Safety and immunogenicity of an intranasal sendai virus-based vaccine for human parainfluenza virus type I and respiratory syncytial virus (SeVRSV) in adults

Figures & data

Table 1. Summary of baseline characteristics and solicited local/systemic events

A. Baseline Characteristics by Treatment Group
Group		SeVRSV			Placebo			Combined
Participant number		17			4			21
Variable	Characteristic	n		%	n	%		n	%
Sex	Female	11		65	2	50		13	62
	Male	6		35	2	50		8	38
Ethnicity	Hispanic or Latino	1		6	0	0		1	5
	Not Hispanic or Latino	16		94	4	100		20	95
Race	Asian	5		29	0	0		5	24
	Black or African American	1		6	0	0		1	5
	White	10		59	4	100		14	67
	Multi-Racial	1		6	0	0		1	5
Age (years)	Mean	30.8			29.8			30.6
	Minimum	18			21			18
	Maximum	41			39			41
B. Solicited local/systemic events from Days 0–14 in the Modified Intent-to-Treat
		SeVRSV N^a = 17			Placebo N^a = 4
Symptom		N	%		N		%
Any Local Symptom		13^b	76		3 ^c		75
Cough		4	24		0		0
Nasal Pain/Irritation		1	6		0		0
Runny Nose		8	47		1		25
Sneezing		6	35		1		25
Sore Throat		8	47		1		25
Stuffy Nose/Stuffiness		7	41		1		25
Wheezing		0	0		0		0
Any Systemic Symptoms		10^d	59		2		50
Arthralgia		0	0		0		0
Fatigue		6	35		1		25
Headache		8	47		0		0
Feverishness		1	6		0		0
Lightheadedness		0	0		0		0
Malaise		2	12		0		0
Myalgia		3	18		2		50
Fever		1	6		0		0

^aN = Number of participants in the modified Intent-to-Treat population. ^bAmong the 13 events, 11 were mild and 2 were moderate (stuffy nose, sore throat). ^cAmong the 3 events, all were mild. ^dAmong the 10 events, 9 were mild and 1 was moderate (One participant experienced 4 symptoms of headache, malaise, myalgia, fever).

Figure 1. Detection of SeV or RSV F protien sequence by PCR

PCR was used to detect vaccine nucleic acids. The percentages of participants with positive scores in the modified intent-to-treat analysis are shown for SeV (A), RSV F (B) and either (C).

Table 2. Antibody response by treatment group in the modified intent-to-treat population

Antibody Specificity	Statistic	SeVRSV Group (N = 17)	Placebo Group (N = 4)
SeV	GMFR^a	2.04	0.96
	95% CI	1.52, 2.75	0.83, 1.11
	% with 4-Fold Rise^b	18	0
	95% CI	6, 41	0, 49
RSV F	GMFR^a	1.08	0.97
	95% CI	1.04, 1.11	0.79, 1.20
	% with 4-Fold Rise^b	0	0
	95% CI	0, 18	0, 49
SeV Day 0 (Pre-Vaccination)	GMT^c	485	202
	95% CI	317, 741	49, 836
SeV Day 28 Post -Vaccination	GMT^c	989	194
	95% CI	736,1329	42, 895
RSV F Day 0 (Pre-Vaccination)	GMT^c	5763	4895
	95% CI	4230, 7852	907, 26416
RSV F Day 28 Post -Vaccination	GMT^c	6194	4760
	95% CI	4529, 8470	979, 23154

The geometric mean fold rise (GMFR)^a, the percentage of participants achieving a four-fold rise in antibodies between baseline sampling and day 28^b, and the geometric mean titer (GMT)^c were calculated.

Figure 2. Antibody responses toward SeV and RSV F

Antibody titers toward SeV and the RSV F protein were measured among individuals in the mITT analysis on days 0 and 28. Correlations were examined between: (A) the fold rise in the SeV antibody (Ab) titer (∆ SeV Ab titer) and age (the quadrant with the lowest age and highest ∆SeV Ab titer is shaded), (B) the baseline SeV Ab titer and age, and (C) the ∆ SeV Ab titer and baseline SeV Ab titer. Each symbol represents a different participant. Diamonds identify the participants with the highest ∆ SeV Ab titers.