Study to Evaluate the Safety and Immunogenicity of Poly ICLC (Hiltonol) in Healthy Volunteers

Inclusion criteria

• Healthy adult males and females, as assessed by a medical history, physical exam, and laboratory tests
• Age of at least 18 years on the day of screening and no greater than 60 years at time of drug/placebo administration
• Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study (screening plus 4 weeks)
• In the opinion of the principal investigator or designee, has understood the information provided. Written informed consent needs to be given before any study-related procedures are performed
• Willing to undergo HIV testing and counseling, and receive HIV test results
• If a sexually active male, willing to use an effective method of contraception (condoms, anatomical sterility) throughout the study period and will be advised not to get his partner pregnant for 6 weeks after study drug administration
• Females of child-bearing potential must agree to use one of the following methods of contraception for 2 weeks prior to date of screening evaluation through 6 weeks after study drug administration:

• Be surgically sterile Be abstinent (or willing to be)
• Use oral contraceptives, or other form of hormonal birth control including hormonal vaginal rings or transdermal patches
• Use an intra-uterine device (IUD)
• Use (by ensuring her male partner(s) uses) barrier contraception (condom) with spermicide
• Any other equivalent (as judged by the investigative team) methods of contraception

Exclusion criteria

• Any clinically significant abnormality on history or examination including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive, anticancer, or other medications considered significant by the trial physician within the last 6 months
• Confirmed HIV-1 or HIV-2 infection
• A medical history that includes any chronic medical problem that requires daily topical nasal medications, prior nasal or sinus surgery (including trans-nasal approaches of other organs such as pituitary, allergic rhinitis, chronic sinusitis, or any other nasal inflammatory disease that requires daily intranasal or oral medication)
• A medical history that includes any chronic pulmonary conditions including but not limited to asthma, chronic obstructive pulmonary disease and chronic bronchitis
• Any clinically significant acute or chronic medical conditions requiring care of a physician (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that in the opinion of the investigator would preclude participation
• Any laboratory value outside of reference range, with the exception of any non-clinically significant Grade 1 elevations of liver function tests (AST, ALT, direct/total bilirubin), CBC, as determined by the Principal Investigator or her designee
• Confirmed diagnosis of hepatitis B (surface antigen, HbsAg); hepatitis C (HCV antibodies) or active syphilis
• If female, pregnant, planning a pregnancy during the trial period or lactating
• Receipt of a live attenuated vaccine within 30 days or other vaccine within 14 days of poly ICLC administration
• Receipt of blood transfusion or blood products 6 months prior to drug administration