Equivalent immunogenicity across three RSVpreF vaccine lots in healthy adults 18-49 years of age: Results of a randomized phase 3 study.

BACKGROUND: Bivalent RSV prefusion F subunit vaccine (RSVpreF), comprised of equal quantities of stabilized prefusion F antigens from the major circulating subgroups (RSV A, RSV B), is licensed for prevention of RSV-associated lower respiratory tract illness (LRTI) in older adults and for maternal vaccination for prevention of RSV-associated LRTI in infants. To support licensure and large-scale manufacturing, this lot consistency study was conducted to demonstrate equivalence in immunogenicity across 3 RSVpreF lots. METHODS: This phase 3, multicenter, parallel-group, placebo-controlled, randomized (1:1:1:1), double-blind study evaluated immunogenicity, safety, and tolerability of RSVpreF in healthy 18-49-year-old adults. Participants received a single 120-µg injection of 1 of 3RSVpreF lots or placebo. Geometric mean ratio (GMR) of RSV serum 50 % neutralizing geometric mean titers obtained 1 month after vaccination were compared between each vaccine lot for RSV A and RSV B, separately. Equivalence between lots was defined using a 1.5-fold criterion (GMR 95 % CIs for every lot pair within the 0.667-1.5 interval). Safety and tolerability were assessed. RESULTS: Of 992participants vaccinated, 948 were included in the evaluable immunogenicity population. All 3 RSVpreF lots elicited strong immune responses, meeting the 1.5-fold equivalence criterion for all between-lot comparisons for both RSV A and RSV B. Across the 3 lots, RSV A and RSV B 50 % neutralizing geometric mean titers substantially increased from baseline (RSV A, 1671-1795; RSV B 1358-1429) to 1 month after RSVpreF vaccination (RSV A, 24,131-25,238; RSV B, 19,238-21,702), corresponding to ≥14-fold increases in 50 % neutralizing titers for both RSV A and RSV B from before to 1 month after vaccination. Single doses of RSVpreF were safe and well tolerated, with similar safety profiles across the 3 RSVpreF lots. CONCLUSIONS: These findings support the reproducibility of RSVpreF vaccine manufacturing with similar safety and reactogenicity profiles (NCT05096208).

Episodic Cost of Lower Respiratory Tract Illness Due to Respiratory Syncytial Virus Among US Infants During the First Year of Life.

A study using two healthcare claims databases (commercial, Medicaid) was undertaken to estimate episodic cost of lower respiratory tract illness due to respiratory syncytial virus (RSV-LRTI) among infants aged <12 months overall, by age, and by birth gestational age (weeks [wGA]). Among commercial-insured infants, mean costs were $28,812 for hospitalized episodes, $2,575 for emergency department episodes, and $336 for outpatient clinic episodes; costs were highest among infants aged <1 month and infants with wGA ≤32, and were comparable-albeit somewhat lower-among Medicaid-insured infants. Cost of RSV-LRTI during acute phase of illness is high, especially among youngest and premature infants.

Efficacy of a 4-Antigen Staphylococcus aureus Vaccine in Spinal Surgery: The STaphylococcus aureus suRgical Inpatient Vaccine Efficacy (STRIVE) Randomized Clinical Trial.

