Placebo Controlled, Dose Response, Safety and Immunogenicity Study of Vesicular Stomatitis Virus (VSV) Ebola Vaccine in Healthy Adults (V920-004)
Official Title
A Phase 1 Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Response Study to Evaluate the Safety and Immunogenicity of the BPSC-1001 (VSVΔG-ZEBOV) Ebola Virus Vaccine Candidate in Healthy Adult Subjects
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Jan 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 5, 2014Actual
Primary Completion Date
Jun 23, 2016Actual
Completion Date
Jun 23, 2016Actual
First Submitted Date
Dec 8, 2014
First Submission Date that Met QC Criteria
Dec 8, 2014
First Posted Date
Dec 11, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 6, 2019
Results First Submitted that Met QC Criteria
Dec 6, 2019
Results First Posted Date
Jan 2, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 21, 2020
Last Update Posted Date
Feb 5, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Name
Class
BioProtection Systems Corporation
INDUSTRY
Department of Health and Human Services
FED
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Ebola virus has infected and killed people, mostly in Africa. In 2014, the Ebola virus 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 BPSC-1001 to see if it is safe and to see how it affects people's immune system.
Detailed Description
Between 1994 and the present, there have been many Ebola viruses (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 replicating vesicular stomatitis virus (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).
Conditions Module
Conditions
Ebola Virus
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
513Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
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.
Biological: V920 Vaccine
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.
Biological: V920 Vaccine
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.
Biological: V920 Vaccine
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.
Biological: V920 Vaccine
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.
Percentage of Participants With One or More Solicited Injection-site Adverse Events by Severity
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.
Up to 14 days postvaccination
Percentage of Participants With One or More Solicited Systemic Adverse Events by Severity
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.
Up to 14 days postvaccination
Percentage of Participants With One or More Unsolicited Vaccine-related Adverse Event by Severity
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..
Secondary Outcomes
Measure
Description
Time Frame
Mean Copies of Vector Ribonucleic Acid (RNA) for Participants With a V920 Polymerase Chain Reaction (PCR) Result ≥ Lower Limit of Quantification (LLOQ)
Participants had blood, assessed for evidence of V920 via polymerase chain reaction (PCR). Mean copies of RNA was reported for all participants who had reading ≥ the LLOQ (62.5 copies/mL)
Days 1, 2, 3, 4, 7, 14 and 28 post-vaccination
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Healthy adult male or non-pregnant, non-lactating adult female, ages 18 to 60 (inclusive) at the time of screening
Have provided written informed consent prior to screening procedures
Free of clinically significant health problems, as determined by pertinent medical history, physical examination and clinical judgment of the investigator.
Available, able, and willing to participate for all study visits and procedures.
Males and females who are willing to practice abstinence from sexual intercourse with the opposite sex, or willing to use effective methods of contraception, from at least 30 days prior to vaccination until study end.
Be willing to minimize blood and body fluid exposure of others for 7 days after vaccination by:
Using effective barrier prophylaxis, such as latex condoms, during penetrative sexual intercourse
Avoiding the sharing of needles, razors, or toothbrushes
Avoiding open-mouth kissing
Resides in the geographic area of a clinical study site for 1 year after vaccination without risk of deployment outside the U.S.
Exclusion Criteria:
History of prior infection with a filovirus or prior participation in a filovirus vaccine trial
History of prior infection with VSV or receipt of a VSV vectored vaccine
Has been involved in the care in any capacity of a patient with Ebola virus infection within the previous 21 days
Is a healthcare worker who has direct contact with patients (nurse, physician, dentist, emergency medical technician, dental hygienist)
Has a house-hold contact (HHC) who is immunodeficient, on immunosuppressive medications, human immunodeficiency virus (HIV)-positive, pregnant, has an unstable medical condition
Has an HHC, or is a childcare worker who has direct contact with children, 5 years of age or younger
Direct hands-on job preparing food in the food industry
History of employment in an industry involved in contact with ruminant animals, veterinary sciences, or other potential exposure to VSV
History of employment or activity which involves potential contact with filoviruses
History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions
Known allergy to the components of the BPSC1001 vaccine product
Receipt of investigational product up to 30 days prior to randomization or ongoing participation in another clinical trial
Receipt of licensed non-live vaccines within 14 days of planned study immunization (30 days for live vaccines)
Ability to observe possible local reactions at the eligible injections sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art
Acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical examination, and/or laboratory screening test. This would include a known hemoglobinopathy or coagulation abnormality.
