NCT01195571

Safety Study of Four Chimera Cytomegalovirus (CMV) Vaccines in Healthy Adult Males 30-50 Years of Age

A Dose Escalation Study to Assess the Safety and Immunogenicity of Four Live Attenuated Human Cytomegalovirus(HCMV) Vaccines in Healthy Adults Without Prior Immunity.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: CMV Research Foundation · Academic / Other
• Sex: Male
• Age: 30 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Cytomegalovirus

Interventions

Type	Name	Description
BIOLOGICAL	cmv vaccine	dose escalation study of 4 towne-toledo chimera vaccines

Timeline

• Start date: 2010-09-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2010-09-06
• Last updated: 2015-05-19

Locations

1 site across 1 country: United States