Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine in patients with immunocompromising conditions: a review of available evidence

Chilson, Erica; Scott, Daniel A.; Schmöele-Thoma, Beate; Watson, Wendy; Moran, Mary; Istúriz, Raúl

doi:10.1080/21645515.2020.1735224

Cited by 8 publications

(8 citation statements)

References 56 publications

(184 reference statements)

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“…Pre-licensure, the safety profile of PCV13 was evaluated in many clinical trials. 9–12 Of them, the incidence and severity of both local and systemic adverse events following immunization (AEFI) were very similar between PCV7 and PCV13 recipients, indicating a comparable safety profile for the two vaccines. However, AEFI detected following the introduction of a new vaccine into a population is different to those detected in pre-licensure controlled clinical trials, as these are rarely powered sufficiently to detect the rare AEFI.…”

Section: Introductionmentioning

confidence: 98%

Surveillance of adverse events following immunization of 13-valent pneumococcal conjugate vaccine among infants, in Zhejiang province, China

Pan

Chen

et al. 2022

Human Vaccines & Immunotherapeutics

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Objectives To evaluate the safety of 13-valent pneumococcal conjugate vaccine (PCV13) after its licensure. Methods Review and describe the AEFI reported to national adverse event following immunization surveillance system (NAEFISS) in Zhejiang province from 2017 to 2020. Reporting rates of AEFI were calculated by age, city, severity of AEFI, categories of AEFI, and reaction categories. The data mining algorithm used in this study was reporting odds ratio (ROR). A value of ROR-1.96SE >1 (standard error [SE]) was considered as the positive signal. Results NAEFISS received