Vesikari Timo, Prymula Roman, Merrall Elizabeth, Kohl Igor, Toneatto Daniela, Dull Peter M
University of Tampere Medical School, Tampere, Finland.
University Hospital Hradec Kralove, Hradec Kralove, Czech Republic.
Vaccine. 2015 Jul 31;33(32):3850-8. doi: 10.1016/j.vaccine.2015.06.079. Epub 2015 Jun 30.
The multicomponent, recombinant serogroup B vaccine, 4CMenB, is approved in Europe, Canada and Australia from two months of age. We investigated persistence to booster doses at 12 months of age following infant vaccination, and immune response to catch-up vaccination of toddlers and children up to two years of age.
We assessed persistence of immune responses after one year in participants vaccinated as infants, and responses to two doses at 12-15 or 24-26 months of age in vaccine-naïve children, as serum bactericidal activity with human complement (hSBA) against indicator strains for four vaccine antigens. Adverse events were recorded after each vaccination.
High antibody titers were induced against all four 4CMenB components following booster vaccination in infant-primed toddlers and after two doses in previously unvaccinated toddlers or two-year-olds. Antibodies waned over 12 months, particularly those against NZ OMV. Systemic reactogenicity in toddlers was lower than in infants, and lower again in vaccine-naïve two-year-olds. Local reactogenicity was common in all groups.
Four infant or two toddler 4CMenB vaccinations elicit immune responses believed to be protective for the first two years of life, which can be boosted. Reactogenicity is lower in toddlers than in infants.
多组分重组B群疫苗4CMenB在欧洲、加拿大和澳大利亚已获批用于两个月龄以上人群。我们研究了婴儿接种疫苗后至12月龄加强剂量时免疫反应的持续性，以及12月龄至2岁幼儿和儿童补种疫苗后的免疫反应。
我们评估了婴儿期接种疫苗的参与者在1年后免疫反应的持续性，以及未接种过疫苗的儿童在12 - 15月龄或24 - 26月龄接种两剂疫苗后的反应，以针对四种疫苗抗原指示菌株的人补体血清杀菌活性（hSBA）来衡量。每次接种后记录不良事件。
在婴儿期接种过疫苗的幼儿加强接种后以及之前未接种过疫苗的幼儿或两岁儿童接种两剂后，均诱导产生了针对4CMenB所有四种组分的高抗体滴度。抗体在12个月内逐渐下降，尤其是针对新西兰外膜囊泡（NZ OMV）的抗体。幼儿的全身反应原性低于婴儿，在未接种过疫苗的两岁儿童中更低。局部反应原性在所有组中都很常见。
婴儿接种四剂或幼儿接种两剂4CMenB可引发被认为在生命的前两年具有保护作用的免疫反应，且可进行加强接种。幼儿的反应原性低于婴儿。
