Table 2.

Solicited adverse events postvaccination (number of subjects experiencing AE)

	PfSPZ vaccine					Normal saline
	Group 1 (N = 21)	Group 2 (N = 21)	Group 3 (N = 21)	Group 4 (N = 21)	Total AE (N = 84)	Groups 1–4 (N = 20)
Any local solicited adverse event*	1 (4.8%)	3 (14%)	6 (29%)	2 (9.5%)	12 (14%)	2 (10%)
Tenderness	1 (4.8%)	3 (14%)	6 (29%)	1 (4.8%)	11 (13%)	1 (5%)†
Bruising	0	0	1 (4.8%)	0	1 (1.2%)	0
Swelling	0	0	0	1 (4.8%)	1 (1.2%)	0
Pruritus	0	0	0	0	0	1 (5%)‡
Any solicited systemic adverse event*	2 (9.5%)	3 (14%)	3 (14%)	1 (4.8%)	9 (11%)§	0§
Headache	0	1 (4.8%)	3 (14%)	1 (4.8%)	5 (6.0%)	0
Fatigue	0	1 (4.8%)	0	0	1 (1.2%)	0
Myalgia	1 (4.8%)	0	0	0	1 (1.2%)	0
Arthralgia	0	1 (4.8%)	2 (9.5%)	0	3 (3.6%)	0
Chills	0	0	1 (4.8%)	0	1 (1.2%)	0
Generalized pruritis	1 (4.8%)	0	0	0	1 (1.2%)	0

AE = adverse event; PfSPZ = Plasmodium falciparum sporozoites.

^*Subjects may have more than one of the listed individual adverse events.

^†Group 4.

^‡Group 1.

^§Comparison between vaccine and placebo for total AEs: P = 0.13, Barnard’s test, two-tailed.