Immune Globulin For Prevention Research Articles

Pharmacokinetic modeling to determine the minimum effective dose of disease-specific antibodies for preventing hepatitis A post-exposure

ABSTRACT Background The minimum effective dose of intramuscular polyvalent immune globulin for prevention of hepatitis A post-exposure is unknown. In Australia current dosing is according to weight category. Methods The peak concentration and decay of hepatitis A antibodies after intramuscular dosing of immune globulin in adults was modeled utilizing published parameters. Models simulated dosing according to current Australian guidelines, then adjusted the dose in clinically relevant increments to estimate the optimal dose of hepatitis A antibodies for post-exposure prophylaxis of nonimmune individuals. Optimal dosing assumed a target serum concentration of hepatitis A antibodies of the correlate of protection plus a 10% margin of error at an incubation period. The effect of weight on hepatitis A antibody concentration at an incubation period under current guidelines was examined by fixing weight in 5 kg increments. Results Current dosing guidelines in Australia may underdose people who weigh in excess of 85 kg. The optimal dose of hepatitis A-specific antibodies according to the model was 3.6, 2.5, and 1.9 IU/kg assuming 50%, 75% and 100% bioavailability respectively. Conclusions For individuals in Australia recommended passive immunization as post-exposure prophylaxis and weighing in excess of 85 kg, conservative management would include dosing between 2.5 and 3.6 IU hepatitis A antibodies/kg.

Resource utilization of cytomegalovirus immune globulin in prevention and treatment of cytomegalovirus infection in pediatric heart transplantation.

There is debate whether cytomegalovirus immunoglobulin (CMV-Ig) is also needed for CMV prevention in heart transplant recipients in the era of good anti-viral drugs. We conducted a cost-savings quality initiative on CMV-Ig eventually leading to discontinuation of routine use of CMV-Ig for CMV prevention. Subsequently, a retrospective cohort study was conducted, comparing patients in cohort I (CMV-Ig plus anti-viral drugs, 2013-2015) to cohort II (anti-virals alone, 2015-2017). The medication acquisition costs and outcomes of CMV infection were assessed. There were 39 total patients: 22/39(56%) in cohort I, with mean follow-up of 35.14±17.38months and 17/39(44%) in cohort II, mean follow-up of 19.12±7.08months. In cohort I, 5/22(22.7%) patients died from causes unrelated to CMV and 0/17 in cohort II died. There were 5/22(22.7%) patients in cohort I, and 2/17(9%) patients in cohort II that developed CMV infection (P=.508). Freedom from rejection was 81.8% (18/22) in cohort I, and 71% (12/17) in cohort II (P=.46), and 100% for allograft vasculopathy. There was significant reduction in medication acquisition cost following the protocol change of $260839 or $15343 per patient. Our study demonstrated an acquisition cost savings with similar clinical outcomes utilizing anti-viral CMV prophylaxis alone vs anti-viral prophylaxis plus CMV-Ig.

Efficacy of Valganciclovir Plus Cytomegalovirus Immune Globulin for Prevention of Cytomegalovirus Disease in High-Risk Renal Transplant Recipients

Efficacy of Valganciclovir Plus Cytomegalovirus Immune Globulin for Prevention of Cytomegalovirus Disease in High-Risk Renal Transplant Recipients

Acute otitis media in the era of effective pneumococcal conjugate vaccine: will new pathogens emerge?

The immunogenicity of pneumococcal conjugate vaccine (PCV) in young infants and its serotype-specific efficacy in otitis media (OM) results in a modest reduction in total episodes of OM and a more substantial reduction in disease due to the most frequent pneumococcal serotypes. Since PCV will only prevent disease due to the most common serotypes, concerns about potential changes in the microbiology of OM have emerged. Insight into potential changes can be obtained from reviewing middle ear and nasopharyngeal isolates from studies of antimicrobial prophylaxis and bacterial polysaccharide immune globulin for prevention of OM and PCV for prevention of invasive pneumococcal disease, respectively. In children receiving PCV, a shift in serotypes of SP colonizing the nasopharynx has been observed. Since non-vaccine serotypes are already present in the community as the etiology of acute purulent OM, it is predictable that these non-vaccine serotypes will become more common especially in children less than two years of age.

Role of steroids in croup and beta agonists in bronchiolitis.

The administration of corticosteroids by various routes in the treatment of croup remains controversial as studies with varying designs and outcome measures have reported conflicting results. However, meta-analysis supports the use of steroids in croup. A dose equivalent to or greater than 100 mg/kg body weight of hydrocortisone, administered orally or parenterally appears to be effective. Nebulized budesonide in a dose of 1,000 micrograms, when dosages are given 30 minutes apart is also effective. The L-epinephrine is as effective as racemic epinephrine and should be used to relieve symptoms with or without steroids. Summarizing the value of beta agonists, for treatment of bronchiolitis is rather challenging. Beta agonists offer significant relief to only a subgroup of infants, with bronchiolitis, albeit, it remains a challenge to identify these infants prospectively. Availability of RSV immune globulin for prevention of RSV disease in high-risk infants and better defining the role of ribavirin for selected patients may offer additional avenues to the treating physician.

