Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in He... | NCT03483961 | Trialant
NCT03483961
Sponsor
Bavarian Nordic
Status
Completed
Last Update Posted
Jul 3, 2023Actual
Enrollment
445Actual
Phase
Phase 2
Conditions
Chikungunya Virus Infection
Interventions
CHIKV VLP/unadjuvanted
CHIKV VLP/adjuvanted
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT03483961
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
PXVX-CV-317-001
Secondary IDs
Not provided
Brief Title
Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults
Official Title
A Phase 2 Parallel-Group, Randomized, Double-Blind Study to Assess the Safety and Immunogenicity of PXVX0317 (Chikungunya Virus Virus-Like Particle Vaccine [CHIKV-VLP], Unadjuvanted or Alum-adjuvanted)
Acronym
Not provided
Organization
Bavarian NordicINDUSTRY
Status Module
Record Verification Date
Jun 2023
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
Apr 18, 2018Actual
Primary Completion Date
Sep 14, 2020Actual
Completion Date
Sep 21, 2020Actual
First Submitted Date
Mar 16, 2018
First Submission Date that Met QC Criteria
Mar 23, 2018
First Posted Date
Mar 30, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Sep 14, 2021
Results First Submitted that Met QC Criteria
Oct 12, 2021
Results First Posted Date
Nov 9, 2021Actual
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
Jun 29, 2023
Last Update Posted Date
Jul 3, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bavarian NordicINDUSTRY
Collaborators
Name
Class
Emergent BioSolutions
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
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
The goal of this Phase 2 trial is to evaluate the immune response to and safety profile of various doses/formulations/and schedules of administration of PXVX0317 in healthy adults.
Primary Objective:
To assess the immune response to the vaccine
Secondary Objectives:
To assess the kinetics of the immune response to different doses/formulations/schedules To assess the persistence of immune responses to different doses/formulations/schedules To assess the effect of a booster dose of the vaccine
Safety Objective:
To assess local and systemic reactions to the vaccine and to describe the safety profile of the vaccine
Detailed Description
The trial will explore 8 formulation/schedule combinations of CHIKV VLP vaccine with or without Alhydrogel adjuvant, and will also explore different dose schedules of Day 1 and 15 or Day 1 and 29 or Day 29 only.
Conditions Module
Conditions
Chikungunya Virus Infection
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
445Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group 1: 20 mcg/unadjuvanted (Day 1 & 29)
Experimental
20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29)
Biological: CHIKV VLP/unadjuvanted
Biological: Placebo
Group 2: 6 mcg/adjuvanted (Day 1 & 29)
Experimental
6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29)
Biological: CHIKV VLP/adjuvanted
Biological: Placebo
Group 3: 10 mcg/adjuvanted (Day 1 & 29)
Experimental
10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29)
Biological: CHIKV VLP/adjuvanted
Biological: Placebo
Group 4: 20mcg/adjuvanted (Day 1 & 29);40mcg/adjuvant (Day 547)
Experimental
20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547)
Biological: CHIKV VLP/adjuvanted
Biological: Placebo
Group 5: 6 mcg/adjuvanted (Day 15 & 29)
Experimental
Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CHIKV VLP/unadjuvanted
Biological
Vaccine consists of virus-like particles of chikungunya virus antigens
Group 1: 20 mcg/unadjuvanted (Day 1 & 29)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Anti-CHIKV Neutralizing Antibody Geometric Mean Titer 28 Days After the Last Injection for Groups 2-8.
To assess the induction of anti-chikungunya virus (CHIKV) neutralizing antibody geometric mean titers by different formulations and schedules, as measured at 28 days after the last injection (Day 57) for Groups 2-8.
Day 57 (from Day 1 vaccination), 28 days after the last injection.
Secondary Outcomes
Measure
Description
Time Frame
Kinetics of Anti-chikungunya Virus (CHIKV) Neutralizing Antibody Geometric Mean Titer for Groups 2-8.
To describe the kinetics of induction of anti-CHIKV neutralizing antibody geometric mean titers by different formulations and schedules for Groups 2-8.
At Days 8, 15, 22, 29, 36, and 57.
Differences in Persistence of Neutralizing Antibody Geometric Mean Titer for Groups 2-8.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female
Age 18 to 45 years old (inclusive)
Using an acceptable method of contraception (if female of childbearing potential).
Able and willing to provide informed consent for study participation.
Exclusion Criteria:
Current acute febrile illness.
Clinically significant cardiac, respiratory, or rheumatologic disease, in the opinion of the Investigator.
Pregnant or breast-feeding.
Laboratory evidence of infection with Hepatitis B/C or HIV.
History of chikungunya virus infection.
Travel to a World Health Organization-designated chikungunya-endemic region within 30 days prior to Day 1.
History of allergic reaction to any component of CHIKV-VLP vaccine, Diluent, or Alhydrogel®.
Inability to discontinue systemic immunomodulatory or immunosuppressive medications 30 days prior to Day 1.
Received or plans to receive any licensed vaccine from 30 days prior to Day 1 through Day 57.
Received or plans to receive an investigational agent from 30 days prior to Day 1 through the duration of study participation.
Any other condition that, in the opinion of the Investigator, creates an unacceptable risk to the subject.
