Trial Outcomes & Findings for Intralesional HPV Vaccine for Condylomata (NCT NCT05087849)

NCT ID: NCT05087849

Last Updated: 2025-10-02

Results Overview

Change in number of warts in genital area.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: Baseline (week 0) and Week 12.
• Results posted on: 2025-10-02

Participant Flow

Participant milestones

Measure	Intralesional Injection of Nonavalent Human Papillomavirus Vaccine Single-arm, open-label study. Intervention consists of intralesional injection of nonavalent human papillomavirus vaccine at 0 and 4 weeks. nonavalent human papillomavirus vaccine: Intralesional injection of nonavalent human papillomavirus vaccine (Gardasil 9) at 0 and 4 weeks
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intralesional Injection of Nonavalent Human Papillomavirus Vaccine n=2 Participants Single-arm, open-label study. Intervention consists of intralesional injection of nonavalent human papillomavirus vaccine at 0 and 4 weeks. nonavalent human papillomavirus vaccine: Intralesional injection of nonavalent human papillomavirus vaccine (Gardasil 9) at 0 and 4 weeks
Age, Categorical <=18 years	0 Participants n=2 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=2 Participants
Age, Categorical >=65 years	0 Participants n=2 Participants
Age, Continuous	38.5 years STANDARD_DEVIATION 3.5 • n=2 Participants
Sex: Female, Male Female	0 Participants n=2 Participants
Sex: Female, Male Male	2 Participants n=2 Participants
Region of Enrollment United States	2 participants n=2 Participants

PRIMARY outcome

Timeframe: Baseline (week 0) and Week 12.

Change in number of warts in genital area.

Outcome measures

Measure	All Subjects n=2 Participants Single-arm.
Change in Wart Number	0.5 warts Standard Deviation 0.5

PRIMARY outcome

Timeframe: to be measured at baseline (week 0) and Week 12

Mean size of warts in genital area, as measured by study personnel at study visits .

Outcome measures

Measure	All Subjects n=2 Participants Single-arm.
Change in Average Size of Genital Warts in mm	0.13 mm Standard Deviation 0.65

SECONDARY outcome

Timeframe: to be measured at baseline (week 0) and week 12

Population: All subjects

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.

Outcome measures

Measure	All Subjects n=2 Participants Single-arm.
Change in Score of Specific Questionnaire for Condylomata Acuminata (CECA)	-18.5 CECA score Standard Deviation 1.5

SECONDARY outcome

Timeframe: to be measured at baseline (week 0) and week 12

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.

Outcome measures

Measure	All Subjects n=2 Participants Single-arm.
Change in Score of Dermatology Quality of Life Index (DLQI)	0 DLQI score Standard Deviation 2

Adverse Events

Intralesional Injection of Nonavalent Human Papillomavirus Vaccine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ayan Kusari

UCSF

Phone: 4153537800

Email: ayan.kusari@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place