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A study aims to investigate the safety and efficacy of Anthrax adsorbed vaccine (AVA). The results indicate that intra-muscular administration of AVA significantly reduced the occurrence of injection site adverse effects.

Use of a primary and a booster shot of the vaccine known as PNCRM7 seems to be safe and shows signs that it may also be effective, based on observed increases in antibodies. The vaccine was heptavalent, meaning it was configured to address seven different serotypes. Of the 212 children randomly assigned to receive four doses of PNCRM7 or another vaccine, the children receiving PNCRM7 had fewer reactions, indicating acceptable levels of safety. Current testing will determine the degree of effectiveness., Objective. To determine the safety and immunogenicity of heptavalent pneumococcal saccharide vaccine (serotypes 4, 6B, 9V, 14, 18C, 19F, 23F) individually conjugated to [CRM.sub.197] (PNCRM7), administered at 2, 4, 6, and 12 to 15 months of age. Design. Two hundred twelve healthy 2-month-old infants were equally randomized to receive four consecutive doses of PNCRM7 or an investigational meningococcal group C conjugate vaccine, which served as a control. Concomitantly administered routine vaccines were oral polio vaccine and combined diphtheria toxoid, tetanus toxoid, and whole cell pertussis vaccine/Haemophilus influenzae type b vaccine consisting of capsular oligosaccharides conjugated to [CRM.sub.197] (DTP/HbOC) at 2, 4, and 6 months, and either measles-mumps-rubella vaccine or HbOC at 12 to 15 months. Active safety surveillance was conducted for 3 days after each dose. Antibody concentrations to each of the 7 pneumococcal serotypes were measured by enzyme-linked immunosorbent assay prevaccination, after doses two and three, prebooster, and postbooster. Results. Significantly fewer children experienced local reactions at the PNCRM7 injection site than at the DTP/HbOC site. There was no increase in the incidence or severity of local reactions at the PNCRM7 site with increasing doses of vaccine. Mild to moderate postvaccination fever was common in both the PNCRM7 and control vaccine groups, however DTP/HbOC was administered concurrently. All 7 vaccine serotypes were immunogenic. The kinetics of the immune responses were serotype-specific. After three doses of PNCRM7, between 92% to 100% of children had 20.15 [micro] g/mL of antibody, and 51% to 90% achieved a level of 21 [micro] g/mL against specific serotypes. A booster dose of PNCRM7 resulted in a brisk anamnestic response to all 7 vaccine serotypes, demonstrating effective stimulation of T-cell memory by the primary series of vaccinations. Conclusions. Primary immunization followed by a booster dose of PNCRM7 seemed to be acceptably safe and resulted in significant rises in antibody to all 7 serotypes. Implications. Studies to assess vaccine efficacy of PNCRM7 for prevention of systemic disease, nasopharyngeal colonization, and acute otitis media are in progress. If PNCRM7 proves to be protective, there is the potential to prevent up to 85% of invasive pneumococcal disease occurring in US children. Pediatrics 1998;101: 604-611; vaccine, pediatric, pneumococcal., ABBREVIATIONS. Hib, Haemophilus influenzae type b conjugate vaccine; [CRM.sub.197], cross-reactive material 197; PNCRM5, pentavalent pneumococcal saccharide vaccine conjugated to [CRM.sub.197]; menC, conjugate meningococcal group C vaccine; PNCRM7, heptavalent pneumococcal saccharide [...]

* Objective.--To compare the safety and immunogenicity of three investigational lots of Haemophilus influenzae type b polysaccharide-tetanus toxoid (PRP-T) conjugate vaccine in infants. Design.--A multicenter, randomized immunogenicity trial. Infants were vaccinated at 2, 4, and 6 months of age with one of three lots of PRP-T. A control group received H influenzae type b oligomers conjugated to [CRM.sub.197] (HbOC). Serum was obtained before each injection and 1 month after the third dose, and assayed blindly for antibody in one laboratory. Subjects.--Four hundred eighty-four infants from private pediatric practices located in five geographic areas. Measurements and Results.--There were no significant differences in the number of adverse events reported for infants receiving PRP-T or HBOC, and the rates did not exceed those observed previously in infants given diphtheriatetanus-pertussis vaccine alone. Total serum anti-PRP antibody responses were analyzed in 336 infants who met strict inclusion criteria. After one, two, or three doses, the respective antibody responses to each of the three lots of PRP-T and to HbOC vaccine were similar. The only exception was one lot of PRP-T, which after one or two injections elicited significantly higher geometric mean antibody responses than the other two lots or the HbOC vaccine. After a third injection, there were no significant lot differences. Combining the data from the different lots, there were no significant differences in the geometric mean antibody concentration after three doses of PRP-T or HbOC (8.3 vs 7.7 [Mu]g/mL), and 95% and 91 %, respectively, of infants had greater than 1.0 [Mu]g/mL of antibody. There were no significant differences in the magnitudes of the respective IgG1-, IgG2-, and IgM-specific antibody concentrations between infants given PRP-T or HbOC. Conclusions.--The three investigational lots of PRP-T tested were safe and were as immunogenic as or more so than the licensed HbOC conjugate vaccine. (AJDC. 1993;147:832-836), A multicenter, randomized immunogenicity trial involving 485 infants from private pediatric practices in five geographic areas was carried out to compare the safety and immunogenicity of three investigational lots of Haemophilus influenzae type b polysaccharide-tetanus toxoid (PRP-T) conjugate vaccine. Each of the infants was vaccinated at 2, 4 and 6 months of age with one of three lots of PRP-T. All the infants received oral polio, DTP and Hib conjugate on the same visit, but adverse events did not surpass those expected from DTP vaccine alone. To compare the immunogenicity of the three lots of PRP-T and the HbOC vaccine, the data from the five study locations were combined. They showed that PRP-T and HbOC were immunologically similar. PRP-T was subsequently licensed in the U.S., France and other European countries.