BACKGROUND: Staphylococcus aureus is a global pathogen that is frequently responsible for healthcare-associated infections, including surgical site infections (SSIs). Current infection prevention and control approaches may be limited, with S. aureus antibiotic resistance remaining problematic. Thus, a vaccine to prevent or reduce S. aureus infection is critically needed. We evaluated the efficacy and safety of an investigational 4-antigen S. aureus vaccine (SA4Ag) in adults undergoing elective open posterior spinal fusion procedures with multilevel instrumentation. METHODS: In this multicenter, site-level, randomized, double-blind trial, patients aged 18-85 years received a single dose of SA4Ag or placebo 10-60 days before surgery. SA4Ag efficacy in preventing postoperative S. aureus bloodstream infection and/or deep incisional or organ/space SSIs was the primary end point. Safety evaluations included local reactions, systemic events, and adverse events (AEs). Immunogenicity and colonization were assessed. RESULTS: Study enrollment was halted when a prespecified interim efficacy analysis met predefined futility criteria. SA4Ag showed no efficacy (0.0%) in preventing postoperative S. aureus infection (14 cases in each group through postoperative day 90), despite inducing robust functional immune responses to each antigen compared with placebo. Colonization rates across groups were similar through postoperative day 180. Local reactions and systemic events were mostly mild or moderate in severity, with AEs reported at similar frequencies across groups. CONCLUSIONS: In patients undergoing elective spinal fusion surgical procedures, SA4Ag was safe and well tolerated but, despite eliciting substantial antibody responses that blocked key S. aureus virulence mechanisms, was not efficacious in preventing S. aureus infection. Clinical Trials Registration. NCT02388165.

Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants.

BACKGROUND: Whether vaccination during pregnancy could reduce the burden of respiratory syncytial virus (RSV)-associated lower respiratory tract illness in newborns and infants is uncertain. METHODS: In this phase 3, double-blind trial conducted in 18 countries, we randomly assigned, in a 1:1 ratio, pregnant women at 24 through 36 weeks' gestation to receive a single intramuscular injection of 120 µg of a bivalent RSV prefusion F protein-based (RSVpreF) vaccine or placebo. The two primary efficacy end points were medically attended severe RSV-associated lower respiratory tract illness and medically attended RSV-associated lower respiratory tract illness in infants within 90, 120, 150, and 180 days after birth. A lower boundary of the confidence interval for vaccine efficacy (99.5% confidence interval [CI] at 90 days; 97.58% CI at later intervals) greater than 20% was considered to meet the success criterion for vaccine efficacy with respect to the primary end points. RESULTS: At this prespecified interim analysis, the success criterion for vaccine efficacy was met with respect to one primary end point. Overall, 3682 maternal participants received vaccine and 3676 received placebo; 3570 and 3558 infants, respectively, were evaluated. Medically attended severe lower respiratory tract illness occurred within 90 days after birth in 6 infants of women in the vaccine group and 33 infants of women in the placebo group (vaccine efficacy, 81.8%; 99.5% CI, 40.6 to 96.3); 19 cases and 62 cases, respectively, occurred within 180 days after birth (vaccine efficacy, 69.4%; 97.58% CI, 44.3 to 84.1). Medically attended RSV-associated lower respiratory tract illness occurred within 90 days after birth in 24 infants of women in the vaccine group and 56 infants of women in the placebo group (vaccine efficacy, 57.1%; 99.5% CI, 14.7 to 79.8); these results did not meet the statistical success criterion. No safety signals were detected in maternal participants or in infants and toddlers up to 24 months of age. The incidences of adverse events reported within 1 month after injection or within 1 month after birth were similar in the vaccine group (13.8% of women and 37.1% of infants) and the placebo group (13.1% and 34.5%, respectively). CONCLUSIONS: RSVpreF vaccine administered during pregnancy was effective against medically attended severe RSV-associated lower respiratory tract illness in infants, and no safety concerns were identified. (Funded by Pfizer; MATISSE ClinicalTrials.gov number, NCT04424316.).

Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age.

