Strengthening community capacity to address trauma through a Community Ambassador Network.

Introduction: Community ambassadors (CAs) are advocates that build trust with communities on behalf of service systems and facilitate access to resources. Whether and how CAs can support community engagement within a large initiative to build capacity to address the impact of trauma is unclear. This study explores how a Community Ambassador Network supported community engagement with "Innovations 2 Initiative" (INN 2), a 5-year initiative that addressed trauma across nine communities in Los Angeles County.

A Phase Three Study of the Safety and Immunogenicity of a Four-dose Series of 20-Valent Pneumococcal Conjugate Vaccine in Healthy Infants.

Background: The 20-valent pneumococcal conjugate vaccine (PCV20) was developed to extend pneumococcal disease protection beyond 13-valent PCV (PCV13).

Methods: This phase 3, double-blind study conducted in the United States/Puerto Rico evaluated PCV20 safety and immunogenicity. Healthy infants were randomized to receive a 4-dose series of PCV20 or PCV13 at 2, 4, 6 and 12-15 months old.

Building trust: Leadership reflections on community empowerment and engagement in a large urban initiative.

Background: Trust is essential for healthy, reciprocal relationships; creating safe environments; engaging in transparent interactions; successfully negotiating power differentials; supporting equity and putting trauma informed approaches into practice. Less is known, however, about the ways that trust-building may be at the forefront of consideration during community capacity building efforts, what trust-building elements are perceived as essential for optimally engaging communities, and what practices might support these efforts.

Methods: The present study examines an evolving understanding of trust-building over the course of 3 years, from qualitative data derived during interviews with nine agency leads from a large and diverse urban community, who are spearheading community-based partnerships to create more trauma-informed communities and foster resiliency.

Prefusion F Protein-Based Respiratory Syncytial Virus Immunization in Pregnancy.

Background: Respiratory syncytial virus (RSV), a major cause of illness and death in infants worldwide, could be prevented by vaccination during pregnancy. The efficacy, immunogenicity, and safety of a bivalent RSV prefusion F protein-based (RSVpreF) vaccine in pregnant women and their infants are uncertain.

Methods: In a phase 2b trial, we randomly assigned pregnant women, at 24 through 36 weeks' gestation, to receive either 120 or 240 μg of RSVpreF vaccine (with or without aluminum hydroxide) or placebo.

Developing trauma resilient communities through community capacity-building.

Background: Trauma is a significant public health issue, negatively impacting a range of health outcomes. Providers and administrators in public mental health systems recognize the widespread experience of trauma, as well as their limited ability to address trauma within their communities. In response, the Los Angeles County Department of Mental Health funded nine regionally based community partnerships to build capacity to address trauma.

A Mixed-method Evaluation of the Behavioral Health Integration and Complex Care Initiative Using the Consolidated Framework for Implementation Research.

Background: Integrated behavioral health and primary care can improve the health of persons with complex chronic conditions. The Behavioral Health Integration and Complex Care Initiative (BHICCI) implemented integrated care across a large health system. Whether Behavioral Health Organizations (BHOs) and Federally Qualified Health Centers (FQHCs) implemented the BHICCI differently is unclear.

Safety and immunogenicity of a novel hexavalent group B streptococcus conjugate vaccine in healthy, non-pregnant adults: a phase 1/2, randomised, placebo-controlled, observer-blinded, dose-escalation trial.

Background: Group B streptococcus (GBS) is a major cause of invasive disease in young infants. Infants born to women with sufficient pre-existing anti-GBS capsular IgG antibodies are at reduced risk of GBS disease, making maternal immunisation a potential strategy for prevention. We aimed to assess the safety and immunogenicity of a novel hexavalent (serotypes Ia, Ib, II, III, IV, and V) GBS conjugate vaccine (GBS6).

Advancing Integrated Care through Practice Coaching.

Introduction: Practice coaches are skilled consultants who work in health care service delivery systems to make changes designed to improve patient outcomes, yet research is limited regarding their use to support integrated health care. This article describes the use of practice coaches in a large-scale effort to implement integrated care in the United States for patients with complex care needs.

Theory And Methods: This immersive, qualitative project involved five implementation team members; eight practice coaches; and 77 staff members from 12 health care organizations.

