2 至 10 岁人类免疫缺陷病毒感染儿童中接种四价脑膜炎球菌结合疫苗的安全性和免疫原性。

Safety and immunogenicity of quadrivalent meningococcal conjugate vaccine in 2- to 10-year-old human immunodeficiency virus-infected children.

机构信息

Pediatric, Adolescent, and Maternal AIDS Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.

出版信息

Pediatr Infect Dis J. 2012 Jan;31(1):47-52. doi: 10.1097/INF.0b013e318236c67b.

DOI:10.1097/INF.0b013e318236c67b

PMID:21987006

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3252429/

Abstract

BACKGROUND

Human immunodeficiency virus (HIV)-infected children are at increased risk of meningococcal infection and poor response to quadrivalent meningococcal conjugate vaccine (MCV4), but MCV4 has not been studied in preadolescent HIV-infected children.

METHODS

The P1065 trial enrolled 2- to 10-year-old HIV-infected children with CD4 ≥ 25% to receive MCV4 at entry and at week 24. Rates of response (≥ 4-fold increase in rabbit serum bactericidal antibody) against each meningococcal serogroup (A, C, Y, W-135), geometric mean titers, and rates of seroprotection (rabbit serum bactericidal antibody titer ≥ 1:128) were determined from sera obtained at entry and weeks 4, 24, 28, and 72. Adverse events were assessed for 6 weeks after each MCV4 dose.

RESULTS

At entry, 47% of the 59 participants were male, 56% black, 31% Latino, median age was 6 years, 88% were receiving antiretroviral therapy, and 75% had viral load <400 copies/mL. There were no serious adverse events within 6 weeks after MCV4 doses; all vaccination reactions were mild. Response after a single MCV4 dose was high to serogroup A (92%) and W-135 (98%); responses improved after a second dose for serogroup C (43%-80%) (P < 0.0001) and Y (76%-84%) (P = 0.38). By week 72, seroprotection rates were 93%, 91%, 78%, and 46% for serogroups W-135, Y, A, and C, respectively.

CONCLUSIONS

Two doses of MCV4 were safe and immunogenic in 2- to 10-year-old HIV-infected children. The second dose increased the proportion of children who made a response to serogroup C. Seroprotection waned substantially for serogroups A and C within 1 year of last MCV4 dose.

摘要

背景

感染人类免疫缺陷病毒（HIV）的儿童感染脑膜炎球菌的风险增加，并且对四价脑膜炎球菌结合疫苗（MCV4）的反应不佳，但尚未在青春期前感染 HIV 的儿童中研究 MCV4。

方法

P1065 试验招募了 2 至 10 岁的 HIV 感染儿童，CD4 百分比≥25%，在入组时和第 24 周接受 MCV4 接种。从入组时和第 4、24、28 和 72 周采集的血清中确定针对每种脑膜炎球菌血清型（A、C、Y、W-135）的反应率（兔血清杀菌抗体增加≥4 倍）、几何平均滴度和血清保护率（兔血清杀菌抗体滴度≥1:128）。在每次 MCV4 剂量后 6 周评估不良事件。

结果

在入组时，59 名参与者中 47%为男性，56%为黑人，31%为拉丁裔，中位年龄为 6 岁，88%正在接受抗逆转录病毒治疗，75%的病毒载量<400 拷贝/ml。MCV4 剂量后 6 周内无严重不良事件；所有疫苗接种反应均为轻度。单次 MCV4 剂量后的反应对血清 A（92%）和 W-135（98%）较高；第二次剂量后，血清 C（43%-80%）（P<0.0001）和 Y（76%-84%）（P=0.38）的反应得到改善。到第 72 周，血清保护率分别为血清型 W-135、Y、A 和 C 的 93%、91%、78%和 46%。