Any other condition that, in the opinion of the Investigator, may interfere with the conduct of the study or the validity of the data.
Any other condition that, in the opinion of the Investigator, creates an unacceptable safety risk for apheresis (Group 9 & 10 only).
Restricted venous access that would prevent the collection of PBMCs, plasma, and lymphocytes necessary for participation (Group 9 & 10 only).
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
FG008
Group 9: 20 mcg/Adjuvant (Day 1 & 29)
20 mcg CHIKV VLP/adjuvanted (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 29). This group will also have plasmapheresis performed on Day 57 and Leukapheresis on Day 182
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
FG009
Group 10: 40 mcg/Adjuvant (Day 1)
40 mcg CHIKV VLP/adjuvanted (Day 1). This group will also have plasmapheresis performed on Day 22.
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00053 subjects
FG00152 subjects
FG00251 subjects
FG00350 subjects
FG00453 subjects
FG00553 subjects
FG00651 subjects
FG00752 subjects
FG00820 subjects
FG00910 subjects
Exposed / Safety
FG00053 subjects
FG00152 subjects
FG00250 subjectsOne subject was randomized to Group 3 but treated in Group 4 due to a dispensing error.
FG003
Immunogenicity-evaluable
FG00047 subjects
FG00144 subjects
FG00244 subjects
FG00345 subjects
FG004
COMPLETED
FG00042 subjects
FG00142 subjects
FG00239 subjects
FG00341 subjects
FG004
NOT COMPLETED
FG00011 subjects
FG00110 subjects
FG00212 subjects
FG0039 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0007 subjects
FG0016 subjects
FG0026 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group 1: 20 mcg/Unadjuvant (Day 1 & 29)
20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29)
CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens
Placebo: Placebo is vaccine diluent alone
BG001
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
Anti-CHIKV Neutralizing Antibody Geometric Mean Titer 28 Days After the Last Injection for Groups 2-8.
To assess the induction of anti-chikungunya virus (CHIKV) neutralizing antibody geometric mean titers by different formulations and schedules, as measured at 28 days after the last injection (Day 57) for Groups 2-8.
Immunogenicity-evaluable: Exposed participants as treated per protocol (no major protocol deviation or exclusion reason prior to unblinding, all doses received, no prohibited medication, and evaluable serum samples within required time frames).
Posted
Geometric Mean
95% Confidence Interval
titer
Day 57 (from Day 1 vaccination), 28 days after the last injection.
ID
Title
Description
OG000
Group 1: 20 mcg/Unadjuvant (Day 1 & 29)
20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29)
CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens
Placebo: Placebo is vaccine diluent alone
Adverse Events Module
Frequency Threshold
5
Time Frame
Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported.
Description
One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
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
Group 1: 20 mcg/Unadjuvant (Day 1 & 29)
20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29)
CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens
20 mcg CHIKV VLP/adjuvanted (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 29). This group will also have plasmapheresis performed on Day 57 and Leukapheresis on Day 182
Biological: CHIKV VLP/adjuvanted
Group 10: 40 mcg/adjuvanted (Day 1)
Experimental
40 mcg CHIKV VLP/adjuvanted (Day 1). This group will also have plasmapheresis performed on Day 22.
Biological: CHIKV VLP/adjuvanted
CHIKV VLP/adjuvanted
Biological
Adjuvanted formulation includes Alhydrogel
Group 10: 40 mcg/adjuvanted (Day 1)
Group 2: 6 mcg/adjuvanted (Day 1 & 29)
Group 3: 10 mcg/adjuvanted (Day 1 & 29)
Group 4: 20mcg/adjuvanted (Day 1 & 29);40mcg/adjuvant (Day 547)
Group 5: 6 mcg/adjuvanted (Day 15 & 29)
Group 6: 10 mcg/adjuvanted (Day 15 & 29)
Group 7: 20 mcg/adjuvanted (Day 15 & 29)
Group 8: 40 mcg/adjuvanted (Day 29)
Group 9: 20 mcg/adjuvanted (Day 1 & 29)
Placebo
Biological
Placebo is vaccine diluent alone
Group 1: 20 mcg/unadjuvanted (Day 1 & 29)
Group 2: 6 mcg/adjuvanted (Day 1 & 29)
Group 3: 10 mcg/adjuvanted (Day 1 & 29)
Group 4: 20mcg/adjuvanted (Day 1 & 29);40mcg/adjuvant (Day 547)
Group 5: 6 mcg/adjuvanted (Day 15 & 29)
Group 6: 10 mcg/adjuvanted (Day 15 & 29)
Group 7: 20 mcg/adjuvanted (Day 15 & 29)
Group 8: 40 mcg/adjuvanted (Day 29)
To assess differences in persistence of neutralizing antibody geometric mean titers induced by different formulations and schedules, as measured up to 731 days after the last injection (Day 760) relative to earlier time points for Groups 2-8.
At Days 182, 365, 547, and 760.
Boosting of Vaccine-induced Neutralizing Antibody Geometric Mean Titer by a Booster Dose of PXVX0317 for Group 4 Only.
To assess the effect of a booster dose of PXVX0317 on neutralizing antibody geometric mean titers when given at Day 547 for Group 4 only. Antibody levels will be measured at Day 547 prior to the booster dose and again 28 days later on Day 575 and then at Day 760.
