Table 2.
Adverse effects | FP9 dose 1 | Rabies dose 1 | FP9 dose 2 | Rabies dose 2 | MVA (after 2 doses of FP9) | Rabies dose 3 |
---|---|---|---|---|---|---|
Headache | 4 (13%) | 3 (10%) | 2 (8%) | 6 (9%) | 9 (31%) | 7 (11%) |
(4, 31) | (0, 10) | (1, 24) | (3, 19) | (15, 51) | (5, 21) | |
Fever | 0 | 0 | 0 | 0 | 0 | 0 |
(0, 10) | (0, 4) | (0, 10) | (0, 4) | (0, 10) | (0, 5) | |
Malaise | 2 (6%) | 2 (3%) | 1 (4%) | 0 | 7 (24%) | 11 (19%) |
(1, 22) | (0, 10) | (0, 18) | (0, 4) | (10, 44) | (9, 29) | |
Nausea or vomiting | 0 | 2 (3%) | 0 | 1 (2%) | 6 (21%) | 5 (12) |
(0, 10) | (0, 10) | (0, 10) | (0, 8) | (8, 40) | (3, 17) | |
Pain | 15 (50%) | 4 (6%) | 13 (46%) | 4 (6%) | 6 (21%) | 1 (2%) |
(31, 69) | (2, 14) | (28, 66) | (2, 15) | (8, 40) | (0, 8) | |
Discoloration | 19 (63%) | 19 (26%) | 16 (57%) | 22 (33%) | 8 (28%) | 6 (9%) |
(44, 80) | (17, 38) | (37, 76) | (22, 46) | (13, 47) | (4, 19) | |
Itching | 8 (27%) | 5 (7%) | 8 (29%) | 4 (6%) | 2 (7%) | 2 (3%) |
(12, 46) | (2, 16) | (13, 49) | (2, 15) | (1, 23) | (0, 11) | |
Induration | 30 (100%) | 25 (35%) | 24 (86%) | 23 (35%) | 24 (83%) | 27 (42%) |
(90, 100) | (24, 47) | (67, 96) | (24, 48) | (64, 94) | (30, 55) | |
Blistering | 16 (53%) | 3 (4%) | 7 (25%) | 0 | 7 (24%) | 0 |
(34, 72) | (1, 12) | (11, 50) | (0, 4) | (10, 44) | (0, 5) | |
Limited arm motion | 7 (23%) | 1 (1%) | 2 (3%) | 0 | 0 | 0 |
(10, 42) | (0, 8) | (0, 18) | (0, 4) | (0, 10) | (0, 5) | |
Total | 30 | 72 | 28 | 66 | 29 | 64 |
Note: Adverse events were assessed 1 hour and 1, 2, 7, and 28 days after each vaccination. Observations were made in 30 volunteers in the malaria vaccine group (FFM), in 37 in the rabies + SP group, and in 35 in the rabies group who received at least one dose of vaccine. Results are presented as n (%) and 95% CI.