Any baseline laboratory screening test which in the opinion of the investigator, is considered clinically significant
Any serologic evidence of hepatitis B or C infection
Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV-1, HIV-2 infection, cytotoxic therapy in the previous 5 years, and/or diabetes
Any chronic or active neurologic disorder, including migraines, seizures, and epilepsy, excluding a single febrile seizure as a child
Have a known history of Guillain-Barré Syndrome
Have an active malignancy or history of metastatic or hematologic malignancy
Suspected or known alcohol and/or illicit drug abuse within the past 5 years
Moderate or severe illness and/or fever >100.4°F within 1 week prior to vaccination (can be rescheduled)
Pregnant or lactating female, or female who intends to become pregnant during the study period
Administration of IgGs and/or any blood products within the 120 days preceding study entry or planned administration during the study period
History of blood donation within 60 days of enrollment or plans to donate within the study period
Administration of chronic (defined as more than 14 days) immunosuppressants or other immune modifying drugs within 6 months of study entry
For corticosteroids, this includes prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day
Intranasal, topical, and intra-articular steroids are allowed
Unwilling to allow storage and use of blood for future vaccine research
28. Research staff or the immediate family of research staff directly involved with the clinical study.
29. Unwilling to undergo diagnostic evaluation of joint signs and symptoms, which may include arthrocentesis if clinically indicated based on presence of effusion and if the procedure is acceptable to the subject at the time (Cohort 2 only) 30. Unwilling to undergo diagnostic evaluation of skin rash, to include punch biopsy if clinically indicated and if the procedure is acceptable to the subject at the time (Cohort 2 only) 31. Research staff or the immediate family of research staff directly involved in the clinical study 32. Any other significant finding that in the opinion of the investigator would increase the risk of the individual having an adverse outcome from participating in this study 33. Elective surgery or hospitalization planned during the period of study participation 34. Has traveled to an area where the World Health Organization has declared as an Ebola outbreak zone 35. History of chronic inflammatory disease (e.g., rheumatoid arthritis, psoriatic arthritis, reactive arthritis, ankylosing spondylitis, systemic lupus erythematosus, psoriasis, Crohn's disease, ulcerative colitis, and gout), symptomatic osteoarthritis, or any other autoimmune or autoinflammatory disorder
Participants received a single 1.0 mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0.
FG001
3x10^4 Pfu V920: Cohort 1
Participants received a single 1.0 mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0.
FG002
3x10^5 Pfu V920: Cohort 1
Participants received a single 1.0 mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0.
FG003
3x10^6 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0.
FG004
Placebo: Cohort 1
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.
FG005
3x10^6 Pfu V920: Cohort 2
Participants received a single 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0
FG006
9x10^6 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0.
FG007
2x10^7 Pfu V920: Cohort 2
Participants received a single 1.0 mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0.
FG008
1x10^8 Pfu V920: Cohort 2
Participants received a single 1.0 mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0.
FG009
Placebo: Cohort 2
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00064 subjects
FG00164 subjects
FG00264 subjects
FG00364 subjects
FG00474 subjects
FG00520 subjects
FG00648 subjects
FG00747 subjects
FG00848 subjects
FG00920 subjects
Treated
FG00064 subjects
FG00164 subjects
FG00264 subjects
FG00364 subjects
FG004
COMPLETED
FG00061 subjects
FG00160 subjects
FG00262 subjects
FG00363 subjects
FG004
NOT COMPLETED
FG0003 subjects
FG0014 subjects
FG0022 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Baseline characteristics were reported for treated participants. 1 participant in 9x10^6 pfu V920: Cohort 2 arm did not receive vaccine
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
3x10^3 Pfu V920: Cohort 1
Participants received a single 1.0 mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0
BG001
3x10^4 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Outcome Measures Module
Outcome Measures
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 One or More Solicited Injection-site Adverse Events by Severity
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.
All randomized participants who received study vaccination and had data available for the endpoint.
Posted
Number
Percentage of Participants
Up to 14 days postvaccination
Adverse Events Module
Frequency Threshold
5
Time Frame
Up to 360 days
Description
All participants that received study vaccination (V920 dose or placebo).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
3x10^3 Pfu V920: Cohort 1
Participants received a single 1.0 mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Chest pain
General disorders
MedDRA 17.0
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
1-800-672-6372
ClinicalTrialsDisclosure@merck.com
Jul 10, 2026
Removed Countries
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
The study comprised two separate cohorts. Cohort 1 consisted of the 4 lower V920 dose groups (3x10^3 pfu, 3x10^4 pfu, 3x10^5 pfu, and 3x10^6 pfu). Cohort 2 consisted of the 3 higher V920 dose groups (9x10^6 pfu, 2x10^7 pfu, 1x10^8 pfu) plus a bridging group that received vaccine at the highest dose evaluated in Cohort 1 (i.e. 3x10^6 pfu). Both Cohorts 1 and 2 had a placebo group.
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
Experimental
Participants will receive a 1-mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0.
Biological: V920 Vaccine
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.
Biological: V920 Vaccine
Placebo Cohort 1
Placebo Comparator
Participants will receive a 1-mL intramuscular injection of placebo in the deltoid on Day 0.
Other: Placebo
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.
Biological: V920 Vaccine
Placebo Cohort 2
Placebo Comparator
Participants will receive a 1-mL intramuscular injection of placebo in the deltoid on Day 0.
Other: Placebo
2x10^7 pfu Vaccine Cohort 2
3x10^3 pfu Vaccine Cohort 1
3x10^4 pfu Vaccine Cohort 1
3x10^5 pfu Vaccine Cohort 1
3x10^6 pfu Vaccine Cohort 1
3x10^6 pfu Vaccine Cohort 2
9x10^6 pfu Vaccine Cohort 2
BPSC-1001
Placebo
Other
0.9% Saline
Placebo Cohort 1
Placebo Cohort 2
Up to 56 days postvaccination
Percentage of Participants With One or More Serious Adverse Event (SAE) by Severity
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.
Up to 360 days postvaccination
Geometric Mean Titers (GMTs) of Zaire Ebola Virus- (ZEBOV)-Specific Immunoglobulin-G (IgG) Antibody
Blood was drawn on Day 28 to assess the GMTs of ZEBOV-specific IgG antibodies as determined by Enzyme-linked immunosorbent assay (ELISA).
28 days postvaccination
Optimum Dose for General Use Prophylaxis With V920
The optimum dose for general use prophylaxis with V920 was determined following the review of all immunogenicity and safety data.
Day 360
Percentage of Participants With Seroconversion for ZEBOV-specific IgG
Blood was drawn on Days 7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days to assess the GMTs via ELISA. Seroconversion was defined as a post-vaccination titer ≥ 200 ELISA Units/mL that was also at least a 4-fold increase in titer compared to baseline.
7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days postvaccination
Percentage of Participants With Seroconversion for ZEBOV Neutralizing Antibodies
Blood was drawn on Days 7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days to assess the GMTs of Zaire ebolavirus neutralizing antibodies as determined plaque reduction neutralization titer (reciprocal of the dilution that resulted in a 60% decrease in plaques) (PRNT60).
7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days postvaccination
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.
74 subjects
FG00520 subjects
FG00647 subjectsOne participant did not receive vaccination due to missing blood sample at randomization.
FG00747 subjects
FG00848 subjects
FG00920 subjects
73 subjects
FG00519 subjects
FG00643 subjects
FG00742 subjects
FG00846 subjects
FG00920 subjects
1 subjects
FG0051 subjects
FG0065 subjects
FG0075 subjects
FG0082 subjects
FG0090 subjects
1 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Lost to Follow-up
FG0002 subjects
FG0013 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0063 subjects
FG0074 subjects
FG0082 subjects
FG0090 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Participant unavailable
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Screen failure
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Participant relocation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
BG002
3x10^5 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0.
BG003
3x10^6 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0.
BG004
Placebo Cohort 1
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.
BG005
3x10^6 Pfu V920: Cohort 2
Participants received a single 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0
BG006
9x10^6 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0.
BG007
2x10^7 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0.
BG008
1x10^8 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0.
BG009
Placebo: Cohort 2
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
BG010
Total
Total of all reporting groups
64
BG00164
BG00264
BG00364
BG00474
BG00520
BG00647
BG00747
BG00848
BG00920
BG010512
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
Between 18 and 65 years
BG00064
BG00164
BG00264
BG00364
BG004
>=65 years
BG0000
BG0010
BG0020
BG0030
BG004
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00032
BG00133
BG00231
BG00333
BG00439
BG0058
BG00624
BG00722
BG00815
BG0098
BG010245
Male
BG00032
BG00131
BG00233
BG00331
BG004
ID
Title
Description
OG000
3x10^3 Pfu V920: Cohort 1
Participants received a single 1.0 mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0.
OG001
3x10^4 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0.
OG002
3x10^5 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0.
OG003
3x10^6 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0.
OG004
Placebo: Cohort 1
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.
OG005
3x10^6 Pfu V920: Cohort 2
Participants received a single 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0
OG006
9x10^6 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0.
OG007
2x10^7 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0.
OG008
1x10^8 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0.
OG009
Placebo: Cohort 2
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Units
Counts
Participants
OG00064
OG00164
OG00264
OG00364
OG00474
OG00520
OG00647
OG00747
OG00848
OG00920
Title
Denominators
Categories
Grade 1 (Mild)
Title
Measurements
OG00017.2
OG00121.9
OG00229.7
OG00345.3
OG00410.8
OG00530.0
OG00661.7
OG00763.8
OG00847.9
OG0095.0
Grade 2 (Moderate)
Title
Measurements
OG0000
OG0011.6
OG0021.6
OG003
Grade 3 (Severe)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 4 (Potentially life-threatening)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Percentage of Participants With One or More Solicited Systemic Adverse Events by Severity
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.
All randomized participants who received study vaccination and had data available for the endpoint.
Posted
Number
Percentage of Participants
Up to 14 days postvaccination
ID
Title
Description
OG000
3x10^3 Pfu V920: Cohort 1
Participants received a single 1.0 mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0.
OG001
3x10^4 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0.
OG002
3x10^5 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0.
OG003
3x10^6 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0.
OG004
Placebo: Cohort 1
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.
OG005
3x10^6 Pfu V920: Cohort 2
Participants received a single 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0
OG006
9x10^6 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0.