Antibody levels will be measured at Day 547 prior to the booster dose and again 28 days later on Day 575 and then at Day 760.
Percentage of Participants With an Anti-CHIKV Neutralizing Antibody Titer Exceeding the Following Cutoff Values: ≥15, 40, 160, 640, and 4-fold Rise Over Baseline.
Percentage of participants with an anti-CHIKV neutralizing antibody titer exceeding the following cutoff values: ≥15, 40, 160, 640, and 4-fold rise over baseline.
Day 57 (from Day 1 vaccination), 28 days after the last injection.
Kansas City
Missouri
64114
United States
Advanced Clinical Research
West Jordan
Utah
84088
United States
51 subjects
One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error.
FG00453 subjectsOne subject did not receive PXVX0317 but is in the Exposed / Safety population because of receipt of placebo.
FG00553 subjects
FG00651 subjectsOne subject did not receive PXVX0317 but is in the Exposed / Safety population because of receipt of placebo.
FG00752 subjectsTwo subjects did not receive PXVX0317 but are in the Exposed / Safety population because of receipt of placebo.
FG00820 subjects
FG00910 subjects
48 subjects
FG00548 subjects
FG00647 subjects
FG00750 subjects
FG00820 subjects
FG00910 subjects
43 subjects
FG00547 subjects
FG00646 subjects
FG00739 subjects
FG00818 subjects
FG00910 subjects
10 subjects
FG0056 subjects
FG0065 subjects
FG00713 subjects
FG0082 subjects
FG0090 subjects
6 subjects
FG0046 subjects
FG0054 subjects
FG0064 subjects
FG00711 subjects
FG0081 subjects
FG0090 subjects
Withdrawal by Subject
FG0003 subjects
FG0014 subjects
FG0025 subjects
FG0033 subjects
FG0044 subjects
FG0052 subjects
FG0061 subjects
FG0072 subjects
FG0081 subjects
FG0090 subjects
Other than AE, death, PI decision, LTFU, noncompliance, study terminated, or withdrawal of consent
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Group 2: 6 mcg/Adjuvant (Day 1 & 29)
6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
BG002
Group 3: 10 mcg/Adjuvant (Day 1 & 29)
10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
BG003
Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547)
20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
BG004
Group 5: 6 mcg/Adjuvant (Day 15 & 29)
Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
BG005
Group 6: 10 mcg/Adjuvant (Day 15 & 29)
Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
BG006
Group 7: 20 mcg/Adjuvant (Day 15 & 29)
Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
BG008
Group 9: 20 mcg/Adjuvant (Day 1 & 29)
20 mcg CHIKV VLP/adjuvanted (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 29). This group will also have plasmapheresis performed on Day 57 and Leukapheresis on Day 182
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
BG009
Group 10: 40 mcg/Adjuvant (Day 1)
40 mcg CHIKV VLP/adjuvanted (Day 1). This group will also have plasmapheresis performed on Day 22.
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
BG010
Total
Total of all reporting groups
53
BG00152
BG00251
BG00350
BG00453
BG00553
BG00651
BG00752
BG00820
BG00910
BG010445
Participants
Title
Denominators
Categories
ParticipantsBG00053
ParticipantsBG00152
ParticipantsBG00251
ParticipantsBG00350
ParticipantsBG00453
ParticipantsBG00553
ParticipantsBG00651
ParticipantsBG00752
ParticipantsBG00820
ParticipantsBG00910
ParticipantsBG010445
Title
Measurements
<=18 years
BG0003
BG0011
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG00053
ParticipantsBG00152
ParticipantsBG00251
ParticipantsBG00350
ParticipantsBG00453
ParticipantsBG00553
ParticipantsBG00651
ParticipantsBG00752
ParticipantsBG00820
ParticipantsBG00910
ParticipantsBG010445
Title
Measurements
BG00030.4± 8.22
BG00131.2± 8.26
BG00231.2± 7.64
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00053
ParticipantsBG00152
ParticipantsBG00251
ParticipantsBG00350
ParticipantsBG00453
ParticipantsBG00553
ParticipantsBG00651
ParticipantsBG00752
ParticipantsBG00820
ParticipantsBG00910
ParticipantsBG010445
Title
Measurements
Female
BG00030
BG00130
BG00237
BG003
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00053
ParticipantsBG00152
ParticipantsBG00251
ParticipantsBG00350
ParticipantsBG00453
ParticipantsBG00553
ParticipantsBG00651
ParticipantsBG00752
ParticipantsBG00820
ParticipantsBG00910
ParticipantsBG010445
Title
Measurements
Hispanic or Latino
BG0003
BG0014
BG0024
BG003
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00053
ParticipantsBG00152
ParticipantsBG00251
ParticipantsBG00350
ParticipantsBG00453
ParticipantsBG00553
ParticipantsBG00651
ParticipantsBG00752
ParticipantsBG00820
ParticipantsBG00910
ParticipantsBG010445
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG003
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
ParticipantsBG00053
ParticipantsBG00152
ParticipantsBG00251
ParticipantsBG00350
ParticipantsBG00453
ParticipantsBG00553
ParticipantsBG00651
ParticipantsBG00752
ParticipantsBG00820
ParticipantsBG00910
ParticipantsBG010445
Title
Measurements
BG00053
BG00152
BG00251
BG003
Day 1 predose (baseline) geometric mean anti-chikungunya luciferase neutralizing antibody titer.
