Evaluation of the Safety and Immunogenicity of a SARS-CoV-2 rS Nanoparticle Vaccine With/Without Matrix-M Adjuvant
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: COVID-19
In brief
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.
Key facts
- Study ID
- NCT04368988
- Run by
- Novavax
- People needed
- 1419
- Starts
- 2020-05-25
- Expected to finish
- 2022-06-01
- Last updated by the study team
- 2023-04-10
Who can join
Age: 18 and older, up to 84. Sex: any. Healthy volunteers: accepted.
Where it is running
- Meridian Clinical Research-(Savannah Georgia) - Platinum - PPDS - Phase 2 — Savannah, Georgia, United States
- Advanced Clinical Research - Meridian - ERN-PPDS - Phase 2 — Meridian, Idaho, United States
- Alliance for Multispecialty Research, LLC - Phase 2 — Newton, Kansas, United States
- Alliance for Multispecialty Research, LLC - Phase 2 — Wichita, Kansas, United States
- Central Kentucky Research Associates Inc - Phase 2 — Lexington, Kentucky, United States
- Meridian Clinical Research-(Rockville Maryland) - Platinum - PPDS - Phase 2 — Rockville, Maryland, United States
- Synexus Clinical Research US, Inc. - Cincinnati - Phase 2 — Cincinnati, Ohio, United States
- Rapid Medical Research Inc - ERN-PPDS - Phase 2 — Cleveland, Ohio, United States
- Paratus Clinical Research - Canberra - Phase 2 — Bruce, Australian Capital Territory, Australia
- Paratus Clinical Research - Western Sydney - Phase 2 — Blacktown, New South Wales, Australia
- Paratus Clinical Research - Central Coast - Phase 2 — Kanwal, New South Wales, Australia
- Australian Clinical Research Network - Phase 2 — Maroubra, New South Wales, Australia
- Scientia Clinical Research Limited - Phase 2 — Randwick, New South Wales, Australia
- Q Pharm Pty Limited - Phase 1 — Herston, Queensland, Australia
- University of the Sunshine Coast, Health Hub Morayfield - Phase 2 — Morayfield, Queensland, Australia
- University of the Sunshine Coast - Phase 2 — Sippy Downs, Queensland, Australia
- Barwon Health - Phase 2 — Geelong, Victoria, Australia
- Center for Clinical Studies - Phase 1 and Phase 2 — Melbourne, Victoria, Australia
Full record on ClinicalTrials.gov
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