CMV Glycoprotein B Vaccine in Allograft Recipients

• Status: Unknown status
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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 safety and immune response of a CMV vaccine in patients (18 years old and older) who are awaiting a transplant. Following immunization with vaccine or placebo (inactive substance), patients will be followed for the development of immune responses to CMV and for evidence of CMV infection following transplantation. One hundred forty eligible patients will receive 3 injections of the CMV gB vaccine or 3 doses of placebo during 5 visits. Participants will participate in the study for approximately 7 months (if they do not undergo a transplant) or 10 months (if they undergo a transplant).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Krestin; Vaccines

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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a patient who is competent to give informed consent enters the trial but subsequently becomes incompetent, they will be withdrawn.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.