Safety and immunogenicity of a Zika purified inactivated virus vaccine given via standard, accelerated, or shortened schedules: a single-centre, double-blind, sequential-group, randomised, placebo-controlled, phase 1 trial.
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SUBMITTER: Stephenson KE
PROVIDER: S-EPMC7472641 | biostudies-literature | 2020 Sep
REPOSITORIES: biostudies-literature
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Safety and immunogenicity of a Zika purified inactivated virus vaccine given via standard, accelerated, or shortened schedules: a single-centre, double-blind, sequential-group, randomised, placebo-controlled, phase 1 trial.
Stephenson Kathryn E KE Tan Chen Sabrina CS Walsh Stephen R SR Hale Andrew A Ansel Jessica L JL Kanjilal Diane G DG Jaegle Kate K Peter Lauren L Borducchi Erica N EN Nkolola Joseph P JP Makoni Tatenda T Fogel Rachel R Bradshaw Connor C Tyler Anna A Moseley Edward E Chandrashekar Abishek A Yanosick Katherine E KE Seaman Michael S MS Eckels Kenneth H KH De La Barrera Rafael A RA Thompson Jason J Dawson Peter P Thomas Stephen J SJ Michael Nelson L NL Modjarrad Kayvon K Barouch Dan H DH
The Lancet. Infectious diseases 20200506 9
<h4>Background</h4>The development of an effective vaccine against Zika virus remains a public health priority. A Zika purified inactivated virus (ZPIV) vaccine candidate has been shown to protect animals against Zika virus challenge and to be well tolerated and immunogenic in humans up to 8 weeks of follow-up. We aimed to assess the safety and immunogenicity of ZPIV in humans up to 52 weeks of follow-up when given via standard or accelerated vaccination schedules.<h4>Methods</h4>We did a single ...[more]
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Project description:Inactivated mouse-brain-derived Japanese encephalitis vaccine has a worrisome safety profile and the live attenuated vaccine is unsuitable in immunodeficiency. This study aimed to evaluate the immunogenicity and safety of an inactivated chromatographically purified Vero-cell-derived JE vaccine (CVI-JE, Beijing P-3 strain) in children. 152 healthy Thai children, with an average (SD) age of 14.4 (3.8) months, received 3 doses of CVI-JE on days 0, 7-28, and one year. Homologous JE neutralizing antibody titers (NT) were measured. All subjects had seroprotection [geometric mean titer (GMT) 150] 28 days' post 2nd vaccination. The seroprotection rates at 1 year after primary series and and 1 month after the booster were 89.3% (GMT 49) and 100% (GMT 621), respectively. Local and systemic reactions-fever (17.6%), vomiting (8%), and poor appetite (5.3%)-were noted within 28 days' post-vaccination. All these symptoms were self-limited.ConclusionsCVI-JE is safe, immunogenic, and provided high NT.
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