Safety Study of Four Chimera Cytomegalovirus (CMV) Vaccines in Healthy Adult Males 30-50 Years of Age
The purpose of this research study is to test the safety and tolerability of four new investigational Cytomegalovirus (CMV) vaccines (Towne-Toledo 1, 2, 3, 4) in healthy male volunteers who are CMV negative. CMV is a common virus, infecting 50-80% of adults in the United States by the age of twenty-one. CMV does not usually cause illness in adults or children. However, CMV can be a cause of deafness and mental retardation in a child if a mother is infected during pregnancy. It also can be a serious illness in patients with impaired immunity (decreased ability to fight infection).
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Dose Escalation Study to Assess the Safety and Immunogenicity of Four Live Attenuated Human Cytomegalovirus(HCMV) Vaccines in Healthy Adults Without Prior Immunity.|
- Safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]To evaluate the safety and tolerability, in adults without prior HCMV immunity (seronegative), of four live attenuated HCMV investigational vaccines at each of three dose levels.
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
No Intervention: vaccine administration
Each subject will receive on of four chimera CMV vaccines
Biological: cmv vaccine
dose escalation study of 4 towne-toledo chimera vaccines
A total of thirty six participants will be enrolled. The first 12 participants will be randomized into four groups. Four groups will receive one of the four investigational vaccines. The four investigational HCMV vaccine candidates will be administered subcutaneously to 3 volunteers at 10 pfu (the lowest dose to be used). The safety and tolerability of the four investigational HCMV vaccine candidates will be monitored closely for a period of 12 weeks following vaccination at this dose. Investigational vaccines that are found to be safe and well tolerated at a dose of 10pfu will be administered to 3 additional individuals at 102 pfu and then at 103 pfu. Safety and tolerability will be evaluated at each dose level by monitoring clinical signs and symptoms, laboratory parameters and virus detection in the blood, urine, and saliva. After the 12-week safety-monitoring period, participants will be followed for the remainder of one year to assess long-term safety and immunogenicity of the investigational vaccines.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195571
|Contact: Stuart P Adler, MDfirstname.lastname@example.org|
|Contact: Anne-marie Manganello, RNemail@example.com|
|United States, Virginia|
|Virginia Commonwealth University||Recruiting|
|Richmond, Virginia, United States, 23298|
|Principal Investigator: Stuart P Adler, MD|
|Principal Investigator:||Stuart P Adler, MD||Virginia Commonwealth University|