Abstract Background Seasonal influenza imposes a substantial personal morbidity and societal cost burden. Vaccination is the major strategy for influenza prevention; however, because antigenically drifted influenza A and B viruses circulate annually, influenza vaccines must be updated to provide protection against the predicted prevalent strains for the next influenza season. The aim of this study was to assess the efficacy, safety, reactogenicity, and immunogenicity of a trivalent inactivated split virion influenza vaccine (TIV) in healthy adults over two influenza seasons in the US. Methods The primary endpoint of this double-blind, randomized study was the average efficacy of TIV versus placebo for the prevention of vaccine-matched, culture-confirmed influenza (VMCCI) across the 2005-2006 and 2006-2007 influenza seasons. Secondary endpoints included the prevention of laboratory-confirmed (defined by culture and/or serology) influenza, as well as safety, reactogenicity, immunogenicity, and consistency between three consecutive vaccine lots. Participants were assessed actively during both influenza seasons, and nasopharyngeal swabs were collected for viral culture from individuals with influenza-like illness. Blood specimens were obtained for serology one month after vaccination and at the end of each influenza season's surveillance period. Results Although the point estimate for efficacy in the prevention of all laboratory-confirmed influenza was 63.2% (97.5% confidence interval [CI] lower bound of 48.2%), the point estimate for the primary endpoint, efficacy of TIV against VMCCI across both influenza seasons, was 46.3% with a 97.5% CI lower bound of 9.8%. This did not satisfy the pre-specified success criterion of a one-sided 97.5% CI lower bound of >35% for vaccine efficacy. The VMCCI attack rates were very low overall at 0.6% and 1.2% in the TIV and placebo groups, respectively. Apart from a mismatch for influenza B virus lineage in 2005-2006, there was a good match between TIV and the circulating strains. TIV was highly immunogenic, and immune responses were consistent between three different TIV lots. The most common reactogenicity events and spontaneous adverse events were associated with the injection site, and were mild in severity. Conclusions Despite a good immune response, and an average efficacy over two influenza seasons against laboratory-confirmed influenza of 63.2%, the pre-specified target (lower one-sided 97.5% confidence bound for efficacy > 35%) for the primary efficacy endpoint, the prevention of VMCCI, was not met. However, the results should be interpreted with caution in view of the very low attack rates we observed at the study sites in the 2005-2006 and 2006-2007, which corresponded to relatively mild influenza seasons in the US. Overall, the results showed that TIV has an acceptable safety profile and offered clinical benefit that exceeded risk. Trial registration NCT00216242

OBJECTIVES. Influenza is a leading cause of illness among children. Studies rarely have measured influenza vaccine effectiveness among young children, particularly when antigenic match between vaccine and circulating viruses is [...]

Objectives. To assess vancomycin utilization at children's hospitals, to determine risk factors for vancomycin use and length of therapy, and to facilitate adapting recommendations to optimize vancomycin prescribing practices in pediatric patients. Methods. Two surveys were conducted at Pediatric Prevention Network hospitals. The first (Survey I) evaluated vancomycin control programs. The second (Survey II) prospectively reviewed individual patient records. Each hospital was asked to complete questionnaires on 25 consecutive patients or all patients for whom vancomycin was prescribed during a 1-month period. Results. In Survey I, 55 of 65 (85%) hospitals reported their vancomycin control policies. Three quarters had specific policies in place to restrict vancomycin use. One half had at least 3 vancomycin restriction measures. In Survey II, personnel at 22 hospitals reviewed 416 vancomycin courses, with 2 to 25 (median = 12) patients tracked per hospital. Eighty-two percent of the vancomycin prescribed was for treatment of neonatal sepsis, fever/neutropenia, fever of unknown origin, positive blood culture, pneumonia, or meningitis. In an additional 6% (26/416), vancomycin was prescribed for patients with [beta]-lactam allergies and in 13% (56/416) for prophylaxis. Median duration of prophylaxis was 2 days (range: 1-15 days). Almost half (196, 47%) of the patients who received vancomycin were in intensive care units; 27% of the vancomycin courses were initiated by neonatologists and 19% by hematologists/oncologists. The predominant risk factor at the time of vancomycin initiation was the presence of vascular catheters (322, 77%); other host factors included cancer chemotherapy (55, 13%), transplant (30, 7%), shock (24, 6%), other immunosuppressant therapy (17, 4%), or hyposplenic state (2, Conclusions. At children's hospitals, vancomycin is initiated for therapy in patients who have vascular catheters and compromised host factors. Only 7% had laboratory-confirmed [beta]-lactam-resistant organisms isolated at the time vancomycin was prescribed. Efforts to modify empiric vancomycin use in children's hospitals should be targeted at intensivists, neonatologists, and hematologists. Initiatives to decrease length of therapy by decreasing the number of surgical prophylaxis doses and days of therapy before laboratory results may decrease vancomycin exposure. URL: http://www.pediatrics.org/cgi/content/full/112/2/ e104; vancomycin, pediatrics, antimicrobial resistance, antimicrobial use.

