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The appropriate use of clinically accurate diagnostic tests is essential for the detection of pertussis, a poorly controlled vaccine-preventable disease. The purpose of this study was to estimate the sensitivity and specificity of different diagnostic criteria including culture, multi-target polymerase chain reaction (PCR), anti-pertussis toxin IgG (IgG-PT) serology, and the use of a clinical case definition. An additional objective was to describe the optimal timing of specimen collection for the various tests. Clinical specimens were collected from patients with cough illness at seven locations across the United States between 2007 and 2011. Nasopharyngeal and blood specimens were collected from each patient during the enrollment visit. Patients who had been coughing for ≤ 2 weeks were asked to return in 2-4 weeks for collection of a second, convalescent blood specimen. Sensitivity and specificity of each diagnostic test were estimated using three methods-pertussis culture as the \"gold standard,\" composite reference standard analysis (CRS), and latent class analysis (LCA). Overall, 868 patients were enrolled and 13.6% were B. pertussis positive by at least one diagnostic test. In a sample of 545 participants with non-missing data on all four diagnostic criteria, culture was 64.0% sensitive, PCR was 90.6% sensitive, and both were 100% specific by LCA. CRS and LCA methods increased the sensitivity estimates for convalescent serology and the clinical case definition over the culture-based estimates. Culture and PCR were most sensitive when performed during the first two weeks of cough; serology was optimally sensitive after the second week of cough. Timing of specimen collection in relation to onset of illness should be considered when ordering diagnostic tests for pertussis. Consideration should be given to including IgG-PT serology as a confirmatory test in the Council of State and Territorial Epidemiologists (CSTE) case definition for pertussis.

Invasive Haemophilus influenzae disease has increased, particularly due to nontypeable strains and serotype a. A considerable burden of invasive H. influenzae disease affects the oldest and youngest age groups, particularly American Indian and Alaska Native children. Abstract Background Following Haemophilus influenzae serotype b (Hib) conjugate vaccine introduction in the 1980s, Hib disease in young children dramatically decreased, and epidemiology of invasive H. influenzae changed. Methods Active surveillance for invasive H. influenzae disease was conducted through Active Bacterial Core surveillance sites. Incidence rates were directly standardized to the age and race distribution of the US population. Results During 2009-2015, the estimated mean annual incidence of invasive H. influenzae disease was 1.70 cases per 100000 population. Incidence was highest among adults aged ≥65 years (6.30) and children aged <1 year (8.45); many cases in infants aged <1 year occurred during the first month of life in preterm or low-birth-weight infants. Among children aged <5 years (incidence: 2.84), incidence was substantially higher in American Indian and Alaska Natives AI/AN (15.19) than in all other races (2.62). Overall, 14.5% of cases were fatal; case fatality was highest among adults aged ≥65 years (20%). Nontypeable H. influenzae had the highest incidence (1.22) and case fatality (16%), as compared with Hib (0.03; 4%) and non-b encapsulated serotypes (0.45; 11%). Compared with 2002-2008, the estimated incidence of invasive H. influenzae disease increased by 16%, driven by increases in disease caused by serotype a and nontypeable strains. Conclusions Invasive H. influenzae disease has increased, particularly due to nontypeable strains and serotype a. A considerable burden of invasive H. influenzae disease affects the oldest and youngest age groups, particularly AI/AN children. These data can inform prevention strategies, including vaccine development.

