Table 2.
Comparison of RiVax and RVEc Phase I and NHP Studies
Humans | R. macaques | ||
---|---|---|---|
RVEca | RiVaxa | RiVaxa | |
Trial IDb |
NCT01317667 NCT01846104 |
NCT00812071 | |
Group size (n=) | 10 | 5 | 12 |
Groups (µg) | 20, 50, 100 | 1,10,100 | 100 |
Vaccination-days | 0, 28, 56 | 0, 42, 180 | 0, 30, 60 |
AEc | 2/30 | 1/14 (Grade III) | n.a. |
Peak endpoint-day | 84 | 210 | 75 |
Peak titers | 4500–4800d | 25–260 µg/ml | 1534 µg/ml |
Peak TNA-day | 70 | n.r. | 110 |
Peak TNA-titer | 73–78e | 20–24f | 1280f |
Ab half life-day | 100 | 180 | n.r. |
Reference | [65] | [66] | [47] |
Adsorbed to Alhydrogel;
clinicaltrials.gov identifier number(s);
Adverse events (AE). In the RiVax trial, s all volunteers experienced Grade I toxicities, one individual suffered Grade II headache and Grade III nausea. In the RVEc trial, one individual suffered shoulder injury related to vaccine administration, while another suffered rhabdomyolysis;
refers to GMT of reciprocal endpoint determined by ELISA using ricin-coated plates;
reciprocal toxin-neutralizing endpoint titers (IC50) established in Daudi cells;
reciprocal dilution of serum that conferred positive toxin-neutralizing activity in EL4 cells;n.a., not applicable, n.r., not reported.