Antibody persistence and immune memory 15 months after priming with an investigational tetravalent meningococcal tetanus toxoid conjugate vaccine (MenACWY-TT) in toddlers and young children

Figures & data

Figure 1. Participant flow. ACWY_T, toddlers vaccinated with MenACWY-TT at 12–14 mo of age; MenCCRM, toddlers vaccinated with MenC-CRM₁₉₇ at 12–14 mo of age; ACWY_C, children vaccinated with MenACWY-TT at 3–5 y of age; MenPS, children vaccinated with MenPS at 3–5 y of age; ATP, according to protocol; TVC, total vaccinated cohort; N, number of participants. ¹Several formulations were evaluated in the primary study, but participants who received the selected formulation for further development or control vaccine were eligible to participate in the persistence study. Participants who withdrew from the primary phase were described in the previous publication.⁶

Table 1. Percentage of participants with rSBA titers above defined thresholds at pre-vaccination, at 1 mo and 15 mo after primary vaccination (ATP cohort for persistence) and at 1 mo after the polysaccharide challenge (ATP cohort for immune memory)

		Toddlers			Children
		N	% ≥ 1:8 [95% CI]	% ≥ 1:128 [95% CI]	N	% ≥ 1:8 [95% CI]	% ≥ 1:128 [95% CI]
rSBA-MenA
ACWY-TT	M0^1	37	10.8 [3.0, 25.4]	10.8 [3.0, 25.4]	39	20.5 [9.3, 36.5]	15.4 [5.9, 30.5]
	M1^1	38	100 [90.7, 100]	100 [90.7, 100]	46	100 [92.3, 100]	100 [92.3, 100]
	M15	40	97.5* [86.8, 99.9]	92.5* [79.6, 98.4]	45	100* [92.1, 100]	97.8* [88.2, 99.9]
	M16	25	100 [86.3, 100]	100 [86.3, 100]	-	-	-
Control	M0^1	39	2.6 [0.1, 13.5]	0.0 [0.0, 9.0]	27	33.3 [16.5, 54.0]	33.3 [16.5, 54.0]
	M1^1	41	2.4 [0.1, 12.9]	2.4 [0.1, 12.9]	33	100 [89.4, 100]	100 [89.4, 100]
	M15	36	30.6 [16.3, 48.1]	27.8 [14.2, 45.2]	29	89.7 [72.6, 97.8]	82.8 [64.2, 94.2]
	M16	30	100 [88.4, 100]	90.0 [73.5, 97.9]	-	-	-
rSBA-MenC
ACWY-TT	M0^1	39	10.3 [2.9, 24.2]	2.6 [0.1, 13.5]	44	22.7 [11.5, 37.8]	18.2 [8.2, 32.7]
	M1^1	38	100 [90.7, 100]	97.4 [86.2, 99.9]	46	100 [92.3, 100]	95.7 [85.2, 99.5]
	M15	39	92.3* [79.1, 98.4]	69.2* [52.4, 83.0]	46	100* [92.3, 100]	65.2* [49.8, 78.6]
	M16	32	100 [89.1, 100]	100 [89.1, 100]	-	-	-
Control	M0^1	40	10.0 [2.8, 23.7]	2.5 [0.1, 13.2]	32	37.5 [21.1, 56.3]	18.8 [7.2, 36.4]
	M1^1	42	97.6 [87.4, 99.9]	88.1 [74.4, 96.0]	34	97.1 [84.7, 99.9]	88.2 [72.5, 96.7]
	M15	40	60.0 [43.3, 75.1]	27.5 [14.6, 43.9]	32	59.4 [40.6, 76.3]	28.1 [13.7, 46.7]
	M16	30	100 [88.4, 100]	100 [88.4, 100]	-	-	-
rSBA-MenW-135
ACWY-TT	M0^1	28	39.3 [21.5, 59.4]	25.0 [10.7, 44.9]	31	54.8 [36.0, 72.7]	35.5 [19.2, 54.6]
	M1^1	28	100 [87.7, 100]	100 [87.7, 100]	31	100 [88.8, 100]	100 [88.8, 100]
	M15	40	97.5* [86.8, 99.9]	90.0* [76.3, 97.2]	46	100 [92.3, 100]	100 [92.3, 100]
	M16	32	100 [89.1, 100]	100 [89.1, 100]	-	-	-
Control	M0^1	31	29.0 [14.2, 48.0]	19.4 [7.5, 37.5]	19	57.9 [33.5, 79.7]	31.6 [12.6, 56.6]
	M1^1	31	32.3 [16.7, 51.4]	22.6 [9.6, 41.1]	19	100 [82.4, 100]	100 [82.4, 100]
	M15	41	41.5 [26.3, 57.9]	26.8 [14.2, 42.9]	32	93.8 [79.2, 99.2]	93.8 [79.2, 99.2]
	M16	30	100 [88.4, 100]	96.7 [82.8, 99.9]	-	-	-
rSBA-MenY
ACWY-TT	M0^1	38	52.6 [35.8, 69.0]	28.9 [15.4, 45.9]	45	75.6 [60.5, 87.1]	57.8 [42.2, 72.3]
	M1^1	38	100 [90.7, 100]	100 [90.7, 100]	46	100 [92.3, 100]	100 [92.3, 100]
	M15	40	97.5* [86.8, 99.9]	90.0* [76.3, 97.2]	46	100* [92.3, 100]	100* [92.3, 100]
	M16	32	100 [89.1, 100]	100 [89.1, 100]	-	-	-
Control	M0^1	40	42.5 [27.0, 59.1]	17.5 [7.3, 32.8]	33	60.6 [42.1, 77.1]	45.5 [28.1, 63.6]
	M1^1	41	46.3 [30.7, 62.6]	31.7 [18.1, 48.1]	34	100 [89.7, 100]	97.1 [84.7, 99.9]
	M15	40	75.0 [58.8, 87.3]	45.0 [29.3, 61.5]	33	78.8 [61.1, 91.0]	66.7 [48.2, 82.0]
	M16	30	96.7 [82.8, 99.9]	93.3 [77.9, 99.2]	-	-	-

