Advances in Preventive Medicine

Review Article

Conjugate Meningococcal Vaccines Development: GSK Biologicals Experience

Table 3

rSBA-MenC, rSBA-MenY antibody responses after Hib-MenCY-TT vaccination.


Reference	Vaccine dose 1–3	Vaccine dose 4	Timepoint		rSBA ≥ 1 : 8		rSBA ≥ 1 : 128		GMT
					%	[95% CI]	%	[95% CI]	Value	[95% CI]

rSBA-MenC

Habermehl et al., 2010 [68] 2, 3, 4 + 12–18 months of age	Hib-MenCY-TT + DTPa-HBV-IPV	Hib-MenCY-TT + DTPa-HBV-IPV	PD3	70	100	[94.9–100]	95.7	[88.0–99.1]	1005.8	[773.5–1308.0]
			Pre-D4	46	91.3	[79.2–97.6]	63.0	[47.5–76.8]	153.1	[90.4–259.4]
			PD4	40	100	[91.2–100]	100	[91.2–100]	4762.6	[3427.5–6617.7]
	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-D4	42	95.2	[83.8–99.4]	69.0	[52.9–82.4]	199.2	[129.6–306.2]
			PD4	39	100	[91.0–100]	100	[91.0–100]	11819.3	[8458.6–16515.2]

Nolan et al., 2007 [81] 2, 4, 6 + 11–14 months of age	Hib-MenCY-TT + DTPa-HBV-IPV	Men-PS Challenge	PD3	74*	100	[94.8–100]	98.6	[92.2–100]	1293.1	[1027.7–1627.1]
			Pre-Ch	80*	97.4	[90.8–99.7]	78.9	[68.1–87.5]	265.5	[197.8–356.3]
			Post-Ch	73*	100	[94.8–100]	98.6	[92.2–100]	1985.5	[1542.6–2555.8]
	MenC-CRM₁₉₇ + DTPa-HBV-IPV/Hib	Men-PS Challenge	PD3	77*	100	[95.1–100]	98.6	[92.7–100]	1931.9	[1541.2–2421.6]
			Pre-Ch	81*	90.8	[81.9–96.2]	64.5	[52.7–75.1]	176.6	[117.9–264.4]
			Post-Ch	79*	97.5	[91.2–99.7]	84.8	[75.0–91.9]	774.8	[536.7–1118.5]

Nolan et al., 2011 [84] 2, 4, 6 + 12–15 months of age	Hib-MenCY-TT + 7vCRM + DTPa-HBV-IPV	Hib-MenCY-TT + MMR + VAR	PD3	287	99.0	[97.0–99.8]	94.4	[91.1–96.8]	805	[700–925]
			Pre-D4	495	90.7	[87.8–93.1]	48.7	[44.2–53.2]	103	[90.1–117]
			PD4	496	99.6	[98.6–100]	97.2	[95.3–98.4]	1697	[1516–1900]
	MenC-CRM₁₉₇ + Hib-TT + 7vCRM + DTPa-HBV-IPV	Hib-MenCY-TT + MMR + VAR	PD3	99	100	[96.3–100]	96.0	[90.0–98.9]	790	[649–961]
			Pre-D4	169	84.6	[78.3–89.7]	29.6	[22.8–37.1]	53.7	[43.0–67.1]
			PD4	162	95.7	[91.3–98.2]	71.0	[63.3–77.8]	262	[204–336]

rSBA-MenY

Habermehl et al., 2010 [68] 2, 3, 4 + 12–18 months of age	Hib-MenCY-TT + DTPa-HBV-IPV	Hib-MenCY-TT + DTPa-HBV-IPV	PD3	69	97.1	[89.9–99.6]	92.8	[83.9–97.6]	470.7	[351.1–631.2]
			Pre-D4	45	86.7	[73.2–94.9]	60.0	[44.3–74.3]	103.2	[64.6–164.9]
			PD4	40	100	[91.2–100]	100	[91.2–100]	1708.1	[1313.3–2221.4]

Nolan et al., 2007 [81] 2, 4, 6 + 11–14 months of age	Hib-MenCY-TT + DTPa-HBV-IPV	Men-PS Challenge	PD3	74*	98.5	[92.0–100]	95.5	[87.5–99.1]	843.5	[640.1–1111.7]
			Pre-Ch	80*	89.2	[79.8–95.2]	60.8	[48.8–72.0]	114.7	[80.0–164.4]
			Post-Ch	73*	100	[94.7–100]	100	[94.7–100]	1838.0	[1427.9–2366.0]

Nolan et al., 2011 [84] 2, 4, 6 + 12–15 months of age	Hib-MenCY-TT + 7vCRM + DTPa-HBV-IPV	Hib-MenCY-TT + MMR + VAR	PD3	288	99.7	[98.1–100]	91.7	[87.9–94.6]	728	[636–835]
			Pre-D4	514	98.4	[97.0–99.3]	80.5	[76.9–83.9]	264	[241–290]
			PD4	496	100	[99.3–100]	99.4	[98.2–99.9]	1987	[1826–2161]

: numbers of subjects with available data, *: numbers of subjects in the ATP Cohort, %: percentage of subjects with titre within the specified range, 95% CI: 95% confidence interval, GMT: Geometric Mean Titre, PD3: one month after dose 3 (ATP Cohort for Immunogenicity), Pre-D4: just prior dose 4 (ATP Cohort for Persistence), PD4: one month after dose 4 (ATP Cohort for Immunogenicity), Pre-Ch: just prior to meningococcal polysaccharide challenge (ATP Cohort for safety challenge phase), Post-Ch: one month after meningococcal polysaccharide challenge (ATP Cohort for Immunogenicity), Results of this table were previously published [68, 81, 84].