Dryvax Dilution-Prev Vacc Adults

Back to results

Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Dryvax

About this trial

This is an interventional prevention trial for Smallpox

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)

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.

Sites / Locations

Saint Louis University Health Sciences Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00032708

First Posted

March 28, 2002

Last Updated

August 26, 2010

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

1. Study Identification

Unique Protocol Identification Number

NCT00032708

Brief Title

Dryvax Dilution-Prev Vacc Adults

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2006

Overall Recruitment Status

Completed

Study Start Date

April 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Smallpox

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

90 (false)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

Dryvax

10. Eligibility

Eligibility Criteria

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.

Facility Information:

Facility Name

Saint Louis University Health Sciences Center

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110-0250

Country

United States

Smallpox

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial