作者
Xavier Sáez-Llorens, Ananda S Bandyopadhyay, Christopher Gast, Tirza De Leon, Rodrigo DeAntonio, Jose Jimeno, Maria Isabel Caballero, Gabriela Aguirre, M Steven Oberste, William C Weldon, Jennifer L Konopka-Anstadt, John Modlin, Novilia S Bachtiar, Alan Fix, John Konz, Ralf Clemens, Sue Ann Costa Clemens, Ricardo Rüttimann
发表日期
2021/1/2
期刊
The Lancet
卷号
397
期号
10268
页码范围
27-38
出版商
Elsevier
简介
Background
Continued emergence and spread of circulating vaccine-derived type 2 polioviruses and vaccine-associated paralytic poliomyelitis from Sabin oral poliovirus vaccines (OPVs) has stimulated development of two novel type 2 OPV candidates (OPV2-c1 and OPV2-c2) designed to have similar immunogenicity, improved genetic stability, and less potential to reacquire neurovirulence. We aimed to assess safety and immunogenicity of the two novel OPV candidates compared with a monovalent Sabin OPV in children and infants.
Methods
We did two single-centre, multi-site, partly-masked, randomised trials in healthy cohorts of children (aged 1–4 years) and infants (aged 18–22 weeks) in Panama: a control phase 4 study with monovalent Sabin OPV2 before global cessation of monovalent OPV2 use, and a phase 2 study with low and high doses of two novel OPV2 candidates. All participants received one …
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X Sáez-Llorens, AS Bandyopadhyay, C Gast… - The Lancet, 2021