Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Uterine Cervical Dysplasia

Squamous Intraepithelial Lesions of the Cervix

Carcinoma

Carcinoma, Squamous Cell

Carcinoma in Situ

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Cervical Intraepithelial Neoplasia

Participants received three IM injections of 6 milligram (mg) (in 1 milliliter \[mL\]) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.

Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.

1 mL VGX-3100 will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.

VGX-3100

1 mL of Placebo will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.

Placebo

Intramuscular injection followed by EP with the CELLECTRA™ 5PSP device.

Electroporation (EP)

Jeffrey Skolnik, MD

HPV-301 is a prospective, randomized, double-blind, placebo controlled Phase 3 study to determine the efficacy, safety, and tolerability of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed cervical high grade squamous intraepithelial lesion (HSIL) (cervical intraepithelial neoplasia grade 2 \[CIN2\] or grade 3 \[CIN3\]) associated with human papillomavirus (HPV) 16 and/or HPV-18.

REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)

A Prospective, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VGX-3100 Delivered Intramuscularly Followed by Electroporation With CELLECTRA™-5PSP for the Treatment of HPV-16 and/or HPV-18 Related High Grade Squamous Intraepithelial Lesion (HSIL) of the Cervix

Participants with no histologic (i.e., biopsies or excisional treatment) evidence of cervical HSIL, no evidence of HPV-16 and/or HPV-18 at the Week 36 time frame, and participants in which excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined by histology as negative, squamous atypia, or low-grade intraepithelial lesion (LSIL). Cervical samples for HPV-16 and/or HPV-18 were collected using the ThinPrep®.

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. An SAE is any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.

Participants with no histologic (i.e., biopsies or excisional treatment) evidence of cervical HSIL at Week 36 and participants in which an excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined by histology as negative, squamous atypia, or LSIL.

Participants with no evidence of HPV-16 and/or HPV-18 at the Week 36 time frame and participants in which an excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. Cervical samples for HPV-16 and/or HPV-18 were collected using the ThinPrep®.

Participants with no histologic evidence of cervical HSIL, squamous atypia, or LSIL at the Week 36 time frame and participants in which an excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined as no evidence of cervical squamous intraepithelial neoplasia 1 (CIN1), CIN2, or CIN3 on biopsies or excisional treatment.

Participants with no histologic evidence of cervical HSIL, squamous atypia, and LSIL, no evidence of HPV-16 and/or HPV-18 by type specific HPV testing at the Week 36 time, and participants in which an excision or biopsy sample was not obtained between initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined as no evidence of CIN1, CIN2, or CIN3 on biopsies or excisional treatment.

Participants with no histologic evidence of cervical Adenocarcinoma in situ or cervical carcinoma at the Week 36 timeframe relative to baseline and participants in which an excision or biopsy sample was not obtained between initial dose up to Week 36 were considered as responders.

Participants with no evidence of HPV-16 and/or HPV-18 on specimens from noncervical anatomic locations (oropharynx, vagina and intra-anal) at the Week 36 time frame were considered as responder.

A standardized binding enzyme-linked immunosorbent assay (ELISA) was performed to measure the anti-HPV-16/18 antibody response induced by VGX-3100.

Assessment of cellular immune activity occurred via the application of the Interferon-γ enzyme-linked immunosorbent spot (IFN-γ ELISpot). Peripheral blood mononuclear cells (PBMCs) isolated from whole blood sample were used for analysis.

Assessment of cellular immune activity was measured using the application flow cytometry for the purposes of performing a Lytic Granule Loading Assay. The Lytic Granule Loading assay examines the following external cellular markers: CD3, CD4, CD8 (T cell identification), CD137, CD38 and CD69 (T cell activation markers) as well as PD-1 (exhaustion/activation marker). Here change from baseline in CD8+CD137+Perforin+, CD8+CD38+Perforin+ and CD8+CD69+Perforin+ are reported.