BACKGROUND: Safe and effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in young children. METHODS: We conducted a phase 1 dose-finding study and are conducting an ongoing phase 2-3 safety, immunogenicity, and efficacy trial of the BNT162b2 vaccine in healthy children 6 months to 11 years of age. We present results for children 6 months to less than 2 years of age and those 2 to 4 years of age through the data-cutoff dates (April 29, 2022, for safety and immunogenicity and June 17, 2022, for efficacy). In the phase 2-3 trial, participants were randomly assigned (in a 2:1 ratio) to receive two 3-µg doses of BNT162b2 or placebo. On the basis of preliminary immunogenicity results, a third 3-µg dose (≥8 weeks after dose 2) was administered starting in January 2022, which coincided with the emergence of the B.1.1.529 (omicron) variant. Immune responses at 1 month after doses 2 and 3 in children 6 months to less than 2 years of age and those 2 to 4 years of age were immunologically bridged to responses after dose 2 in persons 16 to 25 years of age who received 30 µg of BNT162b2 in the pivotal trial. RESULTS: During the phase 1 dose-finding study, two doses of BNT162b2 were administered 21 days apart to 16 children 6 months to less than 2 years of age (3-µg dose) and 48 children 2 to 4 years of age (3-µg or 10-µg dose). The 3-µg dose level was selected for the phase 2-3 trial; 1178 children 6 months to less than 2 years of age and 1835 children 2 to 4 years of age received BNT162b2, and 598 and 915, respectively, received placebo. Immunobridging success criteria for the geometric mean ratio and seroresponse at 1 month after dose 3 were met in both age groups. BNT162b2 reactogenicity events were mostly mild to moderate, with no grade 4 events. Low, similar incidences of fever were reported after receipt of BNT162b2 (7% among children 6 months to <2 years of age and 5% among those 2 to 4 years of age) and placebo (6 to 7% among children 6 months to <2 years of age and 4 to 5% among those 2 to 4 years of age). The observed overall vaccine efficacy against symptomatic Covid-19 in children 6 months to 4 years of age was 73.2% (95% confidence interval, 43.8 to 87.6) from 7 days after dose 3 (on the basis of 34 cases). CONCLUSIONS: A three-dose primary series of 3-µg BNT162b2 was safe, immunogenic, and efficacious in children 6 months to 4 years of age. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04816643.).

Staphylococcus aureus infections after elective pediatric surgeries.

OBJECTIVE: To determine the 180-day cumulative incidence of culture-confirmed Staphylococcus aureus infections after elective pediatric surgeries. DESIGN: Retrospective cohort study utilizing the Premier Healthcare database (PHD). SETTING: Inpatient and hospital-based outpatient elective surgical discharges. PATIENTS: Pediatric patients <18 years who underwent surgery during elective admissions between July 1, 2010, and June 30, 2015, at any of 181 PHD hospitals reporting microbiology results. METHODS: In total, 74 surgical categories were defined using ICD-9-CM and CPT procedure codes. Microbiology results and ICD-9-CM diagnosis codes defined S. aureus infection types: bloodstream infection (BSI), surgical site infection (SSI), and other types (urinary tract, respiratory, and all other). Cumulative postsurgical infection incidence was calculated as the number of infections divided by the number of discharges with qualifying elective surgeries. RESULTS: Among 11,874 inpatient surgical discharges, 180-day S. aureus infection incidence was 1.79% overall (1.00% SSI, 0.35% BSI, 0.45% other). Incidence was highest among children <2 years of age (2.76%) and lowest for those 10-17 years (1.49%). Among 50,698 outpatient surgical discharges, incidence was 0.36% overall (0.23% SSI, 0.05% BSI, 0.08% others); it was highest among children <2 years of age (0.57%) and lowest for those aged 10-17 years (0.30%). MRSA incidence was significantly higher after inpatient surgeries (0.68%) than after outpatient surgeries (0.14%; P < .0001). Overall, the median days to S. aureus infection was longer after outpatient surgery than after inpatient surgery (39 vs. 31 days; P = .0116). CONCLUSIONS: These findings illustrate the burden of postoperative S. aureus infections in the pediatric population, particularly among young children. These results underscore the need for continued infection prevention efforts and longer-term surveillance after surgery.

Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age.