OG007
2x10^7 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0.
OG008
1x10^8 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0.
OG009
Placebo: Cohort 2
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Units
Counts
Participants
OG00064
OG00164
OG00264
OG003
Title
Denominators
Categories
Grade 1 (Mild)
Title
Measurements
OG00029.7
OG00139.1
OG00245.3
OG003
Primary
Percentage of Participants With One or More Unsolicited Vaccine-related Adverse Event by Severity
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..
All randomized participants who received study vaccination and had data available for the endpoint.
Posted
Number
Percentage of Participants
Up to 56 days postvaccination
ID
Title
Description
OG000
3x10^3 Pfu V920: Cohort 1
Participants received a single 1.0 mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0.
OG001
3x10^4 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0.
OG002
3x10^5 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0.
OG003
3x10^6 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0.
OG004
Placebo: Cohort 1
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.
OG005
3x10^6 Pfu V920: Cohort 2
Participants received a single 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0
OG006
9x10^6 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0.
OG007
2x10^7 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0.
OG008
1x10^8 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0.
OG009
Placebo: Cohort 2
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Units
Counts
Participants
OG00064
OG00164
OG00264
OG003
Title
Denominators
Categories
1 (Mild)
Title
Measurements
OG0007.8
OG00114.1
OG0027.8
OG003
Primary
Percentage of Participants With One or More Serious Adverse Event (SAE) by Severity
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.
All randomized participants who received study vaccination and had data available for the endpoint.
Posted
Number
Percentage of Participants
Up to 360 days postvaccination
ID
Title
Description
OG000
3x10^3 Pfu V920: Cohort 1
Participants received a single 1.0 mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0.
OG001
3x10^4 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0.
OG002
3x10^5 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0.
OG003
3x10^6 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0.
OG004
Placebo: Cohort 1
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.
OG005
3x10^6 Pfu V920: Cohort 2
Participants received a single 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0
OG006
9x10^6 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0.
OG007
2x10^7 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0.
OG008
1x10^8 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0.
OG009
Placebo: Cohort 2
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Units
Counts
Participants
OG00064
OG00164
OG00264
OG003
Title
Denominators
Categories
1 (Mild)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Geometric Mean Titers (GMTs) of Zaire Ebola Virus- (ZEBOV)-Specific Immunoglobulin-G (IgG) Antibody
Blood was drawn on Day 28 to assess the GMTs of ZEBOV-specific IgG antibodies as determined by Enzyme-linked immunosorbent assay (ELISA).
All participants who were vaccinated, had endpoint titer results on Days 0 (baseline) and 28 (relative Days 24-35), and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints. A subset of 25 placebo recipients in Cohort 1 were prospectively identified for testing of immunogenicity endpoints.
Posted
Geometric Mean
Standard Deviation
ELISA Units/mL
28 days postvaccination
ID
Title
Description
OG000
3x10^3 Pfu V920: Cohort 1
Participants received a single 1.0 mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0.
OG001
3x10^4 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0.
OG002
3x10^5 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0.
OG003
3x10^6 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0.
OG004
Placebo: Cohort 1
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.
OG005
3x10^6 Pfu V920: Cohort 2
Participants received a single 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0
OG006
9x10^6 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0.
OG007
2x10^7 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0.
OG008
1x10^8 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0.
OG009
Placebo: Cohort 2
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Units
Counts
Participants
OG00064
OG00161
OG00264
OG003
Title
Denominators
Categories
Title
Measurements
OG000777.8± 5.06
OG001767.8± 3.96
OG002909.6± 3.26
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANOVA
0.951
Other
OG000
OG002
ANOVA
0.458
Secondary
Mean Copies of Vector Ribonucleic Acid (RNA) for Participants With a V920 Polymerase Chain Reaction (PCR) Result ≥ Lower Limit of Quantification (LLOQ)
Participants had blood, assessed for evidence of V920 via polymerase chain reaction (PCR). Mean copies of RNA was reported for all participants who had reading ≥ the LLOQ (62.5 copies/mL)
All participants who were vaccinated, had endpoint titer results on Days 0 (baseline) and 28 (relative Days 24-35), and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints. A subset of 25 placebo recipients in Cohort 1 were prospectively identified for testing of immunogenicity endpoints.
Posted
Geometric Mean
Standard Deviation
copies/mL
Days 1, 2, 3, 4, 7, 14 and 28 post-vaccination
ID
Title
Description
OG000
3x10^3 Pfu V920: Cohort 1
Participants received a single 1.0 mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0.
OG001
3x10^4 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0.
OG002
3x10^5 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0.
OG003
3x10^6 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0.
OG004
Placebo: Cohort 1
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.
OG005
3x10^6 Pfu V920: Cohort 2
Participants received a single 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0
OG006
9x10^6 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0.
OG007
2x10^7 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0.
OG008
1x10^8 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0.
