Conjugate Meningococcal Vaccines Development: GSK Biologicals Experience

Table 2

rSBA-MenC antibody response after Hib-MenC-TT vaccination.

Reference	Primary vaccination	Booster vaccination	Timepoint	𝑁	rSBA-MenC ≥1 : 8		rSBA-MenC ≥1 : 128		GMT
					%	[95% CI]	%	[95% CI]	Value	[95% CI]
Schmitt et al., 2007 [70] 2, 3, 4 + 12–15 months of age	Hib-MenC-TT + DTPa-HBV-IPV	Men-PS + DTPa-HBV-IPV/Hib	PD3	95	100	[96.2–100]	—	—	944.2	[779.4–1143.8]
			Pre-Ch	90	87.1	[78.0–93.4]	—	—	159.3	[107.9–235.3]
			Post-Ch	83	100	[95.5–100]	—	—	5385.4	[4425.0–5554.2]
	MenC-CRM197 + DTPa-HBV-IPV/Hib	Men-PS + DTPa-HBV-IPV/Hib	PD3	105	100	[96.5–100]	—	—	1400.7	[1165.4–1683.5]
			Pre-Ch	93	80.2	[70.6–87.8]	—	—	104.0	[68.4–158.3]
			Post-Ch	86	96.5	[90.0–99.3]	—	—	1552.6	[1044.4–2307.9]
Pace et al., 2007 & 2008 [69, 73] Khatami et al., 2011 [76] 2, 3, 4 + 12–15 months of age	Hib-MenC-TT + DTPa-IPV	Hib-MenC-TT + MMR	PD3	354	99.2	[97.5–99.8]	92.9	[89.8–95.4]	581.1	[514.7–656.2]
			Pre-B	346	78.0	[73.3–82.3]	43.9	[38.6–49.3]	61.3	[50.9–73.7]
			Post-B	347	99.1	[97.5–99.8]	97.7	[95.5–99.0]	2193.7	[1881.1–2558.1]
			Post-B (Y1)	200	89.0	[83.8–93.0]	54.5	[47.3–61.5]	123.0	[98.9–153.0]
			Post-B (Y2)	219	67.1	[60.5–73.3]	39.3	[32.8–46.1]	48.0	[36.8–62.6]
	MenC-CRM197 + DTPa-IPV/Hib	Hib-MenC-TT + MMR	PD3	117	100	[96.9–100]	91.1	[95.3–100]	1002.6	[833.8–1205.6]
			Pre-B	109	67.9	[58.3–76.5]	33.0	[24.3–42.7]	38.6	[27.5–54.2]
			Post-B	114	95.6	[90.1–98.6]	86.0	[78.2–91.8]	477.9	[357.3–639.2]
			Post-B (Y1)	59	69.5	[56.1–80.8]	28.8	[17.8–42.1]	35.7	[23.4–54.5]
			Post-B (Y2)	74	40.5	[29.3–52.6]	13.5	[6.7–23.5]	14.4	[9.7–21.6]
Tejedor et al., 2007 & 2008 [62, 74] 2, 4, 6 + 13–14 months of age	Hib-MenC-TT + DTPa-HBV-IPV	Hib-MenC-TT	PD3	111	100	[96.7–100]	99.1	95.1–100	2467.1	[2045.7–2975.3]
			Pre-B	81	96.3	[89.6–99.2]	84.0	74.1–91.2	366.1	[270.1–496.2]
			Post-B	81	100	[95.5–100]	100	[95.5–100]	5266.2	[4265.6–6501.3]
			Post-B (Y1)	56	87.5	[75.9– 94.8]	—	—	94.0	[59.8–147.9]
	MenC-TT + DTPa/Hib-containing	Hib-MenC-TT	PD2	107	100	[96.6–100]	98.1	[93.4–99.8]	1542.9	[1282.2–1856.5]
			Pre-B	169	90.5	[85.1–94.5]	59.8	[52.0–67.2]	131.0	[103.5–165.6]
			Post-B	167	99.4	[96.7–100]	99.4	[96.7–100]	11710.0	[9441.5–14524.8]
			Post-B (Y1)	121	95.0	[89.5–98.2]	—	—	293.8	[212.8–405.7]
	MenC-CRM197 + DTPa-HBV-IPV/Hib	DTPa-HBV-IPV/Hib	PD3	114	99.1	[95.2–100]	98.2	93.8–99.8	1833.7	[1493.7–2251.0]
			Pre-B	82	85.4	[75.8–92.2]	56.1	44.7–67.0	120.5	[80.2–180.9]
			Post-B	84	77.4	[67.0–85.8]	56.0	[44.7–66.8]	94.1	[59.6–148.7]
Carmona et al., 2010 [75] 2, 4, 6 + 13–14 months of age	MenC-CRM197 + DTPa/Hib-containing	Hib-MenC-TT + MMR	Pre-B*	93	88.2	[79.8–93.9]	46.2	[35.8–56.9]	103.8	[74.2–145.1]
			Post-B	95	98.9	[94.3–100]	89.5	[81.5–94.8]	670.2	[497.9–902.1]
	MenC-CRM197 + DTPa/Hib-containing	Hib-MenC-TT	Pre-B*	94	85.1	[76.3–91.6]	56.4	[45.8–66.6]	107.1	[74.1–154.7]
			Post-B	95	98.9	[94.3–100]	92.6	[85.4–97.0]	685.0	[527.0–890.4]
Habermehl et al., 2010 [68] 2, 3, 4 + 12–18 months	Hib-MenC-TT + DTPa-HBV-IPV	Hib-MenC-TT + DTPa-HBV-IPV	PD3	74	100	[95.1–100]	95.9	[88.6–99.2]	871.0	[677.3–1120.0]
