Immunogenicity and safety after the third vaccination with the 23-valent pneumococcal polysaccharide vaccine in elderly patients with chronic lung disease

Figures & data

Table 1. Baseline characteristics of 16 patients with chronic pulmonary diseases.

Characteristic	Value
Sex
Male	7
Female	9
Mean age, years (SD)	80 (4.1)
70–79 years, n (%)	10 (62.5)
≥80 years	6 (37.5)
Comorbid illness, n (%)
Sequelae of pulmonary tuberculosis	7 (44)
Asthma	3 (19)
Bronchiectasis	2 (13)
Nontuberculous mycobacteriosis	1 (6)
Aspergillosis	1 (6)
Interstitial pneumonia	1 (6)
Diaphragmatic hernia	1 (6)
Home oxygen therapy, n (%)	6 (37.5)
Mean time between second and third vaccinations, months (SD)	63 (0.9)

SD: standard deviation.

Table 2. Comparison of geometric mean concentrations (GMCs) and geometric increases (n-fold) in levels of serotype-specific IgG and the opsonization index (OI) for serum samples from the 16 participants before and after the first, second, and third vaccinations.

Serotype	Time point	GMC of IgG (µg/mL) (95% CI)	Geometric mean increase (n-fold; post/pre)	GMT of OI (95%CI)	Geometric mean increase (n-fold; post/pre)
6B	Predose 1	0.85 (0.57–1.27)		72 (31–166)
	Postdose 1	2.00 (1.01–3.95)^a	2.34	527 (186–1495)^a	7.32
	Predose 2	1.55 (0.89–2.70)^b		347 (114–1050)^a
	Postdose 2	2.50 (1.38–4.52)^a,d	1.62	1281 (658–2492)^a,d	3.69
	Predose 3	1.14 (0.65–1.98)		109 (40–300)
	Postdose 3	1.67 (0.96–2.88)^a,g	1.46	895 (477–1681)^a,e	8.21
14	Predose 1	2.31 (1.37–3.89)		59 (21–161)
	Postdose 1	8.05 (5.91–10.96)^a	3.48	647 (229–1831)^a	10.97
	Predose 2	3.17 (1.60–6.28)		281 (106–745)^a
	Postdose 2	5.65 (3.04–10.50)^a,d	1.78	680 (264–1751)^a,d	2.42
	Predose 3	4.91 (2.75–8.76)^a,d		189 (48–745)^b
	Postdose 3	9.00 (4.66–17.39)^a,d,f,g	1.83	562 (149–2120)^a,g	2.97
19F	Predose 1	2.12 (1.55–2.91)		24 (10–58)
	Postdose 1	3.70 (2.62–5.22)^a	1.74	262 (144–477)^a	10.92
	Predose 2	2.47 (1.63–3.73)		104 (46–233)^a
	Postdose 2	3.88 (2.63–5.74)^a,d	1.57	380 (195–739)^a,c,d	3.65
	Predose 3	2.84 (1.79–4.51)		127 (47–348)^b,e
	Postdose 3	5.03 (2.95–8.56)^a,d,g	1.77	336 (140–808)^a,d,g	2.65
23F	Predose 1	1.08 (0.63–1.87)		15 (6–35)
	Postdose 1	2.47 (1.33–4.58)^a	2.28	113 (40–322)^a	7.53
	Predose 2	1.39 (0.71–2.73)		52 (22–121)^b
	Postdose 2	1.93 (0.89–4.17)	1.39	159 (74–341)^a,d	3.06
	Predose 3	1.27 (0.74–2.17)		17 (6–45)
	Postdose 3	2.27 (1.19–4.32)^a,e,g	1.79	84 (24–291)^a,g	4.94

GMC: geometric mean concentration, GMT: geometric mean titer, CI: confidence interval.

dose 1: first vaccination, dose 2: second vaccination, dose 3: third vaccination, Predose 1: before first vaccination, Postdose 1: after first vaccination.

Predose 2: before second vaccination, Postdose 2: after second vaccination, Predose 3: before third vaccination, Postdose 3: after third vaccination.

Serum samples were collected 1 month before and after the first, second, and third vaccinations.

