Status:
UNKNOWN
CMV Glycoprotein B Vaccine in Allograft Recipients
Lead Sponsor:
University College, London
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Cytomegalovirus Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Patients who receive transplants are at increased risk of developing serious cytomegalovirus (CMV) infections because they have a decreased immune system. The purpose of this study is to evaluate the ...
Detailed Description
Cytomegalovirus (CMV) is a common infectious agent which is well adapted to survival in the normal human host. Although CMV infection is usually asymptomatic, CMV disease develops when the host: virus...
Eligibility Criteria
Inclusion
- Informed consent and/or assent must be obtained from the patient.
- Patients must be 18 years of age or older.
- Awaiting a liver or kidney transplant.
- All female patients with childbearing potential must have a negative pregnancy test prior to each vaccination.
- All females of childbearing potential must agree to use an effective barrier method of birth control while receiving the vaccine and for 30 days after completion of the course of vaccine. Other contraception in addition to barrier methods is permitted.
- Among the CMV seropositives, HLA type compatible with tetramer assays (currently A2, A24, B7, B8, B35). (seronegatives of any HLA type are eligible).
Exclusion
- Patient unable or unwilling to provide and sign an informed consent or assent.
- If a patient who is competent to give informed consent enters the trial but subsequently becomes incompetent, they will be withdrawn.
- Pregnant or breastfeeding females.
- Participation in another clinical trial of a vaccine or of a systemic drug in the 4 weeks preceding the first trial vaccination (participation in trials of medical devices/ procedures is allowed).
- Planned participation in another clinical trial of a vaccine or of a systemic drug during the present trial period (participation in trials of medical devices/ procedures is allowed).
- Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
- Blood or blood-derived products received in the past 3 months (except albumin).
- Current thrombocytopenia or bleeding disorder contraindicating IM vaccination.
- Among the seropositives, HLA type incompatible with tetramer assays (seronegatives of any HLA type are eligible).
- Requiring emergency transplant for fulminant liver failure.
- Patients known to be HIV positive.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00299260
Start Date
August 1 2006
End Date
September 1 2011
Last Update
April 19 2010
Active Locations (1)
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1
University College Medical School
London, United Kingdom, NW3 2PF