HPV16 Associated Cervical CancerPhase 1NCT02405221
Safety and Feasibility of TA-CIN Vaccine in HPV16 Associated Cervical Cancer
A Phase 1 study testing TA-CIN (arm) and TA-CIN (thigh) in people with HPV16 Associated Cervical Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- HPV16 Associated Cervical Cancer
- What is being tested?
- TA-CIN (arm) and TA-CIN (thigh)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Apr 2019to 31 Jan 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
Women & Infants Center, University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- HPV16 Associated Cervical Cancer
- Being tested
- TA-CIN (arm), TA-CIN (thigh)
- Keywords
- HPV, HPV16, Cervical Cancer, TA-CIN, Vaccine, Adjuvant, Nickles FaderPI
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TA-CIN (arm)Biological
Also called Tissue Antigen - Cervical Intraepithelial Neoplasia
TA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9.
TA-CIN (thigh)Biological
Also called Tissue Antigen - Cervical Intraepithelial Neoplasia
TA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9.
| Study group | Role | What they receive |
|---|---|---|
| TA-CIN administration via thigh | Experimental | 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. Receives: Biological: TA-CIN (thigh) |
| TA-CIN administration via arm | Experimental | 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. Receives: Biological: TA-CIN (arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Feasibility as Assessed by Number of Participants With Treatment-related Adverse Events
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.
Measured: Up to 24 months following the first dose of study vaccine
Secondary outcomes (3)
Antibody Response as Measured by Level of Circulating Antibody in Peripheral Blood
Level of circulating antibody to HPV16 E6, E7, and L2 in the peripheral blood pre- and post-vaccination (visualized by ELISA).
Measured: up to 4 years
T-Cell Response as Measured by Level of Circulating T-cells in Peripheral Blood
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)
Measured: up to 4 years
Mononucleocyte Response
Proliferative responses of peripheral blood mononucleocytes pre- and post-vaccination in response to stimulation by HPV16 E6, E7 and L2
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study start4 Apr 2019
- Primary completion31 Dec 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HPV16 Associated Cervical CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), PapiVax Biotech, Inc.
- Responsible party
- Sponsor
- Investigators
- Stéphanie Gaillard, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405221
- Sponsor's protocol ID
- J1553
- Other IDs
- IRB00054202, P50CA098252
- Status last verified
- Jan 2026
- First submitted
- 27 Mar 2015
- Last updated
- 29 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02405221
- Acronym / sponsor ID
- J1553
- Conditions
- HPV16 Associated Cervical Cancer
- Keywords
- HPV, HPV16, Cervical Cancer, TA-CIN, Vaccine, Adjuvant, Nickles FaderPI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), PapiVax Biotech, Inc.
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 1 Apr 2015 (estimated)
- Results
- Posted 22 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TA-CIN administration via thigh | Experimental | Biological: TA-CIN (thigh)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. |
| TA-CIN administration via arm | Experimental | Biological: TA-CIN (arm)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 may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TA-CIN (arm)Also: Tissue Antigen - Cervical Intraepithelial NeoplasiaTA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9. | Biological | TA-CIN administration via arm |
| TA-CIN (thigh)Also: Tissue Antigen - Cervical Intraepithelial NeoplasiaTA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9. | Biological | TA-CIN administration via thigh |
Primary outcome
Safety and Feasibility as Assessed by Number of Participants With Treatment-related Adverse Events
Time frame: Up to 24 months following the first dose of study vaccine
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.
3 secondary outcomes
Antibody Response as Measured by Level of Circulating Antibody in Peripheral Blood
Time frame: up to 4 years
T-Cell Response as Measured by Level of Circulating T-cells in Peripheral Blood
Time frame: up to 4 years
Mononucleocyte Response
Time frame: up to 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for HPV16 Associated Cervical Cancer
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
RecruitingPhase 2
E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers
Cervical Cancer, Throat Cancer
Active, not recruitingPhase 1/2
A Vaccine (PDS0101) Alone or in Combination With Pembrolizumab for the Treatment of Locally Advanced Human Papillomavirus-Associated Oropharynx Cancer
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Human Papillomavirus-Related Carcinoma
RecruitingPhase 2
CUE-101with Pembrolizumab for Locally Advanced HPV+HNSCCs
Head and Neck Squamous Cell Carcinoma, HPV Positive Oropharyngeal Squamous Cell Carcinoma
Recruiting
Evaluation of the Q-Pad hrHPV Test System for Identifying Precancer
HPV Infection, HPV 16 Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphanie Gaillard, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TA-CIN (arm) and TA-CIN (thigh) in people with HPV16 Associated Cervical Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Feasibility as Assessed by Number of Participants With Treatment-related Adverse Events (time frame: Up to 24 months following the first dose of study vaccine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.