An update of clinical experience with the quadrivalent meningococcal ACWY-CRM conjugate vaccine

Figures & data

Figure 1. Focus on the patient section.

Table 1. Studies supporting the immunogenicity and safety of MenACWY-CRM in healthy infants and toddlers.

Vaccine feature	Schedule or coadministered vaccine	NCT	Country	Key conclusions	Author [references]
4-dose series commencing at age 2 months	2, 4, 6, 12 months	NCT00474526	US, Columbia, Argentina	MenACWY-CRM was immunogenic and well tolerated when administered in three doses at age 2, 4, and 6 months. The fourth dose was well tolerated and induced marked increases in antibodies	Klein et al. [30], Tregnaghi et al. [27]
		NCT01000311	US, Canada, Australia	MenACWY-CRM was immunogenic and well tolerated when administered as 3-dose priming in infants	Nolan et al. [28]
		NCT01214837	US, Canada	Immunogenic and well tolerated when administered in three doses at age 2, 4, and 6 months. Robust responses were observed after the fourth dose	Block et al. [29]
3-dose series commencing at age 2 months	2, 4 (or 6) and 12–13 months	NCT00474526	Columbia, Argentina	Non-inferiority of 2- versus −3-dose primary series demonstrated in terms of hSBA GMTs	Tregnaghi et al. [27]
		NCT01214837	US, Canada	Non-inferiority of 2- versus −3-dose primary series for CWY in terms of seroprotection and GMTs	Block et al. [29]
2-dose series in 6–11 month-olds	7–9 and 12 months	NCT00626327	US	Robust responses when administered in a 2-dose series to older infants	Klein et al. [33]
2-dose series in the second year of life	12 and 15 months	NCT00474526		Highly immunogenic as two doses administered to toddlers	Tregnaghi et al. [27]
Coadministration	DTaP–HBV–IPV, Hib, PCV7	NCT00474526	US, Columbia, Argentina	None of the coadministration studies showed any clinically relevant vaccine interactions and/or impact on vaccine reactogenicity or safety when MenACWY-CRM was coadministered with routine vaccines in all age groups	Tregnaghi et al. [27] Klein et al. [30]
	DTaP, PCV7, HBV	NCT01000311	US, Canada, Australia		Nolan et al. [28]
	PCV13	NCT01214837	US, Canada		Block et al. [29]
	PCV7, DTaP–HBV–IPV/Hib	NCT00667602	Germany, Australia		Gasparini et al. [36]
	MMR/V	NCT00626327	US		Klein et al. [33]
	MMRV/V, HAV	NCT00474526	US, Columbia, Argentina		Tregnaghi et al. [27], Klein et al. [30]
	DTaP, IPV, Hib, PCV7	NCT00806195	US, Peru, Guatemala, Taiwan, Costa Rica, Panama		Abdelnour et al. [34]
Antibody persistence	40 and 60 months after 3-doses in infancy	NCT00601731	UK, Canada	Both studies showed waning of antibodies that was most marked for MenA	Khatami et al. [72]
	60 months after 4-dose series in infancy	NCT01148017	US	Modest antibody persistence to C, W, and Y after infant vaccination to 60 months of age	Klein et al. [31]
	5 years of age after 1 or 2-dose priming	NCT01148017	US	Modest antibody persistence for A and C after toddler vaccination, higher persistence for W and Y	Klein et al. [31]
Booster	5 years of age after 4-dose series in infancy	NCT01148017	US	Booster dose well tolerated and induced robust immune responses with high seroprotection rates	Klein et al. [31]
	5 years of age after 1 or 2-dose priming as toddlers	NCT01148017	US	Booster dose well tolerated and induced robust immune responses with high seroprotection rates	Klein et al. [31]
Safety when administered with routine vaccines	2, 4, 6, and 12 months schedule	NCT00806195	US, Peru, Guatemala, Taiwan, Costa Rica, Panama	The reactogenicity and safety profile was acceptable and no safety concerns were raised	Abdelnour et al. [34]
		NCT00474526	US, Columbia, Argentina		Tregnaghi et al. [27], Klein et al. [30]
B-cell responses after primary and booster vaccination	2, 4, and 12 months	NCT00488683	UK	Few antigen-specific anti-capsular memory B-cells were detected after 2-dose priming but increased after booster.	Blanchard-Rohner et al. [37]
Impact of maternal antibodies on antibody and memory B-cell responses	2 and 4 months	NCT00488683	UK	Maternal antibody had only low-to-moderate impacts on infant responses to vaccination with MenACWY-CRM	Blanchard-Rohner et al. [38]

UK: United Kingdom; US: United States; DTaP–HBV–IPV: combined diphtheria–tetanus–acellular pertussis–hepatitis B-inactivated poliovirus vaccine; DTaP–HBV–IPV/Hib: combined hexavalent diphtheria–tetanus–acellular pertussis-hepatitis B-inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine; MenACWY-TT: quadrivalent meningococcal A, C, E, Y vaccine conjugated to tetanus toxoid; HAV: hepatitis A vaccine; HBV: hepatitis B vaccine; PCV7/13: 7/13-valent pneumococcal conjugate vaccine; MMR/V: measles–mumps–rubella (varicella) vaccine; DTaP: combined diphtheria–tetanus–acellular pertussis vaccine; IPV: inactivated poliovirus vaccine; Hib: Haemophilus influenzae type b conjugate vaccine; GMT: geometric mean titer.

