Any active acute or chronic or uncontrolled infection
Other acute or chronic medical or psychiatric condition
Active (acute or chronic) or uncontrolled severe infections
Have active (acute or chronic) or uncontrolled severe infections
Acute or chronic skin and/or microvascular disorders
Acute urinary tract infection.
Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections or major surgery within days prior to study enrollment
Documented malabsorptive syndromes including enteropathies, gastroenteritis (acute or chronic) or diarrhea (acute or chronic)
Subjects with acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions will be excluded
Other severe acute or chronic medical condition
Acute treatment for an infection (excluding fungal infection of the skin and sexually transmitted infections) or other serious medical illness within days prior to randomization
Acute or chronic infections requiring systemic therapy, including, among others:
Systemic rheumatic or autoimmune diseases or acute or chronic infections
Acute VOC ending days prior to first dosing
Acute viral or active autoimmune, alcoholic, or other types of acute hepatitis
Subjects with active uncontrolled infection or who are human immunodeficiency virus (HIV) positive (subjects with acute infections requiring treatment should delay screening/enrollment until the course of therapy has been completed and the event is considered controlled)
Patients must not have received any prior systemic therapy for ALL, except for the acute management of hyperleukocytosis or acute symptoms (e.g., corticosteroids, cytarabine, etc.)
Significant acute or chronic infections requiring systemic therapy
Acute or chronic skin disorders that would interfere with subcutaneous injection of the vaccine or subsequent assessment of potential skin reactions
Acute, severe infection (e.g., sepsis and opportunistic infections), or active, chronic or persistent infection that might worsen with immunosuppressive treatment (e.g., herpes zoster).
Any acute or chronic psychiatric problems
Subject has any acute infection that requires specific therapy; acute therapy must have been completed within seven days prior to study enrollment
Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections or major surgery within days prior to study enrollment
Subjects with any acute infection or severe or uncontrolled that requires systematic antibiotic therapy; acute therapy must have been completed at least seven days prior to study enrollment
Have active, acute, or chronic clinically significant infections.
Patients with acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions will be excluded
Evidence of active acute or chronic infection
Ongoing acute or chronic inflammatory skin disease.
Subjects with an acute gastrointestinal ulcer
Acute or chronic infections requiring systemic therapy, including, among others:
Subjects have any acute infection that requires specific therapy. Acute therapy must have been completed within seven days prior to study enrollment.
Prostate abscess, chronic or acute prostatitis, or neurogenic bladder
Active (acute or chronic) or uncontrolled severe infections.
Active (acute or chronic) or uncontrolled severe infections
Significant acute or chronic infections
Acute infections requiring parenteral therapy
Acute unresolved Urinary Tract Infection (UTI)
History of acute urinary retention within the last months
Have malabsorptive syndromes, enteropathies, gastroenteritis (acute or chronic), or diarrhea (acute or chronic).
Ongoing acute or chronic inflammatory skin disease.
Active (acute or chronic) or uncontrolled severe infections (not responding to antibiotics), including acute pelvic inflammatory disease
Electrocardiogram showing no acute ischemic changes
Subjects with acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions will be excluded
Active (acute or chronic) or uncontrolled severe infection
Active (acute or chronic) or uncontrolled severe infections hepatitis
Subjects with acute infection: any acute viral, bacterial, or fungal infection which requires specific therapy; acute therapy must have been completed more than days prior to study treatment
No evidence of acute infection
Subject has any acute infection that requires specific therapy; acute therapy must have been completed within seven days prior to study enrollment
Significant acute or chronic infections, including:
Patients with acute or chronic infection
Acute or chronic viral, bacterial immune or other disease associated with abnormal immune function
Ongoing acute or chronic inflammatory skin disease.
Procedures that occur during acute hospitalization.
Acute nephritis
Has an Acute Physiology and Chronic Health Evaluation (APACHE) II score <
Active (acute or chronic) or uncontrolled severe infections
Have active, acute, or chronic clinically significant infections or bleeding.
Skin toxicity including but not limited to erythema, rash, ulceration, and open wound that is still clinically present and considered as acute or chronic.
Acute viral hepatitis or history of chronic or acute HBV, HCV, HAV, HDV, HEV
Acute or chronic skin disorders that will interfere with subcutaneous injection of the vaccine or subsequent assessment of potential skin reactions
History of functionally limiting chronic or acute cardiac, pulmonary, or neuromuscular disease
Sepsis and/or acute, chronic, or ongoing infections that are currently being treated with systemic antimicrobials
Acute medical conditions, such as acute flare-up of joint condition or infection
Subjects with active uncontrolled infection or who are human immunodeficiency virus (HIV) positive (subjects with acute infections requiring treatment should delay screening/enrollment until the course of therapy has been completed and the event is considered controlled)
Participants with acute, active gastrointestinal infection (e.g., typhlitis, diverticulitis, appendicitis)
Acute treatment for an infection (excluding fungal infection of the skin and sexually transmitted infections) or other serious medical illness within weeks before Segment B enrollment
Acute febrile illness
Acute or chronic respiratory disease
Other known causes of significant liver disease including chronic or acute hepatitis B, acute hepatitis A, hemochromatosis, or homozygote alpha- antitrypsin deficiency
Any medical contradiction to use of a Mirena IUD, including:\r\n* Pregnancy (a pregnancy test is required prior to study entry)\r\n* Known uterine anomaly that distorts the shape of the uterine cavity \r\n* Acute pelvic inflammatory disease\r\n* Postpartum endometritis or endometrial infection\r\n* Known or suspected uterine or cervical neoplasia\r\n* Known history or suspected breast cancer or other progestin-sensitive cancer\r\n* Uterine bleeding of unknown etiology\r\n* Untreated acute cervicitis, vaginitis, or other lower genital tract infections\r\n* Acute liver disease or liver tumor (benign or malignant)
Use of systemic antibacterials, antifungals or antivirals for the treatment of acute clinically significant infection within weeks of first veledimex dose. Concomitant therapy for chronic infections is not allowed. Subjects must be afebrile prior to Ad-RTS-hIL- injection; only prophylactic antibiotic use is permitted perioperatively.
acute respiratory failure,
acute infection without septic shock,
acute myocarditis or
acute systemic infection and
Patients with acute serious illnesses at the discretion of the primary investigator
Acute prostatitis within the last months
Patients suffering from active acute or chronic prostatitis
Have an acute or a chronic hematoma and/or acute ecchymosis of the thyroid;
Symptomatic acute prostatitis
Documented acute prostatitis or urinary tract infections
Not in acute crisis