Safety, Tolerability, and Immunogenicity of VAL-181388 in Healthy Subjects
Study Details
Study Description
Brief Summary
This clinical study will assess the safety, tolerability, and immunogenicity of VAL-181388 in healthy subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: VAL-181388
|
Biological: VAL-181388
Escalating dose levels
|
| Placebo Comparator: Placebo
|
Other: Placebo
Saline
|
Outcome Measures
Primary Outcome Measures
- Types of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESI) and laboratory abnormalities [Through 13 months of study participation]
- Frequency of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESI) and laboratory abnormalities [Through 13 months of study participation]
- Severity of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESI) and laboratory abnormalities [Through 13 months of study participation]
Secondary Outcome Measures
- Frequency of seroconversion to CHIKV measured by neutralization assay in comparison with baseline [Through 13 months of study participation]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 to 49 years of age
-
Body mass index between 18 and 35 kg/m2
-
In good health as determined by medical history
-
Female subjects 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 subjects 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 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 subject has any abnormality or permanent body art (eg, 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 subject 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 mL within 30 days of dosing
-
Is an employee or first degree relative of the Sponsor, CRO, or study site personnel
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Optimal Research | Rockville | Maryland | United States | 20850 |
Sponsors and Collaborators
- ModernaTX, Inc.
- Defense Advanced Research Projects Agency
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VAL-181388-P101
- W911NF-13-1-0417