Dataset from A 2-Part, Phase 1/2, Randomized, Observer-Blinded Study To Evaluate The Safety And Immunogenicity Of A SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Or Without MATRIX-M™ Adjuvant In Healthy Subjects
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下载链接:
https://doi.org/10.25934/PR00010062
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资源简介:
2019nCoV-101 is a 2-part, randomized, observer-blinded, placebo-controlled, Phase 1/2 trial.
Part 1 (Phase 1) of the study is designed to evaluate the safety and immunogenicity of
SARS-CoV-2 rS nanoparticle vaccine with or without Matrix-M adjuvant in 131 healthy
participants ≥ 18 to 59 (inclusive) years of age at 2 sites in Australia. An interim analysis
of Part 1 safety and immunogenicity will be performed prior to optional expansion to Part 2.
Part 2 (Phase 2) of the study is designed to evaluate the immunogenicity, safety, and
preliminary efficacy of a single construct of SARS-CoV-2 rS nanoparticle vaccine with
Matrix-M adjuvant in up to 1,500 healthy participants ≥ 18 to 84 (inclusive) years of age at
up to 40 sites across Australia and/or the United States.
创建时间:
2026-02-06



