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

NCT02405221 | Completed Phase 1 Results DMC FDA Drug

• 3 other identifiers: J1553IRB00054202P50CA098252
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

HPV16 Associated Cervical Cancer

Keywords

HPV; HPV16; Cervical Cancer; TA-CIN; Vaccine; Adjuvant; Nickles FaderPI

Outcome Measures

Primary Outcomes (1)

• Safety and Feasibility as Assessed by Number of Participants With Treatment-related Adverse Events

  Safety and feasibility of intramuscular TA-CIN vaccine via arm or thigh as assessed by number of participants with with a history of HPV16 associated IB1-IV cervical cancer experiencing treatment-emergent adverse events as defined by CTCAE v4.0.

  Up to 24 months following the first dose of study vaccine

Secondary Outcomes (3)

• Antibody Response as Measured by Level of Circulating Antibody in Peripheral Blood

  up to 4 years

• T-Cell Response as Measured by Level of Circulating T-cells in Peripheral Blood

  up to 4 years

• Mononucleocyte Response

  up to 4 years

Other Outcomes (4)

• Circulating HPV16 E6-/E7-specific CD8+ T Cells

  up to 4 years

• Levels of HPV-specific Neutralizing Antibodies

  up to 4 years

• Residual HPV16 Viral Load

  4 years

Study Arms (2)

TA-CIN administration via thigh

EXPERIMENTAL

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.

Biological: TA-CIN (thigh)

TA-CIN administration via arm

EXPERIMENTAL

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.

Biological: TA-CIN (arm)

Interventions

TA-CIN (thigh) BIOLOGICAL

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

Also known as: Tissue Antigen - Cervical Intraepithelial Neoplasia

TA-CIN administration via thigh

TA-CIN (arm) BIOLOGICAL

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

Also known as: Tissue Antigen - Cervical Intraepithelial Neoplasia

TA-CIN administration via arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with HPV16 related stage IB1-IV cervical cancer who completed definitive treatment within 12 months
• Patients with no evidence of disease recurrence within 8 weeks of enrollment
• Documented to have HPV16 nucleic acid within the cervical tumor specimen as determined by in situ hybridization
• 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
• Adequate organ function as defined by study-specified laboratory tests
• Ability to understand and willingness to sign a written informed consent document
• Willing and able to comply with study schedule and other protocol requirements

You may not qualify if:

• Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
• Patients with a diagnosis of immunosuppression or prolonged, active use of immunosuppressive agents such as systemic steroids
• Prior HPV vaccination
• Had surgery, chemotherapy, or radiation therapy within 28 days prior to receiving study drug
• Another investigational product within 28 days prior to receiving study drug
• Active or chronic HIV, HBV, or HCV infection
• Pregnant or lactating
• Patients who have an active autoimmune disease
• Patients with a recognized immunodeficiency disease or are being chronically treated with immunosuppressive drugs
• Women of childbearing potential
• Patients with non-healed wounds
• A history of current or recent concurrent malignancy (≤5 years) except basal cell cancer.
• Inability to understand or unwillingness to sign an informed consent document

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• PapiVax Biotech, Inc.: collaborator
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (2)

Women & Infants Center, University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Stephanie Gaillard, MD, PhD
• Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

HopkinsGynTrials@jhmi.edu

410-955-8240

Study Officials

• Stéphanie Gaillard, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2015
• First Posted: April 1, 2015
• Study Start: April 4, 2019
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: January 29, 2026
• Results First Posted: January 22, 2026

Record last verified: 2026-01

Locations

US (2)