Safety and Feasibility of TA-CIN Vaccine in HPV16 Associated Cervical Cancer

NCT ID: NCT02405221

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-04
• Study Completion Date: 2025-01-31

Brief Summary

This study will be looking at what dose of the TA-CIN vaccine is safe and effective in patients with a history of HPV16-associated cervical cancer.

Detailed Description

This is a randomized, multi-center, open label pilot study. The primary goal of this study is to determine the safety of TA-CIN vaccine as adjuvant therapy, and to assess evidence of induction of HPV antigen-specific immunologic response when administered at different locations (arm or thigh). In this pilot study, a single dose level (100µg) assessment of the safety and tolerability of administering TA-CIN vaccine three times to either the arm versus the thigh of patients who have previously been treated for HPV16-related cervical cancer in the past year and are documented to have no evidence of disease recurrence based on standard-of-care imaging and/or clinical assessment upon eligibility.

A total of 14 patients will be enrolled to assess the safety of TA-CIN vaccine via different injection sites as adjuvant therapy. Safety assessments will continue for a period for 1 month after the last vaccination. Few or no serious adverse events (SAEs) are expected from this regimen and routes of administration. The motivation for the design is to confirm that the dose and site of injection implemented here has minimal or no systemic toxicity, as well as determining the preferred injection site that can elicit more potent immune response.

The study will consist of the following parts:

• Screening evaluation
• Dosing period and response assessments
• Follow-up visits after last dose

Screening Evaluation:

The screening visit will be performed within 60 days of the first study drug administration visit. The study team will check the results of these screening tests to see if patient qualifies to participate.

Dosing Period:

Those who meet the study requirements during the screening period will then begin the dosing phase of this study. TA-CIN will be given as a single intramuscular injection every 4 weeks for a maximum of 3 times. The location of the injection (arm or thigh) will depend on randomization. Patients will be assessed for safety and response to treatment during this period.

Follow-Up Period:

Four follow-up evaluations will be performed during a clinic visit after the last dose of the vaccine. These will take place at the following time points: (1) 1-3 weeks after the last dose of the study drug, (2) about 6 months after the last dose of the study drug, (3) about 12 months after the last dose of the study drug, and (4) about 24 months after the last dose of the study drug.

Conditions

HPV16 Associated Cervical Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TA-CIN administration via thigh

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 Type: EXPERIMENTAL

TA-CIN (thigh)

Intervention Type: BIOLOGICAL

TA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9.

TA-CIN administration via arm

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.

Group Type: EXPERIMENTAL

TA-CIN (arm)

Intervention Type: BIOLOGICAL

TA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9.

Interventions

TA-CIN (arm)

TA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9.

Intervention Type: BIOLOGICAL

TA-CIN (thigh)

TA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9.

Intervention Type: BIOLOGICAL

Other Intervention Names

Tissue Antigen - Cervical Intraepithelial Neoplasia; Tissue Antigen - Cervical Intraepithelial Neoplasia

Eligibility Criteria

Inclusion Criteria

1. Patients with HPV16 related stage IB1-IV cervical cancer who completed definitive treatment within 12 months

2. Patients with no evidence of disease recurrence within 8 weeks of enrollment

3. Documented to have HPV16 nucleic acid within the cervical tumor specimen as determined by in situ hybridization

4. Fresh-frozen or paraffin-embedded material must be available for in situ hybridization testing for HPV16 nucleic acid for central confirmation

5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1

6. Adequate organ function as defined by study-specified laboratory tests

7. Ability to understand and willingness to sign a written informed consent document

8. Willing and able to comply with study schedule and other protocol requirements

Exclusion Criteria

1. Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions

2. Patients with a diagnosis of immunosuppression or prolonged, active use of immunosuppressive agents such as systemic steroids

3. Prior HPV vaccination

4. Had surgery, chemotherapy, or radiation therapy within 28 days prior to receiving study drug

5. Another investigational product within 28 days prior to receiving study drug

6. Active or chronic HIV, HBV, or HCV infection

7. Pregnant or lactating

8. Patients who have an active autoimmune disease

9. Patients with a recognized immunodeficiency disease or are being chronically treated with immunosuppressive drugs

10. Women of childbearing potential

11. Patients with non-healed wounds

12. A history of current or recent concurrent malignancy (≤5 years) except basal cell cancer.

13. Inability to understand or unwillingness to sign an informed consent document

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

PapiVax Biotech, Inc.

OTHER

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stéphanie Gaillard, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Women & Infants Center, University of Alabama at Birmingham

Birmingham, Alabama, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00054202

Identifier Type: OTHER

Identifier Source: secondary_id

P50CA098252

Identifier Type: NIH

Identifier Source: secondary_id

View Link

J1553

Identifier Type: -

Identifier Source: org_study_id