Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CV2CoV · 1 trial · 2 indications
An AESI (serious or nonserious) is defined as an AE or 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 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.
Assessed solicited local reactions were injection site pain, redness, swelling, and lymphadenopathy.
Assessed solicited systemic reactions 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.
| Arm | Type | Description |
|---|---|---|
| CV2CoV Dose Cohort 1 (Group 1a 2μg) | EXPERIMENTAL | Participants received 2 μg CV2CoV intramuscularly. |
| CV2CoV Dose Cohort 1 (Group 1b 4μg) | EXPERIMENTAL | Participants received 4 μg CV2CoV intramuscularly. |
| CV2CoV Dose Cohort 2 (8 μg) | EXPERIMENTAL | Participants received 8 μg CV2CoV intramuscularly. |
| CV2CoV Dose Cohort 3 (12 μg) | EXPERIMENTAL | Participants received 12 μg CV2CoV intramuscularly. |
| CV2CoV Dose Cohort 4 (16 μg) | EXPERIMENTAL | Participants received 16 μg CV2CoV intramuscularly. |
| CV2CoV Dose Cohort 5 (20 μg) | EXPERIMENTAL | Participants were scheduled to receive 20 μg CV2CoV Intramuscularly, but there were no participants enrolled in this group, and hence, there was no vaccine administered in this study group. |
| Name | Type | Description |
|---|---|---|
| CV2CoV (2 µg) | BIOLOGICAL | Study vaccine was administered as a single intramuscular injection. |
| CV2CoV (4 µg) | BIOLOGICAL | Study vaccine was administered as a single intramuscular injection. |
| CV2CoV (8 µg) | BIOLOGICAL | Study vaccine was administered as a single intramuscular injection. |
| CV2CoV (12 µg) | BIOLOGICAL | Study vaccine was administered as a single intramuscular injection. |
| CV2CoV (16 µg) | BIOLOGICAL | Study vaccine was administered as a single intramuscular injection. |
| CV2CoV (20 µg) | BIOLOGICAL | Study vaccine was planned to be administered intramuscularly. No vaccine was administered in the CV2CoV (20 µg) Group, since there were no participants enrolled in it. |
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, including being willing and able to use electronic devices durin...
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 |
CV2CoV is an investigational vaccine candidate developed for the prevention of COVID-19, the disease caused by SARS-CoV-2. It was studied in adult participants who were already seropositive for SARS-CoV-2, meaning they had prior evidence of infection or immune exposure. It is not an approved product and remains in clinical development.
CV2CoV is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating the candidate. The company holds the asset and is responsible for its development in the COVID-19 vaccine space.
CV2CoV is in Phase 1 clinical development. Its single recorded trial, NCT05260437, has been completed. The study enrolled 99 participants and assessed safety, reactogenicity, and immunogenicity in seropositive adults. CV2CoV is investigational and has not been approved for any use.
CV2CoV has been evaluated in one clinical trial, NCT05260437, titled a Safety, Reactogenicity, and Immunogenicity Trial of CV2CoV mRNA Vaccine Against SARS-CoV-2 in Seropositive Adult Participants. The Phase 1 study enrolled 99 adults aged 18 years and older in the United States and is now completed.