Cervical CancerPhase 1NCT06315257
A Clinical Trial to Assess PVX7 Immunotherapy Regimens in Advanced Cervical Cancer Patients
A Phase 1 study testing PVX7 in people with Cervical Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
Trial summary
A Feasibility Trial of PVX7 vaccine in advanced cervical cancer patients who have completed primary definitive therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- PVX7
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jul 2025to Jun 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female subjects age 18 years or older with diagnosis of advanced (stage IB1-IVA) HPV+ cervical cancer and have completed primary treatment (consisting of any of the following as per NCCN guideline standard of care: surgical resection, radiation, and/or platinum-based chemotherapy) within the past 12 months.
- Patients who are recommended to receive anto-PD-1 or anti-PD-L1 therapy after chemoradiation are eligible to enroll and can continue to receive such therapy while receiving study drug.
- No history of or current evidence of residual disease or disease recurrence based on imaging and clinical assessments within 8 weeks of enrollment
- HIV uninfected
- Hepatitis B surface antigen negative
- Anti-hepatitis C (HCV) antibody negative or negative HCV polymerase chain reaction (PCR)
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- Patients who are able and willing to comply with all study procedures and voluntarily sign an informed consent form
- Adequate organ function as defined by the following parameters:
- white blood cell count ≥ 3,000 cells/cu mm
- lymphocyte number ≥ 500 cells/cu mm
- absolute neutrophil count ≥ 1,000 cells/cu mm
- platelets ≥ 90,000/cu mm
- hemoglobin ≥ 9 g/dL
- total bilirubin <1.5 X upper limit of normal (ULN), <3 x ULN if Gilbert's disease
- Aspartate Transferase(AST) and Alanine Transaminase (ALT) <3 X ULN
- creatinine < 1.5 X ULN or estimated creatinine clearance ≥ 60 ml/min per Modified Cockcroft-Gault Formula
- Eastern Cooperative Oncology Group performance status of 0 or 1
- All clinically significant toxicities related to prior therapy should be less than or equal to Grade 1 at time of enrollment
- Ability and willingness for one month post vaccination to follow vaccine inoculation site care and avoid close social contact with children under 1 year old or close social or domestic contact with a pregnant woman or individuals at high risk of serious adverse effects of vaccinia virus, for instance, those with past or present eczema, or immunodeficiency states including HIV infection
Who cannot join
- Women of child-bearing potential (i.e., those who have had fertility-sparing procedures for the management of cervical cancer) will be excluded unless agreed to remain sexually abstinent or have a partner who is sterile (i.e. vasectomy), or use methods of contraception (e.g., oral contraception, barrier methods, spermicide, intrauterine device (IUD)), throughout the first 6 months of the study.
- Because there is a risk for adverse events in nursing infants, breastfeeding must be discontinued if the mother is treated on study.
- Diagnosed with a recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; patients diagnosed with acquired, hereditary, or congenital immunodeficiencies
- Diagnosis with a medical condition that requires systemic treatment with immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone (ACTH), alkylating agents, antimetabolites, radiation, Tumor Necrosis Factor (TNF) inhibitors, or systemic corticosteroids, either chronically or within 30 days of first PVX7 vaccination.
- Administration of any blood product within 30 days of signing informed consent.
- Need for ongoing therapeutic anticoagulation during the study period due to concern for increased risk of bleeding.
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- Previous severe allergic reaction or hypersensitivity to a vaccine or any of its components
- Participation in a study with an investigational compound or device within 30 days of signing informed consent
- Known active central nervous system disease
- Surgery within 30 days of first PVX7 vaccination, excluding minor procedures
- Diagnosis with an uncontrolled intercurrent illness including, but not limited to, ongoing, or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
- Diagnosis with an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), ankylosing spondylitis)
- History of myocarditis or pericarditis.
- Known underlying heart disease (e.g., cardiomyopathy, congestive heart failure, symptomatic arrhythmia not controlled by medication, unstable angina, history of acute myocardial infarction or cerebrovascular accident within the past 6 months).
- Patients and the patients close social, sexual, or domestic contacts may not have non-healed wounds or active exfoliative skin conditions such as: Eczema, Burns, Impetigo, Varicella-zoster virus infection, Herpes simplex virus infection, Severe acne, Severe diaper dermatitis with extensive areas of denuded skin, Psoriasis, Lichen planus, Darier disease (keratosis follicularis).
