Dose Safety, Tolerability, and Immunogenicity of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination

Stopped early · Phase 2

Conditions studied: Smallpox

In brief

The purpose of this study is to examine the safety and the effectiveness of a new vaccine for the prevention of the disease, smallpox.

Key facts

Study ID

NCT00053508

Run by

Sanofi Pasteur, a Sanofi Company

People needed

274

Starts

2002-09-01

Expected to finish

2003-09-01

Last updated by the study team

2014-01-22

Who can join

Age: 18 and older, up to 29. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• in good general health.
• not pregnant and using effective birth control
• agreed to participate in entire study and comply with protocol requirements.

You may not qualify if…

• military service prior to 1989.
• no previous smallpox vaccination.
• no contact with with children 1 year of age or younger
• immunodeficiency individuals or close contacts who are immunodeficient
• past history or current renal disease
• diagnosis or past history of eczema
• known allergy or past allergic reactions to latex gloves or to some antibiotics (neomycin, streptomycin, chlortetracycline, and polymyxin B).
• known allergy or past allergic to blood products.
• known allergy or past allergic reaction to cidofovir or sulfa-containing drugs.
• transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit.
• serology positive for HIV, hepatitis B or hepatitis C.
• current diagnosis or history within six months of drug or alcohol abuse disorders, psychiatric illness.
• inoculation with any other live vaccine within 30 days of Day 0 or participation in another drug or vaccine trial within 30 days of Day 0.

Where it is running

• Orlando Clinical Research Center — Orlando, Florida, United States
• Mayo Vaccine Research Group — Rochester, Minnesota, United States
• Radiant Research — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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