Day 1 predose (baseline) geometric mean anti-chikungunya luciferase neutralizing antibody titer. Values below the lower limit of quantitation of 15 were imputed as half the lower limit of quantitation or 7.5.
Immunogenicity-evaluable: Exposed participants as treated per protocol (no major protocol deviation or exclusion reason prior to unblinding, all doses received, no prohibited medication, and evaluable serum samples within required time frames).
Geometric Mean
Full Range
titer
Title
Denominators
Categories
ParticipantsBG00047
ParticipantsBG00144
ParticipantsBG00244
ParticipantsBG00345
ParticipantsBG00448
ParticipantsBG00548
ParticipantsBG00647
ParticipantsBG00750
ParticipantsBG00820
ParticipantsBG00910
ParticipantsBG010403
Title
Measurements
BG0007.5(7.5 to 7.5)
BG0017.5(7.5 to 7.5)
BG0027.5(7.5 to 7.5)
BG003
OG001
Group 2: 6 mcg/Adjuvant (Day 1 & 29)
6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
OG002
Group 3: 10 mcg/Adjuvant (Day 1 & 29)
10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
OG003
Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547)
20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
OG004
Group 5: 6 mcg/Adjuvant (Day 15 & 29)
Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
OG005
Group 6: 10 mcg/Adjuvant (Day 15 & 29)
Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
OG006
Group 7: 20 mcg/Adjuvant (Day 15 & 29)
Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
Units
Counts
Participants
OG00047
OG00144
OG00244
OG00345
OG00448
OG00548
OG00647
OG00750
Title
Denominators
Categories
Title
Measurements
OG0002057.0(1584.8 to 2670.0)
OG0011116.2(852.5 to 1461.4)
OG0021465.3(1119.1 to 1918.4)
OG0032023.8(1550.5 to 2641.7)
OG004920.1(710.9 to 1190.9)
OG0051206.9(932.4 to 1562.2)
OG0061562.8(1204.1 to 2028.3)
OG0071712.5(1330.0 to 2205.0)
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
OG002
OG003
OG004
OG005
OG006
OG007
Groups 2-8 are compared to Group 1.
ANOVA
ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 2 vs. Group 1.
0.0015
All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.
Superiority
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
Groups 2-8 are compared to Group 1
ANOVA
ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 3 vs. Group 1.
0.0761
All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.
Superiority
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
Groups 2-8 are compared to Group 1.
ANOVA
ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 4 vs. Group 1.
0.9317
All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.
Superiority
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
Groups 2-8 are compared to Group 1.
ANOVA
ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 5 vs. Group 1.
<.0001
All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.
Superiority
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
Groups 2-8 are compared to Group 1.
ANOVA
ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 6 vs. Group 1.
0.0045
All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.
Superiority
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
Groups 2-8 are compared to Group 1.
ANOVA
ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 7 vs. Group 1.
0.1437
All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.
Superiority
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
Groups 2-8 are compared to Group 1.
ANOVA
ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 8 vs. Group 1.
0.3216
All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.
Superiority
Secondary
Kinetics of Anti-chikungunya Virus (CHIKV) Neutralizing Antibody Geometric Mean Titer for Groups 2-8.
To describe the kinetics of induction of anti-CHIKV neutralizing antibody geometric mean titers by different formulations and schedules for Groups 2-8.
Immunogenicity-evaluable: Exposed participants as treated per protocol (no major protocol deviation or exclusion reason prior to unblinding, all doses received, no prohibited medication, and evaluable serum samples within required time frames).
Posted
Geometric Mean
95% Confidence Interval
titer
At Days 8, 15, 22, 29, 36, and 57.
ID
Title
Description
OG000
Group 1: 20 mcg/Unadjuvant (Day 1 & 29)
20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29)
CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens
Placebo: Placebo is vaccine diluent alone
OG001
Group 2: 6 mcg/Adjuvant (Day 1 & 29)
6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
OG002
Group 3: 10 mcg/Adjuvant (Day 1 & 29)
10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
OG003
Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547)
20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
OG004
Group 5: 6 mcg/Adjuvant (Day 15 & 29)
Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
OG005
Group 6: 10 mcg/Adjuvant (Day 15 & 29)
Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
OG006
Group 7: 20 mcg/Adjuvant (Day 15 & 29)
Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
Units
Counts
Participants
OG00047
OG00144
OG00244
OG003
Title
Denominators
Categories
Day 8
ParticipantsOG00047
ParticipantsOG00143
ParticipantsOG00244
ParticipantsOG003
Secondary
Differences in Persistence of Neutralizing Antibody Geometric Mean Titer for Groups 2-8.
To assess differences in persistence of neutralizing antibody geometric mean titers induced by different formulations and schedules, as measured up to 731 days after the last injection (Day 760) relative to earlier time points for Groups 2-8.
Immunogenicity-evaluable: Exposed participants as treated per protocol (no major protocol deviation or exclusion reason prior to unblinding, all doses received, no prohibited medication, and evaluable serum samples within required time frames).
Posted
Geometric Mean
95% Confidence Interval
titer
At Days 182, 365, 547, and 760.
