Vaccine Therapy in Healthy Volunteers With or Without Previous Exposure to Cytomegalovirus (NCT01941056) | Clinical Trial Compass
CompletedPhase 1
Vaccine Therapy in Healthy Volunteers With or Without Previous Exposure to Cytomegalovirus
United States24 participantsStarted 2014-01-05
Plain-language summary
This phase I trial studies the side effects and the best dose of vaccine therapy in healthy volunteers with or without previous exposure to cytomegalovirus. Vaccines made from a gene-modified virus may help the body build an immune response and may help prevent cytomegalovirus infection.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Sodium range from within normal institutional limits to less than a grade I toxicity
* Potassium range from within normal institutional limits to less than a grade I toxicity
* Chloride range from within normal institutional limits to less than a grade I toxicity
* Carbon dioxide range from within normal institutional limits to less than a grade I toxicity
* Glucose range from within normal institutional limits to less than a grade I toxicity
* Alkaline phosphatase (AP) range from within normal institutional limits to less than a grade I toxicity
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) range from within normal institutional limits to less than a grade I toxicity
* Blood urea nitrogen (BUN) range from within normal institutional limits to less than a grade I toxicity
* Creatinine range from within normal institutional limits to less than a grade I toxicity
* Lactic dehydrogenase (LDH) range from within normal institutional limits to less than a grade I toxicity
* Total bilirubin range from within normal institutional limits to less than a grade I toxicity
* Uric acid range from within normal institutional limits to less than a grade I toxicity
* Albumin \> lower limit of normal institutional limits
* White blood count range from within normal institutional limits to less than a grade I toxicity
* Hemoglobin (HGB) range from within normal institutional limits to less than a grade I toxicity
* Hematocrit (HCT) range from within n…
What they're measuring
1
Successful completion of 2 injections without dose-limiting toxicity (DLT) according to the Division of Microbiology and Infectious Diseases (DMID) adult toxicity tables