A Clinical Trial of an Alphavirus Replicon Vaccine for Cytomegalovirus (CMV)

Summary

AVX601, a bivalent alphavirus replicon vaccine expressing three CMV proteins (gB, pp65 and IE1) is a candidate vaccine against cytomegalovirus (CMV). The objectives of this Phase 1 study are to test the safety of the vaccine and the immune response to the vaccine in healthy volunteers who have not previously been infected with CMV. Volunteers will be assigned by randomization to receive either the vaccine or an inactive substance (placebo) by injections in each arm on three occasions over 6 months. The study will last 12 months and will have a total of 12 visits.

Timeline

Start

2007-04

Primary completion

2008-07

Completion

2008-07

Drugs

Indications