Table 2.
Adverse event* | PfSPZ-CVac groups 1† (N = 10) and 3 (N = 2†/N = 8‡) | Control groups 2† (N = 5) and 4‡ (N = 5) | ||||
---|---|---|---|---|---|---|
No. of volunteers | Mean duration ± SD (days) | Occurrence after injections (days) | No. of volunteers | Mean duration ± SD (days) | Occurrence after injections (days) | |
Abdominal pain | 2 | 0.9 ± 1.0 | −6, 25 | 2 | 0.1 ± 0.02 | 1–10 |
Chills | 2 | 1.1 ± 1.2 | 2–4, 4 | N/A | N/A | N/A |
Diarrhea | 1 | 0.6 | 20 | N/A | N/A | N/A |
Headache | 6 | 0.2 ± 0.2 | −2 to 33 | 3 | 0.5 ± 0.6 | 1–20 |
Nausea | 4 | 0.4 ± 0.6 | −6 to 27 | 1 | 0.1 ± 0.1 | 20 |
Vomiting | 2 | 0.02 ± 0.0 | −1, 6 | N/A | N/A | N/A |
Any | 11 | 0.3 ± 0.5 | N/A | 6 | 0.3 ± 0.4 | N/A |
AE = adverse events; N/A = not applicable; PfSPZ-CVac = Plasmodium falciparum sporozoite chemoprophylaxis vaccine; SD = standard deviation.
Subjects could have more than one AE. Only solicited AEs that were possibly or probably related to the study are listed. Solicited AEs were fever, headache, malaise, fatigue, dizziness, myalgia, arthralgia, nausea, vomiting, chills, diarrhea, abdominal pain, chest pain, palpitations, and shortness of breath.
Total of three PfSPZ or normal saline immunizations.
Total of four PfSPZ or normal saline immunizations.