. 2019 Jul 9;15(12):2940–2951. doi: 10.1080/21645515.2019.1627159

Table 3.

Clinical studies assessing booster doses of 4CMenB.

					% with hSBA ≥ 4 (95% CI)				hSBA GMT (95% CI)
Study number, country (identifier*)	Priming schedule	Age at booster	N	Time point	fHbp	NadA	PorA	NHBA	fHbp	NadA	PorA	NHBA
Study 5, Europe NCT01894919 Martinon-Torres et al, 2017²¹	2.5, 3.5, 5, 11m	35-47m	78-92	Pre	48	84	45	38	3.91	39	3.41	3.05
	2.5, 3.5, 5, 11m	35-47m	78-92	Pre	(37.3-58.5)	(74.5-90.6)	(34.2-55.3)	(27.7-50.2)	(3.01-5.08)	(26–58)	(2.57-4.54)	(2.08-4.46)
			88-96	Post	99	99	99	75	158	2908	92	13
			88-96	Post	(94.3-99.97)	(94.3-99.97)	(94.3-99.97)	(64.6-83.6)	(116-215)	(2059-4107)	(70-122)	(9.15-18)
	3.5, 5, 11m	35-47m	68-87	Pre	51	91	42	37	4.84	53	3.17	3.10
	3.5, 5, 11m	35-47m	68-87	Pre	(40.1-62.1)	(82.7-95.9)	(31.3-53.0)	(25.4-49.3)	(3.66-6.41)	(35-82)	(2.34-4.31)	(2.05-4.68)
			79-87	Post	100	99	100	84	205	3593	91	18
			79-87	Post	(95.8-100)	(93.8-99.97)	(95.8-100)	(73.5-90.9)	(147-287)	(2474-5218)	(68-123)	(13-26)
	6, 8, 11m	35-47m	65-76	Pre	64	95	52	49	6.21	89	4.86	3.58
	6, 8, 11m	35-47m	65-76	Pre	(52.1-74.8)	(87.1-98.5)	(40.2-63.7)	(36.6-61.9)	(4.65-8.31)	(57-139)	(3.54-6.67)	(2.35-5.45)
			67-76	Post	100	97	100	97	288	3677	133	40
			67-76	Post	(95.2-100)	(90.8-99.68)	(95.2-100)	(89.6-99.64)	(204-408)	(2495-5419)	(97-181)	(27-59)
	2 doses at 2-5yrs	4-7yrs	39-32	Pre	39	74	25	28	3.14	19	2.99	2.31
	2 doses at 2-5yrs	4-7yrs	39-32	Pre	(21.8-57.8)	(55.4-88.1)	(11.5-43.4)	(12.7-47.2)	(2.08-4.75)	(9.92-35)	(1.92-4.65)	(1.29-4.13)
			30-32	Post	97	100	100	93	155	3205	71	32
			30-32	Post	(83.8-99.9)	(89.1-100)	(89.1-100)	(77.9-99.2)	(95-252)	(1860-5526)	(46-110)	(19-54)
	2 doses at 6-10yrs	8-12yrs	87-91	Pre	59	86	47	69	6.15	22	4.49	7.83
	2 doses at 6-10yrs	8-12yrs	87-91	Pre	(48.5-69.5)	(76.8-92.2)	(36.7-58.0)	(58.1-78.5)	(4.77-7.93)	(15-32)	(3.40-5.92)	(5.52-11)
			89-91	Post	99	100	100	96	258	2921	82	53
			89-91	Post	(94.0-99.97)	(96.0-100)	(96.0-100)	(88.9-98.8)	(190-349)	(2079-4104)	(63-108)	(38-73)
Study 1, Europe, UK NCT00721396 Iro et al, 2017²²	2, 4, 6, 12m	4yrs	65-67	Pre	12	93	9	54	1.75	36	1.25	6.14
	2, 4, 6, 12m	4yrs	65-67	Pre	(5-22)	(83-98)	(2-18)	(41-66)	(1.36-2.25)	(27-48)	(1.03-1.52)	(4.19-8.99)
			25-26	Post	100	100	92	84	109	766	21	22
			25-26	Post	(87-100%)	(87-100%)	(75-99)	(64-95)	(68-175)	(492-1192)	(13-34)	(14-35)
	2, 4, 6, 18m	4yrs	59-60	Pre	18	98	8	68	1.68	69	1.29	7.36
	2, 4, 6, 18m	4yrs	59-60	Pre	(10-30)	(91-100)	(3-18)	(54-79)	(1.29-2.19)	(50-94)	(1.05-1.59)	(4.94-11)
			18	Post	100	100	83	89	119	1725	11	21
			18	Post	(81-100)	(81-100)	(59-96)	(65-99)	(67-211)	(1013-2936)	(6-19)	(12-35)
	2, 4, 6, 24m	4yrs	58-60	Pre	24	97	12	74	2.41	69	1.38	9.08
	2, 4, 6, 24m	4yrs	58-60	Pre	(14-37)	(88-100)	(5-23)	(61-85)	(1.83-3.19)	(50-96)	(1.11-1.72)	(5.97-14)
			16	Post	100	100	94	88	112	923	30	31
			16	Post	(79-100)	(79-100)	(70-100)	(62-98)	(61-208)	(520-1637)	(16-55)	(17-55)
