Status:
WITHDRAWN
High Dose Influenza in Immunosuppressed Subjects
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Influenza is a common infection of the upper airways and lungs, and is caused by viruses. Cancer patients may need a stronger influenza vaccine than the general population to protect against influenza...
Detailed Description
Bone marrow transplantation (BMT) patients are immunocompromised to a varying degree depending upon genetic relationship between donor and recipient with compromising therapy required for allogeneic t...
Eligibility Criteria
Inclusion
- At least 18 years of age, between 6 and 12 months after undergoing their last allogeneic donor hematopoietic stem cell transplantation with no or stable chronic graft versus host disease (score 0-1).
- Underlying cancer is stable or in complete remission within 3 months prior to enrollment as determined by the treating oncologist in written documentation stating such fact.
- Ambulatory; community dwelling. Subjects will be considered ambulatory if they are not institutionalized, bedridden or homebound.
- Able to return to the clinical site for reactogenicity examinations for at least 7 days after each injection.
- Patients with stable chronic viral infection \[(other than Hepatitis B or C and human immunodeficiency virus (HIV)\]; any bacterial, mycobacterial or invasive fungal infections that are on maintenance antimicrobial therapy are eligible. Antimicrobial therapy includes: any antiviral, antibacterial or antifungal therapy use under the standard guidelines for treatment or maintenance treatment of viral, bacterial or invasive fungal infections.
- Women of childbearing potential (not surgically sterile or postmenopausal for greater than or equal to 1 year) who are at risk of becoming pregnant must agree to practice adequate contraception (i.e., barrier method, abstinence, or licensed hormonal methods as recommended by her primary care provider) from at least 30 days prior to enrollment and for at least 3 months after receipt of dose 2.
- Able to understand and comply with planned study procedures.
- Provides informed consent prior to initiation of any study procedures and is available for all study visits.
Exclusion
- Has moderate or severe chronic graft versus host disease (score 2-3) or uncontrolled chronic graft-versus-host disease (GvHD).
- Has required high-dose corticosteroids: \>16 mg prednisone or equivalent daily dose (high-dose methylprednisolone, high-dose dexamethasone), or receiving immunosuppressive agents such as tacrolimus, antithymocyte globulins, cyclosporine, or methotrexate in past 4 weeks.
- Has long-term use (greater than 4 weeks) of moderate to high-dose inhaled steroids (e.g., more than the equivalent of 264 mcg fluticasone; 600 mcg budesonide; 240 mcg beclomethasone; 1000 mcg flunisolide, 750 mcg triamcinolone or 200 mcg mometasone, as a daily dose) within 1 month prior to enrollment.
- Has received chemotherapy within the past 3 months for a refractory or relapsed cancer.
- Was given rituximab or ibritumomab tiuxetan in the past 6 months.
- Splenectomized individuals.
- Has a known allergy to eggs or other components of the vaccine (i.e., thimerosal) or a severe reaction to influenza vaccine in the past.
- Has an acute or chronic condition or an acute change in a chronic condition that (in the opinion of the investigator) would render vaccination unsafe or would interfere with the evaluation of responses including but not limited to the following: acute febrile illness, known chronic liver disease \[history of increased alanine transaminase (ALT) and aspartate aminotransferase (AST) levels in the past 4 weeks\]; significant renal disease on dialysis; oxygen-dependent chronic lung disease, New York Heart Association Functional Class III or IV; unstable or progressive neurologic disorder; or uncontrolled diabetes mellitus. Medically unstable patients with systolic blood pressure \< 90 mmHg, pulse \> 100 beats per minutes, or respiratory rate of \> 24 per minutes will not be included in this study.
- Has received immunoglobulin within 3 months or monoclonal antibodies within 4 weeks prior to enrollment into the study.
- Has a history of Guillian-Barré Syndrome, vasovagal syncope, clinically symptomatic pericardial effusion or cardiac tamponade, or Bell's palsy.
- Has an acute illness including an oral temperature greater than or equal to 100.0 degrees Fahrenheit, within one week prior to vaccination.
- Has a known history of human immunodeficiency virus (HIV) or Hepatitis B or Hepatitis C. Screening for HIV will not be performed for this study.
- Has a positive urine pregnancy test prior to vaccination (if female of childbearing potential), is breast-feeding, or has the intention to become pregnant within 3 months of receipt of their second dose of vaccine.
- Has received the current licensed trivalent influenza vaccine within the past 4 weeks.
- Has received an investigational agent (drug, vaccine, biologic agent or a device) within 4 weeks before vaccination, or expects to receive an experimental agent prior to completing study visit 5.
- Has a diagnosis of schizophrenia, bipolar disease or other major psychiatric diagnosis.
- Has been hospitalized for psychiatric illness, history of suicide attempt or confinement for danger to self or others.
- Is receiving psychiatric drugs (aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, trifluopromazine, chlorprothixene, chlorpromazine, perphenazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate). Subjects who are receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without de-compensating symptoms will be allowed to be enrolled in the study.
- Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
- Has any condition that the investigator believes may interfere with successful completion of the study.
- Has a history of alcohol or drug abuse in the last 5 years.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00766285
End Date
September 1 2010
Last Update
August 3 2015
Active Locations (1)
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1
The University of Texas - MD Anderson Cancer Center - Infectious Diseases
Houston, Texas, United States, 77030-4000