Inovio Pharmaceuticals

Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.

Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.

VGX-3100 + Electroporation (EP)

Placebo + EP

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

American Indian or Alaska Native

Asian

Black or African American

Native Hawaiian or Other Pacific Islander

White

Other

Multiple

Missing

Race/Ethnicity, Customized

ITT population included all participants who were randomized.

Study Director

Percentage of Participants With No Evidence of Cervical HSIL on Histology and No Evidence of HPV-16 and/or HPV-18 in Cervical Samples

Number of Participants with any AE

Number of Participants with any SAE

Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Investigational Treatment for the Duration of the Study

Percentage of Participants With No Evidence of Cervical HSIL on Histology

Percentage of Participants With No Evidence of HPV-16 and/or HPV-18 in Cervical Samples by Type Specific HPV Testing

Percentage of Participants With No Evidence of LSIL or HSIL on Histology

Percentage of Participants With No Evidence of LSIL or HSIL and No Evidence of HPV-16 and/or HPV-18

Percentage of Participants With No Progression of Cervical HSIL to Cervical Carcinoma

Percentage of Participants Who Have Cleared HPV-16 and/or HPV-18 in Non-cervical Anatomic Locations

HPV-16 E7 at Week 15

HPV-16 E7 at Week 36

HPV-18 E7 at Week 15

HPV-18 E7 at Week 36

mITT population included all participants who received at least one dose of clinical trial treatment and who had the analysis endpoint of interest. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoints.

Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations

HPV-16 E6: Baseline

HPV-16 E6: Change from Baseline at Week 15

HPV-16 E6: Change from Baseline at Week 36

HPV-16 E7: Baseline

HPV-16 E7: Change from Baseline at Week 15

HPV-16 E7: Change from Baseline at Week 36

HPV-18 E6: Baseline

HPV-18 E6: Change from Baseline at Week 15

HPV-18 E6: Change from Baseline at Week 36

HPV-18 E7: Baseline

HPV-18 E7: Change from Baseline at Week 15

HPV-18 E7: Change from Baseline at Week 36

Change From Baseline in Interferon-Gamma Response Magnitude

CD8+CD137+Perforin+: Baseline

CD8+CD137+Perforin+: Change from Baseline at Week 15

CD8+CD38+Perforin+: Baseline

CD8+CD38+Perforin+: Change from Baseline at Week 15

CD8+CD69+Perforin+: Baseline

CD8+CD69+Perforin+: Change from Baseline at Week 15

Change From Baseline in Flow Cytometry Response Magnitude

Overall Study

Infections

Immune System Diseases

Uterine Cervical Neoplasms

Acquired Immunodeficiency Syndrome

HIV Infections

All Drugs and Chemicals

Vaccines

Immunologic Factors

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

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

Human Papillomavirus vaccine

Timothy J Wilkin, M.D. MPH

Cynthia Firnhaber, M.D.

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.

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..

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

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.

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.

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.

Merck Sharp & Dohme LLC

University of Witwatersrand, South Africa

Technical Director of the Clinical HIV Research Unit

Grade 3 or 4 adverse event related to study vaccination. Please note that only deaths, serious adverse events, and grade 3 or 4 adverse events related to study vaccination were captured. Other grade 3 or 4 events were not captured per protocol. Grade 1 or 2 adverse events were not captured per protocol.

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

Human Papillomavirus Vaccine

Saline Placebo

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

Race (NIH/OMB)

South Africa

Region of Enrollment

HSIL= high grade squamous intraepithelial lesions; ASC-H=atypical squamous cells suggestive of HSIL

HSIL/ASC-H cervical cytology

Plasma HIV RNA was missing on 17 participants

Plasma HIV-1 RNA <200 copies/mL

CD4 cell counts were missing on 17 participants

Nadir CD4 counts were not available for two participants

Nadir CD4

Cynthia Frinhaber

Six participants did not have cytologic or histologic samples available for the primary endpoint

Cervical HSIL

Comparison of cytologic outcomes between arms at week 26. Nine participants are missing due to a missed visit, loss to follow-up, or unsatisfactory cytology result.

