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| ID | Type | Description | Link |
|---|---|---|---|
| NLG0207 (Study 15-I-0001) | Other Identifier | NewLink Genetics Corp. |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| BioProtection Systems Corporation | INDUSTRY |
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Ebola virus has infected and killed people, mostly in Africa. In 2014, the Zaire ebolavirus (ZEBOV) has affected several thousand people. There is no approved effective way to treat or prevent Ebola. Researchers are trying to develop a vaccine for it. This is a study of the anti-Ebola vaccine vesicular stomatitis virus (VSV) ZEBOV (V920; BPSC-1001) to see if it is safe and to see how it affects people's immune system.
Between 1994 and the present, there have been many Ebola virus (EBOV) outbreaks affecting mostly central Africa. However, the 2014 West African outbreak significantly exceeds all previous outbreaks in geographic range, number of individuals affected and in disruption of typical activities of civil society.
This is a Phase 1 safety and tolerability study to evaluate a novel vaccine to Ebola using a live VSV replacing the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Zaire strain of Ebola (VSVΔG-ZEBOV also known as V920 and BPSC-1001).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Normal saline placebo. |
| |
| V920 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With 1 or More Unsolicited AE : Vaccination 1 | 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. | Up to 28 days post vaccination 1 (From Day 1 up to Day 28) |
| Percentage of Participants With 1 or More Unsolicited AE : Vaccination 2 | 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. | Up to 28 days post vaccination 2 (From Day 29 to Day 56) |
| Percentage of Participants With 1 or More Solicited Systemic Adverse Event (AE) by Severity: Vaccination 1 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers of Zaire Ebolavirus-(ZEBOV)-Specific Immunoglobin G (IgG) Antibodies: Day 28 | Blood was drawn on Day 28 to assess the GMTs of ZEBOV-specific IgG antibodies as determined by enzyme-linked immunosorbent assay (ELISA). | Day 28 |
| Geometric Mean Titers of ZEBOV-specific IgG Antibodies: Day 56 |
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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:
Must be willing to minimize blood and body fluid exposure of others for at least 7 days after vaccination, which includes:
Must be willing to forgo blood donation for one year
Must agree not to enroll in another study of an investigational agent prior to completion of Day 56 and not participate in an investigational vaccine study until the last required protocol visit on Day 365
Ability to provide informed consent
EXCLUSION CRITERIA:
FACTORS THAT INCREASE RISK TO THE SUBJECT:
Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:
Women who are breast-feeding
Positive urine or serum pregnancy test
Abnormal chemistry panel; defined as:
Abnormal complete blood count (CBC) defined as:
Abnormal urinalysis defined as:
Positive serology for hepatitis B surface antigen
Positive serology for hepatitis C
Positive serology for human immunodeficiency virus (HIV)
Known allergy to the components of the VSVΔG-ZEBOV vaccine (V920) vaccine product (VSV, albumin, tris)
History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions
FACTORS THAT MAY LIMIT VSV REPLICATION OR MAKE INTERPRETATION OF IMMUNOGENICITY DIFFICULT:
FACTORS THAT WOULD INCREASE RISK TO OTHERS DUE TO VSV VIRAL SHEDDING:
FACTORS THAT COULD IMPAIR INTERPRETATION OR EXECUTION OF THE STUDY:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28647166 | Derived | Coller BG, Blue J, Das R, Dubey S, Finelli L, Gupta S, Helmond F, Grant-Klein RJ, Liu K, Simon J, Troth S, VanRheenen S, Waterbury J, Wivel A, Wolf J, Heppner DG, Kemp T, Nichols R, Monath TP. Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic. Vaccine. 2017 Aug 16;35(35 Pt A):4465-4469. doi: 10.1016/j.vaccine.2017.05.097. Epub 2017 Jun 21. | |
| 25830322 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort | Participants will receive a 1-mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0 and Day 28. |
| FG001 | 2x10^7 Pfu Vaccine Cohort | Participants will receive a 1-mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0 and Day 28. |