ID
Title
Description
OG000
Group 1: 20 mcg/Unadjuvant (Day 1 & 29)
20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29)
CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens
Placebo: Placebo is vaccine diluent alone
OG001
Group 2: 6 mcg/Adjuvant (Day 1 & 29)
6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
OG002
Group 3: 10 mcg/Adjuvant (Day 1 & 29)
10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
OG003
Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547)
20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
OG004
Group 5: 6 mcg/Adjuvant (Day 15 & 29)
Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
OG005
Group 6: 10 mcg/Adjuvant (Day 15 & 29)
Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
OG006
Group 7: 20 mcg/Adjuvant (Day 15 & 29)
Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
Units
Counts
Participants
OG00047
OG00144
OG00244
OG003
Title
Denominators
Categories
Day 182
ParticipantsOG00046
ParticipantsOG00140
ParticipantsOG00239
ParticipantsOG003
Secondary
Boosting of Vaccine-induced Neutralizing Antibody Geometric Mean Titer by a Booster Dose of PXVX0317 for Group 4 Only.
To assess the effect of a booster dose of PXVX0317 on neutralizing antibody geometric mean titers when given at Day 547 for Group 4 only. Antibody levels will be measured at Day 547 prior to the booster dose and again 28 days later on Day 575 and then at Day 760.
Immunogenicity-evaluable: Exposed participants as treated per protocol (no major protocol deviation or exclusion reason prior to unblinding, all doses received, no prohibited medication, and evaluable serum samples within required time frames).
Posted
Geometric Mean
95% Confidence Interval
titer
Antibody levels will be measured at Day 547 prior to the booster dose and again 28 days later on Day 575 and then at Day 760.
ID
Title
Description
OG000
Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547)
20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
Units
Counts
Participants
OG00047
Title
Denominators
Categories
Day 547 (pre-boost)
ParticipantsOG00039
Title
Measurements
OG000223.6(166.7 to 299.9)
Day 575 (post-boost)
ParticipantsOG000
Secondary
Percentage of Participants With an Anti-CHIKV Neutralizing Antibody Titer Exceeding the Following Cutoff Values: ≥15, 40, 160, 640, and 4-fold Rise Over Baseline.
Percentage of participants with an anti-CHIKV neutralizing antibody titer exceeding the following cutoff values: ≥15, 40, 160, 640, and 4-fold rise over baseline.
Immunogenicity-evaluable: Exposed participants as treated per protocol (no major protocol deviation or exclusion reason prior to unblinding, all doses received, no prohibited medication, and evaluable serum samples within required time frames).
Posted
Count of Participants
Participants
Day 57 (from Day 1 vaccination), 28 days after the last injection.
ID
Title
Description
OG000
Group 1: 20 mcg/Unadjuvant (Day 1 & 29)
20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29)
CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens
Placebo: Placebo is vaccine diluent alone
OG001
Group 2: 6 mcg/Adjuvant (Day 1 & 29)
6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
OG002
Group 3: 10 mcg/Adjuvant (Day 1 & 29)
10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
OG003
Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547)
20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
OG004
Group 5: 6 mcg/Adjuvant (Day 15 & 29)
Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
OG005
Group 6: 10 mcg/Adjuvant (Day 15 & 29)
Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
OG006
Group 7: 20 mcg/Adjuvant (Day 15 & 29)
Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29)
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Placebo: Placebo is vaccine diluent alone
0
52
3
52
34
52
EG008
Group 9: 20 mcg/Adjuvant (Day 1 & 29)
20 mcg CHIKV VLP/adjuvanted (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 29). This group will also have plasmapheresis performed on Day 57 and Leukapheresis on Day 182
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
0
20
0
20
12
20
EG009
Group 10: 40 mcg/Adjuvant (Day 1)
40 mcg CHIKV VLP/adjuvanted (Day 1). This group will also have plasmapheresis performed on Day 22.
CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
0
10
0
10
4
10
EG0000 events0 affected53 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected50 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected51 at risk
EG0071 events1 affected52 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected10 at risk
Anaphylactic reaction
Immune system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected52 at risk
EG0021 events1 affected50 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected51 at risk
EG0070 events0 affected52 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected10 at risk
Appendicitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected50 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected51 at risk
EG0071 events1 affected52 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected10 at risk
Gastroenteritis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected50 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected53 at risk
EG0061 events1 affected51 at risk
EG0070 events0 affected52 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected10 at risk
Pneumonia
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected50 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected51 at risk
EG0071 events1 affected52 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected10 at risk
Induced abortion haemorrhage
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected52 at risk
EG0020 events0 affected50 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected51 at risk
EG0070 events0 affected52 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected10 at risk
Laryngeal injury
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected50 at risk
EG0031 events1 affected51 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected51 at risk
EG0070 events0 affected52 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected10 at risk
Road traffic accident
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected52 at risk
EG0021 events1 affected50 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected51 at risk
EG0070 events0 affected52 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected10 at risk
Hyperemesis gravidarum
Pregnancy, puerperium and perinatal conditions
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected50 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected53 at risk
EG0061 events1 affected51 at risk
EG0070 events0 affected52 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected10 at risk
Premature separation of placenta
Pregnancy, puerperium and perinatal conditions
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected50 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected53 at risk
EG0061 events1 affected51 at risk
EG0070 events0 affected52 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected10 at risk
Threatened labour
Pregnancy, puerperium and perinatal conditions
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected50 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected53 at risk
EG0061 events1 affected51 at risk
EG0070 events0 affected52 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected10 at risk
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected50 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected53 at risk
EG0061 events1 affected51 at risk
EG0070 events0 affected52 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected10 at risk
EG0004 events4 affected53 at risk
EG0012 events2 affected52 at risk
EG0021 events1 affected50 at risk
EG0033 events2 affected51 at risk
EG0040 events0 affected53 at risk
EG0054 events4 affected53 at risk
EG0062 events2 affected51 at risk
EG0074 events4 affected52 at risk
EG0081 events1 affected20 at risk
EG0090 events0 affected10 at risk
Gastroenteritis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected52 at risk
EG0021 events1 affected50 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected53 at risk
EG0064 events4 affected51 at risk
EG0071 events1 affected52 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected10 at risk
Toothache
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected50 at risk
EG0031 events1 affected51 at risk
EG0041 events1 affected53 at risk
EG0051 events1 affected53 at risk
EG0061 events1 affected51 at risk
EG0070 events0 affected52 at risk
EG0081 events1 affected20 at risk
EG0090 events0 affected10 at risk
Hangover
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected50 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected51 at risk
EG0070 events0 affected52 at risk
EG0081 events1 affected20 at risk
EG0090 events0 affected10 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected50 at risk
EG0032 events2 affected51 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected51 at risk
EG0070 events0 affected52 at risk
EG0080 events0 affected20 at risk
EG0091 events1 affected10 at risk
Presyncope
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected50 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected51 at risk
EG0070 events0 affected52 at risk
EG0081 events1 affected20 at risk
EG0090 events0 affected10 at risk
Nausea, solicited
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0009 events8 affected53 at risk
EG00110 events6 affected52 at risk
EG0028 events8 affected50 at risk
EG00317 events14 affected51 at risk
EG0044 events4 affected53 at risk
EG0057 events5 affected53 at risk
EG0066 events6 affected51 at risk
EG0078 events6 affected52 at risk
EG0081 events1 affected20 at risk
EG0090 events0 affected10 at risk
Injection site pain, solicited
General disorders
MedDRA (20.1)
Systematic Assessment
EG00025 events19 affected53 at risk
EG00141 events27 affected52 at risk
EG00235 events23 affected50 at risk
EG00363 events29 affected51 at risk
EG00425 events18 affected53 at risk
EG00527 events18 affected53 at risk
EG00630 events18 affected51 at risk
EG00732 events26 affected52 at risk
EG00816 events10 affected20 at risk
EG0092 events2 affected10 at risk
Fatigue, solicited
General disorders
MedDRA (20.1)
Systematic Assessment
EG00016 events11 affected53 at risk
EG00118 events12 affected52 at risk
EG00214 events12 affected50 at risk
EG00327 events19 affected51 at risk
EG0047 events7 affected53 at risk
EG00510 events7 affected53 at risk
EG00617 events11 affected51 at risk
EG00715 events10 affected52 at risk
EG0082 events2 affected20 at risk
EG0092 events2 affected10 at risk
Malaise, solicited
General disorders
MedDRA (20.1)
Systematic Assessment
EG0008 events7 affected53 at risk
EG00110 events7 affected52 at risk
EG0027 events6 affected50 at risk
EG00315 events14 affected51 at risk
EG0044 events4 affected53 at risk
EG00510 events7 affected53 at risk
EG00613 events10 affected51 at risk
EG00711 events9 affected52 at risk
EG0082 events2 affected20 at risk
EG0091 events1 affected10 at risk
Chills, solicited
General disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected53 at risk
EG0013 events3 affected52 at risk
EG0025 events5 affected50 at risk
EG0039 events8 affected51 at risk
EG0043 events3 affected53 at risk
EG0056 events4 affected53 at risk
EG0065 events4 affected51 at risk
EG0073 events3 affected52 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected10 at risk
Myalgia, solicited
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG00012 events11 affected53 at risk
EG00115 events12 affected52 at risk
EG00218 events12 affected50 at risk
EG00335 events21 affected51 at risk
EG00414 events11 affected53 at risk
EG00518 events10 affected53 at risk
EG00619 events11 affected51 at risk
EG00711 events11 affected52 at risk
EG0080 events0 affected20 at risk
EG0092 events2 affected10 at risk
Arthralgia, solicited
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0004 events3 affected53 at risk
EG00111 events9 affected52 at risk
EG0026 events4 affected50 at risk
EG00316 events12 affected51 at risk
EG0044 events3 affected53 at risk
EG0057 events4 affected53 at risk
EG0068 events4 affected51 at risk
EG0076 events6 affected52 at risk
EG0081 events1 affected20 at risk
EG0091 events1 affected10 at risk
Headache, solicited
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG00014 events11 affected53 at risk
EG00123 events14 affected52 at risk
EG00221 events18 affected50 at risk
EG00331 events20 affected51 at risk
EG00412 events11 affected53 at risk
EG00517 events11 affected53 at risk
EG00619 events14 affected51 at risk
EG00726 events19 affected52 at risk
EG0084 events3 affected20 at risk
EG0091 events1 affected10 at risk
Pyrexia, solicited
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected53 at risk
EG0012 events2 affected52 at risk
EG0022 events2 affected50 at risk
EG0034 events4 affected51 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected51 at risk
EG0070 events0 affected52 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected10 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
PI may publish or release study data after the earlier of (a) the date of publication of a multi-center publication coordinated by Sponsor on the study data, or (b) the date of submission of the study data by Sponsor to regulatory authorities for regulatory approval; provided that PI furnishes Sponsor with a copy of any proposed publication or release at least ninety days in advance of the proposed submission or presentation date for review. PI must acknowledge Sponsor on any publication.