OG009
Placebo: Cohort 2
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Units
Counts
Participants
OG00064
OG00161
OG00264
OG003
Title
Denominators
Categories
Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Secondary
Percentage of Participants With Seroconversion for ZEBOV-specific IgG
Blood was drawn on Days 7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days to assess the GMTs via ELISA. Seroconversion was defined as a post-vaccination titer ≥ 200 ELISA Units/mL that was also at least a 4-fold increase in titer compared to baseline.
All participants who were vaccinated, had endpoint titer results on Days 0 (baseline) and 28 (relative Days 24-35), and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints. A subset of 25 placebo recipients in Cohort 1 were prospectively identified for testing of immunogenicity endpoints.
Posted
Number
Percentage of Participants
7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days postvaccination
ID
Title
Description
OG000
3x10^3 Pfu V920: Cohort 1
Participants received a single 1.0 mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0.
OG001
3x10^4 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0.
OG002
3x10^5 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0.
OG003
3x10^6 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0.
OG004
Placebo: Cohort 1
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.
OG005
3x10^6 Pfu V920: Cohort 2
Participants received a single 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0
OG006
9x10^6 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0.
OG007
2x10^7 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0.
OG008
1x10^8 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0.
OG009
Placebo: Cohort 2
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Units
Counts
Participants
OG00064
OG00161
OG00264
OG003
Title
Denominators
Categories
Day 7
ParticipantsOG00061
ParticipantsOG00160
ParticipantsOG00264
ParticipantsOG003
Secondary
Percentage of Participants With Seroconversion for ZEBOV Neutralizing Antibodies
Blood was drawn on Days 7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days to assess the GMTs of Zaire ebolavirus neutralizing antibodies as determined plaque reduction neutralization titer (reciprocal of the dilution that resulted in a 60% decrease in plaques) (PRNT60).
All participants who were vaccinated, had endpoint titer results on Days 0 (baseline) and 28 (relative Days 24-35), and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints. A subset of 25 placebo recipients in Cohort 1 were prospectively identified for testing of immunogenicity endpoints.
Posted
Number
Percentage of Participants
7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days postvaccination
ID
Title
Description
OG000
3x10^3 Pfu V920: Cohort 1
Participants received a single 1.0 mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0.
OG001
3x10^4 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0.
OG002
3x10^5 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0.
OG003
3x10^6 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0.
OG004
Placebo: Cohort 1
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.
OG005
3x10^6 Pfu V920: Cohort 2
Participants received a single 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0
OG006
9x10^6 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0.
OG007
2x10^7 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0.
OG008
1x10^8 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0.
OG009
Placebo: Cohort 2
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Units
Counts
Participants
OG00064
OG00161
OG00264
OG003
Title
Denominators
Categories
Day 7
ParticipantsOG00063
ParticipantsOG00160
ParticipantsOG00264
ParticipantsOG003
Primary
Optimum Dose for General Use Prophylaxis With V920
The optimum dose for general use prophylaxis with V920 was determined following the review of all immunogenicity and safety data.
All participants who received study vaccine
Posted
Number
pfu
Day 360
ID
Title
Description
OG000
All Vaccinated Participants
All participants that received study vaccine.
Units
Counts
Participants
OG000512
Title
Denominators
Categories
Title
Measurements
OG00020000000
0
64
0
64
30
64
EG001
3x10^4 Pfu V920: Cohort 1
Participants received a single 1.0 mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0.
0
64
0
64
38
64
EG002
3x10^5 Pfu V920: Cohort 1
Participants received a single 1.0 mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0.
0
64
1
64
44
64
EG003
3x10^6 Pfu V920: Cohort 1
Participants received a 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0.
1
64
2
64
52
64
EG004
Placebo: Cohort 1
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.
0
74
1
74
43
74
EG005
3x10^6 Pfu V920: Cohort 2
Participants received a single 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0
0
20
0
20
14
20
EG006
9x10^6 Pfu V920: Cohort 2
Participants received a 1.0 mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0.
0
47
0
47
43
47
EG007
2x10^7 Pfu V920: Cohort 2
Participants received a single 1.0 mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0.
0
47
0
47
41
47
EG008
1x10^8 Pfu V920: Cohort 2
Participants received a single 1.0 mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0.
