TA-CIN Vaccine for Cervical Cancer

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, TA-CIN, to determine a safe and effective dose for individuals with a history of cervical cancer linked to HPV16. The study administers the vaccine in two ways: in the thigh or the arm, with each participant receiving three doses a few weeks apart. The trial seeks individuals who have had HPV16-related cervical cancer and are currently cancer-free, with no signs of recurrence. Participants must be willing to follow the trial schedule and meet specific health conditions. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive drugs or have certain medical conditions, you may not be eligible to participate.

Is there any evidence suggesting that the TA-CIN vaccine is likely to be safe for humans?

Research has shown that the TA-CIN vaccine is generally safe. Studies have found that administering the vaccine in either the thigh or arm is safe for individuals with HPV16-related cervical cancer. One study found that injecting the vaccine into the thigh not only proved safe but also led to strong immune responses. Another study confirmed that both thigh and arm injections were well-tolerated, with thigh injections producing a better immune response.

Overall, the TA-CIN vaccine does not cause serious side effects, making it a promising option for those considering joining a trial. Although the current trial is in an early phase, which often focuses on safety, earlier research already supports its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the TA-CIN vaccine for cervical cancer because it represents a novel approach to prevention and treatment. Unlike the standard of care, which typically involves surgical procedures, chemotherapy, or radiation, TA-CIN is a therapeutic vaccine designed to stimulate the immune system to target human papillomavirus (HPV) proteins linked to cervical cancer. This vaccine is administered directly into the arm or thigh, making it less invasive and potentially more accessible. By targeting the virus directly, TA-CIN aims to prevent or reduce the progression of cervical lesions, offering a promising alternative to current treatment options.

What evidence suggests that the TA-CIN vaccine might be an effective treatment for cervical cancer?

Research has shown promising results for the TA-CIN vaccine in treating cervical cancer linked to HPV16. Studies have found that similar vaccines can generate strong immune responses against the HPV16 virus, a major cause of cervical cancer. Participants in this trial will receive the TA-CIN vaccine either via thigh or arm administration. This vaccine is designed to help the immune system identify and attack cells infected with HPV16. Early results from related studies suggest that this type of vaccine is generally well-tolerated and can produce a significant immune response. While specific data on the TA-CIN vaccine is still being gathered, its mechanism offers a strong basis for its potential effectiveness. ^{6 7 8 9 10}

Who Is on the Research Team?

Stéphanie Gaillard, MD, PhD

Principal Investigator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Are You a Good Fit for This Trial?

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

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

I am a woman who could become pregnant.

Inability to understand or unwillingness to sign an informed consent document

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04537156?term=HPV&cond=Cervical%20cancer,%20vaccines&viewType=Table&rank=5

Efficacy, Immunogenicity and Safety Study of Recombinant ... This phase III clinical study was designed to evaluate the efficacy,immunogenicity and safety of Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4590015/

A phase I dose-escalation clinical trial of a peptide-based ... Standard surgical treatments of CIN2/3 such as LEEP are effective but result in doubling of preterm delivery rate from 4.4% to 8.9%. Therefore, the new ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/condition/396/cervical-intraepithelial-neoplasia?activelyRecruiting=false&page=24

Cervical Intraepithelial Neoplasia Clinical Research Trials SAbR will be administered as per the guidelines of UTSW with a single 24-27Gy or three 10-14 Gy/fraction fractions totaling 33-48Gy. Lesions receiving SAbR will ...

4. aacrjournals.org aacrjournals.org/clincancerres/article/28/22/4885/710468/A-Therapeutic-Antigen-Presenting-Cell-Targeting

A Therapeutic Antigen-Presenting Cell-Targeting DNA ... The novel therapeutic DNA vaccine VB10.16 was well tolerated and showed promising evidence of efficacy and strong HPV16-specific T-cell responses in subjects ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352578920300746

Topical therapies for the treatment of cervical intraepithelial ... This review describes current research on topical therapies with the potential for self-application for the treatment of HPV or CIN.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11749841/

Safety and efficacy of the therapeutic DNA-based vaccine ... We investigated the safety, efficacy, and immunogenicity of the therapeutic DNA-based vaccine VB10.16 combined with the immune checkpoint inhibitor atezolizumab

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02405221?term=papivax&viewType=Table&rank=6

Safety and Feasibility of TA-CIN Vaccine in HPV16 ... A method used to assign participants to an arm of a clinical study. The types of allocation are randomized allocation and nonrandomized. ... A group or subgroup ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090825825009540

A randomized pilot study of HPV16 L2E7E6 fusion protein ... Conclusions. Thigh or arm vaccination with TA-CIN was well tolerated, but the former elicited higher CD8 T cell and antibody responses in HPV16+ cervical cancer ...

9. mdpi.com mdpi.com/2072-6694/16/3/672

Safety, Efficacy, and Immunogenicity of Therapeutic ... The results of this systematic review indicate that the therapeutic vaccines that are being developed for the treatment of CIN 2/3 are safe and well tolerated.

10. aacrjournals.org aacrjournals.org/cancerpreventionresearch/article/16/4/219/718843/Safety-Run-in-of-Intramuscular-pNGVL4a-Sig-E7

Safety Run-in of Intramuscular pNGVL4a-Sig/E7(detox ... This safety run-in study cohort suggests that PVX2 immunotherapy is well tolerated in the target population and is sufficiently safe to warrant further.