Intralesional HPV Vaccine for Condylomata (NCT05087849) | Clinical Trial Compass
CompletedPhase 1/2
Intralesional HPV Vaccine for Condylomata
United States2 participantsStarted 2022-04-15
Plain-language summary
This study will investigate whether injecting genital warts with small quantities of the Gardasil 9 vaccine has an effect on the warts.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients of all genders aged ≥ 18 years
* Signed informed consent form
* Confirmed clinical diagnosis of genital condylomata with minimum of 3 genital condylomata, each measuring \>3mm
* Individuals who are able to become pregnant will be advised on the following:
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:
* Participants will be asked about pregnancy at time of recruitments. Individuals who are pregnant or are planning to become pregnant will not be permitted to participate in the study, as ACOG does not recommend Gardasil 9 during pregnancy. Participants will be encouraged not to participate in the study if they believe they may become pregnant during the study.
* Participants will be asked about allergic reaction to yeast and vaccin…
What they're measuring
1
Change in Wart Number
Timeframe: Baseline (week 0) and Week 12.
2
Change in Average Size of Genital Warts in mm
Timeframe: to be measured at baseline (week 0) and Week 12