0
48
0
48
41
48
EG009
Placebo: Cohort 2
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
0
20
0
20
9
20
EG0000 events0 affected64 at risk
EG0010 events0 affected64 at risk
EG0021 events1 affected64 at risk
EG0030 events0 affected64 at risk
EG0040 events0 affected74 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected47 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected48 at risk
EG0090 events0 affected20 at risk
Head injury
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected64 at risk
EG0020 events0 affected64 at risk
EG0031 events1 affected64 at risk
EG0040 events0 affected74 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected47 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected48 at risk
EG0090 events0 affected20 at risk
Ulna fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected64 at risk
EG0020 events0 affected64 at risk
EG0030 events0 affected64 at risk
EG0041 events1 affected74 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected47 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected48 at risk
EG0090 events0 affected20 at risk
Presyncope
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected64 at risk
EG0020 events0 affected64 at risk
EG0031 events1 affected64 at risk
EG0040 events0 affected74 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected47 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected48 at risk
EG0090 events0 affected20 at risk
Peripheral ischaemia
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected64 at risk
EG0020 events0 affected64 at risk
EG0030 events0 affected64 at risk
EG0041 events1 affected74 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected47 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected48 at risk
EG0090 events0 affected20 at risk
EG0009 events7 affected64 at risk
EG0013 events3 affected64 at risk
EG0027 events6 affected64 at risk
EG0032 events2 affected64 at risk
EG0045 events4 affected74 at risk
EG0050 events0 affected20 at risk
EG0064 events4 affected47 at risk
EG0073 events3 affected47 at risk
EG0085 events5 affected48 at risk
EG0091 events1 affected20 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG00013 events6 affected64 at risk
EG0013 events2 affected64 at risk
EG0027 events6 affected64 at risk
EG0037 events6 affected64 at risk
EG0049 events8 affected74 at risk
EG0052 events2 affected20 at risk
EG0068 events7 affected47 at risk
EG0077 events6 affected47 at risk
EG00813 events11 affected48 at risk
EG0091 events1 affected20 at risk
Nausea
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0009 events9 affected64 at risk
EG0017 events6 affected64 at risk
EG00214 events13 affected64 at risk
EG00313 events11 affected64 at risk
EG00414 events12 affected74 at risk
EG0054 events4 affected20 at risk
EG0064 events4 affected47 at risk
EG0077 events5 affected47 at risk
EG0086 events6 affected48 at risk
EG0093 events3 affected20 at risk
Vomiting
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0005 events3 affected64 at risk
EG0012 events2 affected64 at risk
EG0024 events4 affected64 at risk
EG0035 events5 affected64 at risk
EG0045 events4 affected74 at risk
EG0051 events1 affected20 at risk
EG0061 events1 affected47 at risk
EG0071 events1 affected47 at risk
EG0084 events3 affected48 at risk
EG0090 events0 affected20 at risk
Chills
General disorders
MedDRA 17.0
Systematic Assessment
EG0006 events6 affected64 at risk
EG0013 events3 affected64 at risk
EG0028 events7 affected64 at risk
EG00322 events21 affected64 at risk
EG0046 events6 affected74 at risk
EG0053 events3 affected20 at risk
EG00618 events16 affected47 at risk
EG00714 events13 affected47 at risk
EG00817 events15 affected48 at risk
EG0091 events1 affected20 at risk
Fatigue
General disorders
MedDRA 17.0
Systematic Assessment
EG00013 events12 affected64 at risk
EG00116 events13 affected64 at risk
EG00217 events14 affected64 at risk
EG00324 events21 affected64 at risk
EG00416 events14 affected74 at risk
EG0056 events6 affected20 at risk
EG00622 events17 affected47 at risk
EG00725 events18 affected47 at risk
EG00825 events22 affected48 at risk
EG0096 events4 affected20 at risk
Pyrexia
General disorders
MedDRA 17.0
Systematic Assessment
EG0003 events3 affected64 at risk
EG0016 events4 affected64 at risk
EG0026 events6 affected64 at risk
EG00319 events16 affected64 at risk
EG0043 events3 affected74 at risk
EG0058 events6 affected20 at risk
EG00618 events14 affected47 at risk
EG00724 events18 affected47 at risk
EG00820 events15 affected48 at risk
EG0090 events0 affected20 at risk
Swelling
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected64 at risk
EG0020 events0 affected64 at risk
EG0030 events0 affected64 at risk
EG0040 events0 affected74 at risk
EG0050 events0 affected20 at risk
EG0062 events2 affected47 at risk
EG0073 events3 affected47 at risk
EG0081 events1 affected48 at risk
EG0090 events0 affected20 at risk
Tenderness
General disorders
MedDRA 17.0
Systematic Assessment
EG00010 events10 affected64 at risk
EG00114 events12 affected64 at risk
EG00217 events16 affected64 at risk
EG00327 events26 affected64 at risk
EG0047 events7 affected74 at risk
EG0054 events4 affected20 at risk
EG00629 events28 affected47 at risk
EG00728 events28 affected47 at risk
EG00824 events24 affected48 at risk
EG0091 events1 affected20 at risk
Bronchitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected64 at risk
EG0010 events0 affected64 at risk
EG0021 events1 affected64 at risk
EG0031 events1 affected64 at risk
