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Vaccinia Immune Globulin in Treating or Preventing Vaccinal Infection

This study has been terminated.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00006630
  Purpose

The purpose of this study is to follow responses to treatment with vaccinia immune globulin (VIG) for safety and clinical benefit [during HIV vaccine research].

VIG is purified from human blood and used to treat serious infections of the vaccinia (smallpox vaccine) virus or similar viruses. It is the only treatment available for those viruses. The only available supply of VIG has developed a discoloration over time and therefore is considered an investigational new drug by the FDA. This study will allow it to be used for intramuscular injection in a controlled setting for people who may need it [during HIV vaccine research].


Condition Intervention Phase
Healthy
Communicable Diseases
Drug: Vaccinia Immune Globulin (Human)
Phase I

MedlinePlus related topics:   AIDS    Smallpox   

Drug Information available for:   Immunoglobulins    Globulin, Immune    PANVAC-V   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Safety Study
Official Title:   Open-Label, Multi-Site Study for the Administration of Vaccinia Immune Globulin (Human) To Subjects Who Experience Complications From Vaccinia Virus Vaccinations or To Unprotected Individuals Accidentally Exposed To Vaccinia Virus or Related Orthopox Viruses [During HIV Vaccine Research]

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Detailed Description:

VIG (Human) is a component of plasma from persons vaccinated with vaccinia vaccine. It is the only product available for the treatment of vaccinia and other orthopox infections. The only lot currently available was released as a licensed product in 1995 but is being treated as an investigational new drug because of slight discoloration in the solution. This study makes existing stocks of VIG available as a short-term solution for the lack of a licensed immune globulin to treat vaccinal infections.

Before receiving injections and 3 and 6 months after injections, patients are tested for HIV, hepatitis B, and hepatitis C with pre- and post-test counseling. Referrals for appropriate medical care are provided. Participants have multiple injections (depending on body weight) of VIG at 1 or 2 clinic visits. Following administration of VIG, participants are observed for 1/2 hour at the clinic. Participants return to the clinic for as many as 10 visits to monitor for any adverse reactions and signs and symptoms of vaccinia infections. On Days 7, 84, and 168 participants return to the clinic for evaluations and have blood drawn to check for the response to the VIG injections.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Participants may be eligible for this study if they:

  • Sign a consent form including consent for pre/post HIV counseling. If under 18 years or unable to sign a consent form, the next of kin or a legal guardian must sign.
  • Experience complications from prior administration of vaccinia virus vaccinations or accidental exposure to vaccinia or similar viruses.
  • Have a pregnancy test.

Exclusion Criteria

Participants will not be eligible for this study if they:

  • Have eye complications.

Note:

  • Caution should be noted if participants are allergic to thimerosal (a preservative in the study drug). Precautions can be taken if participants experience a reaction during VIG administration.
  • Women who are pregnant will be counseled about risks.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006630

Locations
United States, Washington
Drienna Holman    
      Seattle, Washington, United States, 98109

Sponsors and Collaborators
  More Information


Haga clic aquí para ver información sobre este ensayo clínico en español.  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   AVEG 801
First Received:   December 6, 2000
Last Updated:   September 8, 2008
ClinicalTrials.gov Identifier:   NCT00006630
Health Authority:   United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Smallpox Vaccine  
Injections, Intramuscular  
Immunoglobulins  
Orthopoxvirus  

Study placed in the following topic categories:
Virus Diseases
Smallpox
Poxviridae Infections
Vaccinia
HIV Infections
Acquired Immunodeficiency Syndrome
DNA Virus Infections
Healthy
Immunoglobulins

Additional relevant MeSH terms:
Communicable Diseases
Immunologic Factors
Physiological Effects of Drugs
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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