| Eligibility |
Inclusion Criteria:
- Female subjects age 18 years or older with diagnosis of advanced cervical cancer and
have completed primary treatment within the past 12 months.
- 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)
- 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
- lymphocyte number = 500
- absolute neutrophil count = 1,000
- platelets = 90,000
- hemoglobin = 9
- total bilirubin <1.5 X upper limit of normal (ULN), <3 x ULN if Gilbert's disease
- Aspartate Transferase(AST)/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
Exclusion Criteria:
- 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.
- 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
- History of seizures (unless seizure free for 5 years)
- 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
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