Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults
Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults
The objective of this study is to determine the minimum dose of ACAM2000 needed to produce a
 cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age
 and previously vaccinated against smallpox.
Specifically, the objectives of this study are to:

 1. Compare the safety and tolerability of four dose levels of ACAM2000 and a standard dose
 of Dryvax® in healthy adults at least 28 years of age and previously vaccinated to
 smallpox. Safety and tolerability will be determined by examination of the local
 cutaneous reaction, adverse events, physical examinations, vital signs, structured
 interviews, and laboratory analysis.

 2. Determine the immunogenicity of four dose levels of ACAM2000 and a standard dose of
 Dryvax® in healthy adults at least 28 years of age by comparing:

 1. the proportion of subjects at each dose level who develop a major cutaneous
 reaction

 2. the proportion of subjects in each treatment group who develop neutralizing
 antibodies, including the fold-increase in antibody titer between Baseline and Day
 30 sera; and the geometric mean vaccinia neutralizing antibody titer on Day 30.

 3. Determine the minimum dose of ACAM2000 that is calculated to produce a major cutaneous
 reaction in at least 90% of a population of healthy adults at least 28 years of age,
 with a history of smallpox vaccination.
Inclusion criteria:

 -  have a history of previous smallpox vaccination greater than 10 years previous to the
 date of screening and presence of a vaccination scar.

 -  females must not be pregnant, lactating and must agree to use an effective form of
 birth control for the 30 days following vaccination or unable to bear children.

 -  agree to be available for the entire study and agree to comply with all requirements.

 exclusion criteria:

 -  children 1 year of age or younger in the household or be in close contact

 -  smallpox vaccination within ten years

 -  known or suspected Human immunodeficient virus (HIV) infection, primary
 immunodeficiency disorder, leukemia, lymphoma, or current radiation treatment or use
 of immunosuppressive or anti-neoplastic drugs or have a household member or intimate
 contact with the conditions listed above.

 -  renal disease

 -  current or past history of eczema or a household member or direct contact who has
 eczema.

 -  known allergy or past allergic reactions to latex gloves or to antibiotics which
 include neomycin, streptomycin, chlortetracycline, and polymyxin B

 -  known allergy or past allergic reaction to blood products.

 -  known allergy to cidofovir or sulfa-containing drugs.

 -  history of allergic phenomena following smallpox vaccination in the past, including
 urticaria, erythema multiforme, or Stevens-Johnson syndrome.

 -  transfusion of blood or treatment with any blood product.

 -  current or history of drug or alcohol abuse

 -  innoculation with any other live vaccine or participating in another drug or vaccine
 trial within 30 days of enrollment.