- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01928225
Randomized, Double Blind Trial of the Quadrivalent HPV Vaccine to Improve Responses to LEEP Treatment of Cervical HSIL
June 11, 2020 updated by: Cynthia S Firnhaber, University of Witwatersrand, South Africa
A Randomized, Placebo-controlled Trial of Pre-treatment HPV Vaccination on Outcomes to LEEP Treatment of Cervical High Grade Squamous Intraepithelial Lesions in HIV-infected Women.
Cervical cancer occurs commonly in HIV-infected women in South Africa.
These women have poor response to treatment of cervical cancer precursors.
This study will test whether giving the quadrivalent vaccine to women prior to surgical treatment of the cervical cancer precursor will improve outcomes.
We hypothesize that pre-treatment HPV vaccine will result in a reduced occurrence or cervical cancer precursors in follow-up.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This is a single-center, randomized, double-blinded, placebo-controlled, phase II trial of the quadrivalent human papillomavirus vaccine (qHPV) in HIV-infected women to prevent occurrence of cervical HSIL after LEEP/LLETZ.
Participants will undergo colposcopy with directed biopsies, cervical cytology, and stored HPV testing prior to vaccination.
Participants will be randomized to the quadrivalent vaccine or saline placebo to be given at entry, week 4, and week 26.
Women will have LEEP treatment at week 4. Participants will be seen in follow-up for cervical cytology, colposcopy with directed biopsies at weeks 26 and 52, and stored HPV specimens.
Treatment assignment will be unblinded after study follow-up is completed for the last study participant.
Women aged 45 or less randomized to placebo will be offered open label HPV vaccine after the study is concluded..
Study Type
Interventional
Enrollment (Actual)
180
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- HIV infection
- Women aged ≥ 18 years.
- Cervical HSIL on biopsy (i.e. CIN2 and/or CIN3)
- For participants of reproductive potential, negative serum or urine pregnancy test
- All study participants must agree not to participate in a conception process (e.g., active attempt to become pregnant or in vitro fertilization) during study participation (from the time of study entry until week 52).
Exclusion Criteria:
- History or current biopsy diagnosis of invasive or microinvasive cervical, vaginal, vulvar, anal or oropharyngeal cancer
- Prior hysterectomy
- Cervical cryotherapy or LEEP/LEETZ within one year of entry.
- Cervical, vulvar, or vaginal lesions suspicious for cancer, unless biopsies show no invasive cancer
- Prior receipt of one or more doses of an HPV vaccine.
- Receipt of anticoagulants other than aspirin or nonsteroidal anti-inflammatory drugs (NSAIDS) within 14 days prior to entry.
- Known allergy/sensitivity or any hypersensitivity to yeast or any of the components of the study product or its formulation (see section 5.2 for a list of components).
- Hemophilia or other bleeding diatheses.
- Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, other than inhaled corticosteroids or prednisone ≤ 10 mg (or equivalent) , investigational vaccines, interleukins, interferons, growth factors, or intravenous immunoglobulin (IVIG) within 45 days prior to study entry.
- Breastfeeding
- Less than 3 months post-partum
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Human Papillomavirus vaccine
Participants receive the experimental quadrivalent Human Papillomavirus vaccine at entry, week 4 and week 26.
|
The participants receive the qHPV vaccine at entry, week 4 and week 26
Other Names:
|
PLACEBO_COMPARATOR: Saline placebo
The participants receive saline placebo at entry, week 4 and week 26.
|
The participants receive the qHPV vaccine at entry, week 4 and week 26
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cervical HSIL
Time Frame: up to 52 weeks
|
For this trial, the primary endpoint is high-grade squamous intraepithelial lesions (HSIL) or atypical squamous cells suggestive of HSIL found on cervical cytology, or HSIL found on cervical biopsy specimens at either the week 26 or week 52 visit.
|
up to 52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cervical Cytology
Time Frame: Week 26
|
Cervical cytology abnormalities according to the Bethesda scale.
The Bethesda scale classifies cytologic abnormalities.
We have dichotomized the outcomes into high grade squamous intraepithelial lesions (HSIL)/atypical squamous cells suggestive of HSIL, or no evidence of intraepithelial lesions or malignancy (NILM)/atypical squamous cells of unknown significance (ASC-US)/low grade squamous intraepithelial lesions (LSIL).
We report the number of women in each category.
|
Week 26
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Timothy J Wilkin, M.D. MPH, Weill Medical College of Cornell University
- Study Chair: Cynthia Firnhaber, M.D., University or Witswatersrand
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 2, 2014
Primary Completion (ACTUAL)
November 30, 2017
Study Completion (ACTUAL)
March 1, 2018
Study Registration Dates
First Submitted
August 20, 2013
First Submitted That Met QC Criteria
August 22, 2013
First Posted (ESTIMATE)
August 23, 2013
Study Record Updates
Last Update Posted (ACTUAL)
June 24, 2020
Last Update Submitted That Met QC Criteria
June 11, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Uterine Cervical Diseases
- Uterine Diseases
- Precancerous Conditions
- Neoplasms, Squamous Cell
- Carcinoma in Situ
- Carcinoma, Squamous Cell
- Uterine Cervical Dysplasia
- Squamous Intraepithelial Lesions of the Cervix
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- QHPV-RTC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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