Safety, Tolerability, and Immunogenicity of VAL-181388 in... | NCT03325075 | Trialant
NCT03325075
Sponsor
ModernaTX, Inc.
Status
Completed
Last Update Posted
Jun 10, 2024Actual
Enrollment
60Actual
Phase
Phase 1
Conditions
Chikungunya Virus
Interventions
VAL-181388
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
NCT03325075
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
VAL-181388-P101
Secondary IDs
ID
Type
Description
Link
W911NF-13-1-0417
Other Grant/Funding Number
Defense Advanced Research Projects Agency (DARPA)
Brief Title
Safety, Tolerability, and Immunogenicity of VAL-181388 in Healthy Participants
Official Title
A Phase 1, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Immunogenicity of VAL-181388 in Healthy Adults in a Non-endemic Chikungunya Region
Acronym
Not provided
Organization
ModernaTX, Inc.INDUSTRY
Status Module
Record Verification Date
Dec 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
Jul 19, 2017Actual
Primary Completion Date
Mar 19, 2019Actual
Completion Date
Mar 19, 2019Actual
First Submitted Date
Oct 20, 2017
First Submission Date that Met QC Criteria
Oct 24, 2017
First Posted Date
Oct 30, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Dec 21, 2023
Results First Submitted that Met QC Criteria
Dec 21, 2023
Results First Posted Date
Jun 10, 2024Actual
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
Dec 21, 2023
Last Update Posted Date
Jun 10, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ModernaTX, Inc.INDUSTRY
Collaborators
Name
Class
Defense Advanced Research Projects Agency
FED
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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
This clinical study will assess the safety, tolerability, and immunogenicity of VAL-181388 in healthy participants.
Detailed Description
Not provided
Conditions Module
Conditions
Chikungunya Virus
Keywords
VAL-181388
Chikungunya vaccine
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
60Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
VAL-181388
Experimental
Biological: VAL-181388
Placebo
Placebo Comparator
Other: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
VAL-181388
Biological
Escalating dose levels
VAL-181388
Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part A: Number of Participants With Any Solicited Adverse Events (AEs) (Local and Systemic Reactogenicity Events)
Solicited AEs, including local and systemic AEs were recorded by participants daily using the memory aid. Solicited local AEs include injection site induration/swelling, injection site tenderness, injection site erythema/redness, and injection site pain. Solicited systemic AEs include body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, and diarrhea. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
7 days following each vaccination
Part A: Number of Participants With Unsolicited AEs
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
28 days following each vaccination
Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest
An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner (HCP). An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AEs of special interest were evaluated as defined in the protocol. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
28 days following each vaccination
Part B: Number of Participants With SAEs and AEs of Special Interest
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
18 to 49 years of age
Body mass index between 18 and 35 kilograms (kg)/square meter (m^2)
In good health as determined by medical history
Female participants must be non pregnant and non lactating and meet one of the following criteria: a) post menopausal b) surgically sterile, or c) of childbearing potential and agree to use an adequate contraception method
Male participants must use an acceptable method of birth control through 3 months after the final vaccination
Agrees to comply with the study procedures and provides written informed consent
Has access to a consistent and reliable means of telephone contact and agrees to stay in contact with the study site for the duration of the study
Exclusion Criteria:
Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care
Female of childbearing potential and has a positive pregnancy test at screening or on the day of vaccination
Abnormal vital signs or screening safety laboratory test results including liver enzyme tests
Administration of an investigational product within 60 days, or 5 half-lives, whichever is longer
Administration of any live attenuated vaccines within 4 weeks before enrollment or inactive vaccines within 2 weeks before enrollment, or plans to receive any vaccine during the active vaccination period
Prior administration of a vaccine for chikungunya virus (CHIKV), dengue, Yellow Fever, tick-borne encephalitis, a history of confirmed or suspected CHIKV infection, or has lived in a CHIKV-endemic area greater than 1 year or cumulative stay of greater than 30 days in 5 years
Prior administration of investigational agent using formulations similar to VAL-181388
A history of hypersensitivity or serious reactions to previous vaccinations
Any known or suspected autoimmune disease or immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination
A history of inflammatory arthritis
Any neurologic disorder
Prior administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study drug or plans to receive such products at any time during the study
Any chronic administration of an immunosuppressant or other immune modifying drug
Daily or every other day administration of antipyretic or analgesic medication
Any acute illness at the time of enrollment
Any significant disorder of coagulation requiring ongoing or intermittent treatment
A history of idiopathic urticaria
A history of alcohol abuse or drug addiction
A positive test result for drugs of abuse
The participant has any abnormality or permanent body art (for example, tattoo) that, in the opinion of the investigator, would obstruct the ability to observe local reactions at the injection site
Any condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the study drug or interpretation of study results
A positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies
A history of active cancer (malignancy) in the last 10 years
Donation of blood or blood products >450 milliliters (mL) within 30 days of dosing
Is an employee or first degree relative of the Sponsor, clinical research organization (CRO), or study site personnel
Shaw CA, August A, Bart S, Booth PJ, Knightly C, Brasel T, Weaver SC, Zhou H, Panther L. A phase 1, randomized, placebo-controlled, dose-ranging study to evaluate the safety and immunogenicity of an mRNA-based chikungunya virus vaccine in healthy adults. Vaccine. 2023 Jun 13;41(26):3898-3906. doi: 10.1016/j.vaccine.2023.04.064. Epub 2023 May 18.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
VAL-181388 Dose A
Participants received 2 intramuscular (IM) injections of VAL-181388 Dose A separated by 28 days.
FG001
VAL-181388 Dose B
Participants received 2 IM injections of VAL-181388 Dose B separated by 28 days.
FG002
VAL-181388 Dose C
Participants received 2 IM injections of VAL-181388 Dose C separated by 28 days.
FG003
Placebo
Participants received 2 IM injections of VAL-181388 matched placebo separated by 28 days.
Periods
Title
Milestones
Reasons Not Completed
Part A: Dose Escalation (28 Days)
Type
Comment
Milestone Data
STARTED
FG00015 subjects
FG00115 subjects
FG00215 subjects
FG00315 subjects
Received Vaccination 1
FG00015 subjects
FG00115 subjects
FG00215 subjects
FG00315 subjects
Received Vaccination 2
FG00015 subjects
FG00114 subjects
FG00214 subjects
FG00315 subjects
COMPLETED
FG00015 subjects
FG00115 subjects
FG00215 subjects
FG00315 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Part B: Follow-up (Up to 364 Days)
Type
Comment
Milestone Data
STARTED
FG00015 subjects
FG00115 subjects
FG00215 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
VAL-181388 Dose A
Participants received 2 IM injections of VAL-181388 Dose A separated by 28 days.
BG001
VAL-181388 Dose B
Participants received 2 IM injections of VAL-181388 Dose B separated by 28 days.
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, Continuous
Mean
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
Part A: Number of Participants With Any Solicited Adverse Events (AEs) (Local and Systemic Reactogenicity Events)
Solicited AEs, including local and systemic AEs were recorded by participants daily using the memory aid. Solicited local AEs include injection site induration/swelling, injection site tenderness, injection site erythema/redness, and injection site pain. Solicited systemic AEs include body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, and diarrhea. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo). Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
7 days following each vaccination
ID
Title
Description
OG000
Adverse Events Module
Frequency Threshold
0
Time Frame
Through 1 year following the last vaccination
Description
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 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
Part A - VAL-181388 Dose A: Vaccination 1
Participants received first IM injection of VAL-181388 Dose A.
An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AEs of special interest were evaluated as defined in the protocol. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Through 1 year following the last vaccination
15 subjects
COMPLETED
FG00013 subjects
FG00113 subjects
FG00215 subjects
FG00313 subjects
NOT COMPLETED
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG0032 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Other than specified
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
BG002
VAL-181388 Dose C
Participants received 2 IM injections of VAL-181388 Dose C separated by 28 days.
BG003
Placebo
Participants received 2 IM injections of VAL-181388 matched placebo separated by 28 days.
BG004
Total
Total of all reporting groups
15
BG00115
BG00215
BG00315
BG00460
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00032.1± 8.45
BG00133.0± 6.76
BG00232.2± 8.46
BG00329.1± 5.18
BG00431.6± 7.30
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0007
BG0019
BG00210
BG0038
BG00434
Male
BG0008
BG0016
BG0025
BG0037
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0003
BG0012
BG0021
BG0031
BG0047
Not Hispanic or Latino
BG00012
BG00113
BG00214
BG00314
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG0010
BG0020
BG0030
BG0041
Asian
BG0000
BG0011
BG0020
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0031
BG004
Black or African American
BG0007
BG0016
BG0027
BG0036
BG004
White
BG0007
BG0017
BG0027
BG0037
BG004
More than one race
BG0000
BG0011
BG0021
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0031
BG004
VAL-181388 Dose A: Vaccination 1
Participants received first IM injection of VAL-181388 Dose A.
OG001
VAL-181388 Dose A: Vaccination 2
Participants received second IM injection of VAL-181388 Dose A.
OG002
VAL-181388 Dose B: Vaccination 1
Participants received first IM injection of VAL-181388 Dose B.
OG003
VAL-181388 Dose B: Vaccination 2
Participants received second IM injection of VAL-181388 Dose B.
OG004
VAL-181388 Dose C: Vaccination 1
Participants received first IM injection of VAL-181388 Dose C.
OG005
VAL-181388 Dose C: Vaccination 2
Participants received second IM injection of VAL-181388 Dose C.
OG006
Placebo: Vaccination 1
Participants received first IM injection of VAL-181388 matched placebo.
OG007
Placebo: Vaccination 2
Participants received second IM injection of VAL-181388 matched placebo.
Units
Counts
Participants
OG00015
OG00115
OG00214
OG00313
OG00415
OG00514
OG00615
OG00715
Title
Denominators
Categories
Title
Measurements
OG00011
OG00110
OG00211
OG00310
OG00413
OG00512
OG0067
OG0075
Primary
Part A: Number of Participants With Unsolicited AEs
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
Posted
Count of Participants
Participants
28 days following each vaccination
ID
Title
Description
OG000
VAL-181388 Dose A: Vaccination 1
Participants received first IM injection of VAL-181388 Dose A.
OG001
VAL-181388 Dose A: Vaccination 2
Participants received second IM injection of VAL-181388 Dose A.
OG002
VAL-181388 Dose B: Vaccination 1
Participants received first IM injection of VAL-181388 Dose B.
OG003
VAL-181388 Dose B: Vaccination 2
Participants received second IM injection of VAL-181388 Dose B.
OG004
VAL-181388 Dose C: Vaccination 1
Participants received first IM injection of VAL-181388 Dose C.
OG005
VAL-181388 Dose C: Vaccination 2
Participants received second IM injection of VAL-181388 Dose C.
OG006
Placebo: Vaccination 1
Participants received first IM injection of VAL-181388 matched placebo.
OG007
Placebo: Vaccination 2
Participants received second IM injection of VAL-181388 matched placebo.
Units
Counts
Participants
OG00015
OG00115
OG00215
OG003
Title
Denominators
Categories
Title
Measurements
OG0004
OG0013
OG0026
OG003
Primary
Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest
An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner (HCP). An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AEs of special interest were evaluated as defined in the protocol. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
Posted
Count of Participants
Participants
28 days following each vaccination
ID
Title
Description
OG000
VAL-181388 Dose A: Vaccination 1
Participants received first IM injection of VAL-181388 Dose A.
OG001
VAL-181388 Dose A: Vaccination 2
Participants received second IM injection of VAL-181388 Dose A.
OG002
VAL-181388 Dose B: Vaccination 1
Participants received first IM injection of VAL-181388 Dose B.
OG003
VAL-181388 Dose B: Vaccination 2
Participants received second IM injection of VAL-181388 Dose B.
OG004
VAL-181388 Dose C: Vaccination 1
Participants received first IM injection of VAL-181388 Dose C.
OG005
VAL-181388 Dose C: Vaccination 2
Participants received second IM injection of VAL-181388 Dose C.
OG006
Placebo: Vaccination 1
Participants received first IM injection of VAL-181388 matched placebo.
OG007
Placebo: Vaccination 2
Participants received second IM injection of VAL-181388 matched placebo.
Units
Counts
Participants
OG00015
OG00115
OG00215
OG003
Title
Denominators
Categories
SAEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part B: Number of Participants With SAEs and AEs of Special Interest
An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AEs of special interest were evaluated as defined in the protocol. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
Posted
Count of Participants
Participants
Through 1 year following the last vaccination
ID
Title
Description
OG000
VAL-181388 Dose A
Participants who received VAL-181388 Dose A in Part A, were followed up for longer-term safety and immune persistence in Part B.
OG001
VAL-181388 Dose B
Participants who received VAL-181388 Dose B in Part A, were followed up for longer-term safety and immune persistence in Part B.
OG002
VAL-181388 Dose C
Participants who received VAL-181388 Dose C in Part A, were followed up for longer-term safety and immune persistence in Part B.
OG003
Placebo
Participants who received VAL-181388 matched placebo in Part A, were followed up for longer-term safety and immune persistence in Part B.
Units
Counts
Participants
OG00015
OG00115
OG00215
OG003
Title
Denominators
Categories
SAEs
Title
Measurements
OG0000
OG0010
OG0021
OG003
0
15
0
15
4
15
EG001
Part A - VAL-181388 Dose A: Vaccination 2
Participants received second IM injection of VAL-181388 Dose A.
0
15
0
15
3
15
EG002
Part A - VAL-181388 Dose B: Vaccination 1
Participants received first IM injection of VAL-181388 Dose B.
0
15
0
15
6
15
EG003
Part A - VAL-181388 Dose B: Vaccination 2
Participants received second IM injection of VAL-181388 Dose B.
0
14
0
14
3
14
EG004
Part A - VAL-181388 Dose C: Vaccination 1
Participants received first IM injection of VAL-181388 Dose C.
0
15
0
15
3
15
EG005
Part A - VAL-181388 Dose C: Vaccination 2
Participants received second IM injection of VAL-181388 Dose C.
0
14
1
14
6
14
EG006
Part A - Placebo: Vaccination 1
Participants received first IM injection of VAL-181388 matched placebo.
0
15
0
15
8
15
EG007
Part A - Placebo: Vaccination 2
Participants received second IM injection of VAL-181388 matched placebo.
0
15
0
15
6
15
EG008
Part B - VAL-181388 Dose A
Participants who received VAL-181388 Dose A in Part A, were followed up for longer-term safety and immune persistence in Part B.
0
15
0
15
0
15
EG009
Part B - VAL-181388 Dose B
Participants who received VAL-181388 Dose B in Part A, were followed up for longer-term safety and immune persistence in Part B.
0
15
0
15
0
15
EG010
Part B - VAL-181388 Dose C
Participants who received VAL-181388 Dose C in Part A, were followed up for longer-term safety and immune persistence in Part B.
0
15
1
15
0
15
EG011
Part B - Placebo
Participants who received VAL-181388 matched placebo in Part A, were followed up for longer-term safety and immune persistence in Part B.