Prophylactic Vaccines as Therapy: Prevention of Recurrence of Extensive Genital Warts

Merck-MISP-53183

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.

2018-07-01

2025-05-31

2025-07-31

Active (not recruiting)

Early phase I

75

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 75, 'type': 'ESTIMATED'}}

2024-05-08