Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
V920 · 1 trial · 1 indication
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. An unsolicited AE was an AE other than those specifically designated local or systemic. The percentage of participants that experienced at least 1 unsolicited AE was summarized.
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. An unsolicited AE was an AE other than those specifically designated local or systemic. The percentage of participants that experienced at least 1 unsolicited AE was summarized.
A solicited AE was a predetermined specific event. The solicited systemic AEs for this study were the following: redness, swelling, or pain at site of injection, subjective and objective fever, chills, sweats, myalgia, arthralgia, fatigue, headache and gastrointestinal symptoms (nausea, vomiting, abdominal pain, and/or diarrhea). All AEs were assessed for severity by the investigator according to the Food and Drug Administration(FDA's) Guidance "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" and were classified into 4 categories: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3) and Potentially Life-Threatening (Grade 4). The percentage of participants that experienced at least 1 solicited systemic AE were summarized by grade.
A solicited AE was a predetermined specific event. The solicited systemic AEs for this study were the following: redness, swelling, or pain at site of injection, subjective and objective fever, chills, sweats, myalgia, arthralgia, fatigue, headache and gastrointestinal symptoms (nausea, vomiting, abdominal pain, and/or diarrhea). All AEs were assessed for severity by the investigator according to the Food and Drug Administration(FDA's) Guidance "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" and were classified into 4 categories: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3) and Potentially Life-Threatening (Grade 4). The percentage of participants that experienced at least 1 solicited systemic AE were summarized by grade.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study vaccine. An SAE is an AE that results in death, is life-threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. The percentage of participants that experienced 1 or more SAEs was summarized.
A solicited AE was a predetermined specific event. The solicited local AEs for this study were the following: Local reactogenicity signs and symptoms include pain, erythema (redness), and induration (swelling). All AEs were assessed for severity by the investigator according to the Food and Drug Administration(FDA's) Guidance "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" and were classified into 4 categories: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3) and Potentially Life-Threatening (Grade 4). The percentage of participants that experienced at least 1 solicited local AE was summarized by grade.
A solicited AE was a predetermined specific event. The solicited local AEs for this study were the following: Local reactogenicity signs and symptoms include pain, erythema (redness), and induration (swelling). All AEs were assessed for severity by the investigator according to the Food and Drug Administration(FDA's) Guidance "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" and were classified into 4 categories: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3) and Potentially Life-Threatening (Grade 4). The percentage of participants that experienced at least 1 solicited local AE was summarized by grade.
The percentage of participants that had vaccination discontinued for any reason was summarized.
| Arm | Type | Description |
|---|---|---|
| 3x10^6 plaque-forming units (pfu) Vaccine Cohort | EXPERIMENTAL | Participants will receive a 1-mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0 and Day 28. |
| 2x10^7 pfu Vaccine Cohort | EXPERIMENTAL | Participants will receive a 1-mL intramuscular injection of V920 2x10\^7 pfu in the deltoid on Day 0 and Day 28. |
| 1x10^8 pfu Vaccine Cohort | EXPERIMENTAL | Participants will receive a 1-mL intramuscular injection of V920 1x10\^8 pfu in the deltoid on Day 0 and Day 28. |
| Placebo Cohort | PLACEBO_COMPARATOR | Participants will receive a 1-mL intramuscular injection of placebo in the deltoid on Day 0 and Day 28. |
| Name | Type | Description |
|---|---|---|
| Placebo | OTHER | Normal saline placebo. |
| V920 | BIOLOGICAL | Vesicular Stomatitis Virus (VSV)-based vaccine 1-mL injection containing 3x10\^6, 2x10\^7, or 1x10\^8 pfu. |
INCLUSION CRITERIA: * Healthy male or females, ages 18 to 65 (inclusive) at the time of screening * Females of childbearing potential and all males, must be willing to use effective methods of contraception, from at least 14 days prior to vaccination through Day 56 which would include: * Oral co...
V920 is an investigational vaccine being developed for the prevention of Ebola Virus and Ebola Viruses. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The vaccine is being studied in healthy adults to evaluate its safety and immunogenicity.
V920 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the vaccine's safety and immune response in healthy adult volunteers.
V920 is currently in Phase 1 clinical development. It is an investigational vaccine and has not been approved by the FDA or any other regulatory agency. All completed trials for V920 are Phase 1 studies, meaning it is still in the early stages of clinical testing.
V920 has been studied in three completed Phase 1 clinical trials: NCT02269423, NCT02280408, and NCT02314923. These trials enrolled a total of 552 healthy adults and evaluated the vaccine's safety, tolerability, and immunogenicity against Ebola Virus. All trials were randomized, double-blind, and placebo-controlled.
Yes, V920 is also known as the Vesicular Stomatitis Virus (VSV) Ebola vaccine. Clinical trial titles for V920 refer to it as a VSV Ebola vaccine, and studies have evaluated prime-boost regimens and dose-response effects of this vaccine candidate in healthy adults.
V920 is a monoclonal antibody-based vaccine designed to target Ebola Virus. It uses a vesicular stomatitis virus vector to deliver Ebola virus proteins, which is intended to stimulate an immune response against the virus. The vaccine is being evaluated for its ability to generate protective immunity in healthy individuals.