Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04368988 | Evaluation of the Safety and Immunogenicity of a SARS-CoV-2 rS Nanoparticle Vaccine With/Without Matrix-M Adjuvant | PHASE1 | COMPLETED | 1,419 | — | — | May 25, 2020 | Jun 1, 2022 | Apr 10, 2023 | 18 | United States, Australia |
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.
Safety laboratory values (serum chemistry, hematology) by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each vaccination.
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 21.
Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs through Day 35.
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 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 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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Placebo - Phase 1 | PLACEBO_COMPARATOR | 2 doses of Placebo (Saline), 1 dose each on Days 0 and 21. |
| SARS-CoV-2 rS - 25 μg without Matrix-M - Phase 1 | EXPERIMENTAL | 2 doses of SARS-CoV-2 rS - 25 μg, 1 dose each on Days 0 and 21. |
| SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M - Phase 1 | EXPERIMENTAL | 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 μg + 50 μg Matrix-M - Phase 1 | EXPERIMENTAL | 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. |
| SARS-CoV-2 rS - 25 μg + 50 μg Matrix-M then Placebo - Phase 1 | EXPERIMENTAL | 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. |
| Placebo - Phase 2 | PLACEBO_COMPARATOR | 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 | EXPERIMENTAL | 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 - Alternating 5/5 μg + 50 μg Matrix-M - Phase 2 | EXPERIMENTAL | 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 | EXPERIMENTAL | 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 | EXPERIMENTAL | 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 - 5/5/5 μg + 50 μg Matrix-M - Phase 2 | EXPERIMENTAL | 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. |
| SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M - Phase 2 | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| SARS-CoV-2 rS - Phase 1 | BIOLOGICAL | Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS (0.6 mL) on Days 0 and 21. |
| SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 1 | BIOLOGICAL | Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS mixed with Matrix-M adjuvant (0.6 mL) on Days 0 and 21. |
| Normal saline solution (NSS), Placebo - Phase 1 | OTHER | Alternating intramuscular (deltoid) injections of placebo (0.6 mL) on Days 0 and 21. |
| Normal saline solution (NSS), Placebo - Phase 2 | OTHER | Intramuscular (deltoid) injections of placebo (0.5 mL). |
| SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 1 | BIOLOGICAL | Intramuscular (deltoid) injection of SARS-CoV-2 rS mixed with Matrix-M adjuvant (0.6 mL) on Day 0. |
| Normal saline solution (NSS), Placebo, Day 21 - Phase 1 | OTHER | Intramuscular injection of placebo (0.6 mL) in alternate deltoid on Day 21. |
| SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 2 | BIOLOGICAL | Intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL). |
Inclusion Criteria (Part 1): * Healthy adult males or females between 18 and 59 years of age, inclusive, at screening. Healthy status will be determined by the investigator based on medical history, clinical laboratory results, vital sign measurements, and physical examination at screening. * The p...