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

Phase 1

Completed

• Conditions: COVID-19
• Interventions: Biological: SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 1; Other: Normal saline solution (NSS), Placebo - Phase 2; Biological: SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 1; Other: Normal saline solution (NSS), Placebo - Phase 1; Biological: SARS-CoV-2 rS - Phase 1; Biological: SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 2; Other: Normal saline solution (NSS), Placebo, Day 21 - Phase 1

• Registration Number: NCT04368988
• Lead Sponsor: Novavax

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-24
• Study First Submitted QC: 2020-04-28
• Study First Posted: 2020-04-30
• Study Start: 2020-05-25
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01
• Disposition First Submitted: 2023-03-29
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-06
• Disposition First Posted: 2023-04-10
• Last Update Posted: 2023-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1419

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SARS-CoV-2 rS - 25 μg + 50 μg Matrix-M then Placebo - Phase 1	SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 1	1 dose of SARS-CoV-2 rS - 25 μg + 50 μg Matrix-M (mixed together for injection), on Day 0 followed by 1 dose of Placebo on Day 21.
SARS-CoV-2 rS - 5/5 μg + 50 μg Matrix-M - Phase 2	Normal saline solution (NSS), Placebo - Phase 2	2 doses of SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M (co-formulated), 1 dose each on Days 0 and 21, followed by 1 dose of Placebo on Day 189.
SARS-CoV-2 rS - 25 μg + 50 μg Matrix-M - Phase 2	SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 2	1 dose of SARS-CoV-2 rS - 25 μg + 50 μg Matrix-M (co-formulated) on Day 0 then 2 doses of Placebo, 1 dose each on Days 21 and 189.
SARS-CoV-2 rS - 25 μg + 50 μg Matrix-M - Phase 1	SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 1	2 doses of SARS-CoV-2 rS - 25 μg + 50 μg Matrix-M (mixed together for each injection), 1 dose each on Days 0 and 21.
Placebo - Phase 2	Normal saline solution (NSS), Placebo - Phase 2	3 doses of Placebo (Saline), 1 dose each on Days 0, 21, and 189.
SARS-CoV-2 rS - 5/5 μg + 50 μg Matrix-M - Phase 2	SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 2	2 doses of SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M (co-formulated), 1 dose each on Days 0 and 21, followed by 1 dose of Placebo on Day 189.
SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M - Phase 1	SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 1	2 doses of SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M (mixed together for each injection), 1 dose each on Days 0 and 21.
SARS-CoV-2 rS - 25/25 μg + 50 μg Matrix-M - Phase 2	SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 2	2 doses of SARS-CoV-2 rS - 25 μg + 50 μg Matrix-M (co-formulated), 1 dose each on Days 0 and 21, followed by 1 dose of Placebo on Day 189.
SARS-CoV-2 rS - 5/5/5 μg + 50 μg Matrix-M - Phase 2	SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 2	3 doses of SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M (co-formulated), 1 dose each on Day 0, Day 21, and Day 189.
Placebo - Phase 1	Normal saline solution (NSS), Placebo - Phase 1	2 doses of Placebo (Saline), 1 dose each on Days 0 and 21.
SARS-CoV-2 rS - Alternating 5/5 μg + 50 μg Matrix-M - Phase 2	SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 2	1 dose of SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M (co-formulated) on Day 0 then 1 dose of Placebo on Day 21 followed by 1 dose of SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M (co-formulated) on Day 189.
SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M - Phase 2	Normal saline solution (NSS), Placebo - Phase 2	1 dose of SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M (co-formulated) on Day 0 then 2 doses of Placebo, 1 dose each on Days 21 and 189.
SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M - Phase 2	SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 2	1 dose of SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M (co-formulated) on Day 0 then 2 doses of Placebo, 1 dose each on Days 21 and 189.
SARS-CoV-2 rS - 25 μg without Matrix-M - Phase 1	SARS-CoV-2 rS - Phase 1	2 doses of SARS-CoV-2 rS - 25 μg, 1 dose each on Days 0 and 21.
SARS-CoV-2 rS - 25 μg + 50 μg Matrix-M then Placebo - Phase 1	Normal saline solution (NSS), Placebo, Day 21 - Phase 1	1 dose of SARS-CoV-2 rS - 25 μg + 50 μg Matrix-M (mixed together for injection), on Day 0 followed by 1 dose of Placebo on Day 21.
SARS-CoV-2 rS - Alternating 5/5 μg + 50 μg Matrix-M - Phase 2	Normal saline solution (NSS), Placebo - Phase 2	1 dose of SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M (co-formulated) on Day 0 then 1 dose of Placebo on Day 21 followed by 1 dose of SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M (co-formulated) on Day 189.
SARS-CoV-2 rS - 25/25 μg + 50 μg Matrix-M - Phase 2	Normal saline solution (NSS), Placebo - Phase 2	2 doses of SARS-CoV-2 rS - 25 μg + 50 μg Matrix-M (co-formulated), 1 dose each on Days 0 and 21, followed by 1 dose of Placebo on Day 189.
SARS-CoV-2 rS - 25 μg + 50 μg Matrix-M - Phase 2	Normal saline solution (NSS), Placebo - Phase 2	1 dose of SARS-CoV-2 rS - 25 μg + 50 μg Matrix-M (co-formulated) on Day 0 then 2 doses of Placebo, 1 dose each on Days 21 and 189.

