Safety and Immunogenicity of Prime-Boost Vesicular Stomatitis Virus (VSV) Ebola Vaccine in Healthy Adults (V920-002)

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.

Time frame: Up to 14 days post vaccination 1 (Day 1 to Day 14)

Population: All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint

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.

Time frame: Up to 14 days post vaccination 2 (Day 29 up to Day 42)

Population: All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint

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.

Time frame: Up to 14 days post vaccination 1 (From Day 1 up to Day 14)

Population: All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint.

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.

Time frame: Up to 14 days post vaccination 2 (Day 29 up to Day 42)

Population: All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint.

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.

Time frame: Up to 28 days post vaccination 1 (From Day 1 up to Day 28)

Population: All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint

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.

Time frame: Up to 28 days post vaccination 2 (From Day 29 to Day 56)

Population: All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint

The percentage of participants that had vaccination discontinued for any reason was summarized.

Time frame: Up to Day 28

Population: All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint

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.

Time frame: Up to Day 56 (Day 1 up to Day 56)

Population: All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint

Blood was drawn on Day 28 to assess the GMTs of ZEBOV-specific IgG antibodies as determined by enzyme-linked immunosorbent assay (ELISA).

Time frame: Day 28

Population: All randomized participants who were vaccinated twice with V920 or placebo, had ZEBOV IgG ELISA endpoint titer results on Days 0 (baseline) and 28, and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints.

Blood was drawn on Day 56 to assess the GMTs of ZEBOV-specific IgG antibodies as determined by Enzyme-linked immunosorbent assay (ELISA).

Time frame: Day 56 (28 days post vaccination 2)

Population: All randomized participants who were vaccinated twice with V920 or placebo, had ZEBOV IgG ELISA endpoint titer results on Days 0 (baseline) and 56, and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints.

Blood was drawn on Day 28 to assess the GMTs of Zaire ebolavirus neutralizing antibodies as determined by Pseudovirion neutralizing assay (PsVNA). Titers are reported for PsVNA50 values, which was derived from the reciprocal of the dilution that resulted in a 50% decrease in luciferase activity.

Time frame: Day 28 (28 days post vaccination 1)

Population: All randomized participants who were vaccinated twice with V920 or placebo, had ZEBOV IgG ELISA endpoint titer results on Days 0 (baseline) and 28, and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints.

Blood was drawn on Day 56 to assess the GMTs of Zaire ebolavirus neutralizing antibodies as determined by Pseudovirion neutralizing assay (PsVNA). Titers are reported for PsVNA50 values, which was derived from the reciprocal of the dilution that resulted in a 50% decrease in luciferase activity.

Time frame: Day 56 (28 days post vaccination 2)

Population: All randomized participants who were vaccinated twice with V920 or placebo, had ZEBOV IgG ELISA endpoint titer results on Days 0 (baseline) and 56, and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints.

GMTs for Zebov-specific antibodies were determined via ELISA. Seroconversion was defined as a post-vaccination titer ≥ 200 that is also at least a 4-fold increase in titer compared to baseline.

Time frame: Day 28 (28 days post vaccination 1)

Population: All randomized participants who were vaccinated twice with V920 or placebo, had ZEBOV IgG ELISA endpoint titer results on Days 0 (baseline) and 28, and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints

GMTs for Zebov-specific antibodies were determined via ELISA. Seroconversion was defined as a post-vaccination titer ≥ 200 that is also at least a 4-fold increase in titer compared to baseline.

Time frame: Day 56 (28 days post vaccination 2)

Population: All randomized participants who were vaccinated twice with V920 or placebo, had ZEBOV IgG ELISA endpoint titer results on Days 0 (baseline) and 56, and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints

Blood was drawn on Days 3 and 7 to assess the presence of V920 via polymerase chain reaction (PCR) assay. The percentage of participants that were positive for V920 in serum was summarized.

Time frame: Day 3 and Day 7 post vaccination 1

Population: All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint

Blood was drawn on Days 3 and 7 to assess the presence of V920 via polymerase chain reaction (PCR) assay. The percentage of participants that were positive for V920 in serum was summarized.

Time frame: Day 3 and Day 7 post vaccination 2 (Day 31 and Day 35)

Population: All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint