Phase I clinical evaluation of rDEN4Δ30-200,201: A live attenuated dengue 4 vaccine candidate designed for decreased hepatotoxicity

Julie H. McArthur, Anna P. Durbin, Jennifer A. Marron, Kimberli A. Wanionek, Bhavin Thumar, Dennis J. Pierro, Alexander C. Schmidt, Joseph E. Blaney, Brian R. Murphy, Stephen S. Whitehead

Research output: Contribution to journalArticle

Abstract

The rDEN4Δ30-200,201 is a live attenuated DENV-4 vaccine candidate specifically designed to further attenuate the rDEN4Δ30 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 rDEN4Δ30-200,201 previously documented in animal models was confirmed in humans. The rDEN4Δ30-200,201 is a promising candidate and can be considered for inclusion in a tetravalent dengue virus (DENV) vaccine.

Original languageEnglish (US)
Pages (from-to)678-684
Number of pages7
JournalAmerican Journal of Tropical Medicine and Hygiene
Volume79
Issue number5
StatePublished - Nov 1 2008

ASJC Scopus subject areas

  • Parasitology
  • Virology
  • Infectious Diseases

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    McArthur, J. H., Durbin, A. P., Marron, J. A., Wanionek, K. A., Thumar, B., Pierro, D. J., Schmidt, A. C., Blaney, J. E., Murphy, B. R., & Whitehead, S. S. (2008). Phase I clinical evaluation of rDEN4Δ30-200,201: A live attenuated dengue 4 vaccine candidate designed for decreased hepatotoxicity. American Journal of Tropical Medicine and Hygiene, 79(5), 678-684.