► A shortage of Haemophilus influenzae type b (Hib) vaccine occurred in the United States during December 2007 to September 2009. ► Data from the 2009 National Immunization Survey (NIS) were analyzed to examine effects on Hib vaccination coverage. ► As expected booster dose coverage was reduced, but primary series coverage was also reduced in some states. A shortage of Haemophilus influenzae type b (Hib) vaccine that occurred in the United States during December 2007 to September 2009 resulted in an interim recommendation to defer the booster dose, but to continue to vaccinate as recommended with the primary series during the first year of life. To quantify effects of the Hib shortage on vaccination coverage and to determine if any demographic subgroups were disproportionately affected. Data from the 2009 National Immunization Survey (NIS) were divided based on child's age at the onset of the shortage. Comparisons were made in primary series coverage by 9 months between children <7 months versus ≥7 months at the start of the shortage. Comparisons in primary series plus booster dose completion by 19 months were made between children who were <12 months versus ≥12 months at the start of the shortage. Nationally, there was a difference in Hib primary series completion by 9 months among children age <7 months versus ≥7 months at the start of the shortage (73.9% versus 81.2%, P<0.001). There was a large difference in the percentage of children fully vaccinated with the primary series plus booster dose by 19 months among children age <12 months versus ≥12 months at the start of the shortage (39.5% versus 66.0%, P<0.001). There were differential effects of the shortage on primary series coverage among states and for some demographic characteristics. As expected booster dose coverage was reduced consistent with interim recommendations, but primary series coverage was also reduced by 7 percentage points nationally.

This report compiles and summarizes all recommendations from CDC's Advisory Committee on Immunization Practices (ACIP) regarding prevention and control of Haemophilus influenzae type b (Hib) disease in the United States. As a comprehensive summary of previously published recommendations, this report does not contain any new recommendations; it is intended for use by clinicians, public health officials, vaccination providers, and immunization program personnel as a resource. ACIP recommends routine vaccination with a licensed conjugate Hib vaccine for infants aged 2 through 6 months (2 or 3 doses, depending on vaccine product) with a booster dose at age 12 through 15 months. ACIP also recommends vaccination for certain persons at increased risk for Hib disease (i.e., persons who have early component complement deficiencies, immunoglobulin deficiency, anatomic or functional asplenia, or HIV infection; recipients of hematopoietic stem cell transplant; and recipients of chemotherapy or radiation therapy for malignant neoplasms). This report summarizes current information on Hib epidemiology in the United States and describes Hib vaccines licensed for use in the United States. Guidelines for antimicrobial chemoprophylaxis of contacts of persons with Hib disease also are provided.

We describe the first report of temporally related cases of Bordetella holmesii bacteremia. Demographic and clinical data were collected through chart abstraction and case-patient interviews. Twenty-two cases were identified from 6 states. Symptom onset dates ranged from April 2010 to January 2011. Median age of patients was 17.1 years and 64% had functional or anatomic asplenia. Pulsed-field gel electrophoresis profiles of a sample of isolates were identical. These cases occurred during a peak in pertussis outbreaks with documented cases of B. holmesii/Bordetella pertussis respiratory coinfection; whether there is a link between B. holmesii respiratory and bloodstream infection is unknown.

Integration of immunizations with hygiene interventions may improve use of both interventions. We interviewed 1361 intervention and 1139 comparison caregivers about hygiene practices and vaccination history, distributed water treatment and hygiene kits to caregivers during infant vaccination sessions in intervention clinics for 12 months, and conducted a followup survey of 2361 intervention and 1033 comparison caregivers. We observed significant increases in reported household water treatment (30% vs 44%, P < .0001) and correct handwashing technique (25% vs 51%, P < .0001) in intervention households and no changes in comparison households. Immunization coverage improved in both intervention and comparison infants (57% vs 66%, P = .04; 37% vs 53%, P < .0001, respectively). Hygiene kit distribution during routine immunizations positively impacted household water treatment and hygiene without a negative impact on vaccination coverage. Further study is needed to assess hygiene incentives, implement alternative water quality indicators, and evaluate the impact of this intervention in other settings.

Background. Hygiene interventions reduce child mortality from diarrhea. Vaccination visits provide a platform for delivery of other health services but may overburden nurses. We compared 2 strategies to integrate hygiene interventions with vaccinations in Kenya's Homa Bay district, 1 using community workers to support nurses and 1 using nurses. Methods. Homa Bay was divided into 2 geographical areas, each with 9 clinics. Each area was randomly assigned to either the nurse or community-assisted strategy. At infant vaccination visits hygiene kits were distributed by the nurse or community member. Surveys pre- and post-intervention, measured hygiene indicators and vaccination coverage. Interviews and focus groups assessed acceptability. Results. Between April 2009 and March 2010, 39 158 hygiene kits were distributed. Both nurse and communityassisted strategies were well-accepted. Hygiene indicators improved similarly in nurse and community sites. However, residual chlorine in water changed in neither group. Vaccination coverage increased in urban areas. In rural areas coverage either remained unchanged or increased with 1 exception (13% third dose poliovirus vaccine decrease). Conclusions. Distribution of hygiene products and education during vaccination visits was found to be feasible using both delivery strategies. Additional studies should consider assessing the use of community members to support integrated service delivery.

