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NCT00032708 Clinical Trial

Dryvax Dilution-Prev Vacc Adults

Smallpox Clinical Trial

Official title:
A Double Blind, Randomized Dose Response Study of Dryvax Vaccine Against Smallpox in Previously Vaccinated Adults

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00032708
Other study ID # 01-651
Secondary ID
Status Completed
Phase Phase 2
First received March 28, 2002
Last updated August 26, 2010
Start date April 2004
Est. completion date November 2004

Study information
Verified date May 2006
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date November 2004
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- 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).

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• Dryvax

Locations
Country Name City State
United States Saint Louis University Health Sciences Center St. Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

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