Table 2. Studies supporting the immunogenicity and safety of MenACWY-CRM in children 2–10 years of age.

Vaccine features	Key study details	Age at vaccination (years)	Trial registry number	Country	Key conclusions	Author [references]
Immunogenicity and safety	1 or 2 doses	2–10	NCT01998477	United States	1 or 2 doses were immunogenic and well tolerated. While 2 doses induced higher responses, differences were limited 1 year post vaccination	Johnston et al. [41]
	1 dose	2–10	NCT01547715	India	One dose was immunogenic and well-tolerated in Indian children	Lalwani et al. [42]
	1 dose	2–10	NCT01410474	Taiwan	A single dose of MenACWY-CRM demonstrated a robust immune response, and an acceptable safety profile in Taiwanese children	Huang et al. [39]
	1 dose	2–10	NCT01725217	Russia	One dose was immunogenic and well-tolerated in Russian children	Ilyina et al. [40]
	2 doses 12–35 month-olds, 1 dose 36–59 month-olds	1–5	NCT00310817	Finland, Poland	Vaccination was immunogenic and well-tolerated in Finnish and Polish children	www.clinicaltrials.gov [73]
Persistence	6 and 12 months	1–5	NCT00310817	Finland, Poland	Good antibody persistence at 1 year	www.clinicaltrials.gov [73]
	5 years after 1 or 2-dose priming	2–10	NCT01823536	United States	Approximately half the children vaccinated as 2–10 year-olds maintained protective antibodies against serogroups C, W and Y five years later	Block et al. [35]
	12 months after 2-dose priming	2–10	NCT01998477	United States	Good antibody persistence at 1 year	Johnston et al. [41]
Booster	5 years after 1 or 2-dose priming	2–10	NCT01823536	United States	Booster dose well tolerated and induced robust immune responses with high seroprotection rates	Block et al. [35]
	6–12 months after priming dose	1–5	NCT00310817	Finland, Poland	Booster dose well tolerated and induced robust immune responses with high seroprotection rates	www.clinicaltrials.gov [73]
Safety	Prospective cohort study with retrospective data collection using health insurance database	2–10	–	United States	No safety concerns were identified following MenACWY-CRM in 2–10 year olds	Tartof et al. [58]

Table 3. Studies supporting the immunogenicity and safety of MenACWY-CRM in adolescents and adults.