- History or presence of atopic dermatitis
- Inability or unwillingness to for one month post vaccination follow vaccine inoculation site care and avoid social contact with children under 1 year old or close social or domestic contact with a pregnant woman or individuals at high risk of serious adverse effects of vaccinia virus, for instance, those with past or present eczema, or immunodeficiency states including HIV infection
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Amy Deery, RN contact
United States2 sites, 2 recruiting
- Recruiting
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
Amy Deery, RN, BSN, OCN, 410-614-1361, HopkinsGynTrials@jhmi.edu
Stéphanie Gaillard, MD, PhD
- Recruiting
The University of Alabama at Birmingham
Birmingham, Alabama, 35233
Anna Wilbanks, Research Nurse, MSN, RN, WHNP-BC, 205-996-7079, annaburton@uabmc.edu
Charles Leath, MD
About this study
Official title: A Randomized, Open-label Clinical Trial to Assess the Safety, Feasibility and Immunogenicity of Adjuvant PVX7 Immunotherapy Regimens in Advanced Cervical Cancer Patients
A Feasibility Trial of PVX7 vaccine in advanced cervical cancer patients who have completed primary definitive therapy.
Read the detailed description
A Feasibility Trial of PVX7 in advanced cervical cancer patients who have completed primary definitive therapy.
- Safety and immunogenicity study
- Patients are randomized in a 1:1 ratio to two cohorts, up to 16 patients in each of intramuscular or skin inoculation vaccine injection, up to 32 patients total
- Human Immunodeficiency Virus (HIV)-negative patients only
- Treatment dose: Arm A: pBI-11 DNA (3 mg) twice via intramuscular (IM) injection, followed by one dose of TA-HPV (2.5x10^5 pfu) via skin inoculation; Arm B: pBI-11 DNA (3 mg) twice, followed by one dose of TA-HPV (10^7 pfu) via IM injection
- Schedule for administration: PVX7 vaccination at weeks 1, 5, and 9
- Follow-up for 2 years per standard of care (SoC)
- Conditions
- Cervical Cancer
- Being tested
- PVX7
- 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.
PVX7Drug
Also called pBI-11 DNA + TA-HPV
PVX7 Immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| pBI-11 DNA plus TA-HPV via Skin Inoculation | Experimental | Participants will receive pBI-11 DNA by IM injection and TA-HPV via Skin Inoculation Receives: Drug: PVX7 |
| pBI-11 DNA plus TA-HPV via IM Injection | Experimental | Participants will receive pBI-11 DNA and TA-HPV via IM Injection Receives: Drug: PVX7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of PVX7 as assessed by adverse events
To assess the safety of PVX7 immunotherapy to patients with advanced cervical cancer who have completed primary therapy by evaluating Adverse Events (AEs).
Measured: 12 months
Feasibility of PVX7
To assess the feasibility of PVX7 immunotherapy to patients with advanced cervical cancer who have completed primary therapy. Feasibility is measured by the ability of patients to receive all three doses of vaccine.
Measured: 12 months
Secondary outcomes (3)
Cellular Immune Response
To evaluate the systemic Human Papillomavirus (HPV)16/18 E6/E7-specific cellular immune responses to PVX7 immunotherapy by measuring the number of interferon gamma+ Cluster of Differentiation (CD)8 Tcells/mL with overlapping peptides covering HPV16/18 E6/E7 protein
Measured: 12 months
Immune Response
To compare the route of administration associated with the greatest immune response in patients with advanced cervical cancer who have completed primary standard of care treatment
Measured: 12 months
Presence of circulating HPV DNA
Measure presence of circulating HPV DNA load in blood pre- and post-PVX7 immunotherapy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start23 Jul 2025
- Primary completionJun 2029 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Gaillard, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315257
- Sponsor's protocol ID
- J23105sIRB
- Other IDs
- IRB00388854
- Status last verified
- Jun 2026
- First submitted
- 11 Mar 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will be shared with NIH and other participating site.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Clinical Trial to Assess the Safety, Feasibility and Immunogenicity of Adjuvant PVX7 Immunotherapy Regimens in Advanced Cervical Cancer Patients
- ClinicalTrials.gov ID
- NCT06315257
- Acronym / sponsor ID
- J23105sIRB
- Conditions
- Cervical Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Feasibility Trial of PVX7 vaccine in advanced cervical cancer patients who have completed primary definitive therapy.
