BACKGROUND: One schedule for the capsular group B meningococcal vaccine 4CMenB is 2 doses that are administered 2 months apart for children aged 12-23 months, with a booster dose 12-24 months later. Our objective was to provide data on persistence of human serum bactericidal antibody (hSBA) titres in children up to 4 years of age after initial doses at 12-24 months, and immunogenicity of a booster dose at 48 months of age compared with vaccine-naive children. METHODS: Children previously immunized, as part of a randomized controlled trial, with 2 doses of 4CMenB vaccine at 12-24 months of age received a booster at 4 years of age. Vaccine-naive age-matched toddlers received 2 doses of 4CMenB. Human serum bactericidal antibody titres against reference strains H44/76, 5/99, NZ98/254 and M10713 were evaluated before and after innoculation with 4CMenB vaccine in 4-year-old children. RESULTS: Of 332 children in the study, 123 had previously received 4CMenB and 209 were vaccine-naive controls. Before the booster, the proportions of participants (previously vaccinated groups compared with controls) with hSBA titres of 1:5 or more were as follows: 9%-11% v. 1% (H44/76), 84%-100% v. 4% (5/99), 0%-18% v. 0% (NZ98/254) and 59%-60% v. 60% (M10713). After 1 dose of 4CMenB in previously immunized children, the proportions of participants achieving hSBA titres of 1:5 or more were 100% (H44/76 and 5/99), 70%-100% (NZ98/254) and 90%-100% (M10713). INTERPRETATION: We found that waning of hSBA titres by 4 years of age occurred after 2 doses of 4CMenB vaccine administered at 12-24 months, and doses at 12-24 months have a priming effect on the immune system. A booster may be necessary to maintain hSBA titres of 1:5 or more among those children with increased disease risk. Trial registration: ClinicalTrials.gov, no. NCT01717638

Persistence of immunity after vaccination with a capsular group B meningococcal vaccine in 3 different toddler schedules / Sadarangani, Manish; Sell, Tim; Iro, Mildred A.; Snape, Matthew D.; Voysey, Merryn; Finn, Adam; Heath, Paul T.; Bona, Gianni; Esposito, Susanna; Diez-Domingo, Javier; Prymula, Roman; Odueyungbo, Adefowope; Toneatto, Daniela; Pollard, Andrew J.; Kelly, Sarah; Campbell, Danielle; Dymond, Sandra; Kent, Alison; De Martino, Maurizio; Bianchi, Leila; Montagnani, Carlotta; Giaquinto, Carlo; Ghezzi, Benedetta; Kohl, Igor; Inzillo, Simone; Kasim, Linda; Hlavata, Lucie; Lulli, Laura; Wisse, Harry; Gomez, Sheena; Dindore, Vasundhara; Pozzi, Erika; Parlamento, Silvia; Montinaro, Valentina; Tortajada-Girbés, Miguel; Martinón-Torres, Federico; Collazo, Lorenzo Redondo; Chlíbek, Roman; Dražan, Daniel. - In: CMAJ. - ISSN 0820-3946. - 189:41(2017), pp. E1276-E1285. [10.1503/cmaj.161288]

Persistence of immunity after vaccination with a capsular group B meningococcal vaccine in 3 different toddler schedules

Esposito, Susanna;
2017-01-01

Abstract

BACKGROUND: One schedule for the capsular group B meningococcal vaccine 4CMenB is 2 doses that are administered 2 months apart for children aged 12-23 months, with a booster dose 12-24 months later. Our objective was to provide data on persistence of human serum bactericidal antibody (hSBA) titres in children up to 4 years of age after initial doses at 12-24 months, and immunogenicity of a booster dose at 48 months of age compared with vaccine-naive children. METHODS: Children previously immunized, as part of a randomized controlled trial, with 2 doses of 4CMenB vaccine at 12-24 months of age received a booster at 4 years of age. Vaccine-naive age-matched toddlers received 2 doses of 4CMenB. Human serum bactericidal antibody titres against reference strains H44/76, 5/99, NZ98/254 and M10713 were evaluated before and after innoculation with 4CMenB vaccine in 4-year-old children. RESULTS: Of 332 children in the study, 123 had previously received 4CMenB and 209 were vaccine-naive controls. Before the booster, the proportions of participants (previously vaccinated groups compared with controls) with hSBA titres of 1:5 or more were as follows: 9%-11% v. 1% (H44/76), 84%-100% v. 4% (5/99), 0%-18% v. 0% (NZ98/254) and 59%-60% v. 60% (M10713). After 1 dose of 4CMenB in previously immunized children, the proportions of participants achieving hSBA titres of 1:5 or more were 100% (H44/76 and 5/99), 70%-100% (NZ98/254) and 90%-100% (M10713). INTERPRETATION: We found that waning of hSBA titres by 4 years of age occurred after 2 doses of 4CMenB vaccine administered at 12-24 months, and doses at 12-24 months have a priming effect on the immune system. A booster may be necessary to maintain hSBA titres of 1:5 or more among those children with increased disease risk. Trial registration: ClinicalTrials.gov, no. NCT01717638
2017
Persistence of immunity after vaccination with a capsular group B meningococcal vaccine in 3 different toddler schedules / Sadarangani, Manish; Sell, Tim; Iro, Mildred A.; Snape, Matthew D.; Voysey, Merryn; Finn, Adam; Heath, Paul T.; Bona, Gianni; Esposito, Susanna; Diez-Domingo, Javier; Prymula, Roman; Odueyungbo, Adefowope; Toneatto, Daniela; Pollard, Andrew J.; Kelly, Sarah; Campbell, Danielle; Dymond, Sandra; Kent, Alison; De Martino, Maurizio; Bianchi, Leila; Montagnani, Carlotta; Giaquinto, Carlo; Ghezzi, Benedetta; Kohl, Igor; Inzillo, Simone; Kasim, Linda; Hlavata, Lucie; Lulli, Laura; Wisse, Harry; Gomez, Sheena; Dindore, Vasundhara; Pozzi, Erika; Parlamento, Silvia; Montinaro, Valentina; Tortajada-Girbés, Miguel; Martinón-Torres, Federico; Collazo, Lorenzo Redondo; Chlíbek, Roman; Dražan, Daniel. - In: CMAJ. - ISSN 0820-3946. - 189:41(2017), pp. E1276-E1285. [10.1503/cmaj.161288]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11381/2864309
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