| FG002 | 1x10^8 Pfu Vaccine Cohort | Participants will receive a 1-mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0 and Day 28. |
| FG003 | Placebo Cohort | Participants will receive a 1-mL intramuscular injection of placebo in the deltoid on Day 0 and Day 28. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort | Participants will receive a 1-mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0 and Day 28. |
| BG001 | 2x10^7 Pfu Vaccine Cohort |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With 1 or More Unsolicited AE : Vaccination 1 | 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. | All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint | Posted | Number | Percentage of participants | Up to 28 days post vaccination 1 (From Day 1 up to Day 28) |
|
up to Day 365 (approximately 1 years post vaccination 1)
All participants that received at least 1 study vaccination and had follow-up safety data.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 3x106 Pfu V920 | Participants will receive a 1-mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0 and Day 28. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| Biological |
Vesicular Stomatitis Virus (VSV)-based vaccine 1-mL injection containing 3x10^6, 2x10^7, or 1x10^8 pfu. |
|
| Up to 14 days post vaccination 1 (From Day 1 up to Day 14) |
| Percentage of Participants With 1 or More Solicited Systemic AE by Severity: Vaccination 2 | 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. | Up to 14 days post vaccination 2 (Day 29 up to Day 42) |
| Percentage of Participants With One or More Serious Adverse Event | 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. | Up to Day 56 (Day 1 up to Day 56) |
| Percentage of Participants With 1 or More Solicited Local Injection-site AE by Severity: Vaccination 1 | 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. | Up to 14 days post vaccination 1 (Day 1 to Day 14) |
| Percentage of Participants With 1 or More Solicited Local Injection-site AE by Severity: Vaccination 2 | 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. | Up to 14 days post vaccination 2 (Day 29 up to Day 42) |
| Percentage of Participants With Early Discontinuation of Vaccination | The percentage of participants that had vaccination discontinued for any reason was summarized. | Up to Day 28 |
Blood was drawn on Day 56 to assess the GMTs of ZEBOV-specific IgG antibodies as determined by Enzyme-linked immunosorbent assay (ELISA). |
| Day 56 (28 days post vaccination 2) |
| Geometric Mean Titers of ZEBOV-specific Neutralizing Antibodies: Day 28 | 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. | Day 28 (28 days post vaccination 1) |
| Geometric Mean Titers of ZEBOV-specific Neutralizing Antibodies: Day 56 | 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. | Day 56 (28 days post vaccination 2) |
| Percentage of Participants Who Seroconvert: Day 28 | 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. | Day 28 (28 days post vaccination 1) |
| Percentage of Participants Who Seroconvert: Day 56 | 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. | Day 56 (28 days post vaccination 2) |
| Percentage of Participants With Viremia on Day 3 and Day 7: Vaccination 1 | 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. | Day 3 and Day 7 post vaccination 1 |
| Percentage of Participants With Viremia on Day 3 and Day 7: Vaccination 2 | 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. | Day 3 and Day 7 post vaccination 2 (Day 31 and Day 35) |
| Derived |
| Regules JA, Beigel JH, Paolino KM, Voell J, Castellano AR, Hu Z, Munoz P, Moon JE, Ruck RC, Bennett JW, Twomey PS, Gutierrez RL, Remich SA, Hack HR, Wisniewski ML, Josleyn MD, Kwilas SA, Van Deusen N, Mbaya OT, Zhou Y, Stanley DA, Jing W, Smith KS, Shi M, Ledgerwood JE, Graham BS, Sullivan NJ, Jagodzinski LL, Peel SA, Alimonti JB, Hooper JW, Silvera PM, Martin BK, Monath TP, Ramsey WJ, Link CJ, Lane HC, Michael NL, Davey RT Jr, Thomas SJ; rVSVDeltaG-ZEBOV-GP Study Group. A Recombinant Vesicular Stomatitis Virus Ebola Vaccine. N Engl J Med. 2017 Jan 26;376(4):330-341. doi: 10.1056/NEJMoa1414216. Epub 2015 Apr 1. |
Participants will receive a 1-mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0 and Day 28.
