Phase 2
N=180
Randomized, Double Blind Trial of the Quadrivalent HPV Vaccine to Improve Responses to LEEP Treatment of Cervical HSIL
Cervical High Grade Squamous Intraepithelial Lesion
Bottom Line
View on ClinicalTrials.gov: NCT01928225 ↗Enrolled (actual)
180
Serious AEs
1.1%
Results posted
Jun 2020
Primary outcome: Primary: Cervical HSIL — 46; 39 Participants — p=.29
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Human Papillomavirus vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Witwatersrand, South Africa
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cervical HSIL |
46; 39 | .29 |
| SECONDARY Cervical Cytology |
34; 26; 52; 59 | .22 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01928225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.