Vaccine Therapy in Preventing Cytomegalovirus in Healthy Participants

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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 preventing cytomegalovirus in healthy participants.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Vaccines

Criteria

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