Human immune globulin preparations

Three basic approaches are used to control viral diseases vaccination, antiviral chemotherapy, and stimulation of host resistance mechanisms. Vaccination has been used successfully to prevent measles, rubella, mumps, poliomyelitis, yellow fever, smallpox, chickenpox, and hepatitis B. Unfortunately, the usefulness of vaccines appears to be limited when many stereotypes are involved (e.g., rhinoviruses, HIV). Furthermore, vaccines have little or no use once the infection has been established because they cannot prevent the spread of active infections within the host. Passive immunization with human immune globulin, equine antiserum, or antiserum from vaccinated humans can be used to assist the body s own defense mechanisms. Intramuscular preparations of immune globulin may be used to prevent infection following viral exposure and as replacement therapy in individuals with antibody deficiencies. Peak plasma concentrations of intramuscular immune globulins occur in about 2 days. In contrast, intravenously administered immune globulin provides immediate passive immunity. 

The immune globulins are contraindicated in patients with a history of allergic reactions after administration of human immunoglobulin preparations and individuals with isolated immunoglobulin A (IgA) deficiency (individuals could have an anaphylactic reaction to subsequent administration of blood products that contain IgA). 

Injected forms of antibodies which have been generated in another body or animal can be isolated, purified, and administered as standard human immune serum globulin (ISG), and ISG plus preparation, or as an animal antiserum or antitoxin. Some serums which are available are those for rabies, snake and insect bites, botulism, and tetanus. Temporary immunity of up to six months to hepatitis can be imparted by one "gamma globulin" shot. More permanent active immunity is available to health care workers. 

Immune globulin (IG) is a purified preparation of gamma globulin. It is derived from large pools of human plasma and is comprised of four subclasses of antibodies, approximating the distribution of human serum (Ballow, 2005). 

Two types of products are available for the prevention of hepatitis A immune globulin (IG) and hepatitis A vaccine. IG is a solution of antibodies prepared from human plasma that is made with a serial ethanol precipitation procedure that inactivates HBV and HIV. When administered intramuscularly before exposure to HAV, or within 2 weeks after exposure, IG is >85% effective in preventing hepatitis A. IG administration is recommended for a variety of exposure situations (e.g., for persons who have sexual or household contact with patients who have hepatitis A). The duration of protection is relatively short (i.e., 3-6 months) and dose dependent. 

Indicated and approved for the management of allograft rejection in renal transplant patients, antithymocyte globulin preparations are purified immune globulins (primarily IgG) from horses or rabbits immunized with human thymus lymphocytes. The resultant globulin preparations contain cytotoxic antibodies to human T lymphocytes which function as an immunosuppressive agent. As well as its use for the treatment of renal transplant rejection, anti-thymocyte globulin may be administered as an adjunct to other immunosuppressive... 

Anti-lymphocyte globulin (ALG) has been prepared as an highly purified solution of y-globulins with antilymphocyte activity by immunizing horses with human lymphocytes. It activates complement-mediated destruction of lymphocytes and thus decreases cellular immunity with only a limited effect on humoral immunity. Anti-lymphocyte globulin suppresses delayed type hypersensitivity reactions. It is used for the prevention and treatment of rejection episodes of transplanted organs. It also has some indication for the management of idiopathic aplastic anemia. Adverse effects include pain at the site of injection, erythema, serum sickness and rarely anaphylactic shock and thrombocytopenia. 

Antisera directed against lymphocytes have been prepared sporadically for over 100 years. With the advent of human organ transplantation as a therapeutic option, heterologous antilymphocyte globulin (ALG) took on new importance. ALG and antithymocyte globulin (ATG) are now in clinical use in many medical centers, especially in transplantation programs. The antiserum is usually obtained by immunization of large animals such as horses or sheep with human lymphoid cells. 

Human plasma proteins such as serum albumin, fibrinogen or immune -y-globulin may be labelled using Tc04 and a reducing agent, usually The preparation may be... 

Moreover extensive clinical trials have shown the great utility of such preparations in producing temporary passive immunization to measles (163, 203) and to infectious hepatitis (204, 77, 92), and have thereby demonstrated that antibodies to both these diseases are present in the y-globulin fraction of human blood. Unquestionably many other antibodies are present also in this fraction, and have not yet been detected simply because they have not been tested for. 

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