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Cancer Vaccine

TA-CIN Vaccine for Cervical Cancer

Phase 1
Waitlist Available
Led By Stéphanie Gaillard, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Fresh-frozen or paraffin-embedded material must be available for in situ hybridization testing for HPV16 nucleic acid for central confirmation
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study Summary

This trial will be testing what dosage of TA-CIN is safe and effective for people who have had HPV16-associated cervical cancer.

Who is the study for?
This trial is for individuals with HPV16 associated stage IB1-IV cervical cancer who finished treatment within the last year and show no signs of recurrence. They must have documented HPV16 in their tumor, be in good physical condition (ECOG 0-1), have proper organ function, and not be on immunosuppressants or other investigational drugs recently.Check my eligibility
What is being tested?
The study tests different doses of the TA-CIN vaccine for safety and effectiveness in patients with a history of HPV16-associated cervical cancer. It will involve administering the vaccine either in the thigh or arm to determine which dose works best without causing harm.See study design
What are the potential side effects?
While specific side effects are not listed, vaccines like TA-CIN could potentially cause injection site reactions, mild fever, fatigue, headache, muscle pain, joint pain, and may trigger an immune response that affects body organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have tissue samples available for HPV16 testing.
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I am fully active or can carry out light work.
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My organ functions are within normal ranges according to specific tests.
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My cancer has not come back in the last 8 weeks.
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I completed treatment for HPV16 related cervical cancer within the last year.
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My cervical cancer is HPV16 positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and feasibility as assessed by Number of Participants with treatment-related Adverse Events
Secondary outcome measures
Antibody Response as measured by level of circulating antibody in peripheral blood
Mononucleocyte Response
Educational Status
Other outcome measures
Circulating HPV16 E6-/E7-specific CD8+ T cells
Clinical Response as measured by Time to Disease Recurrence
Antibodies, Blocking
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: TA-CIN administration via thighExperimental Treatment1 Intervention
Each dose of TA-CIN vaccine is fixed, 100µg. Patients will receive 3 doses of the TA-CIN 4 weeks apart (Weeks 1, 5, and 9), administered in the thigh. Patients will be followed for 2 years after the 1st dose is given.
Group II: TA-CIN administration via armExperimental Treatment1 Intervention
Each dose of TA-CIN vaccine is fixed, 100µg. Patients will receive 3 doses of the TA-CIN 4 weeks apart (Weeks 1, 5, and 9), administered in the arm. Patients will be followed for 2 years after the 1st dose is given.

Find a Location

Who is running the clinical trial?

PapiVax Biotech, Inc.OTHER
4 Previous Clinical Trials
200 Total Patients Enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,886 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,653 Total Patients Enrolled

Media Library

TA-CIN (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT02405221 — Phase 1

Frequently Asked Questions

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

Are there any other research projects that have been undertaken to evaluate TA-CIN?

"Presently, two research protocols for TA-CIN (arm) are ongoing with none in phase 3. Birmingham, Alabama is the primary site for these investigations; however, three other sites have trials underway utilizing this method of treatment."

Answered by AI

Are septuagenarians within the parameters of eligibility for this experiment?

"This clinical trial is searching for participants who have reached the age of majority, but are not yet centenarians."

Answered by AI

To what extent could TA-CIN treatment present risks to patients?

"Our analysis at Power yields that TA-CIN (arm) has an overall safety rating of 1 due to its Phase 1 categorization, which indicates limited efficacy and safety data."

Answered by AI

Does this trial have any eligibility criteria that must be met to participate?

"Fourteen individuals between the ages of majority and 100, who are currently suffering from a uterine cervical neoplasm, may be accepted into this research. Other qualifications include being compliant with study protocol and having an ECOG Performance Status of 0 to 1 over 8 weeks prior to enrollment."

Answered by AI

What is the upper limit for participants in this clinical trial?

"At this time, no more candidates are being sought for this trial. It was originally posted on April 4th 2019 and its information has been most recently updated on July 22nd 2022. If you're still interested in participating in a clinical study of uterine cervical neoplasms, there are 317 trials open at present alongside 2 TA-CIN (arm) studies that are actively enrolling patients."

Answered by AI

Are there any current openings for enrolment in this trial?

"This clinical trial has finished recruitment as of July 22, 2022. However, there are still 317 studies for uterine cervical neoplasms and two trials searching patients with TA-CIN (arm)."

Answered by AI
~2 spots leftby Apr 2025