EG0042 events2 affected74 at risk
EG0052 events2 affected20 at risk
EG0060 events0 affected47 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected48 at risk
EG0090 events0 affected20 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected64 at risk
EG0012 events1 affected64 at risk
EG0021 events1 affected64 at risk
EG0032 events2 affected64 at risk
EG0046 events6 affected74 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected47 at risk
EG0071 events1 affected47 at risk
EG0080 events0 affected48 at risk
EG0090 events0 affected20 at risk
Alanine aminotransferase increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected64 at risk
EG0012 events2 affected64 at risk
EG0020 events0 affected64 at risk
EG0031 events1 affected64 at risk
EG0040 events0 affected74 at risk
EG0050 events0 affected20 at risk
EG0062 events2 affected47 at risk
EG0072 events2 affected47 at risk
EG0082 events2 affected48 at risk
EG0093 events3 affected20 at risk
Haemoglobin decreased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected64 at risk
EG0020 events0 affected64 at risk
EG0030 events0 affected64 at risk
EG0040 events0 affected74 at risk
EG0050 events0 affected20 at risk
EG0062 events2 affected47 at risk
EG0072 events2 affected47 at risk
EG0081 events1 affected48 at risk
EG0094 events2 affected20 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG00018 events9 affected64 at risk
EG00123 events11 affected64 at risk
EG00223 events15 affected64 at risk
EG00324 events11 affected64 at risk
EG00413 events9 affected74 at risk
EG0056 events4 affected20 at risk
EG00622 events10 affected47 at risk
EG00730 events11 affected47 at risk
EG00821 events7 affected48 at risk
EG00910 events2 affected20 at risk
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0005 events3 affected64 at risk
EG0014 events2 affected64 at risk
EG0022 events2 affected64 at risk
EG0035 events3 affected64 at risk
EG0040 events0 affected74 at risk
EG0051 events1 affected20 at risk
EG0063 events3 affected47 at risk
EG0077 events4 affected47 at risk
EG0080 events0 affected48 at risk
EG0093 events1 affected20 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG00015 events12 affected64 at risk
EG00116 events13 affected64 at risk
EG00216 events15 affected64 at risk
EG00315 events14 affected64 at risk
EG00411 events10 affected74 at risk
EG00512 events8 affected20 at risk
EG00622 events19 affected47 at risk
EG00718 events16 affected47 at risk
EG00818 events16 affected48 at risk
EG0092 events1 affected20 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0005 events5 affected64 at risk
EG0017 events7 affected64 at risk
EG00212 events12 affected64 at risk
EG00320 events20 affected64 at risk
EG0046 events6 affected74 at risk
EG0054 events4 affected20 at risk
EG00630 events28 affected47 at risk
EG00728 events27 affected47 at risk
EG00825 events25 affected48 at risk
EG0091 events1 affected20 at risk
Dizziness
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected64 at risk
EG0020 events0 affected64 at risk
EG0035 events4 affected64 at risk
EG0040 events0 affected74 at risk
EG0051 events1 affected20 at risk
EG0060 events0 affected47 at risk
EG0070 events0 affected47 at risk
EG0081 events1 affected48 at risk
EG0090 events0 affected20 at risk
Headache
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG00024 events15 affected64 at risk
EG00123 events19 affected64 at risk
EG00227 events20 affected64 at risk
EG00341 events32 affected64 at risk
EG00433 events23 affected74 at risk
EG00512 events7 affected20 at risk
EG00632 events23 affected47 at risk
EG00730 events22 affected47 at risk
EG00828 events21 affected48 at risk
EG00911 events3 affected20 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected64 at risk
EG0011 events1 affected64 at risk
EG0020 events0 affected64 at risk
EG0031 events1 affected64 at risk
EG0040 events0 affected74 at risk
EG0050 events0 affected20 at risk
EG0061 events1 affected47 at risk
EG0075 events5 affected47 at risk
EG0081 events1 affected48 at risk
EG0090 events0 affected20 at risk
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0007 events6 affected64 at risk
EG0013 events3 affected64 at risk
EG0025 events5 affected64 at risk
EG0035 events5 affected64 at risk
EG0045 events3 affected74 at risk
EG0054 events4 affected20 at risk
EG0067 events6 affected47 at risk
EG00712 events11 affected47 at risk
EG00815 events13 affected48 at risk
EG0090 events0 affected20 at risk
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected64 at risk
EG0020 events0 affected64 at risk
EG0031 events1 affected64 at risk
EG0040 events0 affected74 at risk
EG0050 events0 affected20 at risk
EG0062 events2 affected47 at risk
EG0073 events2 affected47 at risk
EG0085 events3 affected48 at risk
EG0090 events0 affected20 at risk
Hypertension
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0003 events3 affected64 at risk
EG0011 events1 affected64 at risk
EG0022 events2 affected64 at risk
EG0030 events0 affected64 at risk
EG0043 events3 affected74 at risk
EG0051 events1 affected20 at risk
EG0063 events3 affected47 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected48 at risk
EG0090 events0 affected20 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
All data may be published in the open medical literature with the identity of the subjects protected. Anyone desiring to publish or present data obtained during the conduct of the study will conform to the Sponsor's policies and then forward the publication for review to the Sponsor prior to submission.
