Phase 1 randomized controlled trial to evaluate the safety and immunogenicity of recombinant Pichia pastoris-expressed Plasmodium falciparum apical membrane antigen 1 (PfAMA1-FVO [25-545]) in healthy Malian adults in Bandiagara

Table 2 Signs and solicited symptoms during the 7-day follow-up periods after each immunization

Signs and solicited symptoms	PfAMA1 malaria vaccine						Tetanus toxoid vaccine
	Dose 1 N = 20		Dose 2 N = 20		Dose 3 N = 20		Dose 1 N = 20		Dose 2 N = 20		Dose 3 N = 20
	Overall	Severe	Overall	Severe	Overall	Severe	Overall	Severe	Overall	Severe	Overall	Severe
Local
Pain (%)	12 (0.60)	0	9 (0.45)	0	6 (0.30)	0	8 (0.40)	0	2 (0.10)	0	2 (0.10)	0
Limited arm motion (%)	1 (0.05)	0	1 (0.05)	0	0	0	1 (0.05)	0	0	0	0	0
Swelling (%)	7 (0.35)	2 (0.10)	8 (0.40)	4 (0.20)	7 (0.35)	2 (0.10)	1 (0.05)	0	2 (0.10)	0	9 (0.45)	1 (0.05)
Erythema (%)	0	0	1 (0.05)	0	0	0	0	0	0	0	0	0
Systemic
Fever (%)	2 (0.10)	0	0	0	0	0	1 (0.05)	0	3 (0.15)	0	1 (0.05)	0
Headaches (%)	5 (0.25)	0	6 (0.30)	0	3 (0.15)	0	10 (0.50)		4 (0.20)	0	1 (0.05)	0
Joint pain (%)	1 (0.05)	0	0	0	0	0	1 (0.05)	0	0	0	1 (0.05)	0
Malaise (%)	1 (0.05)	0	0	0	0	0	3 (0.15)	0	0	0	0	0
Myalgia (%)	2 (0.10)	0	4 (0.20)	0	1 (0.05)	0	2 (0.10)	0	0	0	0	0
Nausea (%)	3 (0.15)	0	0	0	0	0	1 (0.05)	0	0	0	0	0
Chills (%)	1 (0.05)	0	0	0	0	0	1 (0.05)	0	0	0	0	0

ISSN: 1475-2875