Uniformly fatal prior to the licensure of vaccinia immune globulin. It is not indicated for allergy or asthma in patients who have normal levels of immunoglobulin. Vaccinia immune globulin vigiv vaccinia ig human vig was developed in the 1960s for ameliorating side effects associated with smallpox vaccinia immunization, including eczema vaccinatum, generalized, and progressive vaccinia. Complications of smallpox vaccination and theirtreatment with.
Vaccinia immune globulin by injection national library of. Immune responses generated from a vaccinia virus infection protects the person against a lethal smallpox infection. Vaccinia virus infection is typically very mild and often does not cause symptoms in healthy individuals, although it may cause rash and fever. Vaccinia virus is used to vaccinate persons to prevent disease with smallpox. A blood product rich in antibodies against vaccinia, the virus in the smallpox vaccine. Other nontemperature sensitive critical products medically ready forceready medical force core products overview. Definition of vaccinia immune globulin medicinenet.
For this reason, vaccinia virus was, and still is, being used as a livevirus vaccine. Information about this vaccinia immune globulin human intravenousroute. Mar 21, 2018 vaccinia immune globulin vig is indicated for certain complications of vaccination live vaccinia virus smallpox vaccine. Blood glucose measurement in patients receiving vaccinia immune globulin intravenous human vigiv must be done with a glucosespecific method monitor and test strips to avoid interference by maltose contained in vigiv. Consultation is available to determine if vaccination with the smallpox vaccine is appropriate for personnel using vaccinia. Feb 02, 2018 vigiv vaccinia immune globulin intravenous human is a vaccination used to treat eczema vaccinatum. Complications of smallpox vaccination and theirtreatment. Hypersensitivity to human immune globulin acute anaphylaxis 5. Information is provided for original product approvals, new indications, and. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Treatment andor management of certain complications of smallpox vaccination, including eczema vaccinatum, progressive vaccinia, severe. It has a linear, doublestranded dna genome approximately 190 kbp in length, which encodes approximately 250 genes. Although serum antibodies from infected mice bound to vaccinia virus infected cells, these antibodies were ineffective in complement mediated lysis of.
Therapeutic goods that contain or are produced from human blood or plasma. Vaccinia immune globulin varicellazoster immune globulin. The need for stockpiling of vaccinia immune globulin vig supplies for. Kidney problems have happened with human immune globulin.
Side effects of vigiv vaccinia immune globulin intravenous. The immune response to vaccinia virus infection in mice. Immune globulin tetanus immune globulin rho d immune globulin hepatitis b immune globulin rabies immune globulin varicellazoster immune globulin vaccinia immune globulin. Table 3 vaccinia immune globulin release vaccinia transmission to contacts united states, january 24may 2, 2003 no. Boxed warning interactions with glucose monitoring systems. It is not known whether vaccinia virus is the product of genetic recombination, or if it is a species derived from cowpox virus or variola virus by prolonged serial passage, or if it is the living representative of a now extinct virus. Strategic national stockpile for persons who are exposed to smallpox virus or at high risk for smallpox infection during a postevent vaccination program following an intentional or accidental release of the virus. Smallpox is a highly lethal viral infection of humans 30% mortality 1, 2, which can spread rapidly through a population.
Thrombosis may occur with immune globulin products, including vigiv. These highlights do not include all the information needed to use cnj016 vaccinia immune globulin intravenous, human, vigiv safely and effectively. Vaccinia immune globulin in treating or preventing. Vaccinia virus is the leading agent of laboratoryacquired poxvirus infections through percutaneous injury. Immune globulin human is not indicated for routine prophylaxis or treatment of rubella, poliomyelitis, mumps, or varicella.
