Antibody persistence and booster responses 24–36 months after different 4CMenB vaccination schedules in infants and children: A randomised trial - 28/02/18
, Alfonso Carmona Martinez c, Róbert Simkó d, Pilar Infante Marquez e, Josep-Lluis Arimany f, Francisco Gimenez-Sanchez g, José Antonio Couceiro Gianzo h, Éva Kovács i, Pablo Rojo j, k, Huajun Wang l, Chiranjiwi Bhusal m, Daniela Toneatto mHighlights |
• | A reduced 2 + 1 and a licensed 3 + 1 4CMenB-schedule in infants result in similar antibody persistence. |
• | Two catch-up doses for 2–10-year-olds induced adequate priming of antibody for 2–3 years. |
• | A booster dose after 2 + 1 or 3 + 1 vaccination elicited similarly high hSBA titres. |
• | An accelerated schedule (in vaccine-naïve) induced an early immune response after first dose. |
• | No safety concerns arose for either schedule. |
Abstract |
Objectives |
This phase IIIb, open-label, multicentre, extension study (NCT01894919) evaluated long-term antibody persistence and booster responses in participants who received a reduced 2 + 1 or licensed 3 + 1 meningococcal serogroup B vaccine (4CMenB)-schedule (infants), or 2-dose catch-up schedule (2–10-year-olds) in parent study NCT01339923.
Materials and methods |
Children aged 35 months to 12 years (N = 851) were enrolled. Follow-on participants (N = 646) were randomised 2:1 to vaccination and non-vaccination subsets; vaccination subsets received an additional 4CMenB dose. Newly enrolled vaccine-naïve participants (N = 205) received 2 catch-up doses, 1 month apart (accelerated schedule). Antibody levels were determined using human serum bactericidal assay (hSBA) against MenB indicator strains for fHbp, NadA, PorA and NHBA. Safety was also evaluated.
Results |
Antibody levels declined across follow-on groups at 24–36 months versus 1 month post-vaccination. Antibody persistence and booster responses were similar between infants receiving the reduced or licensed 4CMenB-schedule. An additional dose in follow-on participants induced higher hSBA titres than a first dose in vaccine-naïve children. Two catch-up doses in vaccine-naïve participants induced robust antibody responses. No safety concerns were identified.
Conclusion |
Antibody persistence, booster responses, and safety profiles were similar with either 2 + 1 or 3 + 1 vaccination schedules. The accelerated schedule in vaccine-naïve children induced robust antibody responses.
Le texte complet de cet article est disponible en PDF.Keywords : Antibody persistence, Meningococcal B vaccine, Infants, Children, Booster response, 2 + 1 schedule, Safety, Open-label randomised clinical trial
Abbreviations : AE, CI, FAS, fHbp, GMT, hSBA, IMD, MenACWY-CRM, MenB, 4CMenB, NadA, NHBA, PorA, rLP2086, SAE, UK
Plan
| Clinical Trial Registration: NCT01894919. |
Vol 76 - N° 3
P. 258-269 - mars 2018 Retour au numéro
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