Smallpox Clinical Trial
Official title:
The Safety, Tolerability, and Immunogenicity of Three Dose Levels of ACAM3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine, in Adults Without Previous Smallpox Vaccination
The purpose of this study is to gather information on the safety and the effectiveness of an
investigational vaccine for the prevention of smallpox disease. Smallpox was one of the
major causes of death and sickness through the first half of the 20th century, but a global
program of smallpox eradication resulted in the elimination of the natural disease. The last
cases of smallpox in the United States occurred in 1949 in Texas. Today, only laboratory
workers who work with smallpox-related viruses, military personnel, and health care workers
are vaccinated.
Historically, individuals in the US were vaccinated with a product such as Dryvax®, which
contains the virus vaccinia in the same family as smallpox. This virus could promote
immunity to smallpox, but not produce the disease itself. Although effective, these vaccines
are not safe to use in people with atopic dermatitis (eczema, allergic immune response to
allergens), children less than 1 year of age, and people with a compromised immune system,
occurring in certain diseases (HIV positive individuals and AIDS), and following treatment
with certain types of drugs. It is important to find a safe vaccine that can be used to
protect people who cannot receive routine vaccinia-based smallpox vaccine.
The vaccine in this study is known as Modified Vaccinia Ankara or MVA vaccine. It is the
objective of this study to find out if MVA vaccine is safe and effective in providing
immunity to smallpox. The effectiveness of this vaccine will be measured in two ways. The
first way is to find out if there are specific antibodies in your blood following MVA
vaccination. Antibodies are chemicals your body produces to fight smallpox virus.
The second way is to see whether or not there is a typical skin reaction following
vaccination with a traditional smallpox vaccine, given about three months after vaccination
with the MVA vaccine. The typical reaction in an unvaccinated person to smallpox vaccine is
formation of a blister or "pox" which occurs at the site of vaccination. In a person with
immunity to smallpox the skin reaction is much less, and typically consists of a little
swelling at the site of vaccination.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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