BACKGROUND: Safe, effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in children younger than 12 years of age. METHODS: A phase 1, dose-finding study and an ongoing phase 2-3 randomized trial are being conducted to investigate the safety, immunogenicity, and efficacy of two doses of the BNT162b2 vaccine administered 21 days apart in children 6 months to 11 years of age. We present results for 5-to-11-year-old children. In the phase 2-3 trial, participants were randomly assigned in a 2:1 ratio to receive two doses of either the BNT162b2 vaccine at the dose level identified during the open-label phase 1 study or placebo. Immune responses 1 month after the second dose of BNT162b2 were immunologically bridged to those in 16-to-25-year-olds from the pivotal trial of two 30-µg doses of BNT162b2. Vaccine efficacy against Covid-19 at 7 days or more after the second dose was assessed. RESULTS: During the phase 1 study, a total of 48 children 5 to 11 years of age received 10 µg, 20 µg, or 30 µg of the BNT162b2 vaccine (16 children at each dose level). On the basis of reactogenicity and immunogenicity, a dose level of 10 µg was selected for further study. In the phase 2-3 trial, a total of 2268 children were randomly assigned to receive the BNT162b2 vaccine (1517 children) or placebo (751 children). At data cutoff, the median follow-up was 2.3 months. In the 5-to-11-year-olds, as in other age groups, the BNT162b2 vaccine had a favorable safety profile. No vaccine-related serious adverse events were noted. One month after the second dose, the geometric mean ratio of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing titers in 5-to-11-year-olds to those in 16-to-25-year-olds was 1.04 (95% confidence interval [CI], 0.93 to 1.18), a ratio meeting the prespecified immunogenicity success criterion (lower bound of two-sided 95% CI, >0.67; geometric mean ratio point estimate, ≥0.8). Covid-19 with onset 7 days or more after the second dose was reported in three recipients of the BNT162b2 vaccine and in 16 placebo recipients (vaccine efficacy, 90.7%; 95% CI, 67.7 to 98.3). CONCLUSIONS: A Covid-19 vaccination regimen consisting of two 10-µg doses of BNT162b2 administered 21 days apart was found to be safe, immunogenic, and efficacious in children 5 to 11 years of age. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04816643.).

Immunogenicity and Safety of a Measles-Mumps-Rubella Vaccine Administered as a First Dose to Children Aged 12 to 15 Months: A Phase III, Randomized, Noninferiority, Lot-to-Lot Consistency Study.

BACKGROUND: MMR II (M-M-R II [Merck & Co, Inc.]) is currently the only measles, mumps, and rubella (MMR) vaccine licensed in the United States. A second MMR vaccine would mitigate the potential risk of vaccine supply shortage or delay. In this study, we assessed the immunogenicity and safety of another MMR vaccine (MMR-RIT [Priorix, GlaxoSmithKline]) compared with those of the MMR II in 12- to 15-month-old children who received it as a first dose. METHODS: In this phase III, observer-blinded, noninferiority, lot-to-lot consistency clinical trial (ClinicalTrials.gov identifier NCT01702428), 5003 healthy children were randomly assigned to receive 1 dose of MMR-RIT (1 of 3 production lots) or MMR II along with other age-recommended routine vaccines. We evaluated the immunogenicity of all vaccines in terms of antibody concentrations (by using an enzyme-linked immunosorbent assay or electrochemiluminescence assay) and/or seroresponse rates 43 days after vaccination. We also assessed the reactogenicity and safety of the vaccines. RESULTS: Immunoresponses after vaccination with MMR-RIT were robust and noninferior to those after vaccination with the MMR II. Immunogenicity of the 3 production lots of MMR-RIT was consistent; more than 97% of the children had a seroresponse to MMR components. The coadministered vaccines elicited similar immunoresponses in the MMR-RIT and MMR II groups. Both MMR vaccines resulted in comparable reactogenicity profiles, and no safety concerns were detected. CONCLUSIONS: If licensed, the MMR-RIT could provide a valid option for the prevention of measles, mumps, and rubella in children in the United States and would reduce potential risks of a vaccine shortage.

Public Health Management of Persons Under Investigation for Ebola Virus Disease in New York City, 2014-2016.

