Abstract：
OBJECTIVE: To compare immunological responses of preterm infants to a four-component meningococcal B vaccine (4CMenB; Bexsero) following a 2+1 vs a 3+1 schedule, and to describe reactogenicity of routine vaccines.
METHODS: An open-label, phase IV randomised study conducted across six UK sites.
METHODS: Neonatal units, postnatal wards, community recruitment following discharge.
METHODS: 129 preterm infants born at a gestation of <35 weeks (64 in group 1 (2+1), 65 in group 2 (3+1)) were included in the analysis. Analysis was completed for postprimary samples from 125 participants (59 in group 1, 66 in group 2) and for postbooster samples from 118 participants (59 in both groups).
METHODS: Infants randomised to 4CMenB according to a 2+1 or a 3+1 schedule, alongside routine vaccines.
METHODS: Serum bactericidal antibody (SBA) assays performed at 5, 12 and 13 months of age: geometric mean titres (GMTs) and proportions of infants achieving titres ≥4 compared between groups.
RESULTS: There were no significant differences in SBA GMTs between infants receiving a 2+1 compared with a 3+1 schedule following primary or booster vaccination, but a significantly higher proportion of infants had an SBA titre ≥4 against strain NZ98/254 (porin A) at 1 month after primary vaccination using a 3+1 compared with a 2+1 schedule (3+1: 87% (95% CI 76 to 94%), 2+1: 70% (95% CI 56 to 81%), p=0.03).At 12 weeks of age those in the 3+1 group, who received a dose of 4CMenB, had significantly more episodes of fever >38.0°C than those in the 2+1 group who did not (group 2+1: 2% (n=1); 3+1: 14% (n=9); p=0.02).
CONCLUSIONS: Both schedules were immunogenic in preterm infants, although a lower response against strain NZ98/254 was seen in the 2+1 schedule; ongoing disease surveillance is important in understanding the clinical significance of this difference.
BACKGROUND: NCT03125616.
METHODS: An open-label, phase IV randomised study conducted across six UK sites.
METHODS: Neonatal units, postnatal wards, community recruitment following discharge.
METHODS: 129 preterm infants born at a gestation of <35 weeks (64 in group 1 (2+1), 65 in group 2 (3+1)) were included in the analysis. Analysis was completed for postprimary samples from 125 participants (59 in group 1, 66 in group 2) and for postbooster samples from 118 participants (59 in both groups).
METHODS: Infants randomised to 4CMenB according to a 2+1 or a 3+1 schedule, alongside routine vaccines.
METHODS: Serum bactericidal antibody (SBA) assays performed at 5, 12 and 13 months of age: geometric mean titres (GMTs) and proportions of infants achieving titres ≥4 compared between groups.
RESULTS: There were no significant differences in SBA GMTs between infants receiving a 2+1 compared with a 3+1 schedule following primary or booster vaccination, but a significantly higher proportion of infants had an SBA titre ≥4 against strain NZ98/254 (porin A) at 1 month after primary vaccination using a 3+1 compared with a 2+1 schedule (3+1: 87% (95% CI 76 to 94%), 2+1: 70% (95% CI 56 to 81%), p=0.03).At 12 weeks of age those in the 3+1 group, who received a dose of 4CMenB, had significantly more episodes of fever >38.0°C than those in the 2+1 group who did not (group 2+1: 2% (n=1); 3+1: 14% (n=9); p=0.02).
CONCLUSIONS: Both schedules were immunogenic in preterm infants, although a lower response against strain NZ98/254 was seen in the 2+1 schedule; ongoing disease surveillance is important in understanding the clinical significance of this difference.
BACKGROUND: NCT03125616.
摘要：
目的：比较早产儿在2+1和3+1方案后对四组分脑膜炎球菌B疫苗（4CMenB;Bexsero）的免疫反应，并描述常规疫苗的反应原性。
方法：开放标签，在英国六个地点进行的IV期随机研究。
方法：新生儿单位，产后病房,出院后的社区招募。
方法：129名妊娠<35周的早产儿（第1组（2+1）为64名，第2组（3+1）中的65例）被包括在分析中。对125名参与者（第1组59名，第2组66名）和118名参与者（两组59名）的增强后样本进行了分析。
方法：根据2+1或3+1时间表随机分配给4CMenB的婴儿，除了常规疫苗。
方法：在5、12和13月龄时进行血清杀菌抗体（SBA）测定：几何平均滴度（GMT）和两组之间达到滴度≥4的婴儿比例。
结果：初次或加强疫苗接种后，接受2+1方案的婴儿与接受3+1方案的婴儿之间的SBAGMT没有显着差异，但与2+1方案相比，在初次接种3+1方案后1个月，针对NZ98/254株（孔蛋白A）的SBA滴度≥4的婴儿比例明显更高（3+1：87％（95％CI76至94％），2+1：70%（95%CI56至81%），p=0.03)。在3+1组的12周龄时，他接受了4CMenB的剂量，>38.0°C的发热发生率明显高于未发热的2+1组(2+1:2%(n=1);3+1:14%(n=9);p=0.02)。
结论：两种治疗方案对早产儿均有免疫原性，尽管在2+1方案中观察到对NZ98/254菌株的反应较低,但持续的疾病监测对于理解这种差异的临床意义很重要.
背景：NCT03125616。
方法：开放标签，在英国六个地点进行的IV期随机研究。
方法：新生儿单位，产后病房,出院后的社区招募。
方法：129名妊娠<35周的早产儿（第1组（2+1）为64名，第2组（3+1）中的65例）被包括在分析中。对125名参与者（第1组59名，第2组66名）和118名参与者（两组59名）的增强后样本进行了分析。
方法：根据2+1或3+1时间表随机分配给4CMenB的婴儿，除了常规疫苗。
方法：在5、12和13月龄时进行血清杀菌抗体（SBA）测定：几何平均滴度（GMT）和两组之间达到滴度≥4的婴儿比例。
结果：初次或加强疫苗接种后，接受2+1方案的婴儿与接受3+1方案的婴儿之间的SBAGMT没有显着差异，但与2+1方案相比，在初次接种3+1方案后1个月，针对NZ98/254株（孔蛋白A）的SBA滴度≥4的婴儿比例明显更高（3+1：87％（95％CI76至94％），2+1：70%（95%CI56至81%），p=0.03)。在3+1组的12周龄时，他接受了4CMenB的剂量，>38.0°C的发热发生率明显高于未发热的2+1组(2+1:2%(n=1);3+1:14%(n=9);p=0.02)。
结论：两种治疗方案对早产儿均有免疫原性，尽管在2+1方案中观察到对NZ98/254菌株的反应较低,但持续的疾病监测对于理解这种差异的临床意义很重要.
背景：NCT03125616。
