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

NCT01928225 | Completed Phase 2 Results DMC

• 1 other identifier: QHPV-RTC
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cervical High Grade Squamous Intraepithelial Lesion

Keywords

HSIL; CIN; HPV; HPV vaccination; gardasil; HIV; cervical dysplasia; LEEP; cervical cancer

Outcome Measures

Primary Outcomes (1)

• Cervical HSIL

  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 Outcomes (1)

• Cervical Cytology

  Week 26

Study Arms (2)

Human Papillomavirus vaccine

EXPERIMENTAL

Participants receive the experimental quadrivalent Human Papillomavirus vaccine at entry, week 4 and week 26.

Biological: Human Papillomavirus vaccine

Saline placebo

PLACEBO COMPARATOR

The participants receive saline placebo at entry, week 4 and week 26.

Biological: Human Papillomavirus vaccine

Interventions

Human Papillomavirus vaccine BIOLOGICAL

The participants receive the qHPV vaccine at entry, week 4 and week 26

Also known as: qHPV vaccine

Human Papillomavirus vaccine; Saline placebo

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Witwatersrand, South Africa: lead
• Merck Sharp & Dohme LLC: collaborator

Related Publications (1)

• Firnhaber C, Swarts A, Jezile V, Mulongo M, Goeieman B, Williams S, Faesen M, Michelow P, Wilkin T. Human Papillomavirus Vaccination Prior to Loop Electroexcision Procedure Does Not Prevent Recurrent Cervical High-grade Squamous Intraepithelial Lesions in Women Living With Human Immunodeficiency Virus: A Randomized, Double-blind, Placebo-controlled Trial. Clin Infect Dis. 2021 Oct 5;73(7):e2211-e2216. doi: 10.1093/cid/ciaa1456.

  PMID: 32975556 DERIVED

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Uterine Cervical Neoplasms

Interventions

Papillomavirus Vaccines

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Cynthia Frinhaber
• Organization: University of Colorado

cynthia.firnhaber@cuanschutz.edu

720-848-0000

Study Officials

• Timothy J Wilkin, M.D. MPH

  Weill Medical College of Cornell University

  STUDY CHAIR

• Cynthia Firnhaber, M.D.

  University or Witswatersrand

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Technical Director of the Clinical HIV Research Unit

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: August 23, 2013
• Study Start: September 2, 2014
• Primary Completion: November 30, 2017
• Study Completion: March 1, 2018
• Last Updated: June 24, 2020
• Results First Posted: June 24, 2020

Record last verified: 2020-06