A total of 43 (adjuvanted) and 37 (non-adjuvanted) subjects completed the study ( Fig. 1). The mean age of enrolled subjects was 39.5 years with 61% of them being male. All were of Asian ethnicity with a Chinese majority (79%, Table 1). Eighty-nine percent of subjects
experienced at least one AE during the study (Day 0-Day 42). No serious/life threatening AEs were reported. A total of 11 (13.4%) subjects developed at least one severe AE (grade 3). In total there were 535 AEs reported (278 in the adjuvanted and 257 in the non-adjuvanted arm), of which 265 (49.5%) were local (Table 2). The most frequent local symptoms were pain and muscle ache, followed by limitation of movement in their vaccinated arm and Selleck Enzalutamide itch (Fig. 2A). The most common treatment-related non-local symptom was fatigue, followed by myalgia, headache, oropharyngeal pain and rhinorrhea (Fig. 2B). Most AEs (76.4%) were mild; with 15.3% moderate and 8.2% severe. All AEs were resolved by day 42 except three: cataract in one http://www.selleckchem.com/products/frax597.html subject; and two symptoms (tiredness and running nose from allergic rhinitis)
in a second subject, considered unrelated to gH1-Qbeta and still on-going at the last visits. No modification was made to the study drug administration because of any AE. The AEs profile was comparable between the adjuvanted and the non-adjuvanted group (Table 2 and Fig. 2). The immunogenicity of the vaccine with and without alhydrogel adjuvant was assessed by HAI titers against A/California/7/2009 (H1N1) at Day 42. The proportion of seroconverted subjects after two doses of vaccine is shown in Table Parvulin 3. In the adjuvanted group, 22/43 (51.2%, 95% CI: 36.8 to 65.4%) and in the non-adjuvanted group 26/37 (70.3%, 95% CI: 54.2 to 82.5%) achieved seroconversion. Hence, only the non-adjuvanted group met the FDA criterion of a ≥40% lower bound CI for seroconversion. An increase in the percentage of subjects with seroconversion
between Day 21 and Day 42 was observed in both groups after boosting. The percentage of subjects with seroconversion was lower in the adjuvanted group than in the non-adjuvanted group on both days. Of the 79 subjects who had baseline HAI titers <40 and HAI titers available on Day 21 and Day 42, 13/43 (30.2%) in the adjuvanted group, and 24/36 (66.7%) in the non-adjuvant group (p = 0.002) showed seroprotection against the strain A/California/7/2009 (H1N1) on Day 21 ( Table 3). The GMT was significantly higher (p = 0.013) in the non-adjuvanted group (GMT = 70.2) than in the adjuvanted group (GMT = 33.2). In addition cross-reactivity of the induced antibodies was evaluated against two drifted influenza strains, A/Brisbane/10/2010 (H1N1) and A/Georgia/01/2013 (H1N1). The immunogenicity against both strains was similar to that demonstrated for A/California/7/2009. The seroconversion rates following two doses of the non-adjuvanted vaccine were 73.0% (95% CI: 57.0 to 84.6%) and 64.9% (95% CI: 48.8 to 78.