7价肺炎球菌结合疫苗减量接种方案对儿童鼻咽部肺炎球菌携带情况的影响：一项随机对照试验

Effect of reduced-dose schedules with 7-valent pneumococcal conjugate vaccine on nasopharyngeal pneumococcal carriage in children: a randomized controlled trial.

作者信息

van Gils Elske J M, Veenhoven Reinier H, Hak Eelko, Rodenburg Gerwin D, Bogaert Debby, Ijzerman Ed P F, Bruin Jacob P, van Alphen Loek, Sanders Elisabeth A M

机构信息

Department of Pediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, PO Box 85090, 3508 AB Utrecht, The Netherlands.

出版信息

JAMA. 2009 Jul 8;302(2):159-67. doi: 10.1001/jama.2009.975.

DOI:10.1001/jama.2009.975

PMID:19584345

Abstract

CONTEXT

The effects of reduced-dose schedules of 7-valent pneumococcal conjugate vaccine (PCV-7) on pneumococcal carriage in children are largely unknown, although highly relevant in the context of subsequent herd effects.

OBJECTIVE

To examine the effects of a 2-dose and 2 + 1-dose PCV-7 schedule on nasopharyngeal pneumococcal carriage in young children compared with controls.

DESIGN, SETTING, AND PATIENTS: A randomized controlled trial of nasopharyngeal carriage of Streptococcus pneumoniae enrolling 1003 healthy newborns and 1 of their parents in a general community in The Netherlands, with follow-up to age 24 months and conducted between July 7, 2005, and February 14, 2008.

INTERVENTION

Infants were randomly assigned to receive 2 doses of PCV-7 at 2 and 4 months; 2 + 1 doses of PCV-7 at 2, 4, and 11 months; or no dosage (control group).

MAIN OUTCOME MEASURE

Vaccine serotype pneumococcal carriage rates in infants in the second year of life.

RESULTS

At 12 months, vaccine serotype pneumococcal carriage was significantly decreased after both PCV-7 schedules, with vaccine serotype pneumococcal carriage rates of 25% (95% confidence interval [CI], 20%-30%) and 20% (95% CI, 16%-25%) in the 2-dose and 2 + 1-dose schedule groups, respectively, vs 38% (95% CI, 33%-44%) in the control group (both P < .001). At 18 months, in the 2 + 1-dose schedule group, vaccine serotype pneumococcal carriage had further decreased to 16% (95% CI, 12%-20%) and, at 24 months, to 14% (95% CI, 11%-18%; both P < .001); whereas in the 2-dose schedule group, vaccine serotype pneumococcal carriage had remained stable at 18 months (24%; 95% CI, 20%-29%), but at 24 months had further decreased to 15% (95% CI, 11%-19%; both P < .001). In the control group, vaccine serotype pneumococcal carriage remained around 36% to 38% until 24 months.

CONCLUSION

Compared with no pneumococcal vaccination, a 2 + 1-dose and 2-dose schedule of PCV-7 resulted in significant reductions of vaccine serotype pneumococcal carriage in the second year of life.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00189020.

摘要

背景

尽管7价肺炎球菌结合疫苗（PCV-7）减量接种方案对儿童肺炎球菌携带情况的影响在后续群体效应方面具有高度相关性，但目前很大程度上尚不清楚。

目的

与对照组相比，研究2剂和2+1剂PCV-7接种方案对幼儿鼻咽部肺炎球菌携带情况的影响。

设计、地点和患者：一项关于肺炎链球菌鼻咽部携带情况的随机对照试验，纳入了荷兰一个普通社区的1003名健康新生儿及其1名父母，随访至24个月龄，研究于2005年7月7日至2008年2月14日进行。

干预措施

婴儿被随机分配接受以下接种方案：2、4月龄各接种2剂PCV-7；2、4、11月龄分别接种2+1剂PCV-7；或不接种（对照组）。

主要观察指标

婴儿出生后第二年疫苗血清型肺炎球菌携带率。

结果

12月龄时，两种PCV-7接种方案后疫苗血清型肺炎球菌携带率均显著降低，2剂接种方案组和2+1剂接种方案组的疫苗血清型肺炎球菌携带率分别为25%（95%置信区间[CI]，20%-30%）和20%（95%CI，16%-25%），而对照组为38%（95%CI，33%-44%）（P均<.001）。18月龄时，2+1剂接种方案组疫苗血清型肺炎球菌携带率进一步降至16%（95%CI，12%-20%），24月龄时降至14%（95%CI，11%-18%；P均<.001）；而2剂接种方案组18月龄时疫苗血清型肺炎球菌携带率保持稳定（24%；95%CI，20%-29%），但24月龄时进一步降至15%（95%CI，11%-19%；P均<.001）。对照组疫苗血清型肺炎球菌携带率在24月龄前一直保持在36%至38%左右。