Recent reports of invasive Haemophilus influenzae non-b capsular serotypes in the era since development of conjugate vaccines have prompted concern about erotype replacement. Unusual clusters of invasive infection due to H. nfluenzae serotype a with clinical features that resemble those of infection due to H. influenzae serotype b have been described. A unique feature often associated with more-virulent H. influenzae serotype a isolates is the IS1016-bexA partial deletion, which was previously identified in the capsule locus of H. nfluenzae serotype b strains. We report the clinical, epidemiologic, and molecular genetic features of 2 cases of severe disease caused by H. influenzae serotype a. Methods. Invasive H. influenzae isolates were serotyped with standard serological methods, and molecular typing was done with PCR. The capsular genotype of each isolate was characterized with PCR, partial sequencing, and Southern blot hybridization. Further strain typing was performed with pulsed-field gel electrophoresis. Results. We identified 2 children with severe invasive disease due to H. influenzae serotype a. Both H. influenzae serotype a isolates ontained the identical pulsed-field gel electrophoresis pattern and capsular serotype. An IS1016- bexA partial deletion in the capsule gene locus similar to hat found in H. influenzae serotype b was identified in both isolates by means of PCR and sequencing of the IS1016-bexA junction. Conclusions. We describe 2 cases of severe invasive disease due to H. influenzae serotype a with the putative virulence-enhancing IS1016-bexA partial deletion and duplication of the apsule locus. Our data support the hypothesis that this mutation may be associated with virulence in non-b capsular serotypes of H. influenzae. [ABSTRACT FROM AUTHOR]

Abstract. Malassezia furfur (Pityrosporum orbiculare, P ovale), a lipophilic yeast that is part of the normal skin flora, causes tinea versicolor but has only rarely been associated with more serious infections. We report five episodes in four infants of catheter-related infection caused by this organism. All episodes occurred in infants who had survived serious neonatal disorders and were receiving prolonged therapy with intravenous fat emulsion. Sudden onset of fever without focal findings was the usual presentation; however, one afebrile patient had recurrent episodes of apnea, bradycardia, and cyanosis. Thrombocytopenia was a prominent finding. Patients were generally treated with amphotericin B. All patients recovered when the colonized catheter was removed or fat emulsion therapy was stopped. The yeast usually grew slowly in blood culture media but grew readily when subcultured onto Sabouraud's medium coated with sterile olive oil. Yeasts were readily identified in all four patients in whom a buffy coat Gram stain was obtained of blood from the central intravenous catheter. M furfur may be a fairly common but unrecognized cause of catheter-related sepsis in infants receiving long-term fat emulsion therapy. This organism should be sought whenever routine blood cultures are negative for bacteria and yeasts are observed in a buffy coat Gram stain. Pediatrics 1985;76:896-900; catheter, infection, infant, lipophilic yeast, Malassezia furfur. [ABSTRACT FROM AUTHOR]

A prospective study of the virology of and serological responses to enterovirus infection in 16 neonates (<2 weeks of life) and their mothers was performed. At study entry, 11 neonates did not have detectable serum neutralizing antibody to their own viral isolates, despite the presence of neutralizing antibody in 9 of 11 mothers of these infants. Viremia and viruria were demonstrated in 8 and 7 neonates, respectively, with maximal detected titers of 6.3 × 103 50% tissue culture infective dose per mL (TCID50) and 6.8 × 101 TCID50/mL, respectively. Viremia was associated with onset of illness in the first 5 days of life, low initial serum neutralization titer, and the presence of echovirus serotypes. Randomized administration of intravenous immune globulin (IVIG; 750 mg/kg) to nine neonates overall modestly increased serum neutralization titers but did not reduce the daily incidence of viremia and viruria compared with that of controls. However, receipt of IVIG containing a neutralization titer of ⩾ 1:800 to the patients' own viral isolates was associated with significantly higher serum neutralization titers and more rapid cessation of viremia and viruria. Future trials of IVIG for neonatal enterovirus disease should assess the efficacy and safety of higher or repeated doses of this agent and/or of IVIG lots selected for their high titers to frequently circulating and/or particularly virulent enterovirus serotypes. [ABSTRACT FROM PUBLISHER]