H5N1 With or Without Topical Aldara in Healthy Adults

Exclusion Criteria

• •5. Oral temperature is less than 100.0 degrees F.
• •6. Pulse is 47 to 100 bpm, inclusive.
• •7. Systolic blood pressure is 85 to 150 mm Hg, inclusive.
• •8. Diastolic blood pressure is 55 to 95 mmHg, inclusive.
• •9. Women of childbearing potential must use an acceptable method of contraception from 30 days prior to vaccination until 60 days after the last study vaccination.
• •\- Not sterilized via tubal ligation, bilateral oophorectomy, hysterectomy, or successful Essure(R) placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or \< 1 year of the last menses if menopausal).
• •\-- Includes non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with a vasectomized partner, male condoms with the use of applied spermicide, intrauterine devices, NuvaRing(R), and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill"). Method of contraception will be captured on the appropriate data collection form.
• •10. Female subjects of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccination.
• •1. Have an acute illness, as determined by the site PI or appropriate sub-investigator, within 72 hours prior to study vaccination.
• •\- An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
• •2. Have any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, is a contraindication to study participation.
• •\- Including acute or chronic medical disease or condition, defined as persisting for at least 90 days, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this study.
• •3. Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
• •4. Have known active neoplastic disease or a history of any hematologic malignancy. Non-melanoma skin cancers that are not active are permitted.
• •5. Have known HIV, chronic hepatitis B virus, or chronic hepatitis C infection.
• •6. Have known hypersensitivity or allergy to eggs, egg or chicken protein, or other components of the study vaccine.
• •7. Have a history of severe reactions following previous immunization with licensed or unlicensed influenza vaccines.
• •8. Have a history of Guillain-Barré Syndrome.
• •9. Have a history of alcohol or drug abuse within 5 years prior to study vaccination.
• •10. Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations.
• •11. Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 10 years prior to study vaccination.
• •12. Have taken oral or parenteral (including intraarticular) corticosteroids of any dose within 30 days prior to study vaccination.
• •13. Have taken high-dose dose inhaled corticosteroids within 30 days prior to study vaccination.
• •\- High-dose defined as the dose in mcg/day of an inhaled steroid used alone or in combination with other inhaled medications. Available at: https://www.nhlbi.nih.gov/health-pro/guidelines/current/asthma-guidelines/quick-reference-html#estimated-comparative-daily-doses
• •\-- Topical and nasal steroids are permissible.
• •14. Received any licensed live vaccine within 30 days prior to the first study vaccination.
• •15. Received a licensed inactivated vaccine within 14 days prior to the first study vaccination.
• •16. Plans to receive any licensed vaccine from the time of the first study vaccination through the follow-up visit at approximately 21 days after the last study vaccination.
• •17. Received immunoglobulin or other blood products (with exception of Rho D immunoglobulin) within 90 days prior to study vaccination.
• •18. Received an experimental agent within 30 days prior to the first study vaccination, or expects to receive an experimental agent during study paticipation.
• •\- Including vaccine, drug, biologic, device, blood product, or medication.
• •\-- Other than from participation in this study.
• •19. Are participating or plan to participate in another clinical trial with an interventional agent that will be received during study participation.
• •-Including agent (licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication) during the 7-month study period.
• •20. Prior participation in a clinical trial of influenza A/H5 vaccine or have a history of A/H5 actual or potential exposure or infection prior to the first study vaccination.
• •\- Assigned to a group receiving influenza A/H5 vaccine (does not apply to documented placebo recipients)
• •21. Plan to travel outside the U.S. (continental U.S., Hawaii and Alaska) in the time between the first study vaccination and 21 days after the last study vaccination.
• •22. Female subjects who are breastfeeding.
• •23. Blood donation or planned blood donation within 30 days prior to the study vaccination through 30 days after the last blood drawn for this study.
• •24. Have signs or symptoms that could confound or confuse assessment of study vaccine reactogenicity.
• •\- The study vaccination should be postponed/deferred until signs or symptoms have resolved and if within the acceptable protocol-specified window for that visit.
• •25. Receiving or planning to receive Aldara, imiquimod or resiquimod for any clinical indication during the duration of study participation.
• •26. Patients with autoimmune skin diseases such as psoriasis or atopic dermatitis.
• •27. Known allergy to Aldara or its components, and/or to aqueous cream B.P.
• •\- Methyl hydroxybenzoate (E 218) and propyl hydroxybenzoate (E 216) may cause allergic reactions (possibly delayed). Cetyl alcohol and stearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
• •\-- Liquid paraffin, white soft paraffin, cetostearyl alcohol, sodium lauryl sulfate, phenoxyethanol may cause local skin reactions (e.g. contact dermatitis).
• •28. Presence of large or dark tattoos on the deltoid area that would significantly interfere with reactogenicity assessment.