Chikungunya Virus
Conditions
Keywords
VAL-181388, Chikungunya vaccine
Brief summary
This clinical study will assess the safety, tolerability, and immunogenicity of VAL-181388 in healthy participants.
Interventions
BIOLOGICALVAL-181388
Escalating dose levels
OTHERPlacebo
Saline
Sponsors
Defense Advanced Research Projects Agency
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Double Blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Number of Participants With Any Solicited Adverse Events (AEs) (Local and Systemic Reactogenicity Events) | 7 days following each vaccination | 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. |
| Part A: Number of Participants With Unsolicited AEs | 28 days following each vaccination | 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. |
| Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest | 28 days following each vaccination | 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. |
| Part B: Number of Participants With SAEs and AEs of Special Interest | Through 1 year following the last vaccination | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VAL-181388 Dose A Participants received 2 IM injections of VAL-181388 Dose A separated by 28 days. | 15 |
| VAL-181388 Dose B Participants received 2 IM injections of VAL-181388 Dose B separated by 28 days. | 15 |
| VAL-181388 Dose C Participants received 2 IM injections of VAL-181388 Dose C separated by 28 days. | 15 |
| Placebo Participants received 2 IM injections of VAL-181388 matched placebo separated by 28 days. | 15 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Part B: Follow-up (Up to 364 Days) | Lost to Follow-up | 2 | 0 | 0 | 0 |
| Part B: Follow-up (Up to 364 Days) | Other than specified | 0 | 1 | 0 | 2 |
| Part B: Follow-up (Up to 364 Days) | Withdrawal by Subject | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | VAL-181388 Dose A | VAL-181388 Dose B | VAL-181388 Dose C | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 32.1 years STANDARD_DEVIATION 8.45 | 33.0 years STANDARD_DEVIATION 6.76 | 32.2 years STANDARD_DEVIATION 8.46 | 29.1 years STANDARD_DEVIATION 5.18 | 31.6 years STANDARD_DEVIATION 7.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 1 Participants | 1 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 13 Participants | 14 Participants | 14 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 6 Participants | 7 Participants | 6 Participants | 26 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 7 Participants | 7 Participants | 7 Participants | 7 Participants | 28 Participants |
| Sex: Female, Male Female | 7 Participants | 9 Participants | 10 Participants | 8 Participants | 34 Participants |
| Sex: Female, Male Male | 8 Participants | 6 Participants | 5 Participants | 7 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 14 | 0 / 15 | 0 / 14 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 4 / 15 | 3 / 15 | 6 / 15 | 3 / 14 | 3 / 15 | 6 / 14 | 8 / 15 | 6 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 14 | 0 / 15 | 1 / 14 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 1 / 15 | 0 / 15 |
Outcome results
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.
Time frame: 7 days following each vaccination
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VAL-181388 Dose A: Vaccination 1 | Part A: Number of Participants With Any Solicited Adverse Events (AEs) (Local and Systemic Reactogenicity Events) | 11 Participants |
| VAL-181388 Dose A: Vaccination 2 | Part A: Number of Participants With Any Solicited Adverse Events (AEs) (Local and Systemic Reactogenicity Events) | 10 Participants |
| VAL-181388 Dose B: Vaccination 1 | Part A: Number of Participants With Any Solicited Adverse Events (AEs) (Local and Systemic Reactogenicity Events) | 11 Participants |
| VAL-181388 Dose B: Vaccination 2 | Part A: Number of Participants With Any Solicited Adverse Events (AEs) (Local and Systemic Reactogenicity Events) | 10 Participants |
| VAL-181388 Dose C: Vaccination 1 | Part A: Number of Participants With Any Solicited Adverse Events (AEs) (Local and Systemic Reactogenicity Events) | 13 Participants |
| VAL-181388 Dose C: Vaccination 2 | Part A: Number of Participants With Any Solicited Adverse Events (AEs) (Local and Systemic Reactogenicity Events) | 12 Participants |
| Placebo: Vaccination 1 | Part A: Number of Participants With Any Solicited Adverse Events (AEs) (Local and Systemic Reactogenicity Events) | 7 Participants |
| Placebo: Vaccination 2 | Part A: Number of Participants With Any Solicited Adverse Events (AEs) (Local and Systemic Reactogenicity Events) | 5 Participants |
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.