On January 14, 2016, GlaxoSmithKline Biologicals (Research Triangle Park, North Carolina) received approval from the Food and Drug Administration (FDA) to expand use of Hiberix (Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate]) for a 3-dose infant primary vaccination series at ages 2, 4, and 6 months. Hiberix was first licensed in the United States in August 2009 for use as a booster dose in children aged 15 months through 4 years under the Accelerated Approval Regulations, in response to a Haemophilus influenzae type b (Hib) vaccine shortage that lasted from December 2007 to July 2009 (1). Expanding the age indication to include infants provides another vaccine option in addition to other currently licensed monovalent or combination Hib vaccines recommended for the primary vaccination series.* Hiberix contains 10 μg purified capsular polyribosyl ribitolphosphate (PRP) conjugated to 25 μg tetanus toxoid (PRP-T) and is supplied as a single-dose vial of lyophilized vaccine to be reconstituted with saline diluent. For the 3-dose primary series, a single (0.5 mL) dose should be given by intramuscular injection at ages 2, 4, and 6 months; the first dose may be given as early as age 6 weeks. The recommended catch-up schedule for PRP-T vaccines (http://www.cdc.gov/vaccines/schedules/hcp/child-adolescent.html) should be followed. As previously recommended, a single booster dose should be administered to children aged 15 months through 18 months; to facilitate timely booster vaccination, Hiberix can be administered as early as age 12 months, in accordance with Hib vaccination schedules for routine and catch-up immunization (1-3).

During its October 2013 meeting, the Advisory Committee on Immunization Practices (ACIP) recommended use of a third meningococcal conjugate vaccine, MenACWY-CRM (Menveo, Novartis), as an additional option for vaccinating infants aged 2 through 23 months at increased risk for meningococcal disease. MenACWY-CRM is the first quadrivalent meningococcal conjugate vaccine licensed for use in children aged 2 through 8 months. MenACWY-D (Menactra, Sanofi Pasteur) is recommended for use in children aged 9 through 23 months who are at increased risk for meningococcal disease, and Hib-MenCY-TT (MenHibrix, GlaxoSmithKline) is recommended for use in children aged 6 weeks through 18 months at increased risk. This report summarizes information on MenACWY-CRM administration in infants and provides recommendations for vaccine use in infants aged 2 through 23 months who are at increased risk for meningococcal disease. Because the burden of meningococcal disease in infants is low in the United States and the majority of cases that do occur are caused by serogroup B, which is not included in any vaccine licensed in the United States, only those infants who are at increased risk for meningococcal disease are recommended to receive a meningococcal vaccine.

Neisseria meningitidis (Nm) urogenital infections, although less common than infections caused by Neisseria gonorrhoeae (Ng), have been associated with urethritis, cervicitis, proctitis, and pelvic inflammatory disease. Nm can appear similar to Ng on Gram stain analysis (gram-negative intracellular diplococci). Because Nm colonizes the nasopharynx, men who receive oral sex (fellatio) can acquire urethral Nm infections. This report describes an increase in Nm-associated urethritis in men attending sexual health clinics in Columbus, Ohio, and Oakland County, Michigan. Demographic characteristics of the Columbus and Oakland County patients were similar. Median age of the Columbus patients was 30.0 years; median age of the Oakland County patients was 29.0 years. Among all patients, 99% reported heterosexual orientation, and 97% had symptomatic urethritis. Oral sex was reported by 100% of Columbus patients and 93% of Oakland County patients. Cases of urethritis caused by a clonal strain of Nm (non-groupable, ST-11 and CC-11/ET-37) are occurring among primarily heterosexual men seeking sexual health services in Columbus, Ohio, and Oakland County MI.