Table 2.
Number of solicited AEs after an injection in recipients of NS and PfSPZ Vaccine
| AE | NS N (%)* | PfSPZ Vaccine N (%)* |
|---|---|---|
| Local (site of injection) | ||
| Any AE | 0 | 0 |
| Systemic | ||
| Headache | 1 (3%) | 2 (3%) |
| Abdominal pain | 0 | 2 (3%) |
| Chills | 0 | 1 (2%) |
| Diarrhea | 0 | 1 (2%) |
| Vomiting | 0 | 1 (2%) |
| Arthralgia | 1 (3%) | 0 |
| Fever | 1 (3%) | 1 (2%) |
| Myalgia | 0 | 0 |
| Allergic reactions | 0 | 0 |
| Chest pain/palpitations/shortness of breath | 0 | 0 |
| TOTAL | 3 (10%) | 8 (13%) |
AE = adverse event; N = number of AEs; NS = normal saline; PfSPZ = Plasmodium falciparum sporozoites.
% = Percentage of injections which gave rise to the AE using number of injections (60 injections for vaccine group, 30 injections for NS group) as denominator. There were no significant differences in the incidence of solicited AEs between recipients of NS and PfSPZ Vaccine.
*
The P value for the Fisher exact test (2-sided) comparing the two groups for each AE and overall AE rate was > 0.05 for all comparisons.