Limited impact of neonatal or early infant schedules of 7-valent pneumococcal conjugate vaccination on nasopharyngeal carriage of Streptococcus pneumoniae in Papua New Guinean children: A randomized controlled trial

Celestine Aho , Audrey Michael , Mition Yoannes , Andrew Greenhill , Peter Jacoby , John Reeder , William Pomat , Gerard Saleu , Pioto Namuigi , Suparat Phuanukoonnon , Heidi Smith-Vaughan , Amanda J. Leach , Peter Richmond , Deborah Lehmann , for the Neonatal Pneumococcal Conjugate Vaccine Trial Study Team
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引用次数: 19

Abstract

Streptococcus pneumoniae is a leading cause of pneumonia, the most common cause of childhood death. Papua New Guinean children experience high rates of nasopharyngeal pneumococcal colonization within weeks of birth, predisposing them to pneumococcal disease. In a trial to determine the safety and immunogenicity of early infant vaccination with 7-valent pneumococcal conjugate vaccine (7vPCV), we investigated the impact of early schedules on pneumococcal carriage.

Infants were randomized at birth to receive 7vPCV in a 0–1–2-month (n = 101) or a 1–2–3-month (n = 105) schedule or no 7vPCV (n = 106). All children received 23-valent pneumococcal polysaccharide vaccine at age 9 months. We cultured nasopharyngeal swabs (NPS) collected at ages 1, 2, 3, 4 weeks and 3, 9, 18 months, and middle ear discharge if present. Pneumococcal serotypes were identified by the Quellung reaction.

A total of 1761 NPS were cultured. The prevalence of pneumococcal carriage was 22% at 1 week of age, rising to 80% by age 3 months and remained >70% thereafter, with high-density carriage in 42% of pneumococcus-positive samples. We identified 63 different serotypes; 43% of isolates from controls were 13vPCV serotypes. There were no significant differences in 7vPCV serotype carriage between 7vPCV recipients and controls at any age (22% vs. 31% at 9 months, p = 0.2). At age 9 months the prevalence of non-7vPCV carriage was 17% higher in 7vPCV recipients (48%) than in controls (25%, p = 0.02). More non-7vPCV serotypes were isolated from ear discharge in 16 7vPCV recipients than from 4 controls (48% vs. 25%, p = 0.13).

The limited impact of neonatal or accelerated infant 7vPCV schedules on vaccine serotype carriage is probably due to the early onset of dense carriage of a broad range of pneumococcal serotypes. While serotype-independent pneumococcal vaccines are needed in high-risk populations, the underlying environmental factors and sources of infection must be investigated.

http://clinicaltrials.gov/ct2/show/NCT00219401.

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Abstract Image

新生儿或早期婴儿接种7价肺炎球菌结合疫苗对巴布亚新几内亚儿童鼻咽携带肺炎链球菌的有限影响:一项随机对照试验
肺炎链球菌是导致肺炎的主要原因,肺炎是儿童死亡的最常见原因。巴布亚新几内亚儿童在出生后几周内鼻咽部肺炎球菌定植率很高,易患肺炎球菌疾病。在一项确定婴儿早期接种7价肺炎球菌结合疫苗(7vPCV)的安全性和免疫原性的试验中,我们调查了早期接种时间表对肺炎球菌携带的影响。婴儿在出生时被随机分为0 - 1 - 2个月(n = 101)或1 - 2- 3个月(n = 105)或不接受7vPCV (n = 106)。所有儿童在9个月大时接种23价肺炎球菌多糖疫苗。我们培养了1、2、3、4周和3、9、18个月时收集的鼻咽拭子(NPS),如果存在中耳分泌物。通过Quellung反应鉴定肺炎球菌血清型。共培养NPS 1761株。1周龄时肺炎球菌携带率为22%,到3个月时上升至80%,此后保持70%,42%的肺炎球菌阳性样本中有高密度携带。我们确定了63种不同的血清型;43%的对照分离株为13vPCV血清型。7vPCV受体和对照组在任何年龄的7vPCV血清型携带无显著差异(9个月时22% vs 31%, p = 0.2)。9月龄时,7vPCV受者非7vPCV携带的患病率(48%)比对照组(25%,p = 0.02)高17%。从16例7vPCV受者耳液中分离出的非7vPCV血清型比从4例对照中分离出的多(48% vs. 25%, p = 0.13)。新生儿或婴儿7vPCV接种计划对疫苗血清型携带的影响有限,可能是由于多种肺炎球菌血清型的密集携带早发。虽然高危人群需要独立于血清型的肺炎球菌疫苗,但必须调查潜在的环境因素和感染源。http://clinicaltrials.gov/ct2/show/NCT00219401。
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