Phase 1 Trial of the Dengue Virus Type 4 Vaccine Candidate rDEN4Δ30-4995 in Healthy Adult Volunteers

• DOI: 10.4269/ajtmh.2009.09-0131
• Publication Date: 2009-10-27T19:03:21Z
• Authors: Peter F. Wright; Anna P. Durbin; Stephen S. Whitehead; Mine R. Ikizler; Susan Henderson; Joseph E. Blaney; Bhavin Thumar; Sharon Ankrah; Michael T. Rock; Brett A. McKinney; Brian R. Murphy; Alexander C. Schmidt
• Keywords: Adult; Male; 0303 health sciences; Dengue Vaccines; Middle Aged; Antibodies, Viral; 3. Good health; Dengue; Young Adult; 03 medical and health sciences; Cytokines; Humans; Female

rDEN4Delta30-4995 is a live attenuated dengue virus type 4 (DENV4) vaccine candidate specifically designed as further derivative of the rDEN4Delta30 parent virus. In previous study, 5 20 vaccinees who received 10(5) plaque-forming units (PFU) developed transient elevation serum alanine aminotransferase (ALT) level and an asymptomatic maculopapular rash in 10 20. current 28 healthy adult volunteers were randomized to receive PFU (20) or placebo (8) single subcutaneous injection. The was safe, well-tolerated, immunogenic. An generalized elevations ALT levels observed 10% vaccinees. None became viremic, yet 95% four-fold greater increase neutralizing antibody titers. Thus, demonstrated be highly attenuated, However, localized erythematous at injection site seen 17/20 Therefore, alternative DENV4 strains selected for clinical development.