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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 belowSelect...
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 cervical cancer is HPV16 positive.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
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 moreTrial 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.
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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
561 Previous Clinical Trials
33,085 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,350 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have an active or chronic HIV, HBV, or HCV infection.I am a woman who could become pregnant.You have a current autoimmune disease that is active.I have tissue samples available for HPV16 testing.I have or had specific heart, liver, kidney, lung, neurological, or immune conditions.I am fully active or can carry out light work.My organ functions are within normal ranges according to specific tests.I have not had any cancer except for basal cell in the last 5 years.My cancer has not come back in the last 8 weeks.I completed treatment for HPV16 related cervical cancer within the last year.You have taken another experimental medication within the past 28 days before starting the study drug.My cervical cancer is HPV16 positive.I have a weakened immune system or have been on long-term steroids.I have received the HPV vaccine.I haven't had surgery, chemo, or radiation in the last 28 days.I have an immune system disorder or take medication that weakens my immune system.I have wounds that have not yet healed.
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