Cervical Intraepithelial NeoplasiaPhase 2NCT02481414
A Clinical Trial of PepCan to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions
A Phase 2 study testing PepCan and Candin® in people with Cervical Intraepithelial Neoplasia, run by University of Arkansas at 1 site in United States.
Trial summary
This is a Phase II study to evaluate the efficacy and safety of a human papilloma virus (HPV) therapeutic vaccine called PepCan (HPV 16 E6 peptides combined with Candida skin testing reagent called Candin®) in adult females over a 12 month time period. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- What is being tested?
- PepCan and Candin®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2015to 14 Sep 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-50 years
- Had recent (≤ 60 days) Pap smear result consistent with high grade squamous intraepithelial lesion (HSIL) or "cannot rule out HSIL" or HSIL on colposcopy-guided biopsy
- Untreated for HSIL or "Cannot rule out HSIL"
- Able to provide informed consent
- Willingness and able to comply with the requirements of the protocol
Who cannot join
- History of disease or treatment causing immunosuppression (e.g., cancer, human immunodeficiency virus (HIV), organ transplant, autoimmune disease)
- Being pregnant or attempting to be pregnant within the period of study participation
- Breast feeding or planning to breast feed within the period of study participation
- Allergy to Candida antigen
- History of severe asthma requiring emergency room visit or hospitalization within the past 5 years
- History of invasive squamous cell carcinoma of the cervix
- History of having received PepCan
- If in the opinion of the Principal Investigator or other Investigators, it is not in the best interest of the patient to enter this study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: A Phase II Clinical Trial of PepCan Randomized and Double-Blinded to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions
This is a Phase II study to evaluate the efficacy and safety of a human papilloma virus (HPV) therapeutic vaccine called PepCan (HPV 16 E6 peptides combined with Candida skin testing reagent called Candin®) in adult females over a 12 month time period. As the results from the Phase I trial demonstrated some efficacy against non-16 HPV types, Candin alone will also be tested. Therefore, there will be two treatment arms: (1) PepCan and (2) Candin. Subjects found to be eligible for vaccination will be randomized in a double-blinded fashion at a 1:1 ratio. Each participant will be receiving injections four times with three weeks between injections. Clinical and virological responses will be assessed at 6 and 12 months. Safety will be assessed from the time of enrollment to 12 Month Visit. Immunological assessments will be made at 4 time points (prevaccination, after 2 injections, 6 month after 4 injections and 12 months after 4 vaccinations).
Read the detailed description
This is a single site Phase II clinical trial of PepCan for treating women with biopsy-proven HSILs (High Grade Intraepithelial Lesions) randomized and double-blinded to two treatment arms. Half of the subjects will receive PepCan, and the other half will receive Candin® alone. The study design closely resembles the latest guidelines for treating young women with HSIL. Study subjects will be patients attending the University of Arkansas for Medical Sciences (UAMS) Obstetrics and Gynecology Clinics with untreated biopsy-proven HSILs and patients referred from other clinics. Four injections (one every 3 weeks) of PepCan or Candin® will be intradermally administered in the extremities. Clinical response will be assessed by comparison of colposcopy-guided biopsy results obtained prior to vaccination and at 12-Month Visit. Safety will be monitored from the time of enrollment through the 12-Month Visit. Blood will be drawn for laboratory testing and immunological analyses ("blood test") prior to injection, after the second vaccination, 6 months after the fourth vaccination, and 12 months after the fourth vaccination. Blood will be drawn to aid T-cell analyses ("blood draw") after the first and third vaccinations, and possibly at the Optional Follow-Up and/or Optional Loop Electrosurgical Excision Procedure (LEEP) visits. HPV-DNA testing will be performed at Screening and 6- and 12-Month Visits. If a subject has persistent HSIL at the 12-Month Visit or if a subject is withdrawn due to excessive toxicity, she will be given an option to return for a LEEP visit. Alternatively, she may choose to exit the study and be followed by a gynecologist for up to 2 years of observation as recommended before surgical treatment
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- PepCan, Candin®
- Keywords
- HSIL, CIN II/III
- Medical subject headings
- Uterine Cervical Dysplasia, Squamous Intraepithelial Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PepCanBiological
Also called HPV 16 E6 peptides combined with Candin®
50 μg peptide + 0.3 mL Candin® per dose administered intradermally in the extremities
Candin®Biological
Also called Candida skin testing reagent
0.3 mL Candin® per dose administered intradermally in the extremities
| Study group | Role | What they receive |
|---|---|---|
| PepCan | Experimental | Four injections (one every 3 weeks) of PepCan Receives: Biological: PepCan |
| Candin | Active comparator | Four injections (one every 3 weeks) of Candin Receives: Biological: Candin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Complete Response With the Intention-to-treat (ITT) Analysis
Histological regression of moderate/severe cervical dysplasia to absence of cervical dysplasia assessed using biopsies (stringent)
Measured: 15 months from time of last vaccination
Number of Subjects With Complete Response With the Per-protocol Analysis
Histological regression of moderate/severe cervical dysplasia to absence of cervical dysplasia assessed using biopsies (stringent)".
