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. Author manuscript; available in PMC: 2017 Sep 1.
Published in final edited form as: Expert Rev Vaccines. 2016 Apr 6;15(9):1213–1222. doi: 10.1586/14760584.2016.1168701

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]
a

Adsorbed to Alhydrogel;

b

clinicaltrials.gov identifier number(s);

c

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;

d

refers to GMT of reciprocal endpoint determined by ELISA using ricin-coated plates;

e

reciprocal toxin-neutralizing endpoint titers (IC50) established in Daudi cells;

f

reciprocal dilution of serum that conferred positive toxin-neutralizing activity in EL4 cells;n.a., not applicable, n.r., not reported.