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Randomized, Double Blind Trial of the Quadrivalent HPV Vaccine to Improve Responses to LEEP Treatment of Cervical HSIL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01928225
Recruitment Status : Unknown
Verified May 2016 by Cynthia S Firnhaber, University of Witwatersrand, South Africa.
Recruitment status was:  Enrolling by invitation
First Posted : August 23, 2013
Last Update Posted : May 13, 2016
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Cynthia S Firnhaber, University of Witwatersrand, South Africa

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cervical High Grade Squamous Intraepithelial Lesion Biological: Human Papillomavirus vaccine Phase 2

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..

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : September 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Human Papillomavirus vaccine
Participants receive the experimental quadrivalent Human Papillomavirus vaccine at entry, week 4 and week 26.
Biological: Human Papillomavirus vaccine
The participants receive the qHPV vaccine at entry, week 4 and week 26
Other Name: qHPV vaccine

Placebo Comparator: Saline placebo
The participants receive saline placebo at entry, week 4 and week 26.
Biological: Human Papillomavirus vaccine
The participants receive the qHPV vaccine at entry, week 4 and week 26
Other Name: qHPV vaccine

Primary Outcome Measures :
  1. Cervical HSIL [ Time Frame: up to 52 weeks ]
    HSIL on cervical cytology or HSIL on cervical biopsy

Secondary Outcome Measures :
  1. Cervical Cytology [ Time Frame: Week 26 and Week 52 ]
    Cervical cytology abnormalities according to the Bethesda scale.

  2. Stored cervical swabs [ Time Frame: Week 0, 4, 26 and 52 ]
    Proportion of participants with stored cervical swabs for future HPV DNA testing at these time points.

  3. Stored specimens from immunology subset participants [ Time Frame: Weeks 0, 4, 26 and 52 ]
    We will report the proportion of participants with stored cervical fluid, plasma, serum, PBMC, and whole blood lysate at these time points.

  4. Subgroup analyses of primary outcome [ Time Frame: Weeks 26 and 52 ]
    Cervical HSIL at week 26 and 52 in women stratified by whether cervical HSIL is found on LEEP/LLETZ biopsy, and stratified by whether LEEP/LLETZ margins have HSIL detected.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. HIV infection
  2. Women aged ≥ 18 years.
  3. Cervical HSIL on biopsy (i.e. CIN2 and/or CIN3)
  4. For participants of reproductive potential, negative serum or urine pregnancy test
  5. 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:

  1. History or current biopsy diagnosis of invasive or microinvasive cervical, vaginal, vulvar, anal or oropharyngeal cancer
  2. Prior hysterectomy
  3. Cervical cryotherapy or LEEP/LEETZ within one year of entry.
  4. Cervical, vulvar, or vaginal lesions suspicious for cancer, unless biopsies show no invasive cancer
  5. Prior receipt of one or more doses of an HPV vaccine.
  6. Receipt of anticoagulants other than aspirin or nonsteroidal anti-inflammatory drugs (NSAIDS) within 14 days prior to entry.
  7. 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).
  8. Hemophilia or other bleeding diatheses.
  9. 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.
  10. Breastfeeding
  11. Less than 3 months post-partum

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 identifier (NCT number): NCT01928225

Sponsors and Collaborators
University of Witwatersrand, South Africa
Merck Sharp & Dohme Corp.
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Study Chair: Timothy J Wilkin, M.D. MPH Weill Medical College of Cornell University
Study Chair: Cynthia Firnhaber, M.D. University or Witswatersrand

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Responsible Party: Cynthia S Firnhaber, Technical Director of the Clinical HIV Research Unit, University of Witwatersrand, South Africa Identifier: NCT01928225     History of Changes
Other Study ID Numbers: QHPV-RTC
First Posted: August 23, 2013    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Cynthia S Firnhaber, University of Witwatersrand, South Africa:
HPV vaccination
cervical dysplasia
cervical cancer
Additional relevant MeSH terms:
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Squamous Intraepithelial Lesions of the Cervix
Uterine Cervical Dysplasia
Precancerous Conditions
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Immunologic Factors
Physiological Effects of Drugs