Status:
COMPLETED
Cytomegalovirus Vaccine in Healthy Participants
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Precancerous/Nonmalignant Condition
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
RATIONALE: Vaccines may help the body build an effective immune response against cytomegalovirus. PURPOSE: This randomized phase I trial is studying the side effects and best dose of cytomegalovirus ...
Detailed Description
OBJECTIVES: * To establish whether 4 dose levels of the CMVpp65-A\*0201 peptide vaccine are safe and well tolerated in cytomegalovirus (CMV)-seropositive participants. * To determine whether the CMVp...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Healthy participant
- Cytomegalovirus seropositive or seronegative
- HLA-A\*0201-positive
- PATIENT CHARACTERISTICS:
- CBC within 1.5 times normal
- SMA-18 within 1.5 times normal
- Hepatitis B virus antigen seronegative
- Hepatitis C virus seronegative
- No diagnosis that is associated with immunodeficiency, including HIV infection
- No serious abnormalities by EKG (in participants ≥ 50 years of age)
- Not pregnant
- PRIOR CONCURRENT THERAPY:
- More than 6 months since prior surgery
- No concurrent daily medications for chronic or current illness, except for the following:
- Thyroid replacement therapy
- Estrogen replacement therapy
- Dietary vitamins and protein supplements
- Antihistamine medication
- Anticholesterol medication
- Cardiac and antihypertensive medication
- Any medication, as determined by the principal investigator, that is not known or likely to be immunosuppressive
Exclusion
Key Trial Info
Start Date :
November 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2009
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00712634
Start Date
November 1 1997
End Date
April 1 2009
Last Update
December 21 2009
Active Locations (1)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000