^ap < .01 (vs. predose 1).

^bp < .05 (vs. predose 1).

^cp < .05 (vs. postdose 1).

^dp < .01 (vs. predose 2).

^ep < .05 (vs. predose 2).

^fp < .05 (vs. postdose 2).

^gp < .01 (vs. predose 3).

Figure 1. The GMCs of serotype-specific IgG required for 50% killing of bacteria for serotypes 6B (diamonds), 14 (squares), 19F (triangles), and 23F (circles) before and after the first, second, and third vaccinations with 23-valent pneumococcal polysaccharide vaccine. **P < .01 and *P < .05 versus before the first vaccination.

Table 3. Percentages of participants with local and systemic reactions by day after the third vaccination.

	Adverse Reaction	Day 0	Day 1	Day 2	Day 3	Day 4	Day 5	Day 6
Local	Maximal diameter of redness or swelling at the injection site, cm
	≥ 1 cm and < 5 cm	2 (12.5)	1 (6.25)	1 (6.25)	4 (25)	4 (25)	2 (12.5)	0 (0)
	≥ 5 cm and < 10 cm	3 (18.75)	6 (37.5)	3 (18.75)	2 (12.5)	1 (6.25)	0 (0)	0 (0)
	≥10 cm	0 (0)	2 (12.5)	3 (18.75)	1 (6.25)	1 (6.25)	0 (0)	0 (0)
	Mild soreness in arm	5 (31.25)	3 (18.75)	2 (12.5)	6 (37.5)	4 (25)	2 (12.5)	1 (6.25)
	Moderate soreness in arm	2 (12.5)	5 (31.25)	4 (25)	0 (0)	0 (0)	0 (0)	0 (0)
	Severe soreness in arm	0 (0)	1 (6.25)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
Systemic	Nausea	0 (0)	0 (0)	1 (6.25)	1 (6.25)	1 (6.25)	1 (6.25)	1 (6.25)
	Headache	1 (6.25)	2 (12.5)	3 (18.75)	2 (12.5)	2 (12.5)	2 (12.5)	2 (12.5)
	Myalgia	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
	Arthralgia	0 (0)	1 (6.25)	1 (6.25)	0 (0)	0 (0)	0 (0)	0 (0)
	Fatigue	2 (12.5)	5 (31.25)	4 (25)	2 (12.5)	1 (6.25)	1 (6.25)	3 (18.75)
	Temperature ≥38°C	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)

All data are presented as n (%) of participants (N = 16).

Figure 2. Comparison of adverse reactions between the first, second, and third vaccinations in the study participants. Local adverse reactions (A) and systemic symptoms (B) were compared between the first, second, and third vaccinations. Data are shown as the frequencies of participants who received the first, second, and third vaccinations (n = 16). The grade of the finding or symptom is expressed as none (open bar), mild (slash bars), moderate (gray bars), or severe (closed bars). **P < .01 and *P < .05 versus the primary vaccination.

Table 4. Relationship between geometric mean concentrations (GMCs) before the third vaccination and local adverse reactions after the third vaccination in the 16 participant.

	Soreness in arm			Redness or swelling
	Present	Absent		Present	Absent
Serotype	(GMC of IgG (µg/mL) (95% CI))	(GMC of IgG (µg/mL) (95% CI))	p value	(GMC of IgG (µg/mL) (95% CI))	(GMC of IgG (µg/mL) (95% CI))	p value
6B	1.29 (0.65–2.56)	0.93 (0.26–3.37)	.99	1.11 (0.56–2.21)	1.17 (0.40–3.41)	0.78
14	5.67 (2.55–12.62)	3.87 (1.24–12.06)	.41	4.89 (2.10–11.40)	4.94 (1.77–13.74)	0.98
19F	3.27 (1.93–5.54)	2.25 (0.72–7.02)	.21	2.97 (1.70–5.18)	2.72 (1.10–6.70)	0.70
23F	1.44 (0.72–2.86)	1.03 (0.31–3.41)	.47	1.09 (0.47–2.50)	1.48 (0.61–3.60)	0.50

GMC: geometric mean concentration, CI: confidence interval.