During 2014-2016, the largest outbreak of Ebola virus disease (EVD) in history occurred in West Africa. The New York City Department of Health and Mental Hygiene (DOHMH) worked with health care providers to prepare for persons under investigation (PUIs) for EVD in New York City. From July 1, 2014, through December 29, 2015, we classified as a PUI a person with EVD-compatible signs or symptoms and an epidemiologic risk factor within 21 days before illness onset. Of 112 persons who met PUI criteria, 74 (66%) sought medical care and 49 (44%) were hospitalized. The remaining 38 (34%) were isolated at home with daily contact by DOHMH staff members. Thirty-two (29%) PUIs received a diagnosis of malaria. Of 10 PUIs tested, 1 received a diagnosis of EVD. Home isolation minimized unnecessary hospitalization. This case study highlights the importance of developing competency among clinical and public health staff managing persons suspected to be infected with a high-consequence pathogen.

Epidemiology of and Risk Factors for Harmful Anti-Infective Medication Errors in a Pediatric Hospital.

BACKGROUND: Literature is limited on pediatric anti-infective medication errors. There is a pressing need for additional research, as studies suggest high rates of overall pediatric medication errors and known harmful side effect profiles for anti-infective medications with narrow dosing ranges. This study aimed to identify risk factors related to harmful anti-infective medication errors in pediatric patients. METHODS: A retrospective chart review of all voluntary error reports involving anti-infective medication errors and pediatric patients (0 to < 22 years old) reported June 2014-December 2015 was conducted. Error reports were generated using the hospital's general error reporting system and a pharmacy-based patient surveillance reporting system and were stratified based on the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Medication Error Index. Harmful errors were compared to nonharmful errors using Fisher's exact test. RESULTS: Of 338 anti-infective medication-related error reports, 13.6% of voluntarily reported errors reached the patient and 1.5% resulted in harm to the patient and required additional monitoring, interventions, and/or prolonged hospitalization. Antibacterials comprised 93.8% of all error reports, with beta-lactams (63.0%), macrolides (6.5%) and glycopeptides (6.2%) the most common classes. When using Fisher's exact test to compare harmful and nonharmful medication errors, the risk factor significantly associated with harmful errors was anti-infective class (p = 0.001). CONCLUSION: Voluntarily reported anti-infective medication errors within the pediatric patient population often reached the patient, and specific anti-infective medications are potentially of higher risk. Further investigation and additional quality and patient safety strategies may be needed for these higher-risk profile medications.

Predictors of inadequate initial echocardiography in suspected Kawasaki disease: Criteria for sedation.

OBJECTIVE: Kawasaki disease is the primary cause of acquired pediatric heart disease in developed nations. Timely diagnosis of Kawasaki disease incorporates transthoracic echocardiography for visualization of the coronary arteries. Sedation improves this visualization, but not without risks and resource utilization. To identify potential sedation criteria for suspected Kawasaki disease, we analyzed factors associated with diagnostically inadequate initial transthoracic echocardiography performed without sedation. DESIGN: This retrospective review of patients < 18 years old undergoing initial transthoracic echocardiography for the inpatient evaluation of suspected Kawasaki disease from 2009 to 2015 occurred at a medium-sized urban children's hospital. The primary outcome was diagnostically inadequate transthoracic echocardiography without sedation due to poor visualization of the coronary arteries, determined by review of clinical records. The associations of the primary outcome with demographics, Kawasaki disease type, laboratory data, fever, and antipyretic or intravenous immunoglobulin treatment prior to transthoracic echocardiography were analyzed. RESULTS: In total, 112 patients (44% female, median age 2.1 years, median BSA 0.54 m2 ) underwent initial transthoracic echocardiography for suspected Kawasaki disease, and 99 were not sedated. Transthoracic echocardiography was diagnostically inadequate in 19 out of these 99 patients (19.2%) and was associated with age ≤ 2.0 years, weight ≤ 10.0 kg, and antipyretic use ≤ 6 hours before transthoracic echocardiography (all P < .05). These variables did not reach statistical significance on multivariable analysis. CONCLUSIONS: Patients ≤ 2.0 years or ≤ 10.0 kg or those recently receiving antipyretics, potentially a surrogate for irritability, were associated with diagnostically inadequate transthoracic echocardiography during the inpatient workup of Kawasaki disease. These factors should be considered when deciding which patients to sedate for initial Kawasaki disease transthoracic echocardiography.

