Randomized, Double Blind Trial of the Quadrivalent HPV Vaccine to Improve Responses to LEEP Treatment of Cervical HSIL
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ClinicalTrials.gov Identifier: NCT01928225 |
Recruitment Status
:
Enrolling by invitation
First Posted
: August 23, 2013
Last Update Posted
: May 13, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cervical High Grade Squamous Intraepithelial Lesion | Biological: Human Papillomavirus vaccine | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Human Papillomavirus vaccine
Participants receive the experimental quadrivalent Human Papillomavirus vaccine at entry, week 4 and week 26.
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Biological: Human Papillomavirus vaccine
The participants receive the qHPV vaccine at entry, week 4 and week 26
Other Name: qHPV vaccine
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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
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- Cervical HSIL [ Time Frame: up to 52 weeks ]HSIL on cervical cytology or HSIL on cervical biopsy
- Cervical Cytology [ Time Frame: Week 26 and Week 52 ]Cervical cytology abnormalities according to the Bethesda scale.
- 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.
- 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.
- 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.

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

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): NCT01928225
Study Chair: | Timothy J Wilkin, M.D. MPH | Weill Medical College of Cornell University | |
Study Chair: | Cynthia Firnhaber, M.D. | University or Witswatersrand |
Responsible Party: | Cynthia S Firnhaber, Technical Director of the Clinical HIV Research Unit, University of Witwatersrand, South Africa |
ClinicalTrials.gov 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:
HSIL CIN HPV HPV vaccination gardasil |
HIV cervical dysplasia LEEP cervical cancer |
Additional relevant MeSH terms:
Squamous Intraepithelial Lesions of the Cervix Uterine Cervical Dysplasia Precancerous Conditions Neoplasms Uterine Cervical Diseases |
Uterine Diseases Genital Diseases, Female Vaccines Immunologic Factors Physiological Effects of Drugs |