Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as V920 Vaccine, BPSC-1001
V920 · 3 trials · 2 indications
An AE can be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, tenderness and swelling. AEs were assessed for severity by the investigator according to a toxicity grading scale based on the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The percentage of participants that experienced at least 1 solicited injection-site AE was summarized by grade.
An AE can be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Systemic AEs included subjective and objective fever, shivering/chills, sweats, myalgia, arthralgia, joint swelling, joint tenderness, fatigue, headache, gastrointestinal symptoms (nausea, vomiting, abdominal pain, and diarrhea), mucosal lesion, and skin lesion (including any blisters). AEs were assessed for severity by the investigator as follows: Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The percentage of participants that experienced at least one systemic AE was summarized by grade.
An AE can be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Unsolicited vaccine-related AEs were those events not specifically listed as either an injection-site (local) or systemic in the VRC and were reported as at least possibly related to the study vaccine or placebo. The AEs were further assessed for severity by the investigator as follows: Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The percentage of participants that experienced at least one unsolicited vaccine-related AE was summarized by grade..
An adverse event is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with 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. SAEs were assessed for severity by the investigator as follows: Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening; 5=Fatal. The percentage of participants that experienced at least 1 SAE was summarized by grade.
Blood was drawn on Day 28 to assess the GMTs of ZEBOV-specific IgG antibodies as determined by Enzyme-linked immunosorbent assay (ELISA).
The optimum dose for general use prophylaxis with V920 was determined following the review of all immunogenicity and safety data.
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event (TEAE) is defined as an AE that starts or worsens on or after the date and time of the study vaccination. Local reactogenicity signs and symptoms include pain, erythema (redness), and induration (swelling). The number of participants that experienced at least one solicited local TEAE was assessed. Solicited TEAEs occurred from the time of each injection through 14 days following the procedure, facilitated with the use of a memory aid to record participant observations.
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A TEAE is defined as an AE that starts or worsens on or after the date and time of the study vaccination. Local reactogenicity signs and symptoms include pain, erythema (redness), and induration (swelling). AEs were assessed for severity by the investigator according to a toxicity grading scale based on the FDA's Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials": Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The number of participants that experienced at least one solicited local TEAE was summarized by grade. Solicited TEAEs occurred from the time of each injection through 14 days following the procedure, facilitated with the use of a memory aid to record participant observations.
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event is defined as an AE that starts or worsens on or after the date and time of the study vaccination. Systemic reactogenicity signs and symptoms include pyrexia (subjective and objective fever), chills, hyperhidrosis (sweats), myalgia, arthralgia, fatigue, headache, and gastrointestinal symptoms including nausea, vomiting, abdominal pain, and/or diarrhea. The number of participants that experienced at least one solicited systemic TEAE was assessed. Solicited TEAEs occurred from the time of each injection through 14 days following the procedure, facilitated with the use of a memory aid to record participant observations.
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A TEAE is defined as an AE that starts or worsens on or after the date and time of the study vaccination. Systemic reactogenicity signs and symptoms include pyrexia (subjective and objective fever), chills, hyperhidrosis (sweats), myalgia, arthralgia, fatigue, headache, and gastrointestinal symptoms including nausea, vomiting, abdominal pain, and/or diarrhea. AEs were assessed for severity by the investigator as follows: Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The number of participants that experienced at least 1 solicited systemic TEAE was summarized by grade. Solicited TEAEs occurred from the time of each injection through 14 days following the procedure, facilitated with the use of a memory aid to record participant observations.
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event is defined as an AE that starts or worsens on or after the date and time of the study vaccination. The number of participants that experienced at least one unsolicited TEAE was assessed. Unsolicited AEs occurred from the time of injection through 28 days following injection.
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event is defined as an AE that starts or worsens on or after the date and time of the study vaccination. A related TEAE is defined as a TEAE that was possibly, probably, or definitely related to the vaccination as assessed by the investigator. The number of participants that experienced at least one unsolicited TEAE related to study vaccination was assessed.
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event is defined as an AE that starts or worsens on or after the date and time of the study vaccination. A related TEAE is defined as a TEAE that was possibly, probably, or definitely related to the vaccination as assessed by the investigator. AEs were assessed for severity by the investigator according to a toxicity grading scale based on the FDA's Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials": Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The number of participants that experienced at least one unsolicited TEAE related to study vaccination was summarized by grade.
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. The number of participants prematurely withdrawing from the study due to an AE was assessed.
An adverse event is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A serious adverse event (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 number of participants that experienced one or more SAE 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.
