Bavarian Nordic GmbH, Martinsried, Germany.
Division of Infectious Diseases, Washington University School of Medicine, St Louis, Missouri, USA.
J Infect Dis. 2021 Mar 29;223(6):1062-1072. doi: 10.1093/infdis/jiaa460.
Respiratory syncytial virus (RSV) is a major cause of severe respiratory disease in young children and the elderly. Protective immunity is not generated after repeated infections, but vaccination may hopefully prove effective.
This phase 2 clinical study investigated a multivalent RSV vaccine (MVA-BN-RSV) designed to induce broad antibody and cellular immune responses by encoding RSV surface proteins F, G (for both A and B subtypes), and internal antigens (M2, N). This study evaluated the immune response in adults aged ≥55 years to identify the optimal MVA-BN-RSV dose and vaccination schedule.
A single dose increased the levels of neutralizing (plaque reduction neutralization test to RSV A and B) and total (IgG and IgA ELISA) antibodies (1.6 to 3.4-fold increase from baseline) and induced a broad Th1-biased cellular immune response (interferon-γ ELISPOT) to all 5 vaccine inserts (5.4 to 9.7-fold increases). Antibody responses remained above baseline for 6 months. A 12-month booster dose elicited a booster effect in antibody and T-cell responses (up to 2.8-fold from preboost levels). No drug-related serious adverse events were reported.
MVA-BN-RSV induces a broad immune response that persists at least 6 months and can be boosted at 12 months, without significant safety findings.
NCT02873286.
呼吸道合胞病毒（RSV）是导致婴幼儿和老年人严重呼吸道疾病的主要原因。反复感染后不会产生保护性免疫，但疫苗接种有望证明是有效的。
这项 2 期临床研究调查了一种多价 RSV 疫苗（MVA-BN-RSV），该疫苗通过编码 RSV 表面蛋白 F、G（A 和 B 两种亚型）和内部抗原（M2、N），旨在诱导广泛的抗体和细胞免疫反应。本研究评估了 55 岁以上成年人的免疫反应，以确定最佳的 MVA-BN-RSV 剂量和接种方案。
单次剂量增加了中和（RSV A 和 B 的蚀斑减少中和试验）和总（IgG 和 IgA ELISA）抗体水平（比基线增加 1.6 至 3.4 倍），并诱导了广泛的 Th1 偏向性细胞免疫反应（干扰素-γ ELISPOT）对所有 5 种疫苗插入物（比基线增加 5.4 至 9.7 倍）。抗体反应在 6 个月内保持在基线以上。12 个月的加强剂量在抗体和 T 细胞反应中产生了加强效应（比预加强水平高 2.8 倍）。没有报告与药物相关的严重不良事件。
MVA-BN-RSV 诱导了广泛的免疫反应，至少持续 6 个月，并可在 12 个月时加强，无明显安全性发现。
NCT02873286。