ATP, according to protocol; Toddlers, participants 12–14 mo of age at the time of the primary vaccination; Children, participants 3–5 y of age at the time of the primary vaccination; ACWY-TT, participants primed with MenACWY-TT; Control, participants primed with MenC-CRM₁₉₇ in the toddlers age stratum or with MenPS in the children age stratum; N, number of participants with available results; %, percentage of participants with titer within the specified range; 95% CI, exact 95% confidence interval; M0, pre-primary vaccination; M1 = one month post-primary vaccination; M15, 15 mo post-primary vaccination; M16, one month post-polysaccharide challenge. ¹These numbers are not the same as those presented in the previous publication at the same timepoints because the analyses for the present study were conducted on the ATP cohort for persistence (Month 15) and in the previous publication the analyses were performed on the ATP cohort for immunogenicity (Month 1). *Statistically significantly higher values compared with the control group (exploratory analysis)

Figure 2. Geometric mean titers for rSBA at pre-vaccination, at 1 mo¹ and 15 mo¹ after primary vaccination (ATP cohort for persistence) and at 1 mo after the polysaccharide challenge (ATP cohort for immune memory). Notes: ATP, according to protocol; ACWY_T, toddlers primed with MenACWY-TT at 12–14 mo of age; MenCCRM, toddlers primed with MenC-CRM₁₉₇ at 12–14 mo of age; ACWY_C, children primed with MenACWY-TT at 3–5 y of age; MenPS, children primed with MenPS at 3–5 y of age; Errors bars, exact 95% confidence interval; Month 0, pre-primary vaccination; Month 1, 1 mo post-primary vaccination; Month 15, 15 mo post-primary vaccination; Month 16, one month post-polysaccharide challenge. ¹These numbers are not the same as those presented in the previous publication at the same timepoints because the analyses for the present study were conducted on the ATP cohorts for persistence and immune memory (Month 15) and in the previous publication the analyses were performed on the ATP cohort for immunogenicity (Month 1). *Statistically significantly higher values compared with the control group (exploratory analysis)

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