Table 1.
Solicited adverse events per vaccine dose, by group
| Group 1 2.7 × 106 PfSPZ Age 18–35 years |
Group 2 2.7 × 106 PfSPZ Age 35–65 years |
Group 3 1.8 × 106 PfSPZ Age 11–17 years |
Group 4 1.8 × 106 PfSPZ Age 6–10 years |
Group 5 1.8 × 106 PfSPZ Age 1–5 years |
Groups 6a/6b 9 × 105/1.8 × 106 PfSPZ Age 6–11 months |
|||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse event | Vaccine N = 56 |
NS N = 18 |
Vaccine N = 32 |
NS N = 9 |
Vaccine N = 35 |
NS N = 12 |
Vaccine N = 33 |
NS N = 12 |
Vaccine N = 31 |
NS N = 9 |
Vaccine N = 38 |
NS N = 9 |
| Any solicited AE | 10 (18%) | 1 (5.5%) | 8 (25%) | 2 (22%) | 10 (29%) | 4 (33%) | 6 (18%) | 0 | 5 (16%) | 0 | 8 (21%) | 2 (22%) |
| Any solicited local AE* | 0 | 0 | 1 (3.1%) | 0 | 4 (11%) | 2 (17%) | 1 (3.0%) | 0 | 3 (9.7%) | 0 | 1 (2.6%) | 0 |
| Any solicited systemic AE† | 10 (18%) | 1 (5.5%) | 7 (22%) | 2 (22%) | 6 (17%) | 2 (17%) | 5 (15%) | 0 | 3 (9.7%) | 0 | 7 (18%) | 2 (22%) |
| Headache | 3 | 0 | 5 | 2 | 6 | 0 | 3 | 0 | – | – | – | – |
| Fatigue | 5 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | – | – | – | – |
| Myalgia | 3 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | – | – | – | – |
| Arthralgia | 3 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | – | – | – | – |
| Allergic reaction† | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 |
| Subjective fever | 3 | 0 | 1 | 1 | 1 | 1 | 2 | 0 | 2 | 0 | 5 | 2 |
| T ≥ 38.0°C‡ | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 3 | 0 |
AE = adverse event; PfSPZ = Plasmodium falciparum sporozoites. For each group, N = the number of doses administered to the participants in that group; T = temperature (axillary). Data are presented as absolute number of injections with events and as the percentage of all injections. Within each group, there were no significant differences in AEs between the vaccinees and controls for any AE (P > 0.27 for all comparisons, Fisher’s exact test, two-tailed).
Solicited local AEs included pain, tenderness, pruritus, erythema, induration, swelling, and bruising.
Solicited systemic AEs included fever, subjective fever, and allergic reaction (defined as urticaria or a rash, swelling, or pruritus distant from the site of injection) for all participants. Additional observations in participants aged 6 years and older included headache, myalgias, arthralgias, fatigue, malaise, and chills. In participants < 5 years old, solicited systemic AEs included drowsiness, irritability/fussiness, or inability or refusal to eat or drink.
Maximum observed temperature in any participant was 38.5°C.