Phase 3
N=52
Effectiveness Study of Human Papilloma Virus (HPV) Vaccines to Prevent Recurrence of Genital Warts
Genital Warts
Bottom Line
View on ClinicalTrials.gov: NCT02750202 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Change in the Maximum Size of the Genital Wart Lesion Over the Trial Period (as Measured in mm) — 8; 6; 11; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Quadrivalent HPV vaccine (Biological); Hepatitis B vaccine (Biological)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- Female
- Sponsor
- University of Pretoria
- Primary completion
- Jul 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Maximum Size of the Genital Wart Lesion Over the Trial Period (as Measured in mm) |
8; 6; 11; 7; 19; 22 | — |
| 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) |
— | — |
| SECONDARY Number of Participants Who Change From HPV 6 DNA Positive in Warts to Negative at Week 72 |
10; 9; 1; 2 | — |
| SECONDARY Number of Participants Who Change From HPV 11 DNA Positive in Warts to Negative at Week 72 |
7; 11; 1; 2 | — |
| SECONDARY Number of Participants Who Change From HPV 16 DNA Positive at Baseline to Negative at Week 60 |
8; 7; 2; 1 | — |
| SECONDARY Number of Participants Who Change From HPV 18 DNA Positive at Baseline to Negative at Week 60 |
3; 2; 0; 2 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02750202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.