D000096724
Mosquito-Borne Diseases
D014777
Virus Diseases
D014036
Togaviridae Infections
D012327
RNA Virus Infections
0
BG0040
BG0051
BG0060
BG0070
BG0080
BG0090
BG0105
Between 18 and 65 years
BG00050
BG00151
BG00251
BG00350
BG00453
BG00552
BG00651
BG00752
BG00820
BG00910
BG010440
>=65 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
33.7
± 7.53
BG00430.6± 7.72
BG00532.9± 7.53
BG00632.4± 7.78
BG00731.6± 7.82
BG00827.1± 7.58
BG00929.6± 7.65
BG01031.5± 7.86
32
BG00438
BG00529
BG00627
BG00726
BG0087
BG0093
BG010259
Male
BG00023
BG00122
BG00214
BG00318
BG00415
BG00524
BG00624
BG00726
BG00813
BG0097
BG010186
3
BG0044
BG0058
BG0062
BG0074
BG0082
BG0091
BG01035
Not Hispanic or Latino
BG00050
BG00148
BG00247
BG00347
BG00449
BG00545
BG00649
BG00748
BG00818
BG0099
BG010410
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
0
BG0040
BG0051
BG0060
BG0070
BG0081
BG0090
BG0102
Asian
BG0000
BG0012
BG0021
BG0032
BG0040
BG0051
BG0060
BG0072
BG0081
BG0090
BG0109
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0041
BG0050
BG0061
BG0070
BG0080
BG0090
BG0102
Black or African American
BG00010
BG0019
BG00214
BG00313
BG00414
BG0059
BG00615
BG0077
BG0087
BG0096
BG010104
White
BG00043
BG00140
BG00236
BG00335
BG00436
BG00540
BG00634
BG00741
BG00811
BG0094
BG010320
More than one race
BG0000
BG0011
BG0020
BG0030
BG0042
BG0052
BG0061
BG0072
BG0080
BG0090
BG0108
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
50
BG00453
BG00553
BG00651
BG00752
BG00820
BG00910
BG010445
7.5
(7.5 to 7.5)
BG0047.8(7.5 to 50.3)
BG0057.5(7.5 to 7.5)
BG0067.5(7.5 to 7.5)
BG0077.5(7.5 to 7.5)
BG0088.6(7.5 to 117.1)
BG0099.0(7.5 to 46.1)
BG0107.6(7.5 to 117.1)
45
OG00448
OG00548
OG00647
OG00750
44
ParticipantsOG00447
ParticipantsOG00547
ParticipantsOG00647
ParticipantsOG00749
Title
Measurements
OG00070.6(53.2 to 93.7)
OG00134.3(25.6 to 46.1)
OG00272.6(54.2 to 97.2)
OG003117.6(87.8 to 157.4)
OG0048.4(6.3 to 11.1)
OG0057.5(5.7 to 10.0)
OG0067.5(5.7 to 10.0)
OG0077.5(5.7 to 9.9)
Day 15
ParticipantsOG00047
ParticipantsOG00144
ParticipantsOG00244
ParticipantsOG00345
ParticipantsOG00448
ParticipantsOG00548
ParticipantsOG00647
ParticipantsOG00750
Title
Measurements
OG000419.3(323.6 to 543.4)
OG001189.4(144.9 to 247.6)
OG002530.2(405.6 to 693.0)
OG003
Day 22
ParticipantsOG00047
ParticipantsOG00144
ParticipantsOG00244
ParticipantsOG00345
ParticipantsOG00448
ParticipantsOG00548
ParticipantsOG00647
ParticipantsOG00750
Title
Measurements
OG000691.5(499.2 to 957.9)
OG001351.3(250.9 to 492.0)
OG0021400.2(999.9 to 1960.8)
OG003
Day 29
ParticipantsOG00047
ParticipantsOG00144
ParticipantsOG00244
ParticipantsOG00345
ParticipantsOG00448
ParticipantsOG00548
ParticipantsOG00647
ParticipantsOG00750
Title
Measurements
OG000417.2(305.4 to 570.0)
OG001277.3(200.9 to 382.8)
OG002890.5(645.1 to 1229.2)
OG003
Day 36
ParticipantsOG00047
ParticipantsOG00144
ParticipantsOG00244
ParticipantsOG00345
ParticipantsOG00448
ParticipantsOG00548
ParticipantsOG00646
ParticipantsOG00750
Title
Measurements
OG0003442.8(2533.9 to 4677.8)
OG0011675.8(1220.9 to 2300.2)
OG0022772.4(2019.8 to 3805.4)
OG003
Day 57
ParticipantsOG00047
ParticipantsOG00144
ParticipantsOG00244
ParticipantsOG00345
ParticipantsOG00448
ParticipantsOG00548
ParticipantsOG00647
