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

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

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).

Sponsors & Collaborators

• Coalition for Epidemic Preparedness Innovations

  collaborator OTHER

• Novavax

  lead INDUSTRY

Principal Investigators

• Clinical Development · Novavax

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

84 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-05-25

Primary Completion

2022-06-01

Completion

2022-06-01

FDA Drug

Yes

Countries

• United States
• Australia

Study Locations