Dryvax Dilution-Prev Vacc Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2004-11-30

Brief Summary

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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

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Detailed Description

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Conditions

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Smallpox

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Dryvax

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Eligible Sex

Accepts Healthy Volunteers

No