NCT02750202CompletedPhase 3
Effectiveness Study of Human Papilloma Virus (HPV) Vaccines to Prevent Recurrence of Genital Warts
Prophylactic Vaccines as Therapy: Prevention of Recurrence of Extensive Genital Warts
Source: ClinicalTrials.gov · Last updated 23 Jan 2026
Brief summary (registry, in English)
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 (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 52 (actual)
- First submitted
- 12 Apr 2016
- Start date
- 1 Jul 2018
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- University of Pretoria
- NCT number
- NCT02750202
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 52
- From 1 Jul 2018 to the primary completion date, 31 Jul 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous HPV vaccination
- Previous radiation for genital warts
Other illness
- 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
Other
- Pregnant of planned pregnancy within 6 months
- Not able to comprehend study method or not able to attend all study visits
Who the study is looking for
- 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
Age in the registry: 16 years to - · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tygerberg Hospital Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Steve Biko Academic Hospital Coordinator of this site? Confirm its status | Pretoria | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.