Evaluation of a prototype dengue-1 DNA vaccine in a Phase 1 clinical trial

Charmagne G. Beckett*, Jeffrey Tjaden, Timothy Burgess, Janine R. Danko, Cindy Tamminga, Monika Simmons, Shuenn Jue Wu, Peifang Sun, Tadeusz Kochel, Kanakatte Raviprakash, Curtis G. Hayes, Kevin R. Porter

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

121 Scopus citations

Abstract

Candidate dengue DNA vaccine constructs for each dengue serotype were developed by incorporating pre-membrane and envelope genes into a plasmid vector. A Phase 1 clinical trial was performed using the dengue virus serotype-1 (DENV-1) vaccine construct (D1ME100). The study was an open-label, dose-escalation, safety and immunogenicity trial involving 22 healthy flavivirus-naïve adults assigned to one of two groups. Each group received three intramuscular injections (0, 1, and 5 months) of either a high dose (5.0mg, n=12) or a low dose (1.0mg, n=10) DNA vaccine using the needle-free Biojector® 2000. The most commonly reported solicited signs and symptoms were local mild pain or tenderness (10/22, 45%), local mild swelling (6/22, 27%), muscle pain (6/22, 27%) and fatigue (6/22, 27%). Five subjects (41.6%) in the high dose group and none in the low dose group developed detectable anti-dengue neutralizing antibodies. T-cell IFN gamma responses were detected in 50% (4/8) and 83.3% (10/12) of subjects in the low and high dose groups, respectively. The safety profile of the DENV-1 DNA vaccine is acceptable at both doses administered in the study. These results demonstrate a favorable reactogenicity and safety profile of the first in human evaluation of a DENV-1 DNA vaccine.

Original languageEnglish
Pages (from-to)960-968
Number of pages9
JournalVaccine
Volume29
Issue number5
DOIs
StatePublished - 29 Jan 2011

Keywords

  • Clinical trials
  • DNA vaccines
  • Dengue

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