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

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).

Timeline

Start

2010-09

Primary completion

2014-10

Completion

2014-10

Publications

• Adler SP, Manganello AM, Lee R, McVoy MA, Nixon DE, Plotkin S, Mocarski E, Cox JH, Fast PE, Nesterenko PA, Murray SE, Hill AB, Kemble G. A Phase 1 Study of 4 Live, Recombinant Human Cytomegalovirus Towne/Toledo Chimera Vaccines in Cytomegalovirus-Seronegative Men. J Infect Dis. 2016 Nov 1;214(9):1341-1348. doi: 10.1093/infdis/jiw365. Epub 2016 Aug 11.

Drugs

Indications