Phase 1 N=15 Randomized Treatment

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

HPV16 Associated Cervical Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02405221 ↗

Enrolled (actual)

Serious AEs

6.7%

Results posted

Jan 2026

Primary outcome: Primary: Safety and Feasibility as Assessed by Number of Participants With Treatment-related Adverse Events — 5; 3; 8; 7 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: TA-CIN (arm) (Biological); TA-CIN (thigh) (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Primary completion: Dec 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety and Feasibility as Assessed by Number of Participants With Treatment-related Adverse Events	5; 3; 8; 7	—
SECONDARY Antibody Response as Measured by Level of Circulating Antibody in Peripheral Blood	1.03; 1.27; 0.91; 0.66; 0.32; 0.17	—
SECONDARY T-Cell Response as Measured by Level of Circulating T-cells in Peripheral Blood	—	—
SECONDARY Mononucleocyte Response	—	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02405221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.