Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CV0501 · 1 trial · 2 indications
Assessed solicited local adverse events were injection site pain, redness, swelling, and Lymphadenopathy.
Assessed solicited systemic AEs were fever, headache, fatigue, myalgia, arthralgia, and chills.
An unsolicited AE is defined as any AE that is volunteered from the participant and occurs within 28 days after vaccination.
An MAAE is defined as an AE that results in a visit to a medical professional. Medically attended visits are defined as a telemedicine visit, physician's office visit, urgent care visit, emergency room visit, hospitalization, or death.
An AESI (serious or nonserious) is defined as an AE or serious adverse event (SAE) of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor could be appropriate.
An SAE is defined as any event that: Results in death Is immediately life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is a spontaneous miscarriage Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered SAEs when, based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.
An abnormal laboratory is defined as any value outside of the normal range. Normal ranges were: Alanine Aminotransferase: (Female: 10-32 micro (u)/ liter (L); Male: 10-40 u/L); Alkaline Phosphatase: (Female: 30-115 u/L; Male: 43-115 u/L); Aspartate Aminotransferase: (Female: 10-36 u/L; Male: 10-43 u/L); Bilirubin total: 0.1-1.1 milligram (mg)/deciliter (dL); Bilirubin, Direct: 0-0.4 mg/dL ;Creatinine:0.7-1.4 mg/dL; Eosinophils: 0%-7%; Eosinophils/Leukocytes: 0.00-0.80 x 10\^3/uL ; Erythrocytes: (Female: 3.70-5.20 x 10\^6/uL; Male: 4.63-6.08x 10\^6/uL); Hemoglobin: (Female: 11.0-15.5 gram (g)/dL; Male: 12.5-17.0 g/dL); Leukocytes: 3.70-11.00 x 10\^3/uL; Lymphocytes 12.0%-46.0%; Lymphocytes/Leukocytes: 0.90-3.60 x 10\^3/uL; Monocytes/Leukocytes: 0.00-1.20 x 10\^3/uL; Neutrophils: 4.0% - 71.0%; Neutrophils/Leukocytes:1.70-7.90x 10\^3/uL; Platelets: 163-375 x 10\^3/uL; Urea Nitrogen: 5-20 mg/dL.
| Arm | Type | Description |
|---|---|---|
| Part A: CV0501 Dose Cohort 1 (12 μg) | EXPERIMENTAL | Healthy participants received a single dose of 12 microgram (μg) CV0501 vaccine intramuscularly at Day 1. |
| Part A: CV0501 Dose Cohort 2 (25 μg) | EXPERIMENTAL | Healthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1. |
| Part A: CV0501 Dose Cohort 3 (50 μg) | EXPERIMENTAL | Healthy participants received a single dose of 50 μg CV0501 vaccine intramuscularly at Day 1. |
| Part A: CV0501 Dose Cohort 4 (100 μg) | EXPERIMENTAL | Healthy participants received a single dose of 100 μg CV0501 vaccine intramuscularly at Day 1. |
| Part A: CV0501 Dose Cohort 5 (200 μg) | EXPERIMENTAL | Healthy participants received a single dose of 200 μg CV0501 vaccine intramuscularly at Day 1. |
| Part B: CV0501 Dose Cohort 6 (3 μg) | EXPERIMENTAL | Healthy participants received a single dose of 3 μg CV0501 vaccine intramuscularly at Day 1. |
| Part B: CV0501 Dose Cohort 7 (6 μg) | EXPERIMENTAL | Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1. |
| Name | Type | Description |
|---|---|---|
| CV0501 (3 μg) | BIOLOGICAL | Study vaccine was administered as a single intramuscular injection. |
| CV0501 (6 μg) | BIOLOGICAL | Study vaccine was administered as a single intramuscular injection. |
| CV0501 (12 μg) | BIOLOGICAL | Study vaccine was administered as a single intramuscular injection. |
| CV0501 (25 μg) | BIOLOGICAL | Study vaccine was administered as a single intramuscular injection. |
| CV0501 (50 μg) | BIOLOGICAL | Study vaccine was administered as a single intramuscular injection. |
| CV0501 (100 μg) | BIOLOGICAL | Study vaccine was administered as a single intramuscular injection. |
| CV0501 (200 μg) | BIOLOGICAL | Study vaccine was administered as a single intramuscular injection. |
Inclusion Criteria: 1. Must provide documented informed consent prior to any study procedures being performed 2. Is capable of understanding and agrees to comply with planned study procedures and to be available for all study visits 3. Has received at least 2 doses of Comirnaty or Moderna COVID-19 ...
Top 9 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | ibuzatrelvir, Nirmatrelvir/ ritonavir, BNT162b2/RIV |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Molnupiravir |
| Invivyd, Inc. | IVVD | 2 | PHASE3 | VYD2311 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Tradipitant |
| Moderna, Inc. | MRNA | 2 | PHASE2 | mRNA-1283, mRNA-1273 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Traws Pharma, Inc. | TRAW | 1 | PHASE2 | Ratutrelvir |
| GeoVax Labs, Inc. | GOVX | 1 | PHASE2 | GEO-CM04S1 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE2 | Remdesivir |
CV0501 is an investigational mRNA COVID-19 vaccine developed by GSK plc. It is designed as a booster dose against COVID-19 and SARS-CoV-2 and has been studied in adults at least 18 years old. It remains in Phase 1 clinical development and is not approved.
CV0501 is being studied as a booster dose to protect against COVID-19 and SARS-CoV-2 infection. The Phase 1 trial evaluated its safety and immunogenicity in adults at least 18 years old. It is investigational and has not been approved for use.
CV0501 is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the Phase 1 study of the vaccine candidate. The company is responsible for its clinical development in COVID-19.
CV0501 is in Phase 1 clinical development. Its single trial, NCT05477186, has been completed. The study enrolled 185 adults at least 18 years old. CV0501 is investigational and has not been approved by the FDA.
CV0501 has been studied in one Phase 1 trial, NCT05477186, titled a safety and immunogenicity study of a booster dose of the investigational CV0501 mRNA COVID-19 vaccine in adults at least 18 years old. The trial is completed and enrolled 185 participants across the United States, Australia, and the Philippines.