drugset / Trial / NCT02750202

Effectiveness Study of Human Papilloma Virus (HPV) Vaccines to Prevent Recurrence of Genital Warts

NCT02750202

RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2018-07-01
Primary completion
2025-07-31
Completion
2025-07-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gardasil Vaccine 0.5 ml Intramuscular
Comparator Hepatitis B vaccine Vaccine 0.5 ml Intramuscular