Table 2.

Solicited adverse events in the safety set

		Dose 1				Dose 2
		3 μg with Algel-IMDG (n=100)	6 μg with Algel-IMDG (n=100)	6 μg with Algel (n=100)	Algel only (n=75)	3 μg with Algel-IMDG (n=100)	6 μg with Algel-IMDG (n=100)	6 μg with Algel (n=100)	Algel only (n=75)
Local reactions
Pain at injection site
	Mild	4 (4%; 1·1– 9·9)	4 (4%; 1·1–9·9)	1 (1%; 0·0–5·5)	2 (3%; 0·3–9·3)	2 (2%; 0·2–7·0)	1 (1%; 0·03–5·5)	1 (1%; 0·0–5·5)	0
	Moderate	1 (1%; 0·0–5·5)	1 (1%; 0·0–5·5)	0	0	0	0	0	0
Swelling
	Mild	0	0	0	1 (1%; 0·0–7·2)	0	0	0	0
	Moderate	0	0	0	0	0	0	0	0
Systemic reactions
Fever
	Mild	0	1 (1%; 0·0–5·5)	1 (1%; 0·0–5·5)	0	2 (2%; 0·2–7·0)	1 (1%; 0·0–5·5)	1 (1%; 0·0–5·5)	0
	Moderate	0	1 (1%; 0·0–5·5)	2 (2%; 0·2–7·0)	0	0	0	0	0
Body ache
	Mild	0	1 (1%; 0·03–5·5)	0	0	0	0	0	0
	Moderate	0	1 (1%; 0·0–5·5)	1 (1%; 0·0–5·5)	0	1 (1%; 0·0–5·5)	0	0	0
Fatigue
	Mild	1 (1%; 0·0–5·4)	0	0	0	1 (1%; 0·03–5·4)	0	3 (3%; 0·6–8·5)	0
	Moderate	2 (2%; 0·2–7·0)	3 (3%; 0·6–8·5)	0	0	1 (1%; 0·0–5·5)	0	0	0
Headache
	Mild	1 (1%; 0·03–5·5)	2 (2%; 0·2–7·0)	0	5 (7%; 2·2–14·9)	0	0	0	0
	Moderate	0	3 (3%; 0·6–8·5)	2 (2%; 0·2–7·0)	0	0	0	0	0
Nausea or vomiting
	Mild	1 (1%; 0·03–5·5)	2 (2%; 0·2–7·0)	2 (2%; 0·2–7·0)	2 (3%; 0·3–9·3)	0	0	0	0
	Moderate	0	0	0	0	0	0	0	0

Data are n (%; 95% CI). The safety set includes all participants who received one dose of the vaccine (n=375). Dose 1 events are from days 0–7 and dose 2 events are days 14–21. The grading scale for most adverse events was based on the US Food and Drug Administration (FDA) guidance document for toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. For adverse events where grading was not mentioned in the FDA guidance document, we have used the common terminology criteria for adverse events grading. There were no severe adverse events.