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单次接种 Ad26.RSV.preF 对健康成年人预防呼吸道合胞病毒感染的人体挑战研究。

Prevention of Respiratory Syncytial Virus Infection in Healthy Adults by a Single Immunization of Ad26.RSV.preF in a Human Challenge Study.

机构信息

Janssen Vaccines and Prevention BV, Leiden, The Netherlands.

Janssen Infectious Diseases, Beerse, Belgium.

出版信息

J Infect Dis. 2022 Aug 26;226(3):396-406. doi: 10.1093/infdis/jiab003.

DOI:10.1093/infdis/jiab003
PMID:33400792
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9417128/
Abstract

BACKGROUND

Respiratory syncytial virus (RSV) is a significant cause of severe lower respiratory tract disease in children and older adults, but has no approved vaccine. This study assessed the potential of Ad26.RSV.preF to protect against RSV infection and disease in an RSV human challenge model.

METHODS

In this double-blind, placebo-controlled study, healthy adults aged 18-50 years were randomized 1:1 to receive 1 × 1011 vp Ad26.RSV.preF or placebo intramuscularly. Twenty-eight days postimmunization, volunteers were challenged intranasally with RSV-A (Memphis 37b). Assessments included viral load (VL), RSV infections, clinical symptom score (CSS), safety, and immunogenicity.

RESULTS

Postchallenge, VL, RSV infections, and disease severity were lower in Ad26.RSV.preF (n = 27) vs placebo (n = 26) recipients: median VL area under the curve (AUC) quantitative real-time polymerase chain reaction: 0.0 vs 236.0 (P = .012; predefined primary endpoint); median VL-AUC quantitative culture: 0.0 vs 109; RSV infections 11 (40.7%) vs 17 (65.4%); median RSV AUC-CSS 35 vs 167, respectively. From baseline to 28 days postimmunization, geometric mean fold increases in RSV A2 neutralizing antibody titers of 5.8 and 0.9 were observed in Ad26.RSV.preF and placebo, respectively. Ad26.RSV.preF was well tolerated.

CONCLUSIONS

Ad26.RSV.preF demonstrated protection from RSV infection through immunization in a human challenge model, and therefore could potentially protect against natural RSV infection and disease.

CLINICAL TRIALS REGISTRATION

NCT03334695; CR108398, 2017-003194-33 (EudraCT); VAC18193RSV2002.

摘要

背景

呼吸道合胞病毒（RSV）是导致儿童和老年人严重下呼吸道疾病的重要原因，但目前尚无批准的疫苗。本研究评估了 Ad26.RSV.preF 在 RSV 人体挑战模型中预防 RSV 感染和疾病的潜力。

方法

在这项双盲、安慰剂对照研究中，18-50 岁的健康成年人按 1:1 的比例随机接受 1×1011 vp Ad26.RSV.preF 或安慰剂肌内注射。免疫接种后 28 天，志愿者通过鼻内接种 RSV-A（孟菲斯 37b）进行挑战。评估包括病毒载量（VL）、RSV 感染、临床症状评分（CSS）、安全性和免疫原性。

结果

在 Ad26.RSV.preF（n=27）和安慰剂（n=26）组中，接种后 VL、RSV 感染和疾病严重程度均低于安慰剂组：定量实时聚合酶链反应 VL 曲线下面积（AUC）中位数：0.0 与 236.0（P=0.012；主要终点的预设定义）；定量培养 VL-AUC 中位数：0.0 与 109；RSV 感染 11（40.7%）与 17（65.4%）；RSV AUC-CSS 中位数分别为 35 与 167。从基线到免疫接种后 28 天，Ad26.RSV.preF 和安慰剂的 RSV A2 中和抗体滴度几何平均倍数增加分别为 5.8 和 0.9。Ad26.RSV.preF 耐受性良好。

结论

Ad26.RSV.preF 通过人体挑战模型中的免疫接种证明了对 RSV 感染的保护作用，因此有可能预防自然 RSV 感染和疾病。

临床试验注册

NCT03334695；CR108398，2017-003194-33（EudraCT）；VAC18193RSV2002。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31e7/9417128/b0fcedbf39d9/jiab003_fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31e7/9417128/28599d4a6fac/jiab003_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31e7/9417128/382329457d47/jiab003_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31e7/9417128/03ba9db7aee3/jiab003_fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31e7/9417128/b0fcedbf39d9/jiab003_fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31e7/9417128/28599d4a6fac/jiab003_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31e7/9417128/382329457d47/jiab003_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31e7/9417128/03ba9db7aee3/jiab003_fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31e7/9417128/b0fcedbf39d9/jiab003_fig4.jpg

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