A Phase 1/2 interventional study of nonavalent human papillomavirus vaccine in Human Papilloma Virus, Warts and Warts, Genital, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-02.
Sponsored by University of California, San Francisco · Phase 1/2, Interventional, and Treatment
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.
116 studies on the registry are indexed under Condylomata Acuminata; 11 are open to participants now.
This study's enrollment of 2 is below the median of 158 across 95 interventional studies indexed under Condylomata Acuminata.
Browse Condylomata Acuminata studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
Compared within Condylomata Acuminata, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Warts. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All individuals who are able to become pregnant will be asked about their reproductive health, sexual activity (partners, practices, prevention of pregnancy) and be advised that administration of vaccine during pregnancy is not recommended while data collection to monitor pregnancy and infant outcomes following exposure to the papillomavirus (9-valent) vaccine is ongoing. However, based on available data, an increased risk of adverse pregnancy outcomes, specifically miscarriage or congenital anomalies, has not been observed following inadvertent administration of the papillomavirus vaccine during pregnancy. Individuals who are able to become pregnant are advised to contact us immediately and will not receive any further intralesional vaccine.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single-arm, open-label study. Intervention consists of intralesional injection of nonavalent human papillomavirus vaccine at 0 and 4 weeks.
Biological: nonavalent human papillomavirus vaccine
Intralesional injection of nonavalent human papillomavirus vaccine (Gardasil 9) at 0 and 4 weeks
Change in Wart Number
Change in number of warts in genital area.
Time frame: Baseline (week 0) and Week 12.
Change in Average Size of Genital Warts in mm
Mean size of warts in genital area, as measured by study personnel at study visits .
Time frame: to be measured at baseline (week 0) and Week 12
Change in Score of Specific Questionnaire for Condylomata Acuminata (CECA)
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.
Time frame: to be measured at baseline (week 0) and week 12
Change in Score of Dermatology Quality of Life Index (DLQI)
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.
Time frame: to be measured at baseline (week 0) and week 12
| Milestone | Intralesional Injection of Nonavalent Human Papillomavirus Vaccine |
|---|---|
| Started | 2 |
| Completed | 2 |
| Not completed | 0 |
Change in number of warts in genital area.
| warts | All Subjects |
|---|---|
| Change in Wart Number | 0.5 ± 0.5 |
Mean size of warts in genital area, as measured by study personnel at study visits .
| mm | All Subjects |
|---|---|
| Change in Average Size of Genital Warts in mm | 0.13 ± 0.65 |
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.
| CECA score | All Subjects |
|---|---|
| Change in Score of Specific Questionnaire for Condylomata Acuminata (CECA) | -18.5 ± 1.5 |
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.
| DLQI score | All Subjects |
|---|---|
| Change in Score of Dermatology Quality of Life Index (DLQI) | 0 ± 2 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intralesional Injection of Nonavalent Human Papillomavirus Vaccine | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | Intralesional Injection of Nonavalent Human Papillomavirus Vaccine |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 0 |
| Age, Continuous(years) | Intralesional Injection of Nonavalent Human Papillomavirus Vaccine |
|---|---|
| Mean | 38.5 ± 3.5 |
| Sex: Female, Male(Participants) | Intralesional Injection of Nonavalent Human Papillomavirus Vaccine |
|---|---|
| Female | 0 |
| Male | 2 |
| Race and Ethnicity Not Collected(Participants) | Intralesional Injection of Nonavalent Human Papillomavirus Vaccine |
|---|
| Region of Enrollment(participants) | Intralesional Injection of Nonavalent Human Papillomavirus Vaccine |
|---|---|
| United States | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
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