			Pre-B*	41	95.1	[83.5–99.4]	65.9	[49.4–79.9]	150.6	[96.7–234.5]
			Post-B	41	100	[91.4–100]	97.6	[87.1–99.9]	3226.2	[2294.7–4535.8]
	MenC-CRM197 + DTPa-HBV-IPV/Hib	MenC-CRM197 + DTPa-HBV-IPV/Hib	PD3	71	100	[94.9–100]	100	[94.9–100]	3557.6	[2978.8–4248.8]
			Pre-B*	38	94.7	[82.3–99.4]	68.4	[51.3–82.5]	195.5	[122.4–312.2]
			Post-B	39	100	[91.0–100]	100	[91.0–100]	11819.3	[8458.6–16515.2]
Knuf et al., 2009 [71] 2, 4, 6 + 11–18 months of age	Hib-MenC-TT + PHiD-CV + DTPa-HBV-IPV	Hib-MenC-TT + PHiD-CV + DTPa-HBV-IPV	PD3	137	100	[97.3–100]	97.1	[92.7–99.2]	1590.9	[1298.5–1949.1]
			Post-B	79	100	[95.4–100]	100	[95.4–100]	5099.2	[3940.4–6598.9]
	Hib-MenC-TT + 7vCRM + DTPa-HBV-IPV	Hib-MenC-TT + 7vCRM + DTPa-HBV-IPV	PD3	120	99.2	[95.4–100]	95.0	[89.4–98.1]	1207.7	[964.4–1512.3]
			Post-B	76	100	[95.3–100]	97.4	[90.8–99.7]	3269.8	[2489.7–4294.4]
	MenC-TT + DTPa-HBV-IPV/Hib + PHiD-CV	MenC-TT + DTPa/Hib-containing + PHiD-CV	PD2	177	100	[97.9–100]	97.2	[93.5–99.1]	1474.2	[1263.3–1 720.4]
			Post-B	84	100	[95.7–100]	100	[95.7–100]	4587.8	[3763.1–5593.2]
	MenC-CRM197 + DTPa-HBV-IPV/Hib + PHiD-CV	MenC-CRM197 + DTPa/Hib-containing + PHiD-CV	PD2	165	98.8	[95.7–99.9]	97.0	[93.1–99.0]	1299.8	[1082.0–1561.5]
			Post-B	89	100	[95.9–100]	98.9	[93.9–100]	2779.6	[2198.5–3514.2]
Booy et al., 2011 [72]12–18 months	3xDTPa/Hib-TT or2xHib-OMP	Hib-MenC-TT + MMR	Pre-Vac	255	14.5	[10.4–19.4]	5.9	[3.3–9.5]	6.3	[5.5–7.3]
			Post-Vac	281	99.6	[98.0–100]	87.9	[83.5–91.5]	482.8	[420.7–554.2]
			Post-Vac (Y1)	249	86.7	[81.9–90.7]	47.0	[40.7–53.4]	91.7	[75.6–111.3]
	3xDTPa/Hib-TT or 2xHib-OMP	Hib-TT + MenC-CRM197 + MMR	Pre-Vac	83	8.4	[3.5–16.6]	3.6	[0.8–10.2]	5.5	[4.3–7.2]
			Post-Vac	98	100	[96.3–100]	90.8	[83.3–95.7]	621.0	[480.3–802.9]
			Post-Vac (Y1)	89	76.4	[66.2–84.8]	41.6	[31.2–52.5]	63.8	[43.3–94.1]

𝑁: numbers of subjects with available data, %: percentage of subjects with titre within the specified range, 95% CI: 95% confidence interval, GMT: Geometric Mean Titre, PD2: one month after dose 2 (Primary ATP cohort for immunogenicity), PD3: one month after dose 3 (Primary ATP Cohort for Immunogenicity), Pre-Ch: just prior to meningococcal polysaccharide challenge (ATP Cohort for Persistence), Post-Ch: one month after meningococcal polysaccharide challenge (ATP Cohort for Immunogenicity), Pre-B: just prior to the booster vaccination (ATP Cohort for Persistence), Pre-B*: just prior to the booster vaccination (ATP Cohort for Immunogenicity), Post-B: one month after booster vaccination (Booster ATP Cohort for Immunogenicity), Post-B (Y1): one year after booster vaccination (ATP Cohort for Persistence Year 1), Post-B (Y2): two years after booster vaccination (ATP Cohort for Persistence Year 1), Pre-Vac: just prior to the vaccination (Vaccination ATP cohort for Immunogenicity), Post-Vac: one month after vaccination (Vaccination ATP cohort for Immunogenicity), Post-Vac (Y1): one year after vaccination (ATP cohort for Persistence Year 1), Results of this table were previously published [62, 68–76].