缺失RNA合成调节蛋白M2-2并带有冷传代突变的减毒活呼吸道合胞病毒疫苗过度减毒。
Live-Attenuated Respiratory Syncytial Virus Vaccine With Deletion of RNA Synthesis Regulatory Protein M2-2 and Cold Passage Mutations Is Overattenuated.
作者信息
Cunningham Coleen K, Karron Ruth, Muresan Petronella, McFarland Elizabeth J, Perlowski Charlotte, Libous Jennifer, Thumar Bhagvanji, Gnanashanmugam Devasena, Moye Jack, Schappell Elizabeth, Barr Emily, Rexroad Vivian, Aziz Mariam, Deville Jaime, Rutstein Richard, Yang Lijuan, Luongo Cindy, Collins Peter, Buchholz Ursula
机构信息
Department of Pediatrics, Duke University Medical Center, Durham, North Carolina.
Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
出版信息
Open Forum Infect Dis. 2019 May 6;6(6):ofz212. doi: 10.1093/ofid/ofz212. eCollection 2019 Jun.
BACKGROUND
The live respiratory syncytial virus (RSV) candidate vaccine LIDcpΔM2-2 is attenuated through deletion of M2-2 and 5 cold-passage mutations.
METHODS
RSV-seronegative children aged 6-24 months received a single intranasal dose of 10 plaque-forming units (PFU) of LIDcpΔM2-2 or placebo. RSV serum antibodies, vaccine infectivity, and reactogenicity were assessed.
RESULTS
Four of 11 (36%) vaccinees shed vaccine virus with median peak titers of 1.6 log PFU/mL by quantitative culture and 4.5 log copies/mL by polymerase chain reaction; 45% had ≥4-fold rise in serum-neutralizing antibodies. Respiratory symptoms or fever were common in vaccinees (64%) and placebo recipients (6/6, 100%).
CONCLUSIONS
RSV LIDcpΔM2-2 is overattenuated. NCT02890381, NCT02948127.
背景
呼吸道合胞病毒（RSV）候选活疫苗LIDcpΔM2-2通过缺失M2-2和5个冷传代突变而减毒。
方法
6至24个月的RSV血清阴性儿童接受单剂量10个空斑形成单位（PFU）的LIDcpΔM2-2鼻内接种或安慰剂。评估RSV血清抗体、疫苗感染性和反应原性。
结果
11名疫苗接种者中有4名（36%）排出疫苗病毒，定量培养的中位峰值滴度为1.6 log PFU/mL，聚合酶链反应为4.5 log拷贝/mL；45%的人血清中和抗体升高≥4倍。呼吸道症状或发热在疫苗接种者（64%）和安慰剂接受者（6/6，100%）中很常见。
结论
RSV LIDcpΔM2-2过度减毒。NCT02890381，NCT02948127。
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