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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

1,419

Participants

Timeline

Start Date

May 25, 2020

Primary Completion Date

June 1, 2022

Study Completion Date

June 1, 2022

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).

Trial Locations (18)

2031

Scientia Clinical Research Limited - Phase 2, Randwick

2035

Australian Clinical Research Network - Phase 2, Maroubra

2148

Paratus Clinical Research - Western Sydney - Phase 2, Blacktown

2259

Paratus Clinical Research - Central Coast - Phase 2, Kanwal

2617

Paratus Clinical Research - Canberra - Phase 2, Bruce

3181

Center for Clinical Studies - Phase 1 and Phase 2, Melbourne

3220

Barwon Health - Phase 2, Geelong

4006

Q Pharm Pty Limited - Phase 1, Herston

4506

University of the Sunshine Coast, Health Hub Morayfield - Phase 2, Morayfield

4556

University of the Sunshine Coast - Phase 2, Sippy Downs

20854

Meridian Clinical Research-(Rockville Maryland) - Platinum - PPDS - Phase 2, Rockville

31406

Meridian Clinical Research-(Savannah Georgia) - Platinum - PPDS - Phase 2, Savannah

40509

Central Kentucky Research Associates Inc - Phase 2, Lexington

44122

Rapid Medical Research Inc - ERN-PPDS - Phase 2, Cleveland

45236

Synexus Clinical Research US, Inc. - Cincinnati - Phase 2, Cincinnati

67114

Alliance for Multispecialty Research, LLC - Phase 2, Newton

67207

Alliance for Multispecialty Research, LLC - Phase 2, Wichita

83642

Advanced Clinical Research - Meridian - ERN-PPDS - Phase 2, Meridian

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Coalition for Epidemic Preparedness Innovations

OTHER

lead

Novavax

INDUSTRY

NCT04368988 - Evaluation of the Safety and Immunogenicity of a SARS-CoV-2 rS Nanoparticle Vaccine With/Without Matrix-M Adjuvant | Biotech Hunter | Biotech Hunter