ACAM 3000 MVA at Harvard Medical School

Inclusion Criteria

General:

• Age: greater than or equal to 18 and born after 1971.
• Complete a written assessment of understanding prior to enrollment and verbalize understanding of all questions answered incorrectly.
• Informed consent: Be able, willing, and have signed the informed consent form.
• Health: Be in good general health without clinically significant medical history, physical examination findings, or clinically significant abnormal laboratory results. A clinically significant condition or process includes one or more of the following: a) A condition that is chronic or recurring and is life threatening b) A process that would affect the immune response c) A process that would require medication that affects the immune response d) A condition for which repeated injections or blood draws may pose additional risk to the participant e) A condition that requires active medical intervention or monitoring to avert grave danger to the participant's health or well-being f) A condition or process in which signs or symptoms could be confused with reactions to vaccine

Laboratory:

• Willing to have blood samples stored for future smallpox related research.
• Hematology and chemistries within institutional normal limits for age and sex for the following: hemoglobin, white blood cell (WBC)], serum creatinine, platelets, troponin, alanine aminotransferase (ALT) [within 1.25 under normal limits (ULN), aspartate aminotransferase (AST) (within 1.25 ULN), alkaline phos (within 1.25 ULN), total bilirubin (within 1.25 ULN).
• Negative for Hepatitis B surface antigen and Hepatitis C virus (HCV) antibodies [If HCV antibodies are positive, and negative for HCV by polymerase chain reaction (PCR), subject is eligible]
• Negative FDA-approved human immunodeficiency virus (HIV) blood test within 8 weeks prior to enrollment
• Normal urine dipstick or urinalysis:
• Negative glucose, and
• Negative or trace protein and negative or trace hemoglobin (if trace hemoglobin is present, a urinalysis is required to exclude participants with counts greater than the institutional normal range)

In addition to meeting ALL of the above criteria, FEMALE participants must meet BOTH of the following criteria:

• Negative serum or urine beta-human chorionic gonadotropin (HCG) pregnancy test performed within 24 hours prior to any vaccination.
• Reproductive status: A female participant either must:
• not be of reproductive potential. Reproductive potential in women is defined as not having reached menopause (no menses for one year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation.
• be with a male partner(s) throughout the duration of the study who has undergone successful vasectomy (A vasectomy is considered successful if a woman reports that a male partner has (1) microscopic documentation of azospermia, or (2) a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post-vasectomy.), or
• agree to avoid pregnancy through alternative methods and agree to consistently use contraception for at least 21 days prior to enrollment until the last protocol visit. Contraception is defined as using one of the following methods:

i) condoms (male or female with or without a spermicide) ii) diaphragm or cervical cap with spermicide iii) intrauterine device (IUD) iv) hormone-based therapy, e.g., contraceptive pills, Norplant, or Depo-Provera

In addition to the above criteria, female participants must meet the following criteria prior to participating in Dryvax vaccination:

• Negative serum or urine beta-HCG pregnancy test performed within 24 hrs prior to vaccination.
• Comply with one of the following methods of contraception for at least 21 days prior to vaccination and at least 2 months post vaccination.
• Hormonal contraception: such as implants, injectables, combined oral contraceptives
• Not be of reproductive potential: this may be due to

i) Hysterectomy or tubal ligation ii) The participant i