A Phase 2 interventional study of PepCan and Candin® in Cervical Intraepithelial Neoplasia, sponsored by University of Arkansas. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-12-18.
Sponsored by University of Arkansas · Phase 2, Interventional, and Treatment
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).
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
356 studies on the registry are indexed under Uterine Cervical Dysplasia; 68 are open to participants now.
This study's enrollment of 81 is below the median of 166 across 249 interventional studies indexed under Uterine Cervical Dysplasia.
Browse Uterine Cervical Dysplasia studies →University of Arkansas is the lead sponsor of 391 studies on the registry; 39 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Four injections (one every 3 weeks) of PepCan
Biological: PepCan
Four injections (one every 3 weeks) of Candin
Biological: Candin®
50 μg peptide + 0.3 mL Candin® per dose administered intradermally in the extremities
Also known as: HPV 16 E6 peptides combined with Candin®
0.3 mL Candin® per dose administered intradermally in the extremities
Also known as: Candida skin testing reagent
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)
Time frame: 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)".
Time frame: 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
Time frame: 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
Time frame: 15 months from time of last vaccination
Safety Assessed by Injection-related Adverse Events (AEs)
Injection-related AEs occurring in \>5% of injections
Time frame: 15 months from time of last vaccination
| Milestone | PepCan | Candin |
|---|---|---|
| Started | 39 | 42 |
| Completed | 35 | 41 |
| Not completed | 4 | 1 |
Histological regression of moderate/severe cervical dysplasia to absence of cervical dysplasia assessed using biopsies (stringent)
| Participants | PepCan | Candin |
|---|---|---|
| Number of Subjects With Complete Response With the Intention-to-treat (ITT) Analysis | 12 | 20 |
Histological regression of moderate/severe cervical dysplasia to absence of cervical dysplasia assessed using biopsies (stringent)".
| Participants | PepCan | Candin |
|---|---|---|
| Number of Subjects With Complete Response With the Per-protocol Analysis | 11 | 18 |
Histological regression of moderate/severe cervical dysplasia to mild dysplasia/no dysplasia (lenient) assessed using biopsies, likely avoiding a need for surgery
| Participants | PepCan | Candin |
|---|---|---|
| Number of Subjects With Complete and Partial Responses With the ITT Analysis | 15 | 24 |
Histological regression of moderate/severe cervical dysplasia to mild dysplasia/no dysplasia (lenient) assessed using biopsies, likely avoiding a need for surgery
| Participants | PepCan | Candin |
|---|---|---|
| Number of Subjects With Complete and Partial Responses With the Per-protocol Analysis | 13 | 22 |
Injection-related AEs occurring in \>5% of injections
| Adverse Events | PepCan | Candin |
|---|---|---|
| Fever : Grade 1 | 9 | 3 |
| Fever : Grade 2 | 1 | 0 |
| Fever : All Grades | 10 | 3 |
| Headache : Grade 1 | 13 | 15 |
| Headache : Grade 2 | 4 | 3 |
| Headache : All Grades | 17 | 18 |
| Injection site reaction, < 24 h : Grade 1 | 63 | 58 |
| Injection site reaction, < 24 h : Grade 2 | 25 | 31 |
| Injection site reaction, < 24 h : All Grades | 88 | 89 |
| Myalgia : Grade 1 | 35 | 9 |
| Myalgia : Grade 2 | 2 | 1 |
| Myalgia : All Grades | 37 | 10 |
| Nausea : Grade 1 | 19 | 18 |
| Nausea : Grade 2 | 0 | 0 |
| Nausea : All Grades | 19 | 18 |
| Injection site reaction, ≥ 24 h : Grade 1 | 23 | 39 |
| Injection site reaction, ≥ 24 h : Grade 2 | 31 | 18 |
| Injection site reaction, ≥ 24 h : All Grades | 54 | 57 |
Collected over Time of enrollment until 15 months from time of last vaccination, approximately 18 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PepCan | 0/39 (0%) | 3/39 (7.7%) | 37/39 (94.9%) |
| Candin | 0/42 (0%) | 2/42 (4.8%) | 40/42 (95.2%) |
| Event | PepCan | Candin |
|---|---|---|
| HeadacheNervous system disorders | 1/39 | 0/42 |
| Fetal DeathPregnancy, puerperium and perinatal conditions | 1/39 | 1/42 |
| Psychiatric Disorders - Other SpecifyPsychiatric disorders | 1/39 | 0/42 |
| AppendicitisInfections and infestations | 0/39 | 1/42 |
| Event | PepCan | Candin |
|---|---|---|
| Injection Site ReactionGeneral disorders | 34/39 | 38/42 |
| NauseaGastrointestinal disorders | 15/39 | 12/42 |
| MyalgiaMusculoskeletal and connective tissue disorders | 12/39 | 9/42 |
| HeadacheNervous system disorders | 10/39 | 12/42 |
| FeverGeneral disorders | 10/39 | 4/42 |
| HypokalemiaMetabolism and nutrition disorders | 7/39 | 10/42 |
| AnemiaBlood and lymphatic system disorders | 9/39 | 7/42 |
| HypoalbuminemiaMetabolism and nutrition disorders | 3/39 | 9/42 |
| FatigueGeneral disorders | 8/39 | 7/42 |
| Alanine Aminotransferase IncreasedInvestigations | 8/39 | 5/42 |
| Age, Customized(years) | PepCan | Candin | Total |
|---|---|---|---|
| Mean | 31.3 ± 6.4 | 31.4 ± 6.1 | 31.3 ± 6.2 |
| Age, Customized(years) | PepCan | Candin | Total |
|---|---|---|---|
| Mean | 31.3 (21.5 to 45.1) | 31.4 (22.4 to 43.6) | 31.3 (21.5 to 45.1) |
| Age, Customized(Participants) | PepCan | Candin | Total |
|---|---|---|---|
| <25 years - number (no.) | 6 | 9 | 15 |
| ≥25 years - number (no.) | 33 | 33 | 66 |
| Sex: Female, Male(Participants) | PepCan | Candin | Total |
|---|---|---|---|
| Female | 39 | 42 | 81 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | PepCan | Candin | Total |
|---|---|---|---|
| Hispanic or Latino | 11 | 12 | 23 |
| Not Hispanic or Latino | 28 | 30 | 58 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | PepCan | Candin | Total |
|---|---|---|---|
| Caucasian | 34 | 37 | 71 |
| African American | 4 | 4 | 8 |
| Other | 1 | 1 | 2 |
| Histological Diagnosis at Study Entry(Participants) | PepCan | Candin | Total |
|---|---|---|---|
| CIN3 and CIN2/3 | 29 | 26 | 55 |
| CIN2 | 10 | 16 | 26 |
| Number (No.) of cervical quadrants(cervical quadrants) | PepCan | Candin | Total |
|---|---|---|---|
| Mean | 1.89 ± 1.06 | 2.05 ± 1.02 | 1.97 ± 1.04 |
13 further baseline measures are reported on the registry.
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University of Arkansas