Dryvax Dilution-Prev Vacc Adults

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase

Completed

Phase 2

Conditions

Smallpox

Treatments

Biological: Dryvax

Study type

Interventional

Funder types

NIH

Identifiers

NCT00032708

01-651

Details and patient eligibility

About

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

Sex

Volunteers

No Healthy Volunteers

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.