NCT04368988

Evaluation of the Safety and Immunogenicity of a SARS-CoV-2 rS Nanoparticle Vaccine With/Without Matrix-M Adjuvant

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1,419 (actual)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 rS - Phase 1	Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS (0.6 mL) on Days 0 and 21.
BIOLOGICAL	SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 1	Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS mixed with Matrix-M adjuvant (0.6 mL) on Days 0 and 21.
OTHER	Normal saline solution (NSS), Placebo - Phase 1	Alternating intramuscular (deltoid) injections of placebo (0.6 mL) on Days 0 and 21.
OTHER	Normal saline solution (NSS), Placebo - Phase 2	Intramuscular (deltoid) injections of placebo (0.5 mL).
BIOLOGICAL	SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 1	Intramuscular (deltoid) injection of SARS-CoV-2 rS mixed with Matrix-M adjuvant (0.6 mL) on Day 0.
OTHER	Normal saline solution (NSS), Placebo, Day 21 - Phase 1	Intramuscular injection of placebo (0.6 mL) in alternate deltoid on Day 21.
BIOLOGICAL	SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 2	Intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL).

Timeline

• Start date: 2020-05-25
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2020-04-30
• Last updated: 2023-04-10

Locations

18 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study