To develop a less reactogenic but equally immunogenic vaccine, this study of 91 human volunteers compared the safety and immunogenic potency of a new, cell culturederived vaccinia virus vaccine administered intradermally and intramuscularly with the licensed vaccinia vaccine administered by scarification. Anthrax immune globulin iv human is a specific immune globulin hyperimmune globulin that contains immunoglobulin g igg prepared from plasma of healthy donors immunized with anthrax vaccine adsorbed to achieve high titers of antianthrax antibody. Vaccinia virus elicited a host antiviral immune response, but also led to the recruitment of immune suppressor cells. Dailymed cnj016 vaccinia immune globulin human injection. Dec 06, 2000 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. Other nontemperature sensitive critical products medically ready. This guidance provides information for sponsors and manufacturers about the regulatory requirements for therapeutic goods that contain, or are produced from, human blood or plasma except biologicals, as defined in the therapeutic goods act 1989 the act examples of the therapeutic goods covered by this guidance are coagulation factors, immunoglobulins of human origin and albumin and. Rabies immune globulin human usp, heat treated, imogam rabies ht, is a sterile solution of antirabies immunoglobulin 1016% protein for wound infiltration and intramuscular administration. Vaccinia immune globulin dosage guide with precautions. Vaccinia immune globulin intravenous vigiv investigation new drug ind products foreign military sales fms other temperature sensitive medical products tsmpshebat, rabies etc. Pox virusesvaccinia fact sheet stanford environmental. Vaccinia immune globulin vig is the only known antidote to the complications of vaccination. The chance of these problems may be raised if you have kidney problems, high blood sugar diabetes, fluid loss dehydration or low blood volume, a blood infection, or proteins in the blood that are not normal. Combination therapy of vaccinia virus infection with human.
Cnj016 is an immune globulin intravenous human, 10% liquid, indicated for the treatment of complications due to vaccinia vaccination 1, including. Antibodies present in immune globulin preparations may interfere with the immune response to live virus vaccines. A recently reported case of progressive vaccinia pv in an immunocompromised patient has refocused attention on this condition. Vaccinia immune globulin an overview sciencedirect topics.
Cnj016, vaccinia immune globulin intravenous human, sterile solution. Vaccinia immune globulin intravenous human vigiv vigiv cdc pdf external has been used safely and effectively to treat vaccinia virus vaccine adverse reactions. Here we show that combination therapy with two fully human mabs against an immunodominant mv antigen, h3 h3l, and an ev antigen, b5 b5r, provides significantly better protection against vaccinia infection in a small animal model of progressive vaccinia. Vaccinia immune globulin vig has been used therapeutically to treat severe orthopoxvirus infections but is in short supply. A method for preparing a concentrated, immunoglobulin composition for treating subjects vaccinated against or infected with a pathogenic microorganism, comprising. The first antiviral for the treatment of smallpox disease, tecovirimat tpoxx, was approved by the us food and drug administration fda in july 2018.
Vaccinia immune globulin vig is made from the pooled blood of individuals who have been inoculated with the smallpox vaccine. Vaccinia immune globulin vig is indicated for certain complications of. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6 apr 2020, wolters kluwer updated. Vaccinia immune globulin vig is indicated for certain complications of vaccination live vaccinia virus smallpox vaccine. Hepatitis b immune globulin human, nabihb, is a sterile solution of immunoglobulin 5 1% protein containing antibodies to hepatitis b surface antigen antihbs. If you have a certain eye infection caused by the vaccinia virus. Adverse reactions are treated with vaccinia immune globulin vig, currently only available from baxter healthcare corporation 5,400 vials of vig in stock. Progressive vaccinia was confirmed on 3 march, and a request for release of vaccinia immune globulin intravenous human vigiv from the department of defense and the strategic national stockpile sns at the cdc was submitted along with an eind application for the use of oral and topical st246. Clinical guidance for smallpox vaccine use in a postevent. Vaccinia immune globulin is used to treat infections caused by the vaccinia virus. Vaccinia virus possesses two immunologically distinct virion forms in vivomature virion mv, imv and extracellular virion ev, eev. The use of hyperimmune antivaccinia gammaglobulin for the. Licensed biological products with supporting documents is arranged alphabetically by the proper name of the products.
Immune response to primary intraperitoneal infection with vaccinia virus strain ihdj was studied in c3hhej mice. Vigiv vaccinia immune globulin, human, 5% sterile solution for intravenous use. Therapeutic goods that contain or are produced from human blood or plasma v1. Cnj016 vaccinia immune globulin human injection dailymed. Wo2007017859a1 intravenous immunoglobulin composition.