Developing Interactive Antimicrobial Stewardship and Infection Prevention Curricula for Diverse Learners: A Tailored Approach.

BACKGROUND: To impart principles of antimicrobial stewardship (AS) and infection prevention and control (IPC), we developed a curriculum tailored to the diverse aptitudes of learners at our medical center. METHODS: We integrated case-based modules, group learning activities, smartphone applications (apps), decision support tools, and prescription audit and feedback into curricula of the medical school, medicine residency program, infectious diseases (ID) fellowship program, and hospital medicine program operations. Interventions were implemented in 2012-2016 using a quasi-experimental before-and-after study design, and this was assessed using pre- and postintervention surveys or audit of antibiotic prescriptions. RESULTS: Over 180 medical students participated in the AS and IPC seminars. After smartphone app introduction, 69% reported using the app as their preferred source of antibiotic information. Approximately 70% of students felt comfortable prescribing antibiotics for a known infection compared with 40% at baseline (P = .02), and approximately 83% were able to identify the appropriate personal protective equipment for specific scenarios. Approximately 99% agreed that they have a role in promoting patient safety and preventing healthcare-associated infections as medical students. At 20 months, appropriateness of trainee antibiotic prescriptions increased by 20% (P < .01). Almost all ID fellows indicated that the AS and IPC seminar was a vital training supplement. Uptake of internist antibiotic recommendations using AS decision support tools was approximately 70%. CONCLUSIONS: All 5 interventions addressed learning objectives and knowledge gaps and are applicable across a range of environments. Evaluating long-term impact of our curriculum is the focus of future study.

Fulminant Sepsis Due to Granulibacter bethesdensis in a 4-Year-Old Boy With X-Linked Chronic Granulomatous Disease.

Granulibacter bethesdensis is a Gram-negative bacillus described as a pathogen exclusively in patients with chronic granulomatous disease, a phagocytic disorder that impairs the ability to clear catalase-producing organisms. Granulibacter usually causes chronic and recurrent lymphadenopathies. We report the fatal case of a 4-year-old boy with chronic granulomatous disease, who presented with sepsis after a few days of abdominal pain and diarrhea.

Meningitis due to Moraxella nonliquefaciens in a paediatric patient: a case report and review of the literature.

Introduction.Moraxella nonliquefaciens is an unusual organism to be isolated from cerebral spinal fluid (CSF) and there exists only one case report of M. nonliquefaciens meningitis from a neonate. Moraxella species normally exist as part of the human upper respiratory tract flora and rarely cause invasive human disease. There are only a handful of case reports implicating the organism as a cause of endocarditis, bacteraemia, septic arthritis and endophthalmitis. Identification to the species level based on routine laboratory techniques has been challenging, with final identification often made through 16S rRNA sequencing. With the use of a newer diagnostic tool, matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) MS, we were able to rapidly identify the organism and initiate appropriate treatment. Case presentation. We present a rare care of M. nonliquefaciens meningitis in a paediatric patient with an underlying cranial anatomical defect due to Crouzon syndrome. She had been admitted to hospital 3 months previously with Streptococcus pneumoniae meningitis and mastoiditis, and returned to the emergency department with meningismus. CSF culture grew M. nonliquefaciens. She was treated with ceftriaxone with rapid improvement and eventually was taken for endoscopic surgical repair of a right encephalocele defect. Conclusion. The use of MALDI-TOF MS allowed for the rapid identification of the organism. The patient recovered with appropriate antimicrobial therapy and eventual surgical correction. An underlying anatomical defect should be considered in all patients who present with meningitis due to this unusual organism.

Protease Inhibitors Do Not Affect Antibody Responses to Pneumococcal Vaccination.

