Advertisement

Topics

Vaccinia Immune Globulin in Treating or Preventing Vaccinal Infection

2014-08-27 03:57:17 | BioPortfolio

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].

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 Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Conditions

Healthy

Intervention

Vaccinia Immune Globulin (Human)

Location

Drienna Holman
Seattle
Washington
United States
98109

Status

Terminated

Source

National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:57:17-0400

Clinical Trials [1628 Associated Clinical Trials listed on BioPortfolio]

Vaccinia Vaccine (ACAM2000) for the Production of Vaccinia Immune Globulin Intravenous(VIGIV)

The purpose of this study is to vaccinate plasma donors with ACAM2000(TM) smallpox vaccine for collection of plasma to be used in the manufacture of Vaccinia Immune Globulin Intravenous (V...

Gammagard Liquid and rHuPH20 in PID

The purpose of the study is to develop a subcutaneous treatment option for subjects with PID that allows an administration of Immune Globulin Intravenous (Human), 10% at the same frequency...

Human Immune Globulin in Treating Patients With Primary Amyloidosis That is Causing Heart Dysfunction

RATIONALE: Antibodies, such as human immune globulin, can block the growth of abnormal cells in different ways. Some block the ability of abnormal cells to grow and spread. Others find abn...

Rapid Infusion Of Immune Globulin Intravenous (IGIV) In Patients With ITP

The objective of this study is to determine if the safety and tolerability of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatograph Purified (IGIV-C) is similar when infused at ...

Study to Determine the Dose of Recombinant Human Hyaluronidase Needed to Infuse a Full Dose of IGIV Subcutaneously

The purpose of the study is to determine the feasibility of infusing a full 4-week dose of Immune Globulin Intravenous (Human), 10% in a single subcutaneous site and the amount of recombin...

PubMed Articles [18386 Associated PubMed Articles listed on BioPortfolio]

Revisiting the roles of VHR/DUSP3 phosphatase in human diseases.

Protein tyrosine phosphatases have long been considered key regulators of biological processes and are therefore implicated in the origins of various human diseases. Heterozygosity, mutations, deletio...

Serum protein electrophoresis in healthy and injured southern white rhinoceros (Ceratotherium simum simum).

Investigation of globulin fractions by serum protein electrophoresis (SPE) is the first step towards evaluation of the proteome in the southern white rhinoceros (Ceratotherium simum simum). Furthermor...

Progress in gene therapy using oncolytic vaccinia virus as vectors.

Vaccinia virus was widely used in the World Health Organization's smallpox eradication campaign and is currently a promising vector for gene therapy owing to its unique characteristics. Vaccinia virus...

Detection of Inflammation via Volatile Cues in Human Urine.

Contagious disease is a major threat to survival, and the cost of relying on the immune system to defeat pathogens is high; therefore, behavioral avoidance of contagious individuals is arguably an ada...

Milieu intérieur: Defining the boundaries of a healthy immune response for improved vaccination strategies.

Immune responses in human populations are highly variable, with this variability presenting challenges for vaccine design. As such a better understanding of the factors that determine this variability...

Medical and Biotech [MESH] Definitions

The type species of ORTHOPOXVIRUS, related to COWPOX VIRUS, but whose true origin is unknown. It has been used as a live vaccine against SMALLPOX. It is also used as a vector for inserting foreign DNA into animals. Rabbitpox virus is a subspecies of VACCINIA VIRUS.

A species in the genus ROSEOLOVIRUS, of the family HERPESVIRIDAE. It was isolated from activated, CD4-positive T-lymphocytes taken from the blood of a healthy human.

Immunizing agent containing IMMUNOGLOBULIN G anti-Rho(D) used for preventing Rh immunization in Rh-negative individuals exposed to Rh-positive red blood cells.

Human experimentation that is not intended to benefit the subjects on whom it is performed. Phase I drug studies (CLINICAL TRIALS, PHASE I AS TOPIC) and research involving healthy volunteers are examples of nontherapeutic human experimentation.

A live VACCINIA VIRUS vaccine of calf lymph or chick embryo origin, used for immunization against smallpox. It is now recommended only for laboratory workers exposed to smallpox virus. Certain countries continue to vaccinate those in the military service. Complications that result from smallpox vaccination include vaccinia, secondary bacterial infections, and encephalomyelitis. (Dorland, 28th ed)

More From BioPortfolio on "Vaccinia Immune Globulin in Treating or Preventing Vaccinal Infection"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Human Immuno Deficiency Virus (HIV)
Human Immunodeficiency Virus (HIV), the causative agent of AIDS. The Human Immunodeficiency Virus, more commonly known as HIV, is a member of the lentivirus sub-set of the retrovirus family of pathogens. It causes AIDS, or Acquired Immuno Deficiency Sy...


Searches Linking to this Trial