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治疗性多克隆 RSV 中和抗体对帕利珠单抗耐药 RSV 感染的体内和人体疗效证据。

In-vivo and human evidence for potential efficacy of therapeutic polyclonal RSV neutralizing antibodies for palivizumab-resistant RSV infections.

机构信息

LeBonheur Children's Hospital, Memphis, TN, United States; Department of Pediatrics, University of Tennessee Health Science Center, Memphis, TN, United States; St Jude Children's Research Hospital, Memphis, TN, United States.

ADMA Biologics, Boca Raton FL, United States.

出版信息

Virology. 2023 Sep;586:115-121. doi: 10.1016/j.virol.2023.07.007. Epub 2023 Jul 18.

DOI:10.1016/j.virol.2023.07.007
PMID:37542818
Abstract

BACKGROUND

Monoclonal antibody (palivizumab), intravenous immune globulin (IGIV), or respiratory syncytial virus (RSV)-polyclonal-hyperimmune-globulin (RSV-IG as Respigam®, RI-001, RI-002) are used with ribavirin in RSV-infected immunocompromised patients, with debated efficacy. Palivizumab-resistance (PR) can arise during treatment of persistent infections in this population. RSV-IG may confer benefit in PR-RSV infection.

METHODS

RSV-IG [RI-001] was provided for an immunocompromised infant with RSV-pneumonitis refractory to ribavirin and palivizumab. RSV-neutralizing antibody, respiratory RSV load (qPCR), and F-gene-sequence-detection of PR was determined. Prophylactic RSV-IG [RI-002] or palivizumab was administered in a cotton-rat model infected with wild-type and PR-RSV. Lung RSV load and neutralizing antibody were measured.

RESULTS

As protective RI-001-neutralizing antibody titers waned in the infant, a subpopulation of PR-escape mutants were detected with a fatal RSV-burden in the lungs. In PR-RSV-infected cotton rats, prophylactic RI-002 reduced RSV-load in the lungs (2.45 vs 0.28 log PFU/g lung-tissue reduction, respectively, p < 0.05) and provided protective RSV-neutralizing antibody.

CONCLUSIONS

RSV-IG and ribavirin use in immunocompromised patients requires further study.

摘要

背景

在 RSV 感染免疫功能低下的患者中，常联合利巴韦林使用单克隆抗体（帕利珠单抗）、静脉注射免疫球蛋白（IVIG）或呼吸道合胞病毒（RSV）多克隆高免疫球蛋白（RSV-IG，如 Respigam®、RI-001、RI-002），但其疗效存在争议。在该人群中，持续性感染的治疗过程中可能会出现帕利珠单抗耐药（PR）。RSV-IG 可能对 PR-RSV 感染有益。

方法

为一名免疫功能低下的 RSV 肺炎患儿提供 RSV-IG[RI-001]，该患儿对利巴韦林和帕利珠单抗治疗的持续性 RSV 感染无效。检测了 RSV 中和抗体、呼吸道 RSV 载量（qPCR）和 PR 的 F 基因序列检测。在感染野生型和 PR-RSV 的棉鼠模型中预防性使用 RSV-IG[RI-002]或帕利珠单抗。测量了肺 RSV 载量和中和抗体。

结果

随着婴儿体内保护性 RI-001 中和抗体效价下降，检测到具有致命性肺部 RSV 负荷的 PR 逃逸突变亚群。在 PR-RSV 感染的棉鼠中，预防性 RI-002 降低了肺部 RSV 载量（分别为 2.45 和 0.28 log PFU/g 肺组织减少，p < 0.05）并提供了保护性 RSV 中和抗体。

结论

免疫功能低下患者使用 RSV-IG 和利巴韦林需要进一步研究。

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