Safety, Tolerability, and Immunogenicity of VAL-181388 in Healthy Subjects

This is an interventional prevention trial for Chikungunya Virus focused on measuring VAL-181388, Chikungunya vaccine Read More

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