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PepCan for Cervical Neoplasia

Phase 2
Waitlist Available
Led By Mayumi N Nakagawa, MD, PhD
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months from time of last vaccination
Awards & highlights

Study Summary

This trial is testing a vaccine for HPV 16, a common type of HPV. The vaccine will be given in four doses over the course of 12 months. Clinical and virological responses will be assessed at 6 and 12 months, and safety will be monitored throughout the study.

Eligible Conditions
  • Cervical Intraepithelial Neoplasia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months from time of last vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months from time of last vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Subjects With Complete Response With the Intention-to-treat (ITT) Analysis
Number of Subjects With Complete Response With the Per-protocol Analysis
Number of Subjects With Complete and Partial Responses With the ITT Analysis
+1 more
Secondary outcome measures
Safety Assessed by Injection-related Adverse Events (AEs)

Side effects data

From 2022 Phase 2 trial • 81 Patients • NCT02481414
90%
Injection Site Reaction
29%
Nausea
29%
Headache
24%
Hypokalemia
21%
Myalgia
21%
Hypoalbuminemia
17%
Anemia
17%
Fatigue
17%
Aspartate Aminotransferase Increased
14%
Skin and Subcutaneous Tissue Disorders - Other, Specify
12%
Dizziness
12%
Alanine Aminotransferase Increased
12%
Vaginal Infection
10%
Hypocalcemia
10%
Infections and Infestations - Others, Specify
10%
Urinary Tract Infection
10%
Fever
10%
Flu-like Symptoms
10%
Gastrointestinal Disorders - Other, Specify
10%
Pain
7%
Creatinine Increased
7%
Hypothyroidism
7%
Back Pain
7%
Anxiety
7%
Vaginal Hemorrhage
7%
Unintended Pregnancy
5%
Depression
5%
White Blood Cell Decreased
5%
Bruising
5%
Abdominal Pain
5%
Diarrhea
5%
Investigations - Other, Specify
5%
Hemoglobin Increased
5%
Dyspareunia
5%
Irregular Menstruation
5%
Allergic Rhinitis
5%
Dyspnea
5%
Bone Pain
5%
Sore Throat
5%
Reproductive System and Breast Disorders - Other, Specify
2%
Rash Acneiform
2%
Somnolence
2%
Hemturia
2%
Urinary Urgency
2%
Breast Pain
2%
Muscle Weakness Upper Limb
2%
Osteoporosis
2%
Nasal Congestion
2%
Paresthesia
2%
Bloating
2%
Upper Respiratory Infection
2%
Sinus Bradycardia
2%
Stomach Pain
2%
Chest Pain - Cardiac
2%
Vomitting
2%
Colitis
2%
Gastrointestinal Pain
2%
Fetal Death
2%
Eye Disorders 0 Other, Specify
2%
Edema Limbs
2%
Localized Edema
2%
Constipation
2%
Alkaline Phosphatase Increased
2%
Obesity
2%
Erythema Multiforme
2%
Hot Flashes
2%
Blood Bilirubin Increased
2%
Non-Cardiac Chest Pain
2%
Platelet Count Decreased
2%
Dehydration
2%
Hyponatremia
2%
Hypotension
2%
Pain in Extremity
2%
Skin Infection
2%
Hyperglycemia
2%
Hypertension
2%
Vaginal Pain
2%
Cough
2%
Alopecia
2%
Skin Ulceration
2%
Appendicitis
2%
Palpitations
100%
80%
60%
40%
20%
0%
Study treatment Arm
Candin
PepCan

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PepCanExperimental Treatment1 Intervention
Four injections (one every 3 weeks) of PepCan
Group II: CandinActive Control1 Intervention
Four injections (one every 3 weeks) of Candin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PepCan
2015
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor
486 Previous Clinical Trials
150,272 Total Patients Enrolled
Mayumi N Nakagawa, MD, PhDPrincipal InvestigatorUniversity of Arkansas

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How effective has PepCan been in other scientific trials?

"Currently, there are 3 ongoing trials investigating the efficacy of PepCan. 0 of these trials have reached Phase 3. The majority of the trial locations for PepCan are situated in Little Rock, Arkansas; however, there are a total of three sites running clinical trials for this medication."

Answered by AI

If a person is below the age of 65, do they qualify for this research project?

"You must be between 18-50 years old to participate in this clinical trial. If you are outside of that age range, there are other trials (3 for people under 18 and 46 for those over 65) which may be a better fit."

Answered by AI

Does PepCan meet the requirements for federal approval?

"While there is some data supporting PepCan's safety, it has not been proven effective yet and thus received a score of 2."

Answered by AI

Are new patients being enrolled in this trial at this time?

"According to information on clinicaltrials.gov, this study is not recruiting patients at the moment. The date when the trial was first posted was 30th November 2015 and it was last updated on 4th October 2022. Although this particular study isn't looking for participants, there are 63 other studies that are currently doing so."

Answered by AI

How do I qualify to participate in this research?

"Eligible patients for this clinical trial must be aged 18-50 years old, have untreated high-grade cervical intraepithelial neoplasia, and be willing to comply with the study requirements. A total of 125 participants are needed."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
University of Arkansas for Medical Sciences
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Clinical Trial of PepCan to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions
2015. "A Clinical Trial of PepCan to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02481414.
~9 spots leftby Apr 2025
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