Genital Warts Clinical Trial
— TheraVACCSOfficial title:
Prophylactic Vaccines as Therapy: Prevention of Recurrence of Extensive Genital Warts
Verified date | May 2024 |
Source | University of Pretoria |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Large genital warts are frequently diagnosed in general gynaecology and oncology clinics in South Africa. Medical and destructive therapy for small warts is generally very effective, however unique problems posed by large or extensive genital warts are not so easily solved and treatment of affected patients remains very challenging. Recurrences are common especially among immune-compromised women. This study will test whether giving the quadrivalent human papilloma virus (HPV) vaccine to women with extensive genital warts prior to surgical treatment will improve outcomes. Investigators hypothesize that pre-treatment with HPV vaccine can play a role in the control of both malignant and benign HPV disease in women with and without HIV infection through stimulation of the antibody response. In addition, HPV types and other associated diseases will be studied in women receiving HPV vaccine and placebo.
Status | Active, not recruiting |
Enrollment | 75 |
Est. completion date | July 31, 2025 |
Est. primary completion date | May 31, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - Female patient > 16 years - Presence of vulvo vaginal genital warts: largest tumour diameter > 3 cm OR Tumour on labia minora and labia majora OR bilateral > 1 cm each side OR Tumour in vagina/cervix as well as on vulva > 1 cm lesion each - HIV negative or HIV infected and CD4 = 300 cells/mm3 OR viral load controlled OR anti retro-viral (ARV) compliant > 6 months Exclusion Criteria: - Pregnant of planned pregnancy within 6 months - Not able to comprehend study method or not able to attend all study visits - Previous HPV vaccination - Active known opportunistic infection or malignancy including Pneumocystis pneumonia (PCP),Pulmonary tuberculosis (PTB), oesophageal Candida or Kaposi sarcoma or lymphoma - Known allergy to vaccines or content of vaccine - Previous radiation for genital warts |
Country | Name | City | State |
---|---|---|---|
South Africa | Tygerberg Hospital | Cape Town | Western Cape |
South Africa | Steve Biko Academic Hospital | Pretoria | Gauteng |
Lead Sponsor | Collaborator |
---|---|
University of Pretoria | University of Stellenbosch |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of participants who change from HIV negative at baseline to positive at week 48 | Baseline, week 48 | ||
Other | Number of participants who require surgical treatment of warts at any of the clinical assessments during the trial, as judged by the attending clinician. | Week 24, 72 | ||
Other | Number of participants who require surgical treatment of cervical disease at any of the clinical assessments during the trial, as judged by the attending clinician. | Week 24, 72 | ||
Primary | Change in the maximum size of the genital wart lesion over the trial period (as measured in mm) | Baseline, week 8, 16, 24, 36, 48, 60, 72 | ||
Secondary | Number of participants who acquire measurable levels of HPV type specific antibodies during the first 18 months of the trail as measured using a competitive Luminex immuno-assay (cLIA; reported in milli-Merck Units [mMU]/ml) | Week 36+ | ||
Secondary | Number of participants who change from HPV 6 DNA positive in warts to negative at week 72 | Baseline, week 72 | ||
Secondary | Number of participants who change from HPV 11 DNA positive in warts to negative at week 72 | Baseline, week 72 | ||
Secondary | Number of participants who change from HPV 16 DNA positive at baseline to negative at week 60 | Baseline, week 60 | ||
Secondary | Number of participants who change from HPV 18 DNA positive at baseline to negative at week 60 | Baseline, week 60 |
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