Detailed description
A Feasibility Trial of PVX7 in advanced cervical cancer patients who have completed primary definitive therapy.
- Safety and immunogenicity study
- Patients are randomized in a 1:1 ratio to two cohorts, up to 16 patients in each of intramuscular or skin inoculation vaccine injection, up to 32 patients total
- Human Immunodeficiency Virus (HIV)-negative patients only
- Treatment dose: Arm A: pBI-11 DNA (3 mg) twice via intramuscular (IM) injection, followed by one dose of TA-HPV (2.5x10^5 pfu) via skin inoculation; Arm B: pBI-11 DNA (3 mg) twice, followed by one dose of TA-HPV (10^7 pfu) via IM injection
- Schedule for administration: PVX7 vaccination at weeks 1, 5, and 9
- Follow-up for 2 years per standard of care (SoC)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pBI-11 DNA plus TA-HPV via Skin Inoculation | Experimental | Drug: PVX7Participants will receive pBI-11 DNA by IM injection and TA-HPV via Skin Inoculation |
| pBI-11 DNA plus TA-HPV via IM Injection | Experimental | Drug: PVX7Participants will receive pBI-11 DNA and TA-HPV via IM Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Female subjects age 18 years or older with diagnosis of advanced (stage IB1-IVA) HPV+ cervical cancer and have completed primary treatment (consisting of any of the following as per NCCN guideline standard of care: surgical resection, radiation, and/or platinum-based chemotherapy) within the past 12 months.
- Patients who are recommended to receive anto-PD-1 or anti-PD-L1 therapy after chemoradiation are eligible to enroll and can continue to receive such therapy while receiving study drug.
- No history of or current evidence of residual disease or disease recurrence based on imaging and clinical assessments within 8 weeks of enrollment
- HIV uninfected
- Hepatitis B surface antigen negative
Key exclusion criteria (17 listed)
- Women of child-bearing potential (i.e., those who have had fertility-sparing procedures for the management of cervical cancer) will be excluded unless agreed to remain sexually abstinent or have a partner who is sterile (i.e. vasectomy), or use methods of contraception (e.g., oral contraception, barrier methods, spermicide, intrauterine device (IUD)), throughout the first 6 months of the study.
- Because there is a risk for adverse events in nursing infants, breastfeeding must be discontinued if the mother is treated on study.
- Diagnosed with a recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; patients diagnosed with acquired, hereditary, or congenital immunodeficiencies
- Diagnosis with a medical condition that requires systemic treatment with immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone (ACTH), alkylating agents, antimetabolites, radiation, Tumor Necrosis Factor (TNF) inhibitors, or systemic corticosteroids, either chronically or within 30 days of first PVX7 vaccination.
- Administration of any blood product within 30 days of signing informed consent.
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 |
|---|---|---|
| PVX7Also: pBI-11 DNA + TA-HPVPVX7 Immunotherapy | Drug | pBI-11 DNA plus TA-HPV via IM Injection, pBI-11 DNA plus TA-HPV via Skin Inoculation |
Primary outcome
Safety of PVX7 as assessed by adverse events
Time frame: 12 months
To assess the safety of PVX7 immunotherapy to patients with advanced cervical cancer who have completed primary therapy by evaluating Adverse Events (AEs).
Feasibility of PVX7
Time frame: 12 months
To assess the feasibility of PVX7 immunotherapy to patients with advanced cervical cancer who have completed primary therapy. Feasibility is measured by the ability of patients to receive all three doses of vaccine.
3 secondary outcomes
Cellular Immune Response
Time frame: 12 months
Immune Response
Time frame: 12 months
Presence of circulating HPV DNA
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No. Participant data will be shared with NIH and other participating site.
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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.
Amy Deery, RN contact
Stephanie Gaillard, MD principal investigator
Johns Hopkins University
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 PVX7 in people with 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 19 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 1 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Gaillard, MD (410-614-1361, HopkinsGynTrials@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of PVX7 as assessed by adverse events (time frame: 12 months). The study lists 2 primary outcomes in all. 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 1 Jul 2026.