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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

Must not have

Active or chronic HIV, HBV, or HCV infection

Women of childbearing potential

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

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 cervical cancer is HPV16 positive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have an active or chronic HIV, HBV, or HCV infection.

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I am a woman who could become pregnant.

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I have or had specific heart, liver, kidney, lung, neurological, or immune conditions.

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I have a weakened immune system or have been on long-term steroids.

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I have received the HPV vaccine.

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I have an immune system disorder or take medication that weakens my immune system.

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I have wounds that have not yet healed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

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.

0 / 11Eligibility criteria met

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Who is running the clinical trial?

PapiVax Biotech, Inc.OTHER

4 Previous Clinical Trials

82 Total Patients Enrolled

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

563 Previous Clinical Trials

33,310 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,748 Previous Clinical Trials

40,959,387 Total Patients Enrolled

Media Library

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

~2 spots leftby Jul 2025

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