Immune response, antibody persistence, and safety of a single dose of the quadrivalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine in adolescents and adults: results of an open, randomised, controlled study

Borja-Tabora, Charissa; Montalban, Cecilia; Memish, Ziad A; Van der Wielen, Marie; Bianco, Veronique; Boutriau, Dominique; Miller, Jacqueline

doi:10.1186/1471-2334-13-116

Table 3 Percentage of participants with rSBA titres ≥8 and ≥128 and GMTs before and after vaccination

From: Immune response, antibody persistence, and safety of a single dose of the quadrivalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine in adolescents and adults: results of an open, randomised, controlled study

Group	Timing	N	% ≥8 [95% CI]	% ≥128 [95% CI]	GMT [95% CI]
rSBA-MenA
ACWY-TT	M0	305	95.1 [92.0, 97.2]	89.5 [85.5, 92.7]	330.7 [285.8, 382.7]
	M1	323	100 [98.9, 100]	99.7 [98.3, 100]	4944.6* [4451.5, 5492.5]
	Y1	354	99.7 [98.4, 100]	99.4 [98.0, 99.9]	2084.9* [1888.3, 2302.0]
	Y2	338	99.7 [98.4, 100]	99.1* [97.4, 99.8]	1326.8* [1197.7, 1469.7]
	Y3	322	100 [98.9, 100]	99.1* [97.3, 99.8]	1238.4* [1126.0, 1361.9]
Men-PS	M0	101	87.1 [79.0, 93.0]	80.2 [71.1, 87.5]	227.8 [162.1, 320.2]
	M1	112	100 [96.8, 100]	100 [96.8, 100]	2190.1 [1857.5, 2582.2]
	Y1	113	100 [96.8, 100]	99.1 [95.2, 100]	1099.1 [931.6, 1296.7]
	Y2	102	99.0 [94.7, 100]	96.1 [90.3, 98.9]	698.9 [561.2, 870.4]
	Y3	104	100 [96.5, 100]	94.2 [87.9, 97.9]	596.9 [488.5, 729.3]
rSBA-MenC
ACWY-TT	M0	324	78.1 [73.2, 82.5]	53.1 [47.5, 58.6]	84.1 [68.5, 103.4]
	M1	341	99.7 [98.4, 100]	99.7 [98.4, 100]	10073.7* [8699.9, 11664.5]
	Y1	353	99.7 [98.4, 100]	97.2 [94.9, 98.6]	1848.6 [1620.3, 2109.2]
	Y2	345	99.4 [97.9, 99.9]	96.2 [93.6, 98.0]	1162.0 [1013.1, 1332.9]
	Y3	337	99.1 [97.4, 99.8]	92.9 [89.6, 95.4]	870.3 [757.1, 1000.4]
Men-PS	M0	113	85.0 [77.0, 91.0]	49.6 [40.0, 59.1]	114.1 [80.3, 162.0]
	M1	114	100 [96.8, 100]	98.2 [93.8, 99.8]	6545.6 [5047.5, 8488.4]
	Y1	115	99.1 [95.3, 100]	95.7 [90.1, 98.6]	1876.5 [1400.7, 2514.0]
	Y2	112	98.2 [93.7, 99.8]	92.0 [85.3, 96.3]	1229.4 [876.4, 1724.7]
	Y3	109	99.1 [95.0, 100]	93.6 [87.2, 97.4]	1124.8 [812.3, 1557,6]
rSBA-MenW-135
ACWY-TT	M0	327	75.5 [70.5, 80.1]	58.4 [52.9, 63.8]	93.0 [74.6, 116.0]
	M1	340	99.7 [98.4, 100]	99.4 [97.9, 99.9]	8576.5* [7614.9, 9659.5]
	Y1	356	99.7 [98.4, 100]	99.4* [98.0, 99.9]	2993.5* [2618.8, 3421.9]
	Y2	346	99.4 [97.9, 99.9]	98.6* [96.7, 99.5]	1984.6* [1757.1, 2241.4]
	Y3	336	99.7* [98.4, 100]	98.8* [97.0, 99.7]	2109.2* [1842.5, 2414.5]
Men-PS	M0	109	81.7 [73.1, 88.4]	61.5 [51.7, 70.6]	115.3 [81.6, 162.9]
	M1	114	100 [96.8, 100]	100 [96.8, 100]	2969.5 [2439.4, 3614.9]
	Y1	117	100 [96.9, 100]	94.9 [89.2, 98.1]	699.9 [569.3, 860.4]
	Y2	111	90.1 [83.0, 94.9]	81.1 [72.5, 87.9]	319.1 [228.0, 446.5]
	Y3	105	86.7 [78.6, 92.5]	80.0 [71.1, 87.2]	332.8 [224.4, 493.8]
rSBA-MenY
ACWY-TT	M0	330	92.7 [89.4, 95.3]	80.0 [75.3, 84.2]	310.0 [261.2, 367.9]
	M1	340	100 [98.9, 100]	99.7 [98.4, 100]	10315.2* [9317.1, 11420.2]
	Y1	355	100 [99.0, 100]	99.7 [98.4, 100]	4207.1* [3767.3, 4698.3]
	Y2	345	99.7 [98.4, 100]	99.1* [97.5, 99.8]	3042.1* [2692.2, 3437.5]
	Y3	338	99.7 [98.4, 100]	99.4 [97.9, 99.9]	2567.3* [2288.6, 2879.8]
Men-PS	M0	113	92.9 [86.5, 96.9]	77.9 [69.1, 85.1]	282.8 [209.9, 380.8]
	M1	114	100 [96.8, 100]	100 [96.8, 100]	4573.7 [3863.9, 5413.9]
	Y1	116	100 [96.9, 100]	98.3 [93.9, 99.8]	1386.5 [1104.2, 1740.9]
	Y2	111	99.1 [95.1, 100]	94.6 [88.6, 98.0]	850.2 [667.5, 1082.9]
	Y3	108	99.1 [94.9, 100]	97.2 [92.1, 99.4]	848.0 [682.6, 1053.5]

ACWY-TT = group of participants who received one dose of MenACWY-TT at Month 0.
Men-PS = group of participants who received one dose of the MenACWY polysaccharide vaccine at Month 0.
N = number of participants with available results.
% = percentage of participants with titres within the specified range.
GMT = geometric mean titre.
95% CI = 95% confidence interval.
M0 = pre-vaccination blood sample taken at Month 0; M1 = post-vaccination blood sample taken at Month 1 (ATP immunogenicity cohort); Y1 = post-vaccination blood sample taken at Year 1 (ATP cohort for persistence Year 1); Y2 = post-vaccination blood sample taken at Year 2 (ATP cohort for persistence Year 2); Y3 = post-vaccination blood sample taken at Year 3 (ATP cohort for persistence Year 3).
^*Statistically significantly higher value in the ACWY-TT group compared to the Men-PS group in exploratory analyses.

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