| BG002 | 1x10^8 Pfu Vaccine Cohort | Participants will receive a 1-mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0 and Day 28. |
| BG003 | Placebo Cohort | Participants will receive a 1-mL intramuscular injection of placebo in the deltoid on Day 0 and Day 28. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort |
Participants will receive a 1-mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0 and Day 28. |
| OG001 | 2x10^7 Pfu Vaccine Cohort | Participants will receive a 1-mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0 and Day 28. |
| OG002 | 1x10^8 Pfu Vaccine Cohort | Participants will receive a 1-mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0 and Day 28. |
| OG003 | Placebo Cohort | Participants will receive a 1-mL intramuscular injection of placebo in the deltoid on Day 0 and Day 28. |
|
|
| Primary | Percentage of Participants With 1 or More Unsolicited AE : Vaccination 2 | 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. | All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint | Posted | Number | Percentage of participants | Up to 28 days post vaccination 2 (From Day 29 to Day 56) |
|
|
|
| Primary | Percentage of Participants With 1 or More Solicited Systemic Adverse Event (AE) by Severity: Vaccination 1 | 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. | All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint. | Posted | Number | Percentage of Participants | Up to 14 days post vaccination 1 (From Day 1 up to Day 14) |
|
|
|
| Primary | Percentage of Participants With 1 or More Solicited Systemic AE by Severity: Vaccination 2 | 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. | All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint. | Posted | Number | Percentage of Participants | Up to 14 days post vaccination 2 (Day 29 up to Day 42) |
|
|
|
| Primary | Percentage of Participants With One or More Serious Adverse Event | 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. | All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint | Posted | Number | Percentage of participants | Up to Day 56 (Day 1 up to Day 56) |
|
|
|
| Primary | Percentage of Participants With 1 or More Solicited Local Injection-site AE by Severity: Vaccination 1 | 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. | All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint | Posted | Number | Percentage of participants | Up to 14 days post vaccination 1 (Day 1 to Day 14) |
|
|
|
| Primary | Percentage of Participants With 1 or More Solicited Local Injection-site AE by Severity: Vaccination 2 | 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. | All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint | Posted | Number | Percentage of participants | Up to 14 days post vaccination 2 (Day 29 up to Day 42) |
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| Primary | Percentage of Participants With Early Discontinuation of Vaccination | The percentage of participants that had vaccination discontinued for any reason was summarized. | All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint | Posted | Number | Percentage of participants | Up to Day 28 |
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| Secondary | Geometric Mean Titers of Zaire Ebolavirus-(ZEBOV)-Specific Immunoglobin G (IgG) Antibodies: Day 28 | Blood was drawn on Day 28 to assess the GMTs of ZEBOV-specific IgG antibodies as determined by enzyme-linked immunosorbent assay (ELISA). | 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. | Posted | Geometric Mean | Standard Deviation | ELISA Units/mL | Day 28 |
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| Secondary | Geometric Mean Titers of ZEBOV-specific IgG Antibodies: Day 56 | Blood was drawn on Day 56 to assess the GMTs of ZEBOV-specific IgG antibodies as determined by Enzyme-linked immunosorbent assay (ELISA). | 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. | Posted | Geometric Mean | Standard Deviation | ELISA Units/mL | Day 56 (28 days post vaccination 2) |
|
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|
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| Secondary | Geometric Mean Titers of ZEBOV-specific Neutralizing Antibodies: Day 28 | 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. | 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. | Posted | Geometric Mean | Standard Deviation | Titer | Day 28 (28 days post vaccination 1) |
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|
