BAYGAM SUMMARY
Immune Globulin (Human) -- BayGam® treated with solvent/detergent is a sterile solution of immune globulin for intramuscular administration; it contains no preservative. BayGam is prepared by cold ethanol fractionation from human plasma. The immune globulin is isolated from solubilized Cohn fraction II. The fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the solution is heated to 30°C and maintained at that temperature for not less than 6 hours. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration. BayGam is formulated as a 15-18% protein solution at a pH of 6.4-7.2 in 0.21-0.32 M glycine. BayGam is then incubated in the final container for 21-28 days at 20-27°C.
The prophylactic value of BayGam is greatest when given before or soon after exposure to hepatitis A. BayGam is not indicated in persons with clinical manifestations of hepatitis A or in those exposed more than 2 weeks previously.
BayGam should be given to prevent or modify measles in a susceptible person exposed fewer than 6 days previously.7 A susceptible person is one who has not been vaccinated and has not had measles previously. BayGam may be especially indicated for susceptible household contacts of measles patients, particularly contacts under 1 year of age, for whom the risk of complications is highest.7 BayGam and measles vaccine should not be given at the same time. 7 If a child is older than 12 months and has received BayGam, he should be given measles vaccine about 3 months later when the measles antibody titer will have disappeared.
If a susceptible child exposed to measles is immunocompromised, BayGam should be given immediately.8 Children who are immunocompromised should not receive measles vaccine or any other live viral vaccine.
Passive immunization against varicella in immunosuppressed patients is best accomplished by use of Varicella-Zoster Immune Globulin (Human) [VZIG]. If VZIG is unavailable, BayGam, promptly given, may also modify varicella.5
The routine use of BayGam for prophylaxis of rubella in early pregnancy is of dubious value and cannot be justified.6 Some studies suggest that the use of BayGam in exposed, susceptible women can lessen the likelihood of infection and fetal damage; therefore, BayGam may benefit those women who will not consider a therapeutic abortion.4
In patients with immunoglobulin deficiencies, BayGam may prevent serious infection. However, BayGam may not prevent chronic infections of the external secretory tissues such as the respiratory and gastrointestinal tract.
Prophylactic therapy, especially against infections due to encapsulated bacteria, is effective in Bruton-type, sex-linked, congenital agammaglobulinemia, agammaglobulinemia associated with thymoma, and acquired agammaglobulinemia.
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NEWS HIGHLIGHTS
Published Studies Related to Baygam (Immune Globulin Human)
Recombinant interferon-alpha2b improves immune response to hepatitis B vaccination in haemodialysis patients: results of a randomised clinical trial. [2009.09.18]
The use of adjuvants capable of improving the deficient immune response to hepatitis B virus (HBV) vaccine in haemodialysis patients is highly needed. Among potential adjuvants, type I interferons deserve a special attention in view of their known effects promoting cellular and humoral immune responses...
Superior immune response to protein-conjugate versus free pneumococcal polysaccharide vaccine in chronic obstructive pulmonary disease. [2009.09.15]
RATIONALE: Debate exists about the immunogenicity and protective efficacy of antibodies produced by the 23-valent pneumococcal polysaccharide vaccine (PPSV23) in chronic obstructive pulmonary disease (COPD). The 7-valent diphtheria-conjugated pneumococcal polysaccharide vaccine (PCV7) induces a more robust immune response than PPSV23 in healthy elderly adults. OBJECTIVES: We hypothesized that serotype-specific IgG antibody concentration and functional antibody activity would be superior after PCV7 vaccination compared with PPSV23 in moderate to severe COPD. We also posited that older age and prior PPSV23 vaccination would be associated with reduced vaccine responsiveness... CONCLUSIONS: PCV7 induces a superior immune response at 1 month post vaccination compared with PPSV23 in COPD. Older age and prior PPSV23 reduce vaccine responsiveness. Clinical trial registered with www.clinicaltrials.gov (NCT00457977).
A prospective, randomized, double-blinded, placebo-controlled study of human intravenous immunoglobulin for the acute management of presumptive primary immune-mediated thrombocytopenia in dogs. [2009.09]
BACKGROUND: Immune-mediated thrombocytopenia (IMT) is a common hematologic disorder in dogs... CONCLUSIONS AND CLINICAL IMPORTANCE: Compared with corticosteroids alone, adjunctive emergency therapy of a single hIVIG infusion was safe and associated with a significant reduction in platelet count recovery time and duration of hospitalization without increasing the expense of medical care in a small group of dogs with presumed pIMT.
Serial combination therapy: is immune modulation in multiple sclerosis enhanced by initial immune suppression? [2009.08]
BACKGROUND: Although the concept that an initial course of immune-suppression facilitates subsequent immune-modulation (such as Th1 to Th2 deviation) is attractive for several autoimmune diseases, such a mechanism for serial-combination therapy has never been formally demonstrated. Recently, brief mitoxantrone induction-chemotherapy followed by immune-modulation with glatiramer acetate (GA) was significantly more effective at reducing multiple sclerosis disease activity than with GA alone. OBJECTIVE: To examine whether the benefit of initial immune suppression with mitoxantrone before GA treatment is associated with more efficient immune modulation... CONCLUSION: These results provide important insights into mechanisms of combination therapy and therapeutic strategies for autoimmune diseases.
Randomized placebo controlled human volunteer trial of a live oral cholera vaccine VA1.3 for safety and immune response. [2009.07.30]
A live oral cholera vaccine developed from a non-toxigenic Vibrio cholerae O1 El Tor strain VA1.3 was tested in a double-blind randomized placebo controlled study for safety and immunogenicity in 304 men aged between 16 and 50 years from Kolkata, India.
Clinical Trials Related to Baygam (Immune Globulin Human)
Phase II Study of Intravenous Immunoglobulin (IVIg) for Alzheimer's Disease [Active, not recruiting]
The overall goal of this double-blind Phase II study is to evaluate the safety, efficacy and
biological mechanisms of action of Intravenous Immunoglobulin (IVIg) in the treatment of mild
to moderate stage Alzheimer's disease (AD). IVIg contains antibodies against the amyloid beta
protein that is the central component of the AD senile plaque. It is hypothesized that IVIg
treatment will reduce the levels of beta amyloid in the brain and improve cognitive abilities
relative to placebo. A total of 24 patients with mild to moderate AD capable of giving
informed consent will be randomly assigned to receive either IVIg (16 patients)or saline
placebo (8 patients) for six months. This study includes comparison of four dosing regimens
of IVIg. Cognitive, behavioral and functional measures will be collected at baseline, three
months and six months of treatment and after a six-week washout period. Plasma samples will
be collected before and after infusions. Subjects will undergo a lumbar puncture before and
after the six months of treatment for cerebrospinal fluid (CSF) biomarker analyses. In
addition, Positron Emission Tomography (PET) imaging substudies will be performed at two time
points during the study. Following the initial 6 month placebo-controlled period, all
participants have the opportunity to receive IVIg for an additional 6 month period.
Intravenous Immunoglobulin After Relapse in Vasculitis [Terminated]
Treatment of Childhood Onset Psychiatric Disorders With Intravenous Immunoglobulin (IVIg) [Completed]
Recent research studies of early onset-obsessive compulsive disorder (OCD) and Tourette's
syndrome have questioned whether autoimmunity could play a role in the development of these
conditions. As a result, there has been an increased interest in the field of research on
the potential involvement of autoimmunity in other psychiatric conditions like
schizophrenia.
Autoimmune conditions occur when the normal immune system of the body begins working against
itself. The immune system recognizes cells as foreign and begins to attack them.
There are several similarities between autoimmune diseases and schizophrenia. Genetics play
some role in the development of both diseases. Both conditions show a similar course, and
both conditions tend to show worsening of symptoms when exposed to stress.
Previous research studies have shown intravenous immunoglobulin to be safe and effective when
used in neurologic diseases involving the immune system. Presently the NIMH is testing the
effectiveness of IVIg in OCD and Tourette's syndrome.
Intravenous Immunoglobulin IVIg is a medication that has been used to treat diseases like
Kawasaki disease, systemic juvenile rheumatoid arthritis, lupus nephritis, and idiopathic
thrombocytopenic purpura. The drug modifies the body's natural immune reactions.
This research study is a 13-week trial of intravenous immunoglobulin (IVIg) on patients
suffering from childhood-onset schizophrenia, who have failed to respond to other therapies.
Efficacy of High-Dose Intravenous Immunoglobulin Therapy for Hyperbilirubinemia Due Rh Hemolytic Disease [Recruiting]
The use of intravenous immunoglobulin G (IVIG) therapy has been reported in
hyperbilirubinemia of Rh hemolytic disease but we don't have enough evidences for it. Human
Immunoglobulin is considered an alternative to delay the hemolytic process and consequently
reduce the number of exchange transfusions and transfusions of red cells concentrate, thus
diminishing the risk of transmitting transfusional therapies-related diseases. OBJECTIVE: To
determine the effect of IVIG in decreasing the incidence and severity of neonatal immune
hemolytic jaundice due to Rh hemolytic disease reducing the need for exchange transfusion
as a primary goal in these babies. METHODS: This will be a randomized, double blind,
clinical trial involving all newborns with risk of significant hyperbilirubinemia due to
direct Coombs-positive Rh hemolytic disease. The primary goal will be need for exchange
transfusion and others are: incidence of late anemia, kernicterus and deafness Babies were
randomly assigned into two groups: group 1 (study group) received phototherapy plus IVIG (500
mg/kg); and group 2 (control group) received phototherapy and normal saline solution (10
ml/Kg) in the first 6 hours of life. Exchange transfusion was carried out in any group if at
any time the bilirubin level reached 340 micromol/l (20 mg/dl) or more, or rose by 8. 5
micromol/l per h (0. 5 mg/dl per h) in group 2. Adverse effects will be related in two
groups. Parents informed consent will be asked in pre-natal time.
Intravenous Immunoglobulin (IVIg) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) [Completed]
Chronic Inflammatory Demylinating Polyneuropathy (CIDP) is an autoimmune condition affecting
the nervous system. Researchers believe the immune system begins attacking the cells
covering nerves called myelin. The destruction of myelin causes muscle weakness, loss of
sensation, abnormal levels of protein in the fluid surrounding the brain (CSF), and slowing
of the nervous system. The disease progresses slowly and disables patients suffering from
it.
CIDP is treated with steroids, plasmapheresis, and immunosuppressive drugs. Many patients
initially respond to these treatments, but develop resistance to the therapy or experience
side effects causing the treatments to be stopped.
Researchers believe that intravenous immunoglobulin (IVIg) may provide patients with CIDP a
safer and more effective alternative to standard therapies for the disease. IVIg is a drug
that has been used successfully to treat other immune-related diseases of the nervous system.
However, because IVIg is so expensive, researchers believe it should first be proven
effective on a small group of patients.
The study will take 60 patients with CIDP and divide them into two groups. Group one will
receive 2 injections of IVIg once a month for three months. Group two will receive 2
injections of placebo "inactive injection of sterile water" once a month for three months.
Following the three months of treatment, group one will begin taking the placebo and group
two will begin taking IVIg for an additional 3 months. The drug will be considered effective
if patients receiving it experience a significant improvement (>25%) in muscle strength.
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