Impact of the 13-Valent Pneumococcal Conjugate Vaccine on Invasive Pneumococcal Disease After Introduction Into Routine Pediatric Use.

Background: In 2010, the 13-valent pneumococcal conjugate vaccine (PCV13) replaced 7-valent PCV (PCV7) for protection against invasive pneumococcal disease (IPD). This study used laboratory surveillance data to examine the effect of PCV13 on IPD before and after PCV13 introduction among children aged 6 weeks to <6 years and those aged ≥6 weeks.

Methods: Observational laboratory-based IPD surveillance data were compared for the periods May 2010-April 2018 and May 2008-April 2010 (the PCV7 period) using a database of Kaiser Permanente Northern California (KPNC) members with laboratory-confirmed IPD.

National impact of 13-valent pneumococcal conjugate vaccine on ambulatory care visits for otitis media in children under 5 years in the United States.

Objective: The 7- and 13-valent pneumococcal conjugate vaccines (PCV7 and PCV13) were approved in the US in 2000 and 2010, respectively, for active immunization against invasive disease caused by all vaccine serotypes and otitis media (OM) caused by 7 serotypes common to both vaccines, starting at ∼6 weeks of age. This study assessed the impact of PCV13 on OM by evaluating changes in US ambulatory care visit rates between the period before PCV7 (1997-1999), during PCV7 (2001-2009), and after the introduction of PCV13 (2011-2013) among US children <5 years old.

Methods: This ecological study used US National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey data.

Evaluation Of The Behavioral Health Integration And Complex Care Initiative In Medi-Cal.

This article reports how a large Medi-Cal managed care plan addressed challenges in accessing health care for approximately 7,000 enrollees with multiple chronic conditions through a project known as the Behavioral Health Integration and Complex Care Initiative. The initiative increased staffing for care management, care coordination, and behavioral health integration. In our evaluation of the initiative, we demonstrated that participation in it was associated with improved clinical indicators for common chronic conditions, reduced inpatient costs in some sites, and improved patient experience in all sites.

Effectiveness of 13-valent pneumococcal conjugate vaccination for protection against acute otitis media caused by Streptococcus pneumoniae in healthy young children: a prospective observational study.

Background: With wide use of the seven-valent pneumococcal conjugate vaccine (PCV7) for protection against acute otitis media caused by Streptococcus pneumoniae serotypes included in the vaccine, efficacy testing for the 13-valent vaccine (PCV13) was not feasible. We aimed to assess the effectiveness of PCV13 in preventing acute otitis media caused by the six serotypes in PCV13 that were not in PCV7.

Methods: We did a longitudinal observational study in healthy children seen as outpatients in a private paediatric practice in Rochester, NY, USA.

Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine (PCV13) formulated with 2-phenoxyethanol in multidose vials given with routine vaccination in healthy infants: An open-label randomized controlled trial.

Background: This open-label randomized controlled trial in infants compared safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate vaccine (PCV13) formulated with the preservative 2-phenoxyethanol (2-PE) in a multidose vial (MDV) to the current PCV13 without 2-PE in a single-dose syringe (SDS).

Methods: Gambian infants were randomized 1:1 to receive PCV13 as either MDV or SDS at ages 2, 3, and 4months. Serotype-specific antipneumococcal antibody responses and opsonophagocytic activity ([OPA]; subset) were measured at age 5months.

A randomized study of fever prophylaxis and the immunogenicity of routine pediatric vaccinations.

Objective: Prophylactic antipyretic use during pediatric vaccination is common. This study assessed whether paracetamol or ibuprofen prophylaxis interfere with immune responses to the 13-valent pneumococcal conjugate vaccine (PCV13) given concomitantly with the combined DTaP/HBV/IPV/Hib vaccine.

Methods: Subjects received prophylactic paracetamol or ibuprofen at 0, 6-8, and 12-16 h after vaccination, or 6-8 and 12-16 h after vaccination at 2, 3, 4, and 12months of age.

Circulating Antibody 1 and 2 Years After Vaccination With the 13-Valent Pneumococcal Conjugate Vaccine in Preterm Compared With Term Infants.