	2, 3, 4, 12m	4yrs	40-42	Pre	12	90	10	68	1.51	52	1.32	9.61
	2, 3, 4, 12m	4yrs	40-42	Pre	(4-26)	(77-97)	(3-23)	(51-81)	(1.04-2.18)	(34-81)	(1.05-1.65)	(5.81-16)
			36-40	Post	97	100	95	97	159	1668	26	51
			36-40	Post	(87-100)	(91-100)	(83-99)	(85-100)	(108-235)	(1155-2408)	(18-38)	(35-75)
	2, 3, 4, 18m	4yrs	28	Pre	25	89	11	75	2.2	62	1.25	11
	2, 3, 4, 18m	4yrs	28	Pre	(11-45)	(72-98)	(2-28)	(55-89)	(1.38-3.49)	(36-108)	(0.94-1.66)	(5.92-20)
			25-26	Post	100	100	92	100	135	1227	18	51
			25-26	Post	(87-100)	(87-100)	(75-99)	(86-100)	(83-219)	(783-1921)	(11-28)	(32-81)
	2, 3, 4, 24m	4yrs	28	Pre	21	96	11	75	2.2	101	1.62	11
	2, 3, 4, 24m	4yrs	28	Pre	(8-41)	(82-100)	(2-28)	(55-89)	(1.37-3.53)	(57-177)	(1.21-2.16)	(5.9-21)
			25-26	Post	100	100	92	100	120	1252	26	44
			25-26	Post	(87-100)	(87-100)	(75-99)	(86-100)	(74-195)	(795-1972)	(16-42)	(27-70)
Sadarangani et al, 2017³¹	2 doses at 12, 14m or 18, 20m or 24, 26m	4yrs	123	Pre	9-11	84-100	0-18	59-60	<5	≥5	<5	≥5
Sadarangani et al, 2017³¹	2 doses at 12, 14m or 18, 20m or 24, 26m		119	Post	100	100	70-100	90-100	>100	>1000	>10	>10
Study 3, UK NCT01027351 Snape et al, 2013²⁵	2,4,6, 12m	3.5yrs	15-17	Pre	65	76	41	67	5.3	28	2.8	5.3
	2,4,6, 12m	3.5yrs	15-17	Pre	(38-86)	(50-93)	(18-67)	(38-88)	(3.3-8.8)	(9.4-83)	(1.4-5.6)	(2.3-12)
			18-19	Post	100	100	89	94	89	1708	47	39
			18-19	Post	(82-100)	(81-100)	(67-99)	(73-100)	(68-116)	(774-3771)	(20-107)	(22-69)
Study 4, UK NCT01026974 Snape et al 2013 ²⁷	6, 8, 12m	3.5yrs	14	Pre	36	100	14	79	2.55	29	1.74	7.11
	6, 8, 12m	3.5yrs	14	Pre	(13-65)	(77-100)	(2-43)	(49-95)	(1.15-5.66)	(18-47)	(0.91-3.33)	(3.61-14)
			14	Post	100	100	93	93	114	926	32	23
			14	Post	(77-100)	(77-100)	(66-100)	(66-100)	(59-222)	(432-1988)	(14-71)	(13-41)
Study 6, Australia, Canada NCT02446743, Nolan et al, 2017^35,39	2 doses at 11-17yrs	15-22yrs	118-142	Pre	30	82	9	75	2.38	22	1.32	13
	2 doses at 11-17yrs	15-22yrs	118-142	Pre	(22.4-38.1)	(74.1-88.6)	(5.0-15.1)	(67.0-81.9)	(1.94-2.93)	(16-30)	(1.15-1.50)	(9.99-17.0)
			124-142	Post	98	100	94	99	162	2421	29	65
			124-142	Post	(93.9-99.6)	(97.1-100)	(89.2-97.5)	(96.1-99.9)	(132-198)	(1981-2959)	(24-36)	(55-76)
Chile	2 doses at 11-17yrs	18-24yrs	93-127	Pre	46	84	28	80	4.65	31	2.48	22
	2 doses at 11-17yrs	18-24yrs	93-127	Pre	(36.8-54.7)	(74.8-90.7)	(20.1-37.0)	(72.3-86.8)	(3.45-6.27)	(21-44)	(1.90-3.23)	(16-29)
			102-127	Post	100	100	93	99	269	1951	41	113
			102-127	Post	(97.1-100)	(96.4-100)	(87.3-97.1)	(95.7-100)	(223-325)	(1629-2337)	(32-52)	(92-138)

*identifier in www.clinicaltrials.gov,

N = number of subjects in the persistence cohorts, CI = confidence interval, hSBA = serum bactericidal assay using human complement source, GMT = geometric mean antibody titer, m = months, yrs = years, UK = United Kingdom, fHbp = factor H binding protein, NadA = Neisseria adhesin A, PorA = porin A, NHBA = Neisserial Heparin Binding Antigen, pre = at the time of the booster dose, post = one month after the booster.