Actively Recruiting
A Randomized, Open-label Clinical Trial to Assess the Safety, Feasibility and Immunogenicity of Adjuvant PVX7 Immunotherapy Regimens in Advanced Cervical Cancer Patients
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2026-05-20
32
Participants Needed
2
Research Sites
112 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the PVX7 immunotherapy vaccine in adult women with advanced cervical cancer who have completed their primary treatment, such as surgery, radiation, or chemotherapy. This Phase 1 clinical trial focuses on the safety and immune response of PVX7, studying how well it is tolerated and whether it stimulates the immune system. The study is sponsored by the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Participants are randomly assigned to one of two groups. One group receives the pBI-11 DNA vaccine by intramuscular injection and then TA-HPV vaccine through skin inoculation. The other group receives both pBI-11 DNA and TA-HPV vaccines via intramuscular injection. Vaccinations occur at weeks 1, 5, and 9. The trial includes a two-year follow-up period according to standard care practices. During the study, participants will undergo safety assessments to monitor for adverse events and immune response tests for up to 12 months. Researchers will track presence of HPV DNA and immune cell activity. Participants must follow specific care instructions after vaccination and avoid close contact with certain vulnerable individuals for one month. The total participation includes treatment and follow-up visits over two years to evaluate safety, feasibility, and immune effects of the PVX7 vaccine.
CONDITIONS
Brief Title
A Clinical Trial to Assess PVX7 Immunotherapy Regimens in Advanced Cervical Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female subjects age 18 years or older with advanced (stage IB1-IVA) HPV-positive cervical cancer
- Completed primary treatment (surgery, radiation, and/or platinum-based chemotherapy) within the past 12 months
- Recommended anti-PD-1 or anti-PD-L1 therapy allowed during study
- No residual disease or recurrence within 8 weeks prior to enrollment
- HIV negative
- Hepatitis B surface antigen negative
- Negative for hepatitis C antibody or PCR
- Able and willing to comply with study procedures and sign informed consent
- Adequate organ function as defined by blood counts and liver/kidney tests
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Prior treatment toxicities grade 1 or less at enrollment
- Willing to follow vaccine site care and avoid close contact with infants under 1 year, pregnant women, or high-risk individuals for one month post vaccination
You will not qualify if you...
- Women of child-bearing potential not agreeing to abstinence or contraception for first 6 months
- Breastfeeding mothers
- Diagnosed immunodeficiency diseases including cellular immunodeficiencies and hypogammaglobulinemia
- Need for systemic immunosuppressive drugs currently or within 30 days before vaccination
- Blood product administration within 30 days before consent
- Need for ongoing anticoagulation
- Previous severe allergic reaction to vaccines or components
- Participation in other investigational studies within 30 days
- Active central nervous system disease
- Surgery within 30 days before vaccination except minor procedures
- Uncontrolled intercurrent illness or psychiatric/social conditions limiting compliance
- Active autoimmune disease
- History of myocarditis or pericarditis
- Known significant heart disease
- Non-healed wounds or active exfoliative skin conditions
- History or presence of atopic dermatitis
- Inability or unwillingness to follow post-vaccination care and contact restrictions for one month
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 9 weeks
Participants receive PVX7 immunotherapy with vaccinations at weeks 1, 5, and 9, involving intramuscular or skin inoculation injections depending on the assigned cohort.
3 vaccination visits (in-person)
Duration - 2 years
Participants are followed for 2 years per standard of care to monitor safety, feasibility, and immune response.
Visits per standard of care for up to 2 years
Trial Site Locations
Total: 2 locations
1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
S
Stephanie Gaillard, MD
A
Amy Deery, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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