Status:
COMPLETED
Accelerated Immunization to Induce Cytomegalovirus Immunity in Stem Cell Donors
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cytomegalovirus Infections
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This study will evaluate the safety and effectiveness of a new vaccine, ALVAC-pp65, in boosting immunity to cytomegalovirus (CMV) infection in stem cell transplant donors. CMV is a member of the herpe...
Detailed Description
Cytomegalovirus (CMV) infection is a major complication following allogeneic stem cell transplantation (SCT). The risk of CMV infection after SCT is inversely related to the number of CMV-specific cyt...
Eligibility Criteria
Inclusion
- \- INCLUSION CRITERIA: VACCINE RECIPIENT
- Under evaluation for enrollment as a donor on a stem cell transplant protocol at the NIH Clinical Center, Or
- CMV sero-negative or sero-positive healthy volunteer
- Age greater than or equal to 18 years, but less than or equal to 80 years
- Ability to comprehend the investigational nature of the study and provide informed consent
- All subjects (men and women) must agree to practice abstinence or effective contraception during the study period
- Baseline laboratory evaluations are within normal limits
- For woman, negative urinary pregnancy test
- Informed consent from transplant recipients obtained
- INCLUSION CRITERIA:
- STEM CELL TRANSPLANT RECIPIENT
- Under evaluation for enrollment as a recipient on a stem cell transplant protocol at the NIH
- Age greater than or equal to 18 years, and less than or equal to 75 years
- Ability to comprehend the investigational nature of the study and provide informed consent
- EXCLUSION CRITERIA:
- VACCINE RECIPIENT
- History of severe adverse reaction or allergy to any vaccine
- Known or suspected allergies to vaccine constituents - eggs, mono-sodium glutamate or neomycin
- Acute febrile illness within the 72 hours preceding the vaccination
- History of any immunosuppressive disease or major chronic disorder
- History of treatment with immunosuppressive medications in the past 6 months
- Pregnant or breast feeding
- Enrolled or planning to enroll in another drug or vaccine clinical trial during the study period (other than the stem cell transplant when applicable)
- EXCLUSION CRITERIA:
- STEM CELL TRANSPLANT RECIPIENT
- \- There are no exclusion criteria for stem cell transplant recipients
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00353977
Start Date
May 1 2004
End Date
March 1 2008
Last Update
July 8 2014
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892