Yeast-recombinant hepatitis B vaccine. Efficacy with hepatitis B immune globulin in prevention of perinatal hepatitis B virus transmission

Yeast-recombinant hepatitis B vaccine. Efficacy with hepatitis B immune globulin in prevention of perinatal hepatitis B virus transmission

Yeast-recombinant hepatitis B vaccine. Efficacy with hepatitis B immune globulin in prevention of perinatal hepatitis B virus transmission.

A yeast-recombinant hepatitis B vaccine was licensed recently by the Food and Drug Administration and is now available. To assess the efficacy of the yeast-recombinant vaccine, we administered the vaccine in combination with hepatitis B immune globulin to high-risk newborns. If infants whose mothers were positive for both hepatitis B surface antigen and the e antigen receive no immunoprophylaxis, 70% to 90% become infected with the virus, and almost all become chronic carriers. Among infants in this study who received hepatitis B immune globulin at birth and three 5-micrograms doses of yeast-recombinant hepatitis B vaccine, only 4.8% became chronic carriers, a better than 90% level of protection and a rate that is comparable with that seen with immune globulin and plasma-derived hepatitis B vaccine. These data suggest that, in this high-risk setting, the yeast-recombinant vaccine is as effective as the plasma-derived vaccine in preventing hepatitis B virus infection and the chronic carrier state.

Efficacy of hepatitis B immune globulin in prevention of perinatal transmission of the hepatitis B virus

An efficacy trial of hepatitis B immune globulin in the prevention of perinatal transmission of hepatitis B virus infection was conducted in Los Angeles. Ten infants born to hepatitis B surface antigen (HBsAg)-and hepatitis B e antigen (HBeAg)-positive carrier mothers as well as 4 infants born to mothers with acute hepatitis B in the third trimester of pregnancy received hepatitis B immune globulin without randomization. Twenty infants born to HBsAg- and antibody to hepatitis B e antigen (anti-HBe)-positive carrier mothers were randomized to receive hepatitis B immune globulin or a placebo. All infants were followed for up to 18 mo. Four infants (2 born to HBeAg carrier mothers, 1 to an anti-HBe carrier, and 1 to a mother with acute hepatitis) became HBsAg-positive carriers, whereas another infant, whose mother was an HBeAg carrier, developed a transient anicteric hepatitis B infection. All infants who became infected did so after 9 mo of age as hepatitis B immune globulin protection waned. In infants born to HBsAg-positive carrier mothers, active immunoprophylaxis with the hepatitis B vaccine must be used in conjunction with hepatitis B immune globulin.

579 INTRAUTERINE OR INTRAPARTUM Rh ISO-SENSITIZATION AND USE OF MICRhoGAM IN THE NEONATE

To investigate incidence and timing of a possible transfusion of Rho (D)-positive (Rh+) maternal cells to a fetus with Rho (D)-negative (Rh-) cells and the role of Rho (D) immune globulin in prevention of potential primary sensitization, 354 Rh-infants born to Rh+ mothers were studied. MICRhoGAM (MRG) (50ug) was administered to 114 female infants in the first 72h. of life and 240 infants were controls (52 females, 188 males). Of 263 cord serums screened, antibody was found in 6, none of which were anti-D on retesting against a 10 red-cell panel. Two of 167 heel stick samples obtained from infants at 2 days of age revealed maternal Rh+ cells (courtesy B.Clauss & E.R. Jennings). No anti-D antibody was found in either infant at 3 and 6 mo. of age. No anti-D was found in 207 serum samples from control infants (158 males, 49 females) who were ½ to 17 mo. of age; however, 26 of 94 MRG recipients had anti-D between 2½ and 5 mo. of age. (RhoGam may be detected up to 6 mo.) Reports indicating significant risk for either intrauterine or parturition primary anti-D sensitization cannot be corroborated by our studies. Primary sensitization not presently detectable may be confirmed later by an amnestic anti-D response on a second exposure to Rh+ cells, perhaps during pregnancy with a Rh+ fetus. Long term follow-up will ultimately decide the immunoprophylactic role of MRG in prevention of Rho (D) iso-sensitization.

Hepatitis B Immune Globulin in Prevention of Hepatitis B among Hospital Staff Members

In a double-blind trial of hospital staff members at risk of contracting hepatitis B, 110 subjects received hepatitis B immune globulin or immune serum globulin prophylactically. An additional 125 individuals working in the same locations were unwilling to participate in the trial and received no prophylaxis. During the study period of 28 months, 13 cases of clinical hepatitis B occurred in the untreated group, whereas only three cases occurred among the subjects who received prophylaxis.

Viral Hepatitis Among American Missionaries Abroad

It is the impression of many physicians that the incidence of viral hepatitis among Americans abroad is much higher than that in the United States. There is very little information available, however, to assist them in determining whether this is indeed true. Attack rates have only been determined for military populations, and may not apply to civilians who obviously live under very different circumstances. To assess the extent to which viral hepatitis is a risk, a group is needed which has been under medical supervision while residing in countries thought to be "hyperendemic." American missionaries and their families are such a group, and seem to be a suitable population in many respects. They remain abroad for long periods of time, work in close contact with the indigenous populations, and in general have not received immune globulin for prevention of infectious hepatitis. Accordingly, in October 1964 the present study was undertaken.