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Immunogenicity and Reactogenicity of a Reduced Schedule of a 4-component Capsular Group B Meningococcal Vaccine: A Randomized Controlled Trial in Infants.

Abstract：

Background:The 4-component capsular group B meningococcal vaccine (4CMenB) was licensed as a 4-dose infant schedule but introduced into the United Kingdom as 3 doses at 2, 4, and 12 months of age. We describe the immunogenicity and reactogenicity of the 2 + 1 schedule in infants. Methods:Infants were randomized to receive 4CMenB with routine immunizations (test group) at 2, 4, and 12 months or 4CMenB alone at 6, 8, and 13 months of age (control group). Serum bactericidal antibody (SBA) assay against a serogroup B meningococcal reference strain (44/76-SL), memory B-cell responses to factor H binding protein, Neisseria adhesion protein A, Neisseria heparin binding antigen, Porin A (PorA), and reactogenicity was measured. Results:One hundred eighty-seven infants were randomized (test group: 94; control group: 93). In the test group, 4CMenB induced SBA titers above the putative protective threshold (1:4) after primary and booster doses in 97% of participants. Postbooster, the SBA GMT (72.1; 95% confidence interval [CI], 51.7-100.4) was numerically higher than the serum bactericidal antibody geometric mean titre (SBA GMT) determined post-primary vaccination (48.6; 95% CI, 37.2-63.4). After primary immunizations, memory B-cell responses did not change when compared with baseline controls, but frequencies significantly increased after booster. Higher frequency of local and systemic adverse reactions was associated with 4CMenB. Conclusions:A reduced schedule of 4CMenB was immunogenic and established immunological memory after booster.

journal_name

Open Forum Infect Dis

journal_title

Open forum infectious diseases

authors

Valente Pinto M,O'Connor D,Galal U,Clutterbuck EA,Robinson H,Plested E,Bibi S,Camara Pellisso S,Hughes H,Kerridge S,Mujadidi YF,Findlow H,Borrow R,Snape MD,Pollard AJ

doi

10.1093/ofid/ofaa143

subject

Has Abstract

pub_date

2020-04-29 00:00:00

pages

ofaa143

issue

5

issn

2328-8957

pii

ofaa143

journal_volume

7

pub_type

杂志文章

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