Cervical Cytology

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

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

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

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

Symptoms and General Pathology

Communicable Diseases

Papillomavirus Infections

Disease Attributes

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

DNA Virus Infections

Tumor Virus Infections

Women will be screened for cervical cancer with HPV testing that provides extended genotyping and DNA quantification. Women will also provide other samples for cervical cancer screening tests. Women will under cervical biopsies.

The Cepheid Xpert HPV Assay (Xpert HPV) is a qualitative, real-time polymerase chain reaction (PCR) assay for the detection of hrHPV DNA. The assay is formatted in a single-use, Xpert HPV test cartridge and is run on the Cepheid Xpert® System, a multi-analyte, random access, molecular-diagnostic platform ranging in capacity from 1 to 80 test processing modules. Importantly, a single hrHPV DNA test can be completed in one hour, permitting same-day screening and diagnosis (e.g. colposcopy) or treatment (e.g. cryotherapy), reducing the potential for loss to follow-up in lower-resource settings. It uses liquid-based cytologic media and yields five separate results or channels: HPV16, HPV18/45, HPV 31/33/35/52/58, HPV51/59, HPV39/68/56/66 all with a corresponding cycle threshold.

Xpert HPV

The S5 classifier is a combination of DNA methylation levels of the late regions of the L1 and L2 proteins from HPV16, HPV18, HPV31, and HPV33, as well as DNA methylation of the promotor region of the human tumor suppressor gene, Erythrocyte Membrane Protein Band 4.1 Like 3 (EPB41L3).

S5 DNA methylation classifier

Caíque Mello, MPH

Glenn Sturge

Lenice Galan de Paula

Luisa L Villa, PhD

Alejandra J Portillo Romero, MD

Eduardo C Lazcano Ponce, MD

Timothy Wilkin, MD, MPH

Grant Ellsworth, MD, MS

Cervical cancer is a relatively common cancer among women living with human immunodeficiency virus (HIV). This study will test women for human papillomavirus (HPV) infection of the cervix. The main purpose of this study is to determine the best way to test for damaged areas of the cervix. Damaged areas of the cervix should be treated and removed to prevent cancer of the cervix.

Women in this study will be seen once, twice or three times in a year. Women will provide several samples related to screening for cervical cancer including a swab of the cervix, a self-collected swab of the vagina and urine. Women will have a detailed examination of the cervix called colposcopy and have a few biopsies, or small pinches of the cervix, to look for areas at risk for turning into cancer. If HPV of the cervix is found but treatment of the cervix is not indicated, women will return in 6 months and in 12 months to repeat these tests. Most women will only need 1 visit. Women found to have damaged areas of the cervix at risk for turning into cancer will be referred for treatment.

This protocol will compare different tests to understand the best test to identify women at risk for cervical cancer.

The overall goal of this research is to develop a point of care high-risk HPV (hrHPV) test and molecular testing that optimizes specificity to detect high-grade squamous intraepithelial lesions (HSIL), specifically cervical intraepithelial neoplasia of grade 2 or more (CIN 2+), in women living with HIV (WHIV) in Latin America while maintaining high test sensitivity. To accomplish this goal, the protocol will optimize cervical screening by modifying the cycle threshold/genotype interpretation of Xpert HPV assay output. In a secondary manner, the protocol will also evaluate whether triage with HPV/host DNA methylation improves the specificity of Xpert alone.

The hypotheses for this protocol includes:

• The Xpert HPV test can be optimized for HSIL detection (CIN2+) in WHIV to significantly improve test specificity, when compared to unmodified test output using manufacturer guidelines.

