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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04583995 | A Study Looking at the Effectiveness, Immune Response, and Safety of a COVID-19 Vaccine in Adults in the United Kingdom | PHASE3 | COMPLETED | 15,185 | — | — | Sep 28, 2020 | Mar 29, 2022 | May 8, 2025 | 33 | United Kingdom |
| NCT04533399 | A Study Looking at the Effectiveness and Safety of a COVID-19 Vaccine in South African Adults | PHASE2 | COMPLETED | 4,422 | — | — | Aug 17, 2020 | Jan 19, 2022 | Feb 17, 2022 | 14 | South Africa |
Number of participants, testing serologically negative for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at baseline, with first occurrence of positive (+) polymerase chain reaction (PCR)-confirmed SARS-CoV-2 illness with symptomatic mild, moderate, or severe COVID-19 with onset from Day 28 through the length of the study.
Number of human immunodeficiency virus negative (HIV-) participants with first occurrence of positive (+) polymerase chain reaction (PCR), (+) PCR-confirmed, SARS-CoV-2 illness with symptomatic mild, moderate, or severe COVID-19 assessed from Day 28 (7 days after second vaccination dose) through the length of the study.
Number of HIV+ participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness with symptomatic mild,moderate or severe COVID-19 assessed from Day 28 (7 days after second vaccination) through the length of the study.
Number of HIV- participants with solicited AEs, local and systemic, for 7 days following each vaccination (Days 0 and 21) by severity score, duration, and peak intensity.
Number of HIV- participants with unsolicited AEs (eg, treatment-emergent, serious, suspected unexpected serious, those of special interest, MAAEs) through Day 35 by Medical Dictionary for Regulatory Activities (MedDRA) classification, severity score, and relatedness.
Number of HIV+ participants with solicited AEs, local and systemic, for 7 days following each vaccination (Days 0 and 21) by severity score, duration, and peak intensity.
Number of HIV+ participants with unsolicited AEs (eg, treatment-emergent, serious, suspected unexpected serious, those of special interest, MAAEs) through Day 35 by MedDRA classification, severity score, and relatedness.
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 at Day 35.
Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Day 35.
Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCR at Day 35. SCR is defined as the percentage of participants with a post-vaccination titer ≥ 4 fold over naïve background and ≥ 2 fold over pre existing titer.
Number of healthy adult HCW, with AESIs for 14 days post second vaccination (Day 35) by severity score, duration, and peak intensity.
Number of healthy adult HCW, with AESIs for 14 days post second vaccination (Day 70) by severity score, duration, and peak intensity.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: SARS-CoV-2 rS/Matrix-M1 Adjuvant | EXPERIMENTAL | 2 doses of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (co-formulated), 1 dose each on Days 0 and 21. |
| Cohort 1: Placebo | PLACEBO_COMPARATOR | 2 doses of Placebo (Saline), 1 dose each on Days 0 and 21. |
| Cohort 2: SARS-CoV-2 rS/Matrix-M1 Adjuvant Plus Licensed Seasonal Flu Vaccine | EXPERIMENTAL | 2 doses of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (co-formulated), 1 dose each on Days 0 and 21. 1 dose of licensed seasonal flu vaccine on Day 0. |
| Cohort 2: Placebo Plus Licensed Seasonal Flu Vaccine | PLACEBO_COMPARATOR | 2 doses of Placebo (Saline), 1 dose each on Days 0 and 21. 1 dose of licensed seasonal flu vaccine on Day 0. |
| Cohort 1 (HIV negative) 5 μg SARS-CoV-2 rS/Matrix-M1 Adjuvant | EXPERIMENTAL | 2 doses of SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M1 adjuvant (co-formulated), 1 dose each on Days 0 and 21. |
| Cohort 1 (HIV negative) Placebo | PLACEBO_COMPARATOR | 2 doses of Placebo (Saline), 1 dose each on Days 0 and 21. |
| Cohort 2 (HIV positive) 5 μg SARS-CoV-2 rS/Matrix-M1 Adjuvant | EXPERIMENTAL | 2 doses of SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M1 adjuvant (co-formulated), 1 dose each on Days 0 and 21. |
| Cohort 2 (HIV positive) Placebo | PLACEBO_COMPARATOR | 2 doses of Placebo (Saline), 1 dose each on Days 0 and 21. |
| Name | Type | Description |
|---|---|---|
| SARS-CoV-2 rS/Matrix M1-Adjuvant | BIOLOGICAL | Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Days 0 and 21. |
| Placebo | OTHER | Alternating intramuscular (deltoid) injections of placebo (0.5 mL) on Days 0 and 21. |
| Licensed seasonal influenza vaccine | BIOLOGICAL | Single intramuscular injection of licensed seasonal flu vaccine, administered ideally in opposite deltoid to SARS-CoV-2 rS with Matrix-M1 adjuvant or placebo injection on Day 0. |
| SARS-CoV-2 rS/Matrix-M1 Adjuvant | BIOLOGICAL | Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Days 0 and 21. |
Inclusion Criteria: * Able and willing to comply with all study requirements. * Willing to allow investigators to discuss medical history with their General Practitioner and access all relevant medical records. * Willing and able to give informed consent. * Women of child-bearing potential must agr...