Table 1.
Summary of AV7909 Efficacy: Survival
Guinea Pig | NHP | ||||||||
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Study 1 | Study 2 | Study 1 | Study 2 | ||||||
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Vaccine | Dilution | Survivala | Time to Deathb | Survivala | Time to Death b | Survivala | Time to Death b | Survivala | Time to Death b |
1:4 | 100 (16/16) d | NA | NT | NT | 100 (8/8) d | NA | 100 (10/10) d | NA | |
1:16 | 100 (16/16) d | NA | NT | NT | 88(7/8) d | 3.9 | 100 (9/9) d | NA | |
1:32 | NT | NT | 100 (24/24) d | NA | NT | NT | NT | NT | |
AV7909c | 1:64 | 100 (16/16) d | NA | 100 (22/22) d | NA | 75 (6/8) d | 4.4 (1.4) | 80 (8/10) d | 4.8 (0.1) |
1:96 | NT | NT | 100 (23/23) c, | NA | NT | 30 (3/10) | 4.7 (1.9) | ||
1:128 | NT | NT | 96 (23/24 d | 5.9 | 75 (6/8) c | 4.8 (1.4) | 40 (4/10) | 5.2 (1.3 | |
1:192 | NT | NT | 83 (19/23)d | 4.5 (0.6) | NT | 10 (1/10) | 3.8 (1.5) | ||
1:256 | 6 (1/14) | 4.1 (1.0) | 77 (17/22) d | 4.6 (1.2) | 25 (2/8) | 5.0 (0.9) | 11 (1/9) | 5.4 (1.3) | |
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1:16 | 67 (10/15) d | 7.5 (2.0) | NT | NT | 88 (7/8) d | 14.9 | NT | NT | |
AVA | 1:96 | NT | NT | 50 (12/24) d | 6.0 (3.2) | NT | NT | NT | NT |
1:64 | NT | NT | NT | NT | NT | NT | 67 (6/9) d | 4.0 (0.9) | |
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Adjuvant/Salinec | N/A | 0 (0/15) | 2.8 (0.4) | 0 (0/12) | 2.6 (1.4) | 13 (1/8) | 3.8 (1.6) | 0 (0/10) | 3.7 (1.1) |
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LD50 equivalents | 399 ± 111 | 336 ± 37 | 287 ± 87 | 178 ± 50 |
% Survival (Number Survived / Total Challenged), Equal numbers of males and females were vaccinated on Day 0. The initial group size was 16 and 24 in Guinea Pig Study 1 and 2 respectively and 8 and 10 NHP Study 1 and 2 respectively. In several groups animals died prior to the challenge due to a non-study related illness or injury, and were not included any further analyses.
Time to death = Days (Standard Deviation)
Study 1 control animals received adjuvant (250 μg CpG 7909 + 0.650 to 0.730 mg Alhydrogel in 0.5 mL) control. Study 2 control animals received 0.5mL saline administered IM.
p < 0.05 compared to the adjuvant group determined by two-sided Fisher’s exact test with Bonferroni-Holm adjustment for multiple comparisons.
N/A, not applicable, NT, Not tested