TA-CIN Vaccine for Cervical Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byStéphanie Gaillard, MD, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Stéphanie Gaillard, MD, PhD

Principal Investigator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria

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.

Inclusion Criteria

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

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

I have tissue samples available for HPV16 testing.

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Exclusion Criteria

Inability to understand or unwillingness to sign an informed consent document

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

I am a woman who could become pregnant.

See 10 more

Treatment Details

Interventions

TA-CIN (Cancer Vaccine)

Trial OverviewThe 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.

Participant Groups

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.