Vaccine features	Key study details	Age at vaccination (years)	Trial registry number	Country	Key conclusions	Author [references]
Immunogenicity and safety	1 dose	18–24	NCT01214850	UK	MenACWY-CRM was highly immunogenic in university students	Read et al. [56]
	1 dose	11–55	NCT01274897	Korea	A single dose of MenACWY-CRM was immunogenic and well tolerated in Korean adolescents and adults	Lee et al. [46]
	1 dose	11–18	NCT01410474	Taiwan	A single dose of MenACWY-CRM demonstrated a robust immune response, and an acceptable safety profile in Taiwanese adolescents	Huang et al. [39]
	1 dose	11–75	NCT01547715	India	One dose was immunogenic and well-tolerated in an Indian population	Lalwani et al. [42]
	1 dose	≥11	NCT01725217	Russia	One dose was immunogenic and well-tolerated in Russian adolescents and adults	Ilyina et al. [40]
	1 dose	18–70	NCT00901940	UK	MenACWY-CRM elicited protective antibody responses in adults aged 18 to 70	Ramasamy et al. [74]
Antibody persistence	3 and 5 years after 1-dose priming	11–18	NCT00856297	US	A majority of subjects previously maintained seroprotective hSBA against serogroups C, W and Y 5 years post vaccination	Baxter et al. [47,48]
	5 years after 1-dose priming	11–18	NCT01018732	US	MenACWY-CRM provided a broad and persistent immune response in adolescents	Jacobson et al. [49]
Booster	3 years after 1-dose priming with MenACWY-CRM or MenACWY-DT	11–18	NCT00856297	US	Booster vaccination with MenACWY-CRM elicited a robust immune response during the 2-year follow-up period, irrespective of previous vaccination	Baxter et al. [47,48]
	5 years after 1-dose priming with MenACWY-CRM or Men-PS	11–18	NCT01018732	US	A booster dose of MenACWY-CRM elicited an adequate antibody response, regardless of vaccine history	Jacobson et al. [49]
	1 dose after MenC-TT or MenC-CRM priming at 3–6 years	16–19	NCT01192997	UK	MenACWY-CRM safely induced protective and sustained antibody responses against all targeted serogroups in MenC-primed teenagers	Ishola et al. [24]
Coadministration	Typhoid, yellow fever, Japanese encephalitis, rabies	18–60	NCT01466387	Germany, Czech Republic	MenACWY-CRM coadministered with traveler vaccines did not compromise the immunogenicity or safety of the individual vaccines	Alberer et al., [51,52]
	Combined HAV-HBV, HAV and/or HBV	18–64	NCT01453348	Germany		Alberer et al. [53]
	Tdap	11–25	NCT00329901	Italy	Immune responses against all 4 meningococcal serogroups were not influenced by concomitant administration with Tdap. For the Tdap antigens, non-inferiority criteria were not met for FHA or PRN	Gasparini et al. [75]
	4CMenB	18–65	NCT00962624	UK	MenACWY-CRM and 4CMenB are safe and immunogenic when administered concomitantly	Findlow et al. [22]
	4CMenB at 0, 2, 6 months, MenACWY-CRM 1 month later	18–50	NCT00560313	Italy, Germany	Sequential administration of 4CMenB and MenACWY-CRM induced immune responses against serogroups A, B, C, W, and Y in laboratory workers routinely exposed to meningococcal isolates	Kimura et al. [54]
	MenACWY-CRM administered 3 days after Td	Military recruits	–	Korea	MenACWY-CRM was immunogenic against all vaccine-serogroups in Korean military recruits rSBA GMTs but not seroprotection rates to A and C were reduced when Td was administered three days earlier	Kim et al. [23]
Safety	Prospective cohort study with retrospective data collection using health insurance database	11–21	–	US	A temporal association between occurrence of Bell’s palsy and receipt of MenACWY-CRM concomitantly with other vaccines was observed	Tseng et al. [59]
	VAERS safety review	All ages	–	US	Adverse event findings were consistent with data from pre-licensure studies	Myers et al. [60]
	Adverse event surveillance in the French Armed Forces	Armed forces	–	France	Adverse events appear to relatively rare, particularly serious adverse events, indicating acceptable tolerance of vaccines	Mayet et al. [57]
Carriage	1-syear follow-up of nasopharyngeal carriage	18–24	NCT01214850	UK	MenACWY-CRM reduced meningococcal carriage rates of CWY during 12 months after vaccination	Read et al. [55,56]

VAERS: Vaccine adverse event reporting system; UK: United Kingdom; US: United States; 4CMenB: 4-component meningococcal serogroup B vaccine; MenC-TT: monovalent serogroup C vaccine conjugate to tetanus toxoid; MenC-CRM: monovalent serogroup C vaccine conjugate to CRM; MenACWY-DT: quadrivalent meningococcal A, C, E, Y vaccine conjugated to diphtheria toxoid; Men-PS: polysaccharide meningococcal vaccine (unconjugated); Td: adult tetanus and diphtheria vaccine; Tdap: adult tetanus, diphtheria, and acellular pertussis vaccine; HAV: hepatitis A vaccine; HBV: hepatitis B vaccine; FHA: filamentous hemagglutinin; PRN: pertactin.

Figure 2. hSBA immunogenicity in infants vaccinated with a 4-dose primary series and a booster dose at 60 months of age of MenACWY-CRM coadministered with routine vaccines (Month 60 booster cohort*). Data from Refs. [30,31].

*Four priming doses of MenACWY-CRM coadministered with DTaP–HBV–IPV, Hib, and PCV7. The Month 60 persistence cohort included participants vaccinated at 2, 4, 6 and 12, or 13 months of age.Post-3: One month after the third priming dose; Pre-4: at the time of the fourth dose; Post-4: 1 month after the fourth dose; M40/M60: at 40/60 months of age; Post-B: 1 month after the booster dose at month 60; GMT: geometric mean antibody titer; hSBA: serum bactericidal assay using human complement source.Error bars indicate 95% confidence intervals.

Figure 3. hSBA immunogenicity in children vaccinated with one dose of MenACWY-CRM at 2–5 or 6–10 years of age. Data from Ref. [35].

Postprimary: One month post vaccination; M60: 60 months after vaccination; Post-B: one month after the booster dose at year 5; GMT: geometric mean antibody titer; hSBA: serum bactericidal assay using human complement source.Vertical lines indicate 95% confidence intervals.

Figure 4. hSBA immunogenicity and antibody persistence in adolescents vaccinated with one dose of MenACWY-CRM at 11–18 years of age (128 subjects). Data from Ref. [48].

Postprimary: One month post vaccination; GMT: geometric mean antibody titer; hSBA: serum bactericidal assay using human complement source.Error bars indicate 95% confidence intervals.

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