Primary Outcome Measures

Name	Time	Method
Serum IgG Antibody Levels Expressed as GMEUs - Phase 2	Day 35	Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs for the two-dose regimens by dose at Day 35 regardless of baseline immune status and stratified by baseline immune status.
Serum IgG Antibody Levels Expressed as SCRs - Phase 2	Day 35	Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCRs (≥4-fold rises) for the two-dose regimens by dose at Day 35 regardless of baseline immune status and stratified by baseline immune status.
Serum IgG Antibody Levels Expressed as Seroconversion Rates (SCRs) - Phase 1	35 days	Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCRs through Day 35. SCR is the proportion of participants with ≥4-fold rises in ELISA units.
Serum IgG Antibody Levels Expressed as Geometric Mean Fold Rises (GMFRs) - Phase 1	35 days	Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs through Day 35.
Participants with Solicited Adverse Events (AEs) - Phase 2	28 days	Percentage of participants with solicited AEs (local, systemic) for 7 days following each primary vaccination (Days 0 and 21) by severity score, duration, and peak intensity.
Participants with Unsolicited AEs - Phase 2	35 days	Percentage of participants with unsolicited AEs (eg, treatment-emergent, serious, suspected unexpected serious, those of special interest, all medically attended adverse events \[MAAEs\]) through the 35 days by Medical Dictionary of Regulatory Activities (MedDRA) classification, severity score, and relatedness.
Participants with Solicited Adverse Events (AEs) - Phase 1	28 days	Percentage of participants with solicited AEs (local, systemic) for 7 days following each primary vaccination (Days 0, 21) by severity score, duration, and peak intensity.
Serum Immunoglobulin G (IgG) Antibody Levels Expressed as Geometric Mean Titers (GMTs) - Phase 1	35 days	Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by enzyme-linked immunosorbent assay (ELISA) expressed as GMTs through Day 35.
Serum IgG Antibody Levels Expressed as GMFRs - Phase 2	Day 35	Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs for the two-dose regimens by dose at Day 35 regardless of baseline immune status and stratified by baseline immune status.
Safety Laboratory Values (Serum Chemistry, Hematology) - Phase 1	28 days	Safety laboratory values (serum chemistry, hematology) by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each vaccination.

