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Phase I Clinical Evaluation of rDEN430-200,201: A Live Attenuated Dengue 4 Vaccine Candidate Designed for Decreased Hepatotoxicity

The rDEN430-200,201 is a live attenuated DENV-4 vaccine candidate specifically designed to further attenuate the rDEN430 parent virus. In the present study, 28 healthy adult volunteers were randomized to receive either 10⁵ plaque-forming unit (PFU) of vaccine (20) or placebo (8) as a single subcutaneous injection. Volunteers were evaluated for safety every other day for 16 days. Serum neutralizing antibody titer against DEN4 was determined at study day 28, 42, and 180. The vaccine infected all vaccinees and was well tolerated without inducing alanine aminotransferase (ALT) elevations. Although virus was not recovered from the serum of any vaccinee, moderate levels of neutralizing antibody were induced in all volunteers. Thus the restricted replication of rDEN430-200,201 previously documented in animal models was confirmed in humans. The rDEN430-200,201 is a promising candidate and can be considered for inclusion in a tetravalent dengue virus (DENV) vaccine.

Received April 1, 2008. Accepted for publication June 30, 2008.

Financial support: This research was supported by the Intramural Research Program of the NIAID, National Institutes of Health.

^* Address correspondence to Anna P. Durbin, Center for Immunization Research, 624 N. Broadway, Room 251, Baltimore, MD 21205. E-mail: adurbin{at}jhsph.edu

Note: This study was registered at clinicaltrials.gov NCT00270699.

Authors’ addresses: Julie H. McArthur, Anna P. Durbin, and Jennifer Marron, Center for Immunization Research, 624 N. Broadway, Room 251, Baltimore, MD 21205, Tel: 410-614-4736, Fax: 410-502-6898, E-mails: jmcarthu{at}jhsph.edu, adurbin{at}jhsph.edu, and jmarron{at}jhsph.edu. Kimberli A. Wanionek and Bhavin Thumar, Center for Immunization Research, 615 North Wolfe Street, Room E5601, Baltimore, MD 21205, Tel: 410-955-7230, Fax: 443-287-3167, E-mails: kwanione{at}jhsph.edu and bthumar{at}jhsph.edu. Dennis J. Pierro, Alexander C. Schmidt, and Brian R. Murphy, Laboratory of Infectious Diseases, NIAID, NIH, 50 South Drive, Bethesda, MD 20892, Tel: 301-594-1616, Fax: 301-480-5033, E-mails: pierrod{at}mail.nih.gov, as337y{at}nih.gov, and bmurphy{at}niaid.nih.gov. Joseph E. Blaney Jr and Stephen S. Whitehead, Laboratory of Infectious Diseases, NIAID, NIH, 33 North Drive, Bethesda, MD 20892, Tel: 301-496-7692, Fax: 301-480-4873, Emails: jblaney{at}niaid.nih.gov and swhitehead{at}niaid.nih.gov.

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