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

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ClinicalTrials.gov Identifier: NCT02750202
Recruitment Status : Recruiting
First Posted : April 25, 2016
Last Update Posted : October 29, 2018
Sponsor:
Collaborator:
University of Stellenbosch
Information provided by (Responsible Party):
Professor Greta Dreyer, University of Pretoria

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.

Condition or disease Intervention/treatment Phase
Genital Warts Biological: Quadrivalent HPV vaccine Biological: Hepatitis B vaccine Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Prophylactic Vaccines as Therapy: Prevention of Recurrence of Extensive Genital Warts
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Quadrivalent HPV vaccine
Three doses of 4 HPV vaccine is given at registered intervals.
Biological: Quadrivalent HPV vaccine
Quadrivalent HPV vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
Other Names:
  • Gardasil
  • 4 HPV vaccine
  • q HPV vaccine

Sham Comparator: Hepatitis B vaccine
Three doses of Hepatitis B vaccine is given at the same intervals as the quadrivalent HPV vaccine.
Biological: Hepatitis B vaccine
Hepatitis B vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
Other Name: Hep B vaccine




Primary Outcome Measures :
  1. Change in the maximum size of the genital wart lesion over the trial period (as measured in mm) [ Time Frame: Baseline, week 8, 16, 24, 36, 48, 60, 72 ]

Secondary Outcome Measures :
  1. 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) [ Time Frame: Week 36+ ]
  2. Number of participants who change from HPV 6 DNA positive in warts to negative at week 72 [ Time Frame: Baseline, week 72 ]
  3. Number of participants who change from HPV 11 DNA positive in warts to negative at week 72 [ Time Frame: Baseline, week 72 ]
  4. Number of participants who change from HPV 16 DNA positive at baseline to negative at week 60 [ Time Frame: Baseline, week 60 ]
  5. Number of participants who change from HPV 18 DNA positive at baseline to negative at week 60 [ Time Frame: Baseline, week 60 ]

Other Outcome Measures:
  1. Number of participants who change from HIV negative at baseline to positive at week 48 [ Time Frame: Baseline, week 48 ]
  2. Number of participants who require surgical treatment of warts at any of the clinical assessments during the trial, as judged by the attending clinician. [ Time Frame: Week 24, 72 ]
  3. 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. [ Time Frame: Week 24, 72 ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750202


Contacts
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Contact: Greta G Dreyer, MMed(O&G)PhD +27 12 354 3900 Greta.Dreyer@up.ac.za
Contact: Cathy Visser, BSc(Hons)MSc +27 82 403 0691 visser.cathy@gmail.com

Locations
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South Africa
Steve Biko Academic Hospital Recruiting
Pretoria, Gauteng, South Africa
Contact: Cathy Visser, MSc    +27 12 354 3900    visser.cathy@gmail.com   
Principal Investigator: Leon C Snyman, MMedO&G;FCOG         
Tygerberg Hospital Not yet recruiting
Cape Town, Western Cape, South Africa
Contact: Frederick H van der Merwe, MMedO&G,FCOG    +27 21 938 9209    haynes@sun.ac.za   
Sponsors and Collaborators
University of Pretoria
University of Stellenbosch
Investigators
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Principal Investigator: Greta G Dreyer, MMed(O&G)PhD University of Pretoria

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Responsible Party: Professor Greta Dreyer, Professor, University of Pretoria
ClinicalTrials.gov Identifier: NCT02750202     History of Changes
Other Study ID Numbers: Merck-MISP-53183
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Professor Greta Dreyer, University of Pretoria:
Genital warts
HPV types
HPV vaccine
Cervical cytology
Therapeutic vaccine
Quadrivalent HPV vaccine

Additional relevant MeSH terms:
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Recurrence
Warts
Condylomata Acuminata
Disease Attributes
Pathologic Processes
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs