Table 3. Clinical response to rDEN2Δ30 in subjects who had received TV003 or control 6 months earlier.

ALT, alanine transaminase; PT, prothrombin time; PTT, partial thromboplastin time.

AEPrimary treatment
TV003 (n = 21)Placebo (n = 20)
Injection site
  Erythema9.5%0.0%
  Pain0.0%0.0%
  Tenderness0.0%0.0%
  Induration0.0%0.0%
Systemic
  Viremia0.0%100.0%*
  Fever0.0%0.0%
  Headache23.8%30.0%
  Rash0.0%80.0%*
  Neutropenia0.0%20.0%
  Elevated ALT0.0%5.0%
  Myalgia4.8%20.0%
  Arthralgia0.0%10.0%
  Retro-orbital pain9.5%25.0%
  Fatigue14.3%15.0%
  Nausea14.3%20.0%
  Photophobia4.8%0.0%
  Elevated PT0.0%0.0%
  Elevated PTT4.8%0.0%
  Thrombocytopenia0.0%10.0%

*P < 0.0001, two-sided.

P = 0.048, two-sided.