Dryvax Dilution-Prev Vacc Adults

Completed · Phase 2

Conditions studied: Smallpox

In brief

A double-blind, randomized, dose-response study of four dilutions of Dryvax in previously vaccinated adults in order to assess the clinical success rates, humoral responses, and virus-specific actifity of cytotoxi T cells and interferon-y producing T cells

Key facts

Study ID

NCT00032708

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

90

Starts

2004-04-01

Expected to finish

2004-11-01

Last updated by the study team

2010-08-27

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For cohort E (never vaccinated): Aged 18-31; Never been vaccinated for smallpox.
• If female, not pregnant or lactating.
• Promise to use an effective method of birth control for 7 months after vaccination.
• Negative result on a test for HIV, AIDS, Hepatitis B and C.
• Acceptable as blood donors.
• For cohorts A, B, C, D (previously vaccinated): Aged 32 to 60 years; known history of smallpox vaccination with a typical vaccinia scar; no smallpox vaccination after 1971.
• Healthy adults (aged 18-60).

You may not qualify if…

• Eczema or history of eczema, or other chronic skin disorder.
• Pregnancy or lactation.
• History of immunodeficiency, liver disease, severe kidney impairment, malignancy, HIV, Hepatitis B, or Hepatitis C.
• Household contact with persons who are under 12 months of age, pregnant or lactating, or have any of the specified diseases.

Where it is running

• Saint Louis University Health Sciences Center — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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