ParticipantsOG00750
Title
Measurements
OG0002057.0(1584.8 to 2670.0)
OG0011116.2(852.5 to 1461.4)
OG0021465.3(1119.1 to 1918.4)
OG003
45
OG00448
OG00548
OG00647
OG00750
43
ParticipantsOG00444
ParticipantsOG00546
ParticipantsOG00647
ParticipantsOG00748
Title
Measurements
OG000345.1(258.1 to 461.3)
OG001209.0(153.1 to 285.2)
OG002358.4(261.6 to 491.2)
OG003486.6(360.5 to 656.9)
OG004253.4(188.4 to 340.9)
OG005303(226.7 to 405.0)
OG006388.1(291.3 to 517.1)
OG007505.7(380.7 to 671.8)
Day 365
ParticipantsOG00042
ParticipantsOG00138
ParticipantsOG00236
ParticipantsOG00342
ParticipantsOG00441
ParticipantsOG00543
ParticipantsOG00643
ParticipantsOG00746
Title
Measurements
OG000243.4(176.8 to 334.9)
OG001137.5(98.3 to 192.3)
OG002226.7(160.6 to 320.0)
OG003
Day 547
ParticipantsOG00041
ParticipantsOG00144
ParticipantsOG00244
ParticipantsOG00341
ParticipantsOG00448
ParticipantsOG00548
ParticipantsOG00647
ParticipantsOG00740
Title
Measurements
OG000169.2(126.2 to 226.8)
OG001NA(NA to NA)Follow-up to Day 365 in this group.
OG002NA(NA to NA)Follow-up to Day 365 in this group.
OG003
Day 760
ParticipantsOG00040
ParticipantsOG00144
ParticipantsOG00244
ParticipantsOG00339
ParticipantsOG00448
ParticipantsOG00548
ParticipantsOG00647
ParticipantsOG00738
Title
Measurements
OG000169.8(122.4 to 235.5)
OG001NA(NA to NA)Follow-up to Day 365 in this group.
OG002NA(NA to NA)Follow-up to Day 365 in this group.
OG003
38
Title
Measurements
OG00012325.8(8951.4 to 16972.4)
Day 760 (post-boost)
ParticipantsOG00038
Title
Measurements
OG0005874.2(4269.4 to 8082.3)
45
OG00448
OG00548
OG00647
OG00750
45
OG00448
OG00548
OG00647
OG00750
Titer at or above 40
Title
Measurements
OG00047
OG00144
OG00243
OG00345
OG00448
OG00548
OG00647
OG00750
Titer at or above 160
Title
Measurements
OG00047
OG00142
OG00243
OG00345
OG00447
OG00548
OG00646
OG00750
Titer at or above 640
Title
Measurements
OG00043
OG00132
OG00241
OG00343
OG00429
OG00540
OG00641
OG00744
Titer at or above 4-fold rise over baseline
Title
Measurements
OG00047
OG00144
OG00243
OG00345
OG00448
OG00548
OG00647
OG00750
912.7
(700.4 to 1189.5)
OG0047.7(6.0 to 10.0)
OG0057.5(5.8 to 9.7)
OG0067.7(5.9 to 9.9)
OG0077.5(5.8 to 9.6)
2198.1
(1575.6 to 3066.5)
OG00446.4(33.6 to 64.1)
OG00563.1(45.7 to 87.1)
OG006119.0(85.9 to 164.9)
OG0077.5(5.5 to 10.3)
1238.1
(900.2 to 1702.9)
OG004258.0(189.5 to 351.3)
OG005328.8(241.5 to 447.6)
OG006886.2(648.7 to 1210.5)
OG0078.2(6.0 to 11.0)
3435.0
(2511.4 to 4698.1)
OG0041327.7(980.4 to 1797.9)
OG0052155.4(1591.6 to 2919.0)
OG0063609.0(2647.7 to 4919.3)
OG007157.9(117.3 to 212.6)
2023.8
(1550.5 to 2641.7)
OG004920.1(710.9 to 1190.9)
OG0051206.9(932.4 to 1562.2)
OG0061562.8(1204.1 to 2028.3)
OG0071712.5(1330.0 to 2205.0)
336.6
(244.6 to 463.2)
OG004195.2(141.3 to 269.6)
OG005246.9(180.1 to 338.4)
OG006302.0(220.3 to 414.0)
OG007491.7(362.5 to 667.0)
215.7
(160.9 to 289.1)
OG004NA(NA to NA)Follow-up to Day 365 in this group.
OG005NA(NA to NA)Follow-up to Day 365 in this group.
OG006NA(NA to NA)Follow-up to Day 365 in this group.
OG007297.9(221.4 to 400.8)
5365.1
(3853.2 to 7470.1)
OG004NA(NA to NA)Follow-up to Day 365 in this group.
OG005NA(NA to NA)Follow-up to Day 365 in this group.
OG006NA(NA to NA)Follow-up to Day 365 in this group.