Vaccinia Immune Globulin in Treating or Preventing Vaccinal Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006630
Recruitment Status : Withdrawn
First Posted : August 31, 2001
Last Update Posted : May 14, 2012
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:

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 or disease Intervention/treatment Phase
Healthy Communicable Diseases Drug: Vaccinia Immune Globulin (Human) Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Primary Purpose: Treatment
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]

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smallpox

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.


  • 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.

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00006630     History of Changes
Other Study ID Numbers: AVEG 801
11551 ( Registry Identifier: DAIDS ES Registry Number )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: May 14, 2012
Last Verified: May 2012

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

Additional relevant MeSH terms:
Communicable Diseases
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs