Status:
COMPLETED
Vaccine Therapy in Preventing Cytomegalovirus in Healthy Participants
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Nonneoplastic Condition
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
RATIONALE: Vaccines made from peptides may help the body build an immune response to kill cytomegalovirus. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in...
Detailed Description
OBJECTIVES: Primary * To establish whether 3 vaccine dose levels of PADRE-CMV and tetanus-CMV fusion peptide vaccines are safe and well tolerated in healthy cytomegalovirus (CMV)-seropositive or -se...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Cytomegalovirus (CMV) seropositivity or seronegativity
- HLA A\*0201 positive OR positive tetramer-binding using CMV peptide 495-503 with HLA A2 subtypes other than HLA A\*0201
- A2-CMV-Tet cells ≤ 10\^8/L
- PATIENT CHARACTERISTICS:
- Platelet count within 1.5 times upper level of normal (ULN)
- The following blood and chemistry studies must be normal:
- Sodium
- Potassium
- Chloride
- Carbon dioxide
- Glucose
- BUN
- Creatinine
- Uric acid
- WBC
- Hemoglobin
- Hematocrit
- The following studies must be ≤ ULN:
- Albumin
- Alkaline phosphatase
- AST and ALT
- Lactic dehydrogenase
- Total bilirubin
- Hepatitis B virus surface antigen negative
- Hepatitis C virus seronegative
- No diagnosis that is associated with immunodeficiency (e.g., HIV)
- No active infection that requires treatment
- No known cardiac disease including hypertension and/or high cholesterol
- No serious abnormalities by EKG (in participants ≥ 50 years of age)
- Not pregnant
- Negative pregnancy test
- Fertile participants must use effective contraception during study and for 6 weeks after the fourth and last dose of vaccine
- No history of allergic reaction to tetanus toxoid
- No history of any of the following:
- Cancer other than basal cell carcinoma of the skin
- Depression
- Allergic diathesis, as defined by a history of asthma
- Anaphylaxis
- Generalized urticaria or daily use of antihistamines
- Episodic (more than once in the past 3 months) inhalational medications including steroidal agents
- Non-steroidal agents or cromolyn sodium
- Frequent migraines, defined as 3 or more episodes in the past year
- No prior or concurrent infectious condition
- PRIOR CONCURRENT THERAPY:
- More than 6 months since prior participation in a CMV immunotherapy trial
- More than 30 days since prior live vaccine
- More than 2 weeks since prior inactivated vaccine
- No concurrent daily medications for chronic or current illness, except for the following:
- Thyroid-replacement therapy
- Estrogen-replacement therapy
- Dietary vitamins and protein supplements
- Any medication, as determined by the principal investigator, that is not known or likely to be immunosuppressive
- No surgery in the past 6 months that required general anesthesia
- Minor procedures (e.g., dental surgery or superficial diagnostics biopsies) allowed
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00722839
Start Date
December 1 2006
End Date
April 1 2012
Last Update
June 25 2012
Active Locations (1)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000