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OpenTrials
Completed

NCT Number: NCT00032708

Dryvax Dilution-Prev Vacc Adults

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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Key information

Conditions

Smallpox DNA Virus Infections Infections Poxviridae Infections Virus Diseases

Study type

Interventional

Phase

Phase 2

Primary location

Saint Louis University Health Sciences Center

St Louis, Missouri, 63110-0250, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dryvax

Biological

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2004
First posted
Mar 29, 2002
Registry last updated
Aug 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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