Vaccinia Immune Globulin in Treating or Preventing Vaccinal Infection

NCT00006630 | Withdrawn Phase 1

• 2 other identifiers: AVEG 80111551
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 \[during HIV vaccine research\].

Conditions

Healthy; Communicable Diseases

Keywords

Smallpox Vaccine; Injections, Intramuscular; Immunoglobulins; Orthopoxvirus

Interventions

Vaccinia Immune Globulin (Human) DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

MeSH Terms

Conditions

Communicable Diseases

Interventions

human intravenous vaccinia immune globulin

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2000
• First Posted: August 31, 2001
• Last Updated: November 1, 2021

Record last verified: 2021-10