NCT00032708

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2002

Completed
2 years until next milestone

Study Start

First participant enrolled

April 1, 2004

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
Last Updated

August 27, 2010

Status Verified

May 1, 2006

First QC Date

March 28, 2002

Last Update Submit

August 26, 2010

Conditions

Smallpox

Interventions

DryvaxBIOLOGICAL

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Louis University Health Sciences Center

St Louis, Missouri, 63110-0250, United States

Location

MeSH Terms

Conditions

Smallpox

Interventions

Smallpox Vaccine

Condition Hierarchy (Ancestors)

Poxviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

March 28, 2002

First Posted

March 29, 2002

Study Start

April 1, 2004

Study Completion

November 1, 2004

Last Updated

August 27, 2010

Record last verified: 2006-05

Locations

US(1)