Vaccinia immune globulin intravenous human vigiv vigiv cdcpdf external has been used safely and effectively to treat vaccinia virus vaccine adverse reactions. If vig andor other antivirals are needed or additional information is required, physicians should contact the cdc eoc at 7704887100. Rational combination of oncolytic vaccinia virus and pdl1. Vaccinia immune globulin iv monograph for professionals. Vaccinia immune globulin intravenous memorial sloan. Vaccinia virus vacv or vv is a large, complex, enveloped virus belonging to the poxvirus family. Vaccinia immune globulin, human intravenous route before. Vaccinia immune globulin by injection treats conditions caused by vaccinia virus, which can affect the skin, eyes, and mouth. Pdf postexposure prevention of progressive vaccinia in scid. Vaccinia immune globulin by injection national library. Aug 31, 2001 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. It is known as immune globulin against vaccinia, and is distributed by the state bacteriological laboratory. For patients at risk of thrombosis, administer vigiv at the minimum dose and infusion rate practicable.
This report outlines recommendations for the clinical use of the three smallpox vaccines stored in the u. Pdf postexposure prevention of progressive vaccinia in. It is intended for prevention and treatment of complications of smallpox vaccination. This is not a list of all drugs or health problems that interact with this drug. Vigiv vaccinia immune globulin intravenous human is a vaccination used to treat eczema vaccinatum. Imogam rabies ht rabies immune globulin human usp, heat treated. The antibodies these individuals developed in response to the smallpox vaccine are removed and purified. The plasma globulins are separated into five fractions by serum protein electrophoresis. Imovax rabies rabies vaccine human diploid cell prescribing information. Human immune globulins from donors who received booster shots of vaccinia virus dryvax pharmacokinetics. Rabies immune globulin day 0, it can be administered up.
Usp on day 0, and either placebo or vaccinia dryvax vaccination on day 4. Uncontrolled data suggest that vaccinia immune globulin may mitigate complications of vaccination. Vaccinia virus produces adverse reactions in a small percentage of vaccinated persons. Vaccinia immune globulin and an antiviral medication may be of value in treating complications. Specific gamma globulin, prepared on the lines given by kempe, has recently been produced in sweden. Vigiv vaccinia immune globulin intravenous human description. Usp plans to publish the proposed omissionof the following monographs in pf 454 jul. Licensed biological products with supporting documents fda. The human elisa was initiated as a manual test and was used at a research level and for the. Feb 02, 2018 cnj016, vaccinia immune globulin intravenous human vigiv vaccinia immune globulin intravenous, is a solventdetergenttreated sterile solution of purified gamma globulin igg fraction of human plasma containing antibodies to vaccinia virus. The prophylaxis of varicella with convalescents serum. Human vaccinia immune globulin vig is a sterile solution. Antibodies reactive with virus structural proteins were detected 6 days and neutralizing antibodies 8 days after infection. 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.
Animal studies have shown an adverse effect and there are no adequate studies in pregnant women or no animal studies have been conducted and there are no adequate studies in pregnant women. Vaccinia virus is a research tool used in a variety of biomedical applications but it can be a human pathogen. Immune responses to smallpox vaccination full text view. Nov 01, 2012 progressive vaccinia was confirmed on 3 march, and a request for release of vaccinia immune globulin intravenous human vigiv from the department of defense and the strategic national stockpile sns at the cdc was submitted along with an eind application for the use of oral and topical st246. Medical management of adverse reactions smallpox cdc. We will obtain blood from vaccinated persons and measure immune responses in vitro to the virus and correlate these findings with symptoms from vaccination. Limited information is available regarding cellular immune responses to vaccinia virus. Clinical experience suggests vigiv is effective in the treatment of smallpox vaccine adverse reactions that are secondary to continued vaccinia virus replication after vaccination. Vaccinia immune globulin, intravenous vigiv has recently been approved by the us food and drug administration. Vig is purified from human blood and used to treat serious infections of the vaccinia smallpox vaccine virus or similar viruses. Vaccinia immune globulin intravenous professional patient. Information about this vacciniaimmuneglobulinhumanintravenousroute.
We generated a large panel of orthopoxvirusspecific human monoclonal antibodies abs from immune subjects to investigate the molecular basis of broadly neutralizing antibody responses for diverse orthopoxviruses. The united states pharmacopeia national formulary usp nf monograph plasma protein fraction is not a standard because it is exempted under the therapeutic goods exempting monographs of pharmacopoeias determination no. All plasma proteins except albumin and prealbumin are globulins. Pdf 123 kb journal of allergy and clinical immunology. Updated dosing instructions for immune globulin human. The united states pharmacopeia national formulary usp nf monograph plasma protein. Vaccinia immune globulin definition of vaccinia immune.
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