Safety and Immunogenicity Study of LC16m8, a Modified Smallpox Vaccine, in Healthy, Previously Unvaccinated Volunteers

Exclusion Criteria

• •Planning to move within 52 weeks from the time of vaccination.
• •Known allergy to any materials used in this study or components of the vaccines, which may include erythromycin, streptomycin, chlortetracycline, polymyxin B, neomycin, phenol, glycerin, Vaccinia Immune Globulin (VIG), immunoglobulin, blood products containing immunoglobulin preparations, cidofovir, probenecid, and/or bandage adhesive tape.
• •Pregnant or breastfeeding, or have close contact\*\* with someone who is pregnant or breastfeeding.
• •Active or past history of atopic dermatitis or eczema, or close contact\*\* with someone with active or past history of atopic dermatitis or eczema.
• •Presence of (or close contact\*\* or sharing a household with) a skin condition with extensive breaks in the skin such as burns, impetigo, contact dermatitis, or zoster (shingles) not likely to heal by the day of vaccination.
• •Darier's disease or close contact\*\* with Darier's disease.
• •Immunosuppression (including HIV), or close contact\*\* with an immunosuppressed individual.
• •Using immunosuppressive medications, in eye drops, by mouth, or topically (corticosteroid nasal sprays and inhalers are permissible at low doses after discussion with VaxGen Medical Monitor).
• •Close contact\*\* with children under 1 year old.
• •Active or past malignancy with the exception of non-metastatic skin cancers.
• •History of exuberant keloid formation.\*
• •Known cardiac disease or three or more cardiac risk factors (high blood pressure, diabetes mellitus, smoking, hypercholesterolemia, heart disease at age 50 or earlier in a first-degree relative, or obesity \[defined as Body Mass Index (BMI)\>30\]).
• •Currently under treatment for high blood pressure.
• •History of solid organ or bone marrow transplantation.
• •Evidence of immunosuppression or autoimmune disease, cardiac disease, renal disease, splenectomy, or unstable medical condition as determined by baseline medical history, physical assessment, or laboratory assessments.
• •Neurological or psychological condition that may place volunteer at heightened risk from vaccination.
• •Psychiatric condition that precludes compliance with the protocol.
• •Received or plan to receive live vaccines 30 days before or after study vaccination.
• •Received or plan to receive subunit or killed vaccines 14 days before or after study vaccination.
• •Received or plan to receive immunoglobulin or other blood products 60 days prior to HIV screening or study vaccination.
• •Received or plan to receive experimental drugs/vaccines 30 days before study vaccination or prior to study completion.
• •Received or plan to receive systemic immunosuppressive therapy or radiation therapy 30 days before study vaccination or prior to study completion.
• •Served in military conflicts and received smallpox vaccination, or military service prior to 1989.
• •* As determined by the Principal Investigator (PI).
• •* Close contact = frequent physical contact or sharing linen/clothing.