Measured: 15 months from time of last vaccination
Number of Subjects With Complete and Partial Responses With the ITT Analysis
Histological regression of moderate/severe cervical dysplasia to mild dysplasia/no dysplasia (lenient) assessed using biopsies, likely avoiding a need for surgery
Measured: 15 months from time of last vaccination
Number of Subjects With Complete and Partial Responses With the Per-protocol Analysis
Histological regression of moderate/severe cervical dysplasia to mild dysplasia/no dysplasia (lenient) assessed using biopsies, likely avoiding a need for surgery
Measured: 15 months from time of last vaccination
Secondary outcomes (1)
Safety Assessed by Injection-related Adverse Events (AEs)
Injection-related AEs occurring in >5% of injections
Measured: 15 months from time of last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study start30 Nov 2015
- Primary completion14 Sep 2022
- Study completion14 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- PepCan or Candin randomized at a 1:1 ratio in a double-blinded design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mayumi N Nakagawa, MD, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481414
- Sponsor's protocol ID
- 202790
- Status last verified
- Nov 2023
- First submitted
- 16 Jun 2015
- Last updated
- 18 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial of PepCan Randomized and Double-Blinded to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions
- ClinicalTrials.gov ID
- NCT02481414
- Acronym / sponsor ID
- 202790
- Conditions
- Cervical Intraepithelial Neoplasia
- Keywords
- HSIL, CIN II/III
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 30 Nov 2015 (actual)
- Primary completion
- 14 Sep 2022 (actual)
- Study completion
- 14 Sep 2022 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Posted 18 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II study to evaluate the efficacy and safety of a human papilloma virus (HPV) therapeutic vaccine called PepCan (HPV 16 E6 peptides combined with Candida skin testing reagent called Candin®) in adult females over a 12 month time period. As the results from the Phase I trial demonstrated some efficacy against non-16 HPV types, Candin alone will also be tested. Therefore, there will be two treatment arms: (1) PepCan and (2) Candin. Subjects found to be eligible for vaccination will be randomized in a double-blinded fashion at a 1:1 ratio. Each participant will be receiving injections four times with three weeks between injections. Clinical and virological responses will be assessed at 6 and 12 months. Safety will be assessed from the time of enrollment to 12 Month Visit. Immunological assessments will be made at 4 time points (prevaccination, after 2 injections, 6 month after 4 injections and 12 months after 4 vaccinations).