Secondary Outcome Measures

Name	Time	Method
Neutralizing Antibody Activity Expressed as GMFRs - Phase 2	357 days	Neutralizing antibody activity as detected by MN expressed as GMFRs at Days 35, 217 and 357 relative to baseline in a subset of subjects by absolute titers and change from baseline.
Participants with MAAEs - Phase 1	105 days	Percentage of participants with MAAEs, defined as AEs that lead to an unscheduled visit to a healthcare practitioner, through Day 105 by MedDRA classification, severity score, and relatedness.
Assessment of Serum IgG Antibody Levels Expressed as GMFRs at Multiple Time Points - Phase 1	189 days	Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at multiple time points through Day 189.
ACE2 Receptor Binding Inhibition Assay Expressed as GMFRs - Phase 1	189 days	Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as GMFRs at multiple time points through Day 189.
Neutralizing Antibody Activity Expressed as GMFRs - Phase 1	49 days	Neutralizing antibody activity as detected by MN expressed as GMFRs at multiple time points through Day 49.
Assessment of Serum IgG Antibody Levels Expressed as GMTs - Phase 2	35 days	Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs for the single-dose regimens compared to the two-dose regimens and to placebo through Day 35 regardless of baseline immune status and stratified by baseline immune status.
Assessment of Serum IgG Antibody Levels Expressed as SCRs (≥ 4-fold change) - Phase 2	35 days	Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCRs (≥ 4-fold change) for the single-dose regimens compared to the two-dose regimens and to placebo through Day 35 regardless of baseline immune status and stratified by baseline immune status.
Assessment of Serum IgG Antibody Levels Expressed as GMEUs at Multiple Time Points - Phase 2	357 days	Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs at multiple time points through Day 357 for the single-dose regimens compared to the two-dose regimens and to placebo, stratified by baseline immune response.
Participants with Abnormal Vital Signs - Phase 1	21 days	Percentage of participants with vital sign abnormalities on the day of vaccination by severity scoring immediately following vaccination.
Participants with Related MAAEs; Serious Adverse Events (SAEs); and Adverse Events of Special Interest (AESI) - Phase 1	386 days	Percentage of participants with MAAEs assessed as related to study vaccine, SAEs, and AESIs until the end of the study (EOS) by MedDRA classification and severity score. All SAEs and AESI, defined as potential immune-mediated medical conditions or AEs relevant to COVID-19, by MedDRA classification, severity score, and relatedness.
Angiotensin-Converting Enzyme 2 (ACE2) Receptor Binding Inhibition Assay Expressed as GMTs - Phase 1	189 days	Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as GMTs at multiple time points through Day 189.
Neutralizing Antibody Activity Expressed as SRRs - Phase 1	49 days	Neutralizing antibody activity as detected by MN expressed as SRRs at multiple time points through Day 49.
Neutralizing Antibody Activity Expressed as SCRs (≥ 4-fold change) - Phase 2	357 days	Neutralizing antibody activity as detected by MN expressed as SCRs (≥ 4-fold change) at Days 35, 217, and 357 relative to baseline in a subset of subjects by absolute titers and change from baseline.
Participants with Unsolicited AEs - Phase 1	49 days	Percentage of participants with unsolicited AEs (eg, treatment-emergent, serious, suspected unexpected serious, those of special interest, all MAAEs) through the first 49 days by MedDRA classification, severity score, and relatedness.
Changes from Baseline in Body Temperature - Phase 1	189 days	Mean changes from baseline in body temperature by treatment group and visit.
Changes from Baseline in Blood Pressure - Phase 1	189 days	Mean changes from baseline in blood pressure by treatment group and visit.
Changes from Baseline in Pulse Rate - Phase 1	189 days	Mean changes from baseline in pulse rate by treatment group and visit.
Assessment of Serum IgG Antibody Levels Expressed as GMTs at Multiple Time Points - Phase 1	189 days	Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs at multiple time points through Day 189.
Neutralizing Antibody Activity Expressed as GMTs - Phase 1	49 days	Neutralizing antibody activity as detected by microneutralization assay (MN) expressed as GMTs at multiple time points through Day 49.
Neutralizing Antibody Activity Expressed as SCRs - Phase 1	49 days	Neutralizing antibody activity as detected by MN expressed as SCRs at multiple time points through Day 49.
Assessment of Serum IgG Antibody Levels Expressed by Seroresponse Rates (SRRs) at Multiple Time Points - Phase 1	189 days	Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SRRs (proportion of participants with rises in ELISA units exceeding the 95th percentile of placebo participants) at multiple time points through Day 189.
Assessment of Cell-Mediated (T helper 1 [Th1]/T helper 2 [Th2]) Pathways - Phase 1	28 days	Cell-mediated (Th1/Th2) pathways as measured by whole blood (flow cytometry) and/or in vitro peripheral blood mononuclear cell (PBMC) stimulation (eg, enzyme-linked immunospot \[ELISpot\], cytokine staining) with SARS-CoV-2 rS protein(s) through Day 28.
Assessment of Serum IgG Antibody Levels Expressed as SCRs (≥ 4-fold change) at Multiple Time Points - Phase 2	357 days	Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCRs (≥ 4-fold change) at multiple time points through Day 357 for the single-dose regimens compared to the two-dose regimens and to placebo, stratified by baseline immune response.
