Table 2.
Adverse events after vaccination.
| Main cohort n=120 | ||||||||
|---|---|---|---|---|---|---|---|---|
| 1·8×106 PfSPZ Vaccine | Placebo (Normal Saline) | |||||||
| Dose 1 (n=60) | Dose 2 (n=58) | Dose 3 (n=57) | Total (n=60) | Dose 1 (n=60) | Dose 2 (n=59) | Dose 3 (n=55) | Total (n=60) | |
| Adverse Events (AEs) | ||||||||
| Local Reactogenicity1 | 2 (2) 3·3% | 2 (2) 3·4% | 0 (0) 0% | 4 (4) 6·7% | 1 (1) 1·7% | 4 (4) 6·8% | 1 (1) 1·8% | 6 (5) 8·3% |
| Systemic Reactogenicity | 1 (1) 1·7% | 5 (2) 3·4% | 1 (1) 1·8% | 7 (3) 5% | 3 (2) 3·3% | 1 (1) 1·7% | 0 (0) 0% | 4 (3) 5% |
| Laboratory Abnormalities2 | 1 (1) 1·7% | 5 (5) 8·6% | 4 (4) 7% | 10 (8) 13·3% | 1 (1) 1·7% | 2 (2) 3·4% | 2 (2) 3·6% | 5 (2) 3·3% |
| Related AEs3 | 4 (4) 6·7% | 11 (7) 12·1% | 5 (5) 8·8% | 20 (12) 20% | 5 (4) 6·7% | 7 (6) 10·2% | 3 (2) 3·6% | 15 (9) 15% |
| Unsolicited AEs4 | 12 (9) 15% | 19 (15) 25·9% | 61 (32) 56·1% | 92 (42) 70% | 20 (18) 30% | 30 (19) 32·2% | 66 (37) 67·3% | 116 (50) 83·3% |
| SAEs | 0 (0) 0% | 0 (0) 0% | 0 (0) 0% | 0 (0) 0% | 1 (1) 1·7% | 0 (0) 0% | 1 (1) 1·8% | 2 (2) 3·3% |
| Symptomatic Malaria AEs 5 | ||||||||
| Total | 0 (0) 0% | 1 (1) 1·7% | 26 (24) 42·1% | 27 (25) 41·7% | 0 (0) 0% | 1 (1) 1·7% | 37 (31) 56·4% | 38 (31) 51·7% |
| Grade 1 | 0 (0) 0% | 0 (0) 0% | 19 (18) 31·6% | 19 (18) 30% | 0 (0) 0% | 1 (1) 1·7% | 24 (20) 36·4% | 25 (20) 33·3% |
| Grade 2 | 0 (0) 0% | 1 (1) 1·7% | 7 (7) 12·3% | 8 (8) 13·3% | 0 (0) 0% | 0 (0) 0% | 11 (11) 20% | 11 (11) 18·3% |
| Grade 3 | 0 (0) 0% | 0 (0) 0% | 0 (0) 0% | 0 (0) 0% | 0 (0) 0% | 0 (0) 0% | 2 (2) 3·6% | 2 (2) 3·3% |
| Grade 4 | 0 (0) 0% | 0 (0) 0% | 0 (0) 0% | 0 (0) 0% | 0 (0) 0% | 0 (0) 0% | 0 (0) 0% | 0 (0) 0% |
Data presented are number of AEs, (number of unique subjects), and % of unique subjects. Solicited local and systemic reactogenicity and laboratory adverse events were documented for 7 days after each vaccination and MedDRA coded and line listed below by preferred term. Unsolicited adverse events, including symptomatic malaria, serious AEs (SAEs), and new chronic medical conditions were recorded throughout the study. Each vaccine receipt is counted once at worst severity for any local and systemic parameter. Additional details regarding solicited local and systemic reactogenicity as well as laboratory adverse events are shown in the supplementary appendix (SA, Table S4, S5). Symptomatic malaria was defined as any Pf asexual parasitemia accompanied by an axillary temperature of at least 37·5°C, clinical signs and symptoms of malaria, or both. PfSPZ=Plasmodium falciparum sporozoite. AE=adverse events.
All local reactogenicity reported were injection site pain.
Laboratory abnormalities were included in this count if they occurred during the scheduled day 7 post vaccination visit and were within window for that visit (up to day 9).
Related AEs includes all AEs reported within 28 days of vaccination and determined as definitely, probably, or possibly related to vaccination; includes expected reactogencity as well as laboratory abnormalities.
Unsolicited AEs represented below does not include malaria AEs, but does include laboratory AEs occurring outside the predefined collection period post vaccination. All unsolicited AEs were determined not related to vaccination except for two transaminases increased in the placebo arm (onset 33, 39 days post dose 2, determined possibly related during the study, Grade 4 and Grade 3; further details provided in SA, Figure S3).
Though reported as malaria AEs, 2 malaria AEs are exclude for PfSPZ Vaccine given detection of P. malariae only, no Pf and 1 malaria AE is excluded in the placebo given detection of P. malariae + P. ovale only, no Pf.