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 |
|---|---|---|
| 3x10^3 pfu Vaccine Cohort 1 | EXPERIMENTAL | Participants will receive a 1-mL intramuscular injection of V920 3x10\^3 pfu in the deltoid on Day 0. |
| 3x10^4 pfu Vaccine Cohort 1 | EXPERIMENTAL | Participants will receive a 1-mL intramuscular injection of V920 3x10\^4 pfu in the deltoid on Day 0. |
| 3x10^5 pfu Vaccine Cohort 1 | EXPERIMENTAL | Participants will receive a 1-mL intramuscular injection of V920 3x10\^5 pfu in the deltoid on Day 0. |
| 3x10^6 pfu Vaccine Cohort 1 | EXPERIMENTAL | Participants will receive a 1-mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0. |
| 9x10^6 pfu Vaccine Cohort 2 | EXPERIMENTAL | Participants will receive a 1-mL intramuscular injection of V920 9x10\^6 pfu in the deltoid on Day 0. |
| 2x10^7 pfu Vaccine Cohort 2 | EXPERIMENTAL | Participants will receive a 1-mL intramuscular injection of V920 2x10\^7 pfu in the deltoid on Day 0. |
| 1x10^8 pfu Vaccine Cohort 2 | EXPERIMENTAL | Participants will receive a 1-mL intramuscular injection of V920 1x10\^8 pfu in the deltoid on Day 0. |
| Placebo Cohort 1 | PLACEBO_COMPARATOR | Participants will receive a 1-mL intramuscular injection of placebo in the deltoid on Day 0. |
| 3x10^6 pfu Vaccine Cohort 2 | EXPERIMENTAL | Participants will receive a 1-mL intramuscular injection of V920 3x10\^3 pfu in the deltoid on Day 0. |
| Placebo Cohort 2 | PLACEBO_COMPARATOR | Participants will receive a 1-mL intramuscular injection of placebo in the deltoid on Day 0. |
| 3x10^6 plaque-forming units (pfu) Vaccine Cohort | EXPERIMENTAL | Participants will receive a 1-mL intramuscular injection of V920 3x10\^6 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0. |
| 2x10^7 pfu Vaccine Cohort | EXPERIMENTAL | Participants will receive a 1-mL intramuscular injection of V920 2x10\^7 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0. |
| 1x10^8 pfu Vaccine Cohort | EXPERIMENTAL | Participants will receive a 1-mL intramuscular injection of V920 1x10\^8 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0. |
| Placebo Cohort | PLACEBO_COMPARATOR | Participants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0. |
| Name | Type | Description |
|---|---|---|
| V920 Vaccine | BIOLOGICAL | Vesicular Stomatitis Virus (VSV)-based vaccine 1-mL injection containing 3x10\^3, 3x10\^4, 3x10\^5, 3x10\^6, 9x10\^6, 2x10\^7, or 1x10\^8 pfu. |
| Placebo | OTHER | 0.9% Saline |
| V920 | BIOLOGICAL | Vesicular Stomatitis Virus (VSV)-based vaccine 1-mL injection containing 3x10\^6, 2x10\^7, or 1x10\^8 pfu. |
Inclusion Criteria: 1. Healthy adult male or non-pregnant, non-lactating adult female, ages 18 to 60 (inclusive) at the time of screening 2. Have provided written informed consent prior to screening procedures 3. Free of clinically significant health problems, as determined by pertinent medical his...
V920 is an investigational vaccine being developed for the prevention of Ebola virus disease. It is a Phase 1 candidate developed by Merck & Company, Inc. (ticker MRK) and is designed to be given to healthy adults. V920 is also known as the V920 Vaccine.
V920 is being studied for protection against Ebola virus infection. Its clinical program has enrolled healthy adult volunteers in studies of Ebola Virus and Ebola Viruses. The vaccine is investigational and has been evaluated in placebo-controlled, double-blind, randomized Phase 1 trials rather than in an approved indication.
V920 is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the V920 clinical program, which includes Phase 1 studies conducted in healthy adult volunteers. The vaccine is also referred to as the V920 Vaccine.
V920 is in Phase 1 clinical development. Its program consists of completed Phase 1 trials in healthy adults, and it is an investigational vaccine rather than an approved product. The studies were randomized, double-blind, and placebo-controlled, with a total enrollment of 552 participants across the program.
V920 has been studied in Phase 1 trials including NCT02314923, a placebo-controlled dose response safety and immunogenicity study in 513 healthy adults; NCT02280408, a prime-boost safety and immunogenicity study in 39 healthy adults; and NCT02269423, a vaccine treatment study in 39 healthy adults. All are completed.
Yes, V920 and the V920 Vaccine refer to the same investigational Ebola vaccine developed by Merck & Company, Inc. (ticker MRK). Searches using either name point to the same Phase 1 program, which includes completed trials NCT02314923, NCT02280408, and NCT02269423 in healthy adult volunteers.