Background: Premature infants have lower short-term immune responses to vaccination than term infants, but patterns of antibody persistence in preterm infants over longer periods are not well established. This study assessed the persistence of antibody response to the 13-valent pneumococcal conjugate vaccine (PCV13) in formerly preterm versus term infants.

Methods: In total, 100 preterm and 100 term infants received PCV13 with routine vaccines at ages 2, 3, 4 and 12 months.

13-valent pneumococcal conjugate vaccine (PCV13) in preterm versus term infants.

Objectives: This study evaluated the immune response and safety profile of 13-valent pneumococcal conjugate vaccine (PCV13) in preterm infants compared with term infants.

Methods: This Phase IV, open-label, 2-arm, multicenter, parallel-group study enrolled 200 healthy infants (preterm, n = 100; term, n = 100) aged 42 to 98 days. All subjects received PCV13 at ages 2, 3, 4 (infant series), and 12 (toddler dose [TD]) months, together with routine vaccines (diphtheria-tetanus-acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b vaccine and meningococcal group C conjugate vaccine).

Multicenter surveillance of Streptococcus pneumoniae isolates from middle ear and mastoid cultures in the 13-valent pneumococcal conjugate vaccine era.

Background: Streptococcus pneumoniae is a common cause of otitis media (OM) in children; mastoiditis remains an important complication of OM. Limited data are available on the impact of the 13-valent pneumococcal conjugate vaccine (PCV13) on pneumococcal otitis.

Methods: Investigators from 8 children's hospitals in the United States prospectively collected pneumococcal isolates from middle ear or mastoid cultures from children from 2011 to 2013.

Stigma experienced by people using mental health services in San Diego County.

Objective: This paper describes how individuals struggling with severe mental illness experience stigma along multiple dimensions including their experiences of discrimination by others, their unwillingness to disclose information about their mental health, and their internalization or rejection of the negative and positive aspects of having mental health problems.

Methods: This cross-sectional study employs descriptive analyses and linear regression to assess the relationship between demographics, mental health diagnoses and self-reported stigma among people receiving mental health services in a large and ethnically diverse county public mental health system (n = 1,237) in 2009. We used the King Stigma Scale to measure three factors related to stigma: discrimination, disclosure, and positive aspects of mental illness.

Decreased immune response to pneumococcal conjugate vaccine after 23-valent pneumococcal polysaccharide vaccine in children.

Background: Pneumococcal polysaccharide vaccine (PPV) is used in children at high risk of IPD. PPV is generally not considered to induce immunologic memory, whereas pneumococcal conjugate vaccines (PCVs) elicit protective antibody responses in infants and induce immunologic memory. Little is known about the characteristics of immune responses to PCV in children who previously received PCV and PPV in series.

Lack of association of Kawasaki disease after immunization in a cohort of infants followed for multiple autoimmune diagnoses in a large, phase-4 observational database safety study of 7-valent pneumococcal conjugate vaccine: lack of association between Kawasaki disease and seven-valent pneumococcal conjugate vaccine.

A large-scale, postmarketing observational database safety study was conducted following 7-valent pneumococcal conjugate vaccine (PCV7) licensure. A secondary outcome was the occurrence of predefined diagnoses among PCV7 vaccinees versus historic controls. Forty-two PCV7 recipients and 17 controls were hospitalized for Kawasaki disease (P = 0.

Safety experience with heptavalent pneumococcal CRM197-conjugate vaccine (Prevenar) since vaccine introduction.

Documentation of the safety of any vaccine is of paramount importance given the nature and scale of vaccination as a public health intervention. Prevenar was first approved for use in 2000, and includes seven pneumococcal serotypes conjugated to CRM(197), a carrier protein that has been used safely in multiple conjugate vaccines for more than 20 years. The safety profile of Prevenar was established prior to licensure in 5 clinical trials involving more than 18,000 infants and children.

Prevenar vaccination: review of the global data, 2006.

The 7-valent pneumococcal conjugate vaccine, Prevenar, was first licensed in the United States in 2000 for the prevention of invasive pneumococcal disease (IPD) caused by the serotypes included in the vaccine. It is presently approved in more than 70 countries, and more than 100 million doses of vaccine have been distributed to date. Within 1 year of routine use in the US, incidence of vaccine-serotype IPD had fallen dramatically among children younger than 2 years, with indirect effects noted among other age groups as well.