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

NCT02750202 | Completed Phase 3 Results

• 1 other identifier: Merck-MISP-53183
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Genital Warts

Keywords

Genital warts; HPV types; HPV vaccine; Cervical cytology; Therapeutic vaccine; Quadrivalent HPV vaccine

Outcome Measures

Primary Outcomes (1)

• Change in the Maximum Size of the Genital Wart Lesion Over the Trial Period (as Measured in mm)

  The number of participants in whom the size of the genital wart lesion(s) measured smaller at Week8, Week24 and Week60 as compared to their baseline measurement (all measured in mm).

  Baseline, week 8, 24, 60

Secondary Outcomes (5)

• 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+

• Number of Participants Who Change From HPV 6 DNA Positive in Warts to Negative at Week 72

  Baseline, week 72

• Number of Participants Who Change From HPV 11 DNA Positive in Warts to Negative at Week 72

  Baseline, week 72

• Number of Participants Who Change From HPV 16 DNA Positive at Baseline to Negative at Week 60

  Baseline, week 60

• Number of Participants Who Change From HPV 18 DNA Positive at Baseline to Negative at Week 60

  Baseline, week 60

Other Outcomes (3)

• Number of Participants Who Change From HIV Negative at Baseline to Positive at Week 48

  Baseline, week 48

• 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

• 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

Study Arms (2)

Quadrivalent HPV vaccine

ACTIVE COMPARATOR

Three doses of 4 HPV vaccine is given at registered intervals.

Biological: Quadrivalent HPV vaccine

Hepatitis B vaccine

SHAM COMPARATOR

Three doses of Hepatitis B vaccine is given at the same intervals as the quadrivalent HPV vaccine.

Biological: Hepatitis B vaccine

Interventions

Quadrivalent HPV vaccine BIOLOGICAL

Quadrivalent HPV vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.

Also known as: Gardasil, 4 HPV vaccine, q HPV vaccine

Quadrivalent HPV vaccine

Hepatitis B vaccine BIOLOGICAL

Hepatitis B vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.

Also known as: Hep B vaccine

Hepatitis B vaccine

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pretoria: lead
• University of Stellenbosch: collaborator

Study Sites (2)

Steve Biko Academic Hospital

Pretoria, Gauteng, South Africa

Location

Tygerberg Hospital

Cape Town, Western Cape, South Africa

Location

MeSH Terms

Conditions

Condylomata Acuminata

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; Hepatitis B Vaccines

Condition Hierarchy (Ancestors)

Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines; Viral Hepatitis Vaccines

Limitations and Caveats

COVID-19 disruptions impacted hugely on this study: gynaecologic outpatient-, HIV- and other clinics scaled down/closed down, and because these clinics were our main sources in recruiting patients, we experienced a huge challenge to find patients fulfilling our inclusion criteria. Participants also experienced financial stress or lost jobs \& subsequently moved to family homes in rural areas, that led to a number of our participants LTFU. We had to adapt, modify or delay our research project.

Results Point of Contact

• Title: Prof G Dreyer
• Organization: University of Pretoria

Greta.Dreyer@up.ac.za

+27123543900

Study Officials

• Greta G Dreyer, MMed(O&G)PhD

  University of Pretoria

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 25, 2016
• Study Start: July 1, 2018
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: January 23, 2026
• Results First Posted: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (2)