TA-CIN Vaccine for Cervical Cancer

Recruiting at 1 trial location

Overseen By Stéphanie Gaillard, MD, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Heart, Liver, Kidney, Lung, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

14 Participants Needed

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

8 weeks

1 visit (in-person)

Dosing Period

TA-CIN vaccine is administered as a single intramuscular injection every 4 weeks for a maximum of 3 times, with safety and response assessments

8 weeks

3 visits (in-person)

Follow-up

Four follow-up evaluations are performed to monitor safety and effectiveness after the last dose of the vaccine

24 months

4 visits (in-person)

Treatment Details

Interventions

• TA-CIN

Trial Overview The 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

Group I: TA-CIN administration via thigh Experimental Treatment 1 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 arm Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

PapiVax Biotech, Inc.

Collaborator

Trials

6

Recruited

120+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+