Numbers of volunteers experiencing local, systemic and laboratory adverse events (days 0–7 post each immunization).

All local AE’s were considered definitely related to immunization, all systemic AE’s were considered probably related to immunization, except for diarrhea that was possibly related, and all laboratory AE’s were considered possibly related to immunization, Solicited local and systemic adverse events were recorded on days 0, 1, 2 and 7 and laboratory tests were recorded on days 0, 2, 7 and 28 after each immunization. Severity classification for signs and symptoms: Gr1 = adverse event does not interfere with daily activities; Gr2 = interferes with but does not prevent daily activities; Gr3 = prevents daily activities. Severity classification for decreased platelets: Gr1 = 75,000/ul; decreased WBC: Gr1 = 3,000/ul; elevated WBC: Gr1 = >upper limit of normal, <15,000/ul; elevated ALT: Gr1 = >upper limit of normal, <3 times upper limit of normal; decreased Hb: Gr1 = 10.0 g/dL. All adverse events in the table are Gr1 (mild) unless noted otherwise.
1 = Gr2 (moderate);
2 = Gr3 (severe). All local adverse events occurred in the arm ipsilateral to the injection site.