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| Secondary | Geometric Mean Titers of ZEBOV-specific Neutralizing Antibodies: Day 56 | 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. | 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. | Posted | Geometric Mean | Standard Deviation | Titer | Day 56 (28 days post vaccination 2) |
|
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| Secondary | Percentage of Participants Who Seroconvert: Day 28 | 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. | 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 | Posted | Number | Percentage of Participants | Day 28 (28 days post vaccination 1) |
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|
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| Secondary | Percentage of Participants Who Seroconvert: Day 56 | 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. | 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 | Posted | Number | Percentage of Participants | Day 56 (28 days post vaccination 2) |
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| Secondary | Percentage of Participants With Viremia on Day 3 and Day 7: Vaccination 1 | 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. | All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint | Posted | Number | Percentage of Participants | Day 3 and Day 7 post vaccination 1 |
|
|
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| Secondary | Percentage of Participants With Viremia on Day 3 and Day 7: Vaccination 2 | 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. | All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint | Posted | Number | Percentage of Participants | Day 3 and Day 7 post vaccination 2 (Day 31 and Day 35) |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 10 |
| 10 |
| EG001 | 2x107 Pfu V920 | Participants will receive a 1-mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0 and Day 28. | 0 | 10 | 0 | 10 | 10 | 10 |
| EG002 | 1x108 Pfu V920 | Participants will receive a 1-mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0 and Day 28. | 0 | 10 | 0 | 10 | 10 | 10 |
| EG003 | Placebo | Participants will receive a 1-mL intramuscular injection of placebo in the deltoid on Day 0 and Day 28. | 0 | 9 | 0 | 9 | 8 | 9 |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Oral disorder | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Oral pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Lymphocyte percentage decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Prothrombin time prolonged | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Glycosuria | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
Not provided
Not provided
| Moderate (Grade 2) |
|
| Severe (Grade 3) |
|
| Life-threatening (Grade 4) |
|
| Moderate (Grade 2) |
|
| Severe (Grade 3) |
|
| Life-threatening (Grade 4) |
|
| Moderate (Grade 2) |
|
| Severe (Grade 3) |
|
| Life-threatening (Grade 4) |
|
| Moderate (Grade 2) |
|
| Severe (Grade 3) |
|
| Life-threatening (Grade 4) |
|
| <0.001 |
| Other |
| ANOVA | Adjustments for multiple comparisons were not performed. | <0.001 | Other |
| ANOVA | Adjustments for multiple comparisons were not performed. | 0.010 | Other |
| ANOVA | Adjustments for multiple comparisons were not performed. | 0.011 | Other |
| ANOVA | Adjustments for multiple comparisons were not performed | 0.969 | Other |
| <0.001 |
| Other |
| ANOVA | Adjustments for multiple comparisons were not performed | <0.001 | Other |
| ANOVA | Adjustments for multiple comparisons were not performed | <0.001 | Other |
| ANOVA | Adjustments for multiple comparisons were not performed | <0.001 | Other |
| ANOVA | Adjustments for multiple comparisons were not performed | 0.733 | Other |
| <0.001 |
| Other |
| ANOVA | Adjustments for multiple comparisons were not performed. | <0.001 | Other |
| ANOVA | Adjustments for multiple comparisons were not performed. | 0.132 | Other |
| ANOVA | Adjustments for multiple comparisons were not performed. | 0.070 | Other |
| ANOVA | Adjustments for multiple comparisons were not performed. | 0.743 | Other |
| <0.001 |
| Other |
| ANOVA | Adjustments for multiple comparisons were not performed. | <0.001 | Other |
| ANOVA | Adjustments for multiple comparisons were not performed. | 0.014 | Other |
| ANOVA | Adjustments for multiple comparisons were not performed. | 0.011 | Other |
| ANOVA | Adjustments for multiple comparisons were not performed. | 0.923 | Other |
| Day 7 post vaccination 1 |
|
| Day 7 post vaccination 2 |
|