74
BG00520
BG00647
BG00747
BG00848
BG00920
BG010512
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
35
BG00512
BG00623
BG00725
BG00833
BG00912
BG010267
1.6
OG0041.4
OG0050
OG0068.5
OG0078.5
OG00816.7
OG0090
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
64
OG00474
OG00520
OG00647
OG00747
OG00848
OG00920
53.1
OG00441.9
OG00525.0
OG00646.8
OG00746.8
OG00843.8
OG00920.0
Grade 2 (Moderate)
Title
Measurements
OG00010.9
OG0014.7
OG00210.9
OG00314.1
OG0044.1
OG00525.0
OG00619.1
OG00723.4
OG00827.1
OG0095.0
Grade 3 (Severe)
Title
Measurements
OG0000
OG0010
OG0023.1
OG0031.6
OG0040
OG0050
OG0062.1
OG0074.3
OG0084.2
OG0090
Grade 4 (Potentially life-threatening)
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
64
OG00474
OG00520
OG00647
OG00747
OG00848
OG00920
9.4
OG0046.8
OG00515.0
OG00614.9
OG00717.0
OG00814.6
OG00910.0
2 (Moderate)
Title
Measurements
OG0004.7
OG0013.1
OG0020
OG0033.1
OG0040
OG0050
OG0066.4
OG0072.1
OG0082.1
OG0090
3 (Severe)
Title
Measurements
OG0000
OG0010
OG0020
OG0031.6
OG0040
OG0050
OG0060
OG0070
OG0080
OG0095.0
4 (Potentially Life-threatening)
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
64
OG00474
OG00520
OG00647
OG00747
OG00848
OG00920
1.6
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
2 (Moderate)
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
3 (Severe)
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041.4
OG0050
OG0060
OG0070
OG0080
OG0090
4 (Potentially Life-threatening)
Title
Measurements
OG0000
OG0010
OG0021.6
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
5 (Fatal)
Title
Measurements
OG0000
OG0010
OG0020
OG0031.6
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
63
OG00425
OG00520
OG00645
OG00746
OG00845
OG00920
1139.9
± 3.25
OG00430.3± 1.00
OG0051518.9± 3.20
OG006977.4± 3.01
OG0071542.8± 3.10
OG0081930.3± 2.22
OG00935.9± 2.13
Other
OG000
OG003
ANOVA
0.071
Other
OG000
OG004
ANOVA
<0.001
Other
OG000
OG005
ANOVA
0.029
Other
OG000
OG006
ANOVA
0.325
Other
OG000
OG007
ANOVA
0.003
Other
OG000
OG008
ANOVA
<0.001
Other
OG001
OG002
ANOVA
0.427
Other
OG001
OG003
ANOVA
0.065
Other
OG001
OG004
ANOVA
<0.001
Other
OG001
OG005
ANOVA
0.027
Other
OG001
OG006
ANOVA
0.303
Other
OG001
OG007
ANOVA
0.003
Other
OG001
OG008
ANOVA
<0.001
Other
OG002
OG003
ANOVA
0.286
Other
OG002
OG004
ANOVA
<0.001
Other
OG002
OG005
ANOVA
0.094
Other
OG002
OG006
ANOVA
0.757
Other
OG002
OG007
ANOVA
0.022
Other
OG002
OG008
ANOVA
0.001
Other
OG003
OG004
ANOVA
<0.001
Other
OG003
OG005
ANOVA
0.348
Other
OG003
OG006
ANOVA
0.508
Other
OG003
OG007
ANOVA
0.191
Other
OG003
OG008
ANOVA
0.024
Other
OG005
OG006
ANOVA
0.169
Other
OG005
OG007
ANOVA
0.961
Other
OG005
OG008
ANOVA
0.454
Other
OG005
OG009
ANOVA
<0.001
Other
OG006
OG007
ANOVA
0.068
Other
OG006
OG008
ANOVA
0.007
Other
OG006
OG009
ANOVA
<0.001
Other
OG007
OG008
ANOVA
0.370
Other
OG008
OG009
ANOVA
<0.001
Other
63
OG00425
OG00520
OG00645
OG00746
OG00845
OG00920
5
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG00827
ParticipantsOG0090
Title
Measurements
OG003118.04± 1.185
OG005109.40± NASD could not be calculated due to low n
OG006144.72± 1.511
OG007184.65± 1.893
OG008304.45± 2.534
Day 2
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00320
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0069
ParticipantsOG0079
ParticipantsOG00813
ParticipantsOG0090
Title
Measurements
OG0004107.00± NASD could not be calculated due to low n
OG003127.13± 1.511
OG005109.40± NASD could not be calculated due to low n
OG006
Day 3
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0033
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0083
ParticipantsOG0090
Title
Measurements
OG00012649.00± NASD could not be calculated due to low n
OG001109.40± NASD could not be calculated due to low n
OG003703.36± 25.106
OG007
Day 4
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00023936.00± NASD could not be calculated due to low n
OG001109.40± NASD could not be calculated due to low n
Day 7
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000787.00± NASD could not be calculated due to low n
OG002160.00± NASD could not be calculated due to low n
Day 14
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG003109.40± NASD could not be calculated due to low n