI -2.19 to 0.19).
Safety outcomes
No significant difference in adverse events and serious adverse events.
Conclusion
In immunocompetent adult patients with high numbers of actinic keratosis, HPV vaccination was superior to sham vaccination with respect to reduction in actinic keratosis at 6 months.
Reference
Emily Wenande, Anna Hastrup, Stine Wiegell et al. Human Papillomavirus Vaccination and Actinic Keratosis Burden: The VAXAK Randomized Clinical Trial. JAMA Dermatol. 2025 Mar 6:e250531. Online ahead of print.
Open reference URL