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Single-arm, open-label study. Intervention consists of intralesional injection of nonavalent human papillomavirus vaccine at 0 and 4 weeks.

Intralesional injection of nonavalent human papillomavirus vaccine (Gardasil 9) at 0 and 4 weeks

nonavalent human papillomavirus vaccine

Ayan Kusari, MD

Kieron Leslie, MD

This study will investigate whether injecting genital warts with small quantities of the Gardasil 9 vaccine has an effect on the warts.

This is a prospective, open-label, proof-of-concept research study to assess the effectiveness of intralesional nonavalent in the treatment of patients with genital condylomata. The study will be conducted at Zuckerberg San Francisco General Hospital. The planned intervention is to provide 10 subjects with at least 3 genital condylomata with intralesional nonavalent human papillomavirus vaccine (Gardasil 9) at 0 and 4 weeks. Then, the study subjects will be followed for a further 8 weeks to monitor for change in wart size and wart number.

This is an open-label, single-arm study in which all participants will receive intralesional Gardasil 9 vaccine to their condyloma.

Intralesional HPV Vaccine for Condylomata

Therapeutic Intralesional Nonavalent HPV Vaccine for Genital Condylomata in Adults: an Open Label Pilot Study

Number of warts in genital area, as counted by study personnel at study visits. Genital area is defined as (1) suprapubic (2) left inguinal (3) right inguinal (4) vulvar (5) perineal (6) perianal in anatomic females, and as (1) suprapubic (2) left inguinal (3) right inguinal (4) dorsal penile (5) ventral penile and scrotal (6) perineal (7) perianal in anatomic males. Warts will be counted by study personnel at in-person evaluations at week 0, week 4 and week 12.

Mean size of warts in genital area, as measured by study personnel at study visits. Genital area is defined as (1) suprapubic (2) left inguinal (3) right inguinal (4) vulvar (5) perineal (6) perianal in anatomic females, and as (1) suprapubic (2) left inguinal (3) right inguinal (4) dorsal penile (5) ventral penile and scrotal (6) perineal (7) perianal in anatomic males. Warts will be counted by study personnel at in-person evaluations at week 0, week 4 and week 12.

Established tool to measure quality of life with respect to condyloma. Will be administered at baseline and week 12 by study personnel. It comprises 10 items and 2 dimensions. The emotional dimension includes 6 items and the sexual activity dimension includes 4 items. The questions refer to the past 7 days. The higher the score the better the quality of life. The global scoring range was 10-50, ranging from 6 to 30 in the emotional dimensions and from 4 to 20 in the sexual activity dimension.

Established tool to measure quality of life with any dermatologic disease. Will be administered at baseline and week 12 by study personnel. Consists of 10 questions scored from 0-3. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Intralesional HPV Vaccine for Condylomata	NCT05087849	Human Papilloma... Warts Warts, Genital Condyloma Condylomata Acu...	nonavalent huma...	18 Years -	University of California, San Francisco
Intralesional HPV Vaccine for Condylomata	NCT05087849	Human Papilloma... Warts Warts, Genital Condyloma Condylomata Acu...	nonavalent huma...	18 Years -	University of California, San Francisco

Spots Global Cancer Trial Database for nonavalent human papillomavirus vaccine