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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.

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.

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

TA-CIN (arm)

TA-CIN (thigh)

Stéphanie Gaillard, MD

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.

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.

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

A Pilot Clinical Trial Assessing the Safety and Feasibility of Intramuscular Administration of the TA-CIN Vaccine as Adjuvant Therapy for Patients With History of HPV16 Associated Cervical Cancer

Levels of circulating HPV16 E6- and E7-specific CD8+ T cells in the peripheral blood pre- and post-vaccination (measured using T-cell receptor sequencing)

Levels of HPV-specific neutralizing antibodies in the peripheral blood pre- and post-vaccination

Clinical response associated with vaccine induced immune responses as measured by Time from administration of TA-CIN to disease recurrence.

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.

Level of circulating antibody to HPV16 E6, E7, and L2 in the peripheral blood pre- and post-vaccination (visualized by ELISA).

Level of circulating HPV16 E6- and E7- specific CD8+ T cells and/or CD4+ T cells in the peripheral blood pre- and post-vaccination (visualized by ELISPOT)

Proliferative responses of peripheral blood mononucleocytes pre- and post-vaccination in response to stimulation by HPV16 E6, E7 and L2

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety and Feasibility of TA-CIN Vaccine in HPV16 Associated Cervical Cancer	NCT02405221	HPV16 Associate...	TA-CIN (arm) TA-CIN (thigh)	18 Years - 100 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Safety and Feasibility of TA-CIN Vaccine in HPV16 Associated Cervical Cancer	NCT02405221	HPV16 Associate...	TA-CIN (arm) TA-CIN (thigh)	18 Years - 100 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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