HIV(+) subjects on optimal antiretroviral therapy have persistently impaired antibody responses to pneumococcal vaccination. We explored the possibility that this effect may be due to HIV protease inhibitors (PIs). We found that in humans and mice, PIs do not affect antibody production in response to pneumococcal vaccination.

Quantitative and Qualitative Antibody Responses to Immunization With the Pneumococcal Polysaccharide Vaccine in HIV-Infected Patients After Initiation of Antiretroviral Treatment: Results From a Randomized Clinical Trial.

BACKGROUND: Pneumococcal vaccination is recommended for human immunodeficiency virus-infected (HIV+) persons; the best timing for immunization with respect to initiation of antiretroviral therapy (ART) is unknown. METHODS: Double-blind, placebo-controlled trial in HIV+ with CD4(+) T cells/µL (CD4) ≥ 200 randomized to receive the 23-valent pneumococcal polysaccharide vaccine (PPV23) or placebo at enrollment, followed by placebo or PPV23, respectively, 9-12 months later (after ≥6 months of ART). Capsular polysaccharide-specific immunoglobin (Ig) G and IgM levels to serotypes 1, 3, 4, 6B, and 23F, and opsonophagocytic killing activity (OPA) to serotypes 6B and 23F were evaluated 1 month postvaccination. RESULTS: One hundred seven subjects were enrolled, 72 (67.3%) were evaluable (36/group). Both groups had significant increases in pre- to 1-month postvaccination IgG levels, but negligible to IgM, and significant increases in OPA titers to serotype 6B but not to 23F. There were no significant differences between groups in serotype-specific IgM or IgG levels or OPA titers. For the combined groups, there was a significant correlation between serotype-specific IgG and OPA titers to 23F but not to 6B. There was no correlation between CD4, viral load and IgG responses. CONCLUSIONS: In HIV+ with CD4 ≥ 200, delaying PPV23 until ≥6 months of ART does not improve responses and may lead to missed opportunities for immunization.

Impact of HIV-1 infection and pregnancy on maternal health: comparison between perinatally and behaviorally infected young women.

BACKGROUND: The introduction of combination antiretroviral therapy has resulted in improved survival and quality of life for individuals infected with the human immunodeficiency virus (HIV). There is, as expected, a growing population of perinatally HIV-infected women who are, have been, or will become pregnant. We describe a large cohort of perinatally infected women, compare it with a similar age-matched behaviorally HIV-infected group, and examine factors affecting maternal and infant health. METHODS: We reviewed the records of 30 perinatally infected women who gave birth at two hospitals between January 2000 and December 2011. The comparison group comprised behaviorally infected women who delivered at these hospitals during the same period. The outcome measures were differences in CD4 counts and viral load between the cohorts, and comparisons of maternal morbidity, mortality, and mother-to-child HIV transmission. RESULTS: Median CD4 counts were significantly lower in the perinatal group before, during, and after pregnancy. The median viral load was significantly higher in the perinatal group. Interval prepregnancy to post partum viral load decline was also greater in the behavioral group. Viral load decreases in the perinatal population were not sustained in the post partum period, at which time viral load trended back to prepregnancy levels. There was one mother-to-child HIV transmission in a perinatally infected woman. Over an extended 4 years of follow-up, there were four deaths in the perinatal group and none in the behavioral group. CONCLUSION: After delivery, the differences between perinatally and behaviorally infected mothers accentuate, with immunologic deterioration in the former group. The perinatal population may require novel management strategies to ensure outcomes comparable with those observed in the behavioral group.

Evaluation of the 3M rapid detection test for respiratory syncytial virus (RSV) in children during the early stages of the 2009 RSV season.

We report the results of the 3M rapid detection respiratory syncytial virus (RSV) assay. This study includes pediatric patient results from nasopharyngeal swabs submitted from October to December 2009. There was a sensitivity of 74% and specificity approaching 100% compared to the PCR-based xTAG respiratory viral panel.