Assessment of Serum IgG Antibody Levels Expressed as SCRs at Multiple Time Points - Phase 1	189 days	Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCRs (proportion of participants with ≥2-fold and ≥4-fold rises in antibody levels) at multiple time points through Day 189.
ACE2 Receptor Binding Inhibition Assay Expressed as SCRs - Phase 1	189 days	Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as SCRs at multiple time points through Day 189.
ACE2 Receptor Binding Inhibition Assay Expressed as SRRs - Phase 1	189 days	Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as SRRs at multiple time points through Day 189.
Assessment of Serum IgG Antibody Levels Expressed as GMFRs - Phase 2	35 days	Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs for the single-dose regimens compared to the two-dose regimens and to placebo through Day 35 regardless of baseline immune status and stratified by baseline immune status.
ACE2 Receptor Binding Inhibition Assay Expressed as GMTs - Phase 2	357 days	Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as GMTs at multiple time points through Day 357 for the single-dose regimens compared to the two-dose regimens and to placebo.
Assessment of Serum IgG Antibody Levels Expressed as GMFRs - Phase 2 Boost	546 days	Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Days 189, 217, and 357 for all treatment groups and additionally at Day 371 and Day 546 for treatment groups B and C for boosting assessment with either placebo or active boost.
Assessment of Serum IgG Antibody Levels Expressed as GMFRs at Multiple Time Points - Phase 2	357 days	Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at multiple time points through Day 357 for the single-dose regimens compared to the two-dose regimens and to placebo, stratified by baseline immune response.
ACE2 Receptor Binding Inhibition Assay Expressed as SCRs - Phase 2	357 days	Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as SCRs (≥ 4-fold change) at multiple time points through Day 357 for the single-dose regimens compared to the two-dose regimens and to placebo.
ACE2 Receptor Binding Inhibition Assay Expressed as GMFRs - Phase 2	357 days	Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as GMFRs at multiple time points through Day 357 for the single-dose regimens compared to the two-dose regimens and to placebo.
Assessment of Cell-Mediated (Th1/Th2) Pathways - Phase 2	28 days	Assessment of cell-mediated (Th1/Th2) pathways as measured by whole blood (flow cytometry) and/or in vitro PBMC stimulation (eg, ELISpot, cytokine staining) with SARS-CoV-2 rS protein(s) through Day 28.
Neutralizing Antibody Activity Expressed as GMTs - Phase 2	357 days	Neutralizing antibody activity as detected by MN expressed as GMTs at Days 35, 217, and 357 relative to baseline in a subset of subjects by absolute titers and change from baseline.
Changes from Baseline in Body Temperature - Phase 2	189 days	Mean changes from baseline in body temperature by treatment group and visit.
Changes from Baseline in Blood Pressure - Phase 2	189 days	Mean changes from baseline in blood pressure by treatment group and visit.
Assessment of SARS-CoV-2 by Qualitative PCR - Phase 2	161 days	Assessment of SARS-CoV-2 by qualitative PCR based on routine screening by self- collection (nasal mid-turbinate or saliva) from Day 28 through 6 months without symptomatology to further describe epidemiologic evolution of the pandemic and potential effect of vaccination.
Assessment of Serum IgG Antibody Levels Expressed as GMTs - Phase 2 Boost	546 days	Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs at Days 189, 217, and 357 for all treatment groups and additionally at Day 371 and Day 546 for treatment groups B and C for boosting assessment with either placebo or active boost.
Participants with Related MAAEs; SAEs; and AESIs - Phase 2	357 days	Percentage of participants with MAAEs assessed as related to study vaccine, SAEs, and AESIs until the end of the study (EOS) by MedDRA classification and severity score. All SAEs and AESI, defined as potential immune-mediated medical conditions or AEs relevant to COVID-19, by MedDRA classification, severity score, and relatedness.
Participants with SARS-CoV-2 Positivity - Phase 2	161 days	Percentage of participants with SARS-CoV-2 positivity as diagnosed by qualitative polymerase chain reaction (PCR) following COVID-19 symptoms assessment from Day 28 through 6 months with severity classification, overall and by age strata (18-59, 60-84 years).
Participants with MAAEs - Phase 2	217 days	All MAAEs, defined as AEs that lead to an unscheduled visit to a healthcare practitioner, through Day 217 by MedDRA classification, severity score, and relatedness.
Participants with Abnormal Vital Signs - Phase 2	21 days	Percentage of participants with vital sign abnormalities on the day of vaccination by severity scoring immediately following vaccination. Descriptive statistics (mean, standard deviation, change from baseline) by treatment group, by visit.
Changes from Baseline in Pulse Rate - Phase 2	189 days	Mean changes from baseline in pulse rate by treatment group and visit.

Trial Locations

Locations (17)

Rapid Medical Research Inc - ERN-PPDS - Phase 2; 🇺🇸 Cleveland, Ohio, United States

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; 🇺🇸 Wichita, Kansas, United States

Meridian Clinical Research-(Rockville Maryland) - Platinum - PPDS - Phase 2; 🇺🇸 Rockville, Maryland, United States

Central Kentucky Research Associates Inc - Phase 2; 🇺🇸 Lexington, Kentucky, United States

Synexus Clinical Research US, Inc. - Cincinnati - Phase 2; 🇺🇸 Cincinnati, 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