Varicella Zoster Immune Globulin Study
Safety and Efficacy of Varicella Zoster Immune Globulin (Human) (VariZIG™) in Patients At-Risk of Varicella Infection
Protocol ID
Protocol Description
Usually chicken pox is not a serious infection, but if people are at risk (i.e., either pregnant, have an immature immune system (very young as in premature infants or neonates) or another condition that affects the immune system), a chicken pox infection might make them very sick.
People, who have been exposed to chicken pox and are at risk as described above, may be treated with a drug called varicella zoster immune globulin. The US Food and Drug Administration (FDA) had approved varicella zoster immune globulin (called VZIG™) for the treatment of people at-risk of developing serious complications after being exposed to someone with chicken pox, but before the development of chicken pox. VZIG™ had been shown to either reduce the chance that the person at risk will develop chicken pox, or decrease the seriousness of chicken pox in those at risk people who develop chicken pox. However, the company that manufactured VZIG™ in the past is no longer manufacturing it, and treatment with an FDA approved alternate is not available in the United States.
An investigational (not licensed in the U.S.) varicella zoster immune globulin product (manufactured and currently under development by Cangene Corporation located in Winnipeg, Canada, called VariZIG™) is currently available as an investigational new drug under a research study. Investigational means that VariZIG™ has not been approved by the FDA.
VariZIG™ is a varicella zoster immune globulin that is manufactured by Cangene Corporation and approved for use in Canada. VariZIG™ is currently being offered in the United States in this research as a potential alternate to VZIG™. This research study is being done to make VariZIG™ available to at-risk people who require varicella zoster immune globulin. It is hoped that VariZIG™ will be as safe and effective as VZIG™ when it was available for use for people at risk of developing serious complications after being exposed to someone with chicken pox.
Eligibility Criteria
The study will enroll subjects whose doctor determines they are at-risk of developing severe complications from chicken pox. These subjects include:
- immune compromised adults or children;
- healthy non-immune adults;
- babies less than 1 year old;
- premature babies;
- pregnant women; and
- babies whose mothers had chicken pox within 5 days before giving birth or within 2 days after giving birth.
Primary Investigator(s)
- Lorry Rubin, MD