To evaluate this hypothesis, the protocol will enroll 1000 cisgender women or transgender men age 25-65 years living with HIV who are undergoing routine cervical cancer screening. These individuals will be recruited from affiliated clinical sites of the National Institute of Public Health in Cuernavaca, Mexico and University of São Paulo, Brazil. Participants will provide a first void urine sample and will be instructed how to self-collect a vaginal swab. An oral gargle specimen will be collected for HPV testing, HPV methylation, and Epstein-Bar Virus (EBV) co-infection. They will receive a baseline questionnaire about risk factors for HPV and cervical cancer, and provide a blood specimen for CD4 count, plasma viral load, DNA methylation of biological aging, circulating tumor HPV DNA (ctHPVDNA) analysis, and stored sera. Next, a provider will collect an anal swab. Then the participant will undergo a speculum exam and a provider will collect a cervical cytobroom sample for cytology and HPV testing followed by a swab for stored specimens. Finally, acetic acid will be applied followed by a digital image of the cervix. Then at least two cervical biopsies will be obtained.

Material from one provider-collected cervical swab will undergo cervical cytology assessment using Bethesda Criteria. Cervical histology results from the collected biopsies will be interpreted according to the Lower Anogenital Squamous Terminology (LAST). HSIL will be defined as CIN 2 with diffuse p16 staining, CIN 2-3, or CIN 3. Women diagnosed with HSIL will be treated according to local standards. The local histology result will be used for the management of participants. Any lesions suspicious for invasive cancer will be referred to the appropriate specialist. Women with HSIL on cytology, but no HSIL on histology will be treated according to the local standard. The management options include repeat colposcopy, endocervical curettage, or a diagnostic loop electro-excision procedure. Similarly, women with a Type 3 transformation zone should have endocervical curettage and be managed according to local standards. After local pathology review, all histology specimens will be shipped centrally for Histology Endpoint Adjudication; these adjudicated histology results will be used for reporting research findings. The details of this process will be in the Manual of Procedures. Discordance between the local and central pathology review will be adjudicated with a second central pathologist. The final histology result will be sent back to the local site and provided to the participant and their providers. Women found to have vulvar, vaginal or perianal lesions suspicious for HSIL will be referred for appropriate evaluation.

The self-collected vaginal swab and material from the provider-collected cytobroom sample will be tested for HPV using Xpert HPV. Xpert testing of self- and provider-collected samples will be conducted locally (at the point of care) in Brazil and Mexico. Remaining material from the vaginal and cervical samples will be shipped to Dr. Villa's lab in Brazil to allow for S5 methylation testing of any WHIV with hrHPV detected. Residual samples, as well as the collected urine, will be stored in Dr. Villa's lab for future studies.

Women with hrHPV detected on a provider-collected cervical sample using a locally available and approved test, but who were negative for HSIL as determined by cervical biopsy, will be asked to return for a follow-up study visit at 6-month to receive the same procedures described above (with the exception of blood draws). If at the 6-month follow-up visit WHIV continue to have detection of hrHPV, but are HSIL negative by biopsy, they will be asked to return for an additional follow-up study visit 6 months later (12-months post-baseline) to receive the same procedures. We estimate that approximately 40% of the population will have hrHPV detected and may need to return for a follow-up visit; and 7% will be HSIL+ and referred for treatment.

The study will enroll cisgender women and transgender men.

Optimization of Cervical Cancer Screening Among Women Living With HIV in Latin American Countries

Individual participant data that underlie results in the publication, after deidentification

Cervical HSIL is defined as cervical intraepithelial neoplasia (CIN) 2 with p16 staining, CIN2-3, or CIN3) or squamous cell carcinoma from histology of cervical biopsies

Cervical HSIL is defined as cervical intraepithelial neoplasia (CIN) 2 with p16 staining, CIN2-3, or CIN3) or squamous cell carcinoma from histology of cervical biopsies.

Only those subjects that had detection of hrHPV in cervical or vaginal specimens at the baseline or 6 month visit will be included in the count.

National Cancer Institute (NCI)

H. Lee Moffitt Cancer Center and Research Institute

University of Sao Paulo

Mexican National Institute of Public Health

Rutgers University

Weill Medical College of Cornell University

IM injections with VGX-3100 followed by electroporation (EP) using the CELLECTRA™-5PSP device on Day 0, Week 4 and Week 12.

IM injections with matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4 and Week 12.

1 milliLiter (mL) VGX-3100 will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.

CELLECTRA™-5PSP is used for EP following IM injection of VGX 3100 or placebo on Day 0, Week 4 and Week 12.

CELLECTRA™-5PSP

HPV-303 is a prospective, randomized, double-blind, placebo-controlled phase 3 study of VGX-3100 delivered intramuscularly (IM) followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed high-grade squamous intraepithelial lesions (HSIL) (cervical intraepithelial neoplasia grade 2 \[CIN2\] or grade 3 \[CIN3\]) of the cervix, associated with HPV-16 and/or HPV-18.

REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)

Randomized Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL

Participants will be evaluated for evidence of cervical HSIL on histology as well as evidence of HPV-16 and/or HPV-18 in cervical samples by type-specific HPV testing at the Week 36 visit.

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. An SAE is any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.

Participants will be evaluated for evidence of HPV-16 and/or HPV-18 in cervical samples by type-specific HPV testing at the Week 36 visit.

Participants will be evaluated for evidence of cervical HSIL on histology at the Week 36 visit.

Participants will be evaluated for evidence of cervical LSIL and HSIL (i.e. no evidence of cervical intraepithelial neoplasia grade 1 \[CIN1\], CIN2 or CIN3) on histology at the Week 36 visit.

Participants will be evaluated for evidence of cervical LSIL and HSIL (i.e. no evidence of CIN1, CIN2 or CIN3) on histology and be evaluated for evidence of HPV-16 and/or HPV-18 in cervical samples by type-specific HPV testing at the Week 36 visit.

Participants will be evaluated for progression of cervical HSIL to cervical carcinoma from baseline on histology at the Week 36 visit.

Participants will be evaluated for HPV-16 and/or HPV-18 status in specimens from non-cervical anatomic locations (oropharynx, vagina and intra-anal) at the Week 36 Visit.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)	NCT03185013	Cervical Dyspla... Cervical High G... HSIL	VGX-3100 Placebo Electroporation...	18 Years -	Inovio Pharmaceuticals
Randomized, Double Blind Trial of the Quadrivalent HPV Vaccine to Improve Responses to LEEP Treatment of Cervical HSIL	NCT01928225	Cervical High G...	Human Papilloma...	18 Years -	University of Witwatersrand, South Africa
Randomized, Double Blind Trial of the Quadrivalent HPV Vaccine to Improve Responses to LEEP Treatment of Cervical HSIL	NCT01928225	Cervical High G...	Human Papilloma...	18 Years -	University of Witwatersrand, South Africa
REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)	NCT03185013	Cervical Dyspla... Cervical High G... HSIL	VGX-3100 Placebo Electroporation...	18 Years -	Inovio Pharmaceuticals
Optimization of Cervical Cancer Screening Among Women Living With HIV in Latin American Countries	NCT06002126	Cervix Cancer HPV Infection Cervical High G... HIV Infections	Xpert HPV S5 DNA methylat...	25 Years - 65 Years	Weill Medical College of Cornell University
Randomized, Double Blind Trial of the Quadrivalent HPV Vaccine to Improve Responses to LEEP Treatment of Cervical HSIL	NCT01928225	Cervical High G...	Human Papilloma...	18 Years -	University of Witwatersrand, South Africa
REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)	NCT03721978	Cervical Dyspla... Cervical High G... HSIL	VGX-3100 Placebo CELLECTRA™-5PSP	18 Years -	Inovio Pharmaceuticals

Spots Global Cancer Trial Database for cervical high grade squamous intraepithelial lesion