A 组、C 组、Y 组和 W-135 组脑膜炎球菌多糖-白喉类毒素结合疫苗在人类免疫缺陷病毒感染青少年中的 I/II 期、开放性、安全性和免疫原性试验。

Phase I/II, open-label trial of safety and immunogenicity of meningococcal (groups A, C, Y, and W-135) polysaccharide diphtheria toxoid conjugate vaccine in human immunodeficiency virus-infected adolescents.

机构信息

Pediatric, Adolescent, and Maternal AIDS Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD 20892-7510, USA.

出版信息

Pediatr Infect Dis J. 2010 May;29(5):391-6. doi: 10.1097/INF.0b013e3181c38f3b.

DOI:10.1097/INF.0b013e3181c38f3b

PMID:20431379

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2868314/

Abstract

BACKGROUND

Quadrivalent meningococcal polysaccharide conjugate vaccine (MCV4) is routinely recommended for healthy youth in the United States, but there are no data about its use in HIV-infected people.

METHODS

P1065 is a Phase I/II trial of MCV4 safety and immunogenicity in HIV-infected children and youth performed at 27 US sites of the IMPAACT network. All youth (11-24 years old) received 1 dose of open-label MCV4 at entry. Standardized questionnaires were used to evaluate safety. Baseline protective immunity was defined as rabbit serum bactericidal antibody (rSBA) titer > or = 1:128. Immunogenic response was defined as a > or = 4-fold rise in rSBA against each meningococcal serogroup. Multivariable logistic regression analysis was used to evaluate the association of demographic and clinical characteristics on immunogenic response to serogroup C.

RESULTS

Among 319 subjects who received MCV4, 10 (3.1%) reported immediate adverse events which were local and mild, and 7 (2.2%) experienced Grade > or = 3 adverse events, unrelated to vaccine. The 305 subjects with serologic data had a median age of 17 years and were 59% male, 50% Black, and 38% Latino. Subjects were stratified by entry CD4%: 12%, CD4 <15%; 40%, 15% to 24%; and 48%, > or = 25%. Baseline protective immunity varied by serogroup: A, 41%; C, 11%; W-135, 15%; Y, 35% The immunogenic response rates to serogroups A, C, W-135, and Y were 68%, 52%, 73%, and 63%, respectively. In multivariable logistic regression models, lower entry CD4%, higher entry viral load, and CDC Class B/C diagnosis were associated with significantly lower odds of response to serogroup C.

CONCLUSION

Many HIV-infected youth naturally acquire meningococcal immunity. MCV4 is safe and immunogenic in HIV-infected youth, but response rates are lower than in healthy youth, particularly for those with more advanced HIV clinical, immunologic, and virologic status.

摘要

背景

四价脑膜炎球菌多糖结合疫苗（MCV4）在美国被常规推荐用于健康的年轻人，但目前尚无关于其在 HIV 感染者中的使用数据。

方法

P1065 是在 IMPAACT 网络的 27 个美国站点进行的一项评估 MCV4 在 HIV 感染儿童和青少年中的安全性和免疫原性的 I/II 期试验。所有青少年（11-24 岁）在入组时均接受了 1 剂开放标签的 MCV4。使用标准化问卷评估安全性。基线保护性免疫定义为兔血清杀菌抗体（rSBA）效价≥1:128。免疫应答定义为针对每种脑膜炎奈瑟菌血清群的 rSBA 增加≥4 倍。多变量逻辑回归分析用于评估人口统计学和临床特征与血清型 C 免疫应答的关系。

结果

在接受 MCV4 的 319 名受试者中，有 10 名（3.1%）报告了轻微的局部即刻不良事件，有 7 名（2.2%）发生了与疫苗无关的≥3 级不良事件。有血清学数据的 305 名受试者的中位年龄为 17 岁，59%为男性，50%为黑人，38%为拉丁裔。根据入组时的 CD4%进行分层：12%，CD4<15%；40%，15%-24%；48%，≥25%。基线保护性免疫因血清群而异：A 型为 41%；C 型为 11%；W-135 型为 15%；Y 型为 35%。血清型 A、C、W-135 和 Y 的免疫应答率分别为 68%、52%、73%和 63%。在多变量逻辑回归模型中，较低的入组 CD4%、较高的入组病毒载量和 CDC 分类 B/C 诊断与血清型 C 应答的可能性显著降低相关。