Detailed description
This is a single site Phase II clinical trial of PepCan for treating women with biopsy-proven HSILs (High Grade Intraepithelial Lesions) randomized and double-blinded to two treatment arms. Half of the subjects will receive PepCan, and the other half will receive Candin® alone. The study design closely resembles the latest guidelines for treating young women with HSIL. Study subjects will be patients attending the University of Arkansas for Medical Sciences (UAMS) Obstetrics and Gynecology Clinics with untreated biopsy-proven HSILs and patients referred from other clinics. Four injections (one every 3 weeks) of PepCan or Candin® will be intradermally administered in the extremities. Clinical response will be assessed by comparison of colposcopy-guided biopsy results obtained prior to vaccination and at 12-Month Visit. Safety will be monitored from the time of enrollment through the 12-Month Visit. Blood will be drawn for laboratory testing and immunological analyses ("blood test") prior to injection, after the second vaccination, 6 months after the fourth vaccination, and 12 months after the fourth vaccination. Blood will be drawn to aid T-cell analyses ("blood draw") after the first and third vaccinations, and possibly at the Optional Follow-Up and/or Optional Loop Electrosurgical Excision Procedure (LEEP) visits. HPV-DNA testing will be performed at Screening and 6- and 12-Month Visits. If a subject has persistent HSIL at the 12-Month Visit or if a subject is withdrawn due to excessive toxicity, she will be given an option to return for a LEEP visit. Alternatively, she may choose to exit the study and be followed by a gynecologist for up to 2 years of observation as recommended before surgical treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- PepCan or Candin randomized at a 1:1 ratio in a double-blinded design.
| Arm | Type | Receives |
|---|---|---|
| PepCan | Experimental | Biological: PepCanFour injections (one every 3 weeks) of PepCan |
| Candin | Active comparator | Biological: Candin®Four injections (one every 3 weeks) of Candin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18-50 years
- Had recent (≤ 60 days) Pap smear result consistent with high grade squamous intraepithelial lesion (HSIL) or "cannot rule out HSIL" or HSIL on colposcopy-guided biopsy
- Untreated for HSIL or "Cannot rule out HSIL"
- Able to provide informed consent
- Willingness and able to comply with the requirements of the protocol
Key exclusion criteria (8 listed)
- History of disease or treatment causing immunosuppression (e.g., cancer, human immunodeficiency virus (HIV), organ transplant, autoimmune disease)
- Being pregnant or attempting to be pregnant within the period of study participation
- Breast feeding or planning to breast feed within the period of study participation
- Allergy to Candida antigen
- History of severe asthma requiring emergency room visit or hospitalization within the past 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PepCanAlso: HPV 16 E6 peptides combined with Candin®50 μg peptide + 0.3 mL Candin® per dose administered intradermally in the extremities | Biological | PepCan |
| Candin®Also: Candida skin testing reagent0.3 mL Candin® per dose administered intradermally in the extremities | Biological | Candin |
Primary outcome
Number of Subjects With Complete Response With the Intention-to-treat (ITT) Analysis
Time frame: 15 months from time of last vaccination
Histological regression of moderate/severe cervical dysplasia to absence of cervical dysplasia assessed using biopsies (stringent)
Number of Subjects With Complete Response With the Per-protocol Analysis
Time frame: 15 months from time of last vaccination
Histological regression of moderate/severe cervical dysplasia to absence of cervical dysplasia assessed using biopsies (stringent)".
Number of Subjects With Complete and Partial Responses With the ITT Analysis
Time frame: 15 months from time of last vaccination
Histological regression of moderate/severe cervical dysplasia to mild dysplasia/no dysplasia (lenient) assessed using biopsies, likely avoiding a need for surgery
Number of Subjects With Complete and Partial Responses With the Per-protocol Analysis
Time frame: 15 months from time of last vaccination
Histological regression of moderate/severe cervical dysplasia to mild dysplasia/no dysplasia (lenient) assessed using biopsies, likely avoiding a need for surgery
1 secondary outcome
Safety Assessed by Injection-related Adverse Events (AEs)
Time frame: 15 months from time of last vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cervical Intraepithelial Neoplasia
RecruitingObservational study
Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring
Cervical Cancer, Cervical Dysplasia
RecruitingObservational study
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Endometrial Cancer, Cervical Cancer
Recruiting
Feasibility Study Comparing Use of One Or Two Probes for Thermal Ablation Among Screen Positive Women Living With HIV in C1001P-CS2 Kenya
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive WLWH in C1001P-CS9 South Africa
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for TA Among Cervical Cancer Screen Positive WLWH in C1001P-CS5 Rwanda
HIV (Human Immunodeficiency Virus), HPV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mayumi N Nakagawa, MD, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PepCan and Candin® in people with Cervical Intraepithelial Neoplasia, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Complete Response With the Intention-to-treat (ITT) Analysis (time frame: 15 months from time of last vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.