PMC full text:
Vaccine. Author manuscript; available in PMC 2014 Jun 26.
Published in final edited form as:
Vaccine. 2013 Jun 26; 31(30): 3051–3058.
Published online 2013 May 10. doi: 10.1016/j.vaccine.2013.04.063Table 3
Number and Percentage of Subjects with Systemic Reactions Recorded on Diary Cards After the First and Second Injections
| MedDRA Preferred Term | BioThrax 0.5 mL (N=18) | AV7909 | Saline Placebo 0.5 mL (N=15) | |||
|---|---|---|---|---|---|---|
| Form. 1 AVA 0.5 mL + CPG 7909 0.5 mg N=18 | Form. 2 AVA 0.5 mL + CPG 7909 0.25 mg N=17 | Form. 3 AVA 0.25 mL + CPG 7909 0.5 mg N=19 | Form. 4 AVA 0.25 mL + CPG 7909 0.25 mg N=18 | |||
| First Injection | ||||||
| Any Systemic Reactiona | 10 (55.6) | 12 (66.7) | 7 (41.2) | 3 (15.8) | 7 (38.9)b | 5 (33.3) |
| Fever | 0 | 2 (11.1) | 1 (5.9) | 0 | 0 | 2 (13.3) |
| Fatiguec | 6 (33.3) | 9 (50.0) | 3 (17.6) | 3 (15.8) | 4 (22.2) | 2 (13.3) |
| Muscle achingd | 4 (22.2) | 8 (44.4) | 3 (17.6) | 0 | 2 (11.1) | 2 (13.3) |
| Headachee | 6 (33.3) | 11 (61.1) | 5 (29.4) | 1 (5.3) | 5 (27.8)b | 2 (13.3) |
| Nausea/GI upset | 1 (5.6) | 4 (22.2) | 2 (11.8) | 2 (10.5) | 2 (11.1) | 2 (13.3) |
| Second Injection | ||||||
| Any Systemic Reactionf | 7 (38.9)b | 14 (77.8)b | 7 (41.2) | 4 (21.1) | 9 (50.0) | 2 (13.3) |
| Fever | 0 | 0 | 0 | 0 | 1 (5.6) | 0 |
| Fatigue | 4 (22.2) | 8 (44.4)b | 4 (23.5) | 3 (15.8) | 7 (38.9) | 1 (6.7) |
| Muscle achingg | 5 (27.8)b | 9 (50.0)b | 3 (17.6) | 2 (10.5) | 7 (38.9) | 0 |
| Headache | 5 (27.8)b | 7 (38.9) | 3 (17.6) | 3 (15.8) | 7 (38.9) | 1 (6.7) |
| Nausea/GI upset | 1 (5.6) | 3 (16.7) | 0 | 0 | 3 (16.7) | 0 |
aThe results of post-hoc analyses of the active treatment groups showed that after the first injection, the frequency of “any systemic reaction” was significantly lower in the AV7909 Formulation 3 group vs. BioThrax group (p=0.02) and significantly higher in the Formulation 1 vs. Formulation 3 group (p=0.003).
bFor 1 of these subjects, the reaction was assessed by the principal investigator as severe.
cThe results of post-hoc analyses of the active treatment groups showed that after the first injection, the frequency of fatigue was significantly higher in the AV7909 Formulation 1 group vs. Formulation 3 group (p=0.04).
dThe results of post-hoc analyses of the active treatment groups showed that after the first injection, the frequency of muscle aching was significantly higher in the AV7909 Formulation 1 group vs. Formulation 3 group (p=0.001) and significantly lower in the Formulation 3 group vs. BioThrax group (p=0.05).
eThe results of post-hoc analyses of the active treatment groups showed that after the first injection, the frequency of headache was significantly higher in the AV7909 Formulation 1 group vs. Formulation 3 group (p=0.0004) and significantly lower in the Formulation 3 group vs. BioThrax group (p=0.04).
fThe results of post-hoc analyses of the active treatment groups showed that after the second injection, the frequency of “any systemic reaction” was significantly higher in the AV7909 Formulation 1 group vs. BioThrax group (p=0.04), Formulation 1 group vs. Formulation 2 group (p=0.04), and Formulation 1 group vs. Formulation 3 group (p=0.0009).
gThe results of post-hoc analyses of the active treatment groups showed that after the second injection, the frequency of muscle aching was significantly higher in the AV7909 Formulation 1 group vs. Formulation 3 group (p=0.01).