Time frame: 28 days following each vaccination
Population: The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VAL-181388 Dose A: Vaccination 1 | Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest | SAEs | 0 Participants |
| VAL-181388 Dose A: Vaccination 1 | Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest | AEs of Special Interest | 0 Participants |
| VAL-181388 Dose A: Vaccination 1 | Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest | Medically-Attended AEs | 1 Participants |
| VAL-181388 Dose A: Vaccination 2 | Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest | AEs of Special Interest | 0 Participants |
| VAL-181388 Dose A: Vaccination 2 | Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest | SAEs | 0 Participants |
| VAL-181388 Dose A: Vaccination 2 | Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest | Medically-Attended AEs | 0 Participants |
| VAL-181388 Dose B: Vaccination 1 | Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest | AEs of Special Interest | 0 Participants |
| VAL-181388 Dose B: Vaccination 1 | Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest | SAEs | 0 Participants |
| VAL-181388 Dose B: Vaccination 1 | Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest | Medically-Attended AEs | 0 Participants |
| VAL-181388 Dose B: Vaccination 2 | Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest | AEs of Special Interest | 0 Participants |
| VAL-181388 Dose B: Vaccination 2 | Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest | SAEs | 0 Participants |
| VAL-181388 Dose B: Vaccination 2 | Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest | Medically-Attended AEs | 0 Participants |
| VAL-181388 Dose C: Vaccination 1 | Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest | SAEs | 0 Participants |
| VAL-181388 Dose C: Vaccination 1 | Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest | AEs of Special Interest | 0 Participants |
| VAL-181388 Dose C: Vaccination 1 | Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest | Medically-Attended AEs | 0 Participants |
| VAL-181388 Dose C: Vaccination 2 | Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest | Medically-Attended AEs | 0 Participants |
| VAL-181388 Dose C: Vaccination 2 | Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest | SAEs | 1 Participants |
| VAL-181388 Dose C: Vaccination 2 | Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest | AEs of Special Interest | 0 Participants |
| Placebo: Vaccination 1 | Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest | SAEs | 0 Participants |
| Placebo: Vaccination 1 | Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest | Medically-Attended AEs | 0 Participants |
| Placebo: Vaccination 1 | Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest | AEs of Special Interest | 0 Participants |
| Placebo: Vaccination 2 | Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest | SAEs | 0 Participants |
| Placebo: Vaccination 2 | Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest | AEs of Special Interest | 0 Participants |
| Placebo: Vaccination 2 | Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest | Medically-Attended AEs | 1 Participants |
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.
Time frame: 28 days following each vaccination
Population: The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VAL-181388 Dose A: Vaccination 1 | Part A: Number of Participants With Unsolicited AEs | 4 Participants |
| VAL-181388 Dose A: Vaccination 2 | Part A: Number of Participants With Unsolicited AEs | 3 Participants |
| VAL-181388 Dose B: Vaccination 1 | Part A: Number of Participants With Unsolicited AEs | 6 Participants |
| VAL-181388 Dose B: Vaccination 2 | Part A: Number of Participants With Unsolicited AEs | 3 Participants |
| VAL-181388 Dose C: Vaccination 1 | Part A: Number of Participants With Unsolicited AEs | 3 Participants |
| VAL-181388 Dose C: Vaccination 2 | Part A: Number of Participants With Unsolicited AEs | 6 Participants |
| Placebo: Vaccination 1 | Part A: Number of Participants With Unsolicited AEs | 8 Participants |
| Placebo: Vaccination 2 | Part A: Number of Participants With Unsolicited AEs | 6 Participants |
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.
Time frame: Through 1 year following the last vaccination
Population: The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VAL-181388 Dose A: Vaccination 1 | Part B: Number of Participants With SAEs and AEs of Special Interest | SAEs | 0 Participants |
| VAL-181388 Dose A: Vaccination 1 | Part B: Number of Participants With SAEs and AEs of Special Interest | AEs of Special Interest | 0 Participants |
| VAL-181388 Dose A: Vaccination 2 | Part B: Number of Participants With SAEs and AEs of Special Interest | AEs of Special Interest | 0 Participants |
| VAL-181388 Dose A: Vaccination 2 | Part B: Number of Participants With SAEs and AEs of Special Interest | SAEs | 0 Participants |
| VAL-181388 Dose B: Vaccination 1 | Part B: Number of Participants With SAEs and AEs of Special Interest | AEs of Special Interest | 0 Participants |
| VAL-181388 Dose B: Vaccination 1 | Part B: Number of Participants With SAEs and AEs of Special Interest | SAEs | 1 Participants |
| VAL-181388 Dose B: Vaccination 2 | Part B: Number of Participants With SAEs and AEs of Special Interest | AEs of Special Interest | 0 Participants |
| VAL-181388 Dose B: Vaccination 2 | Part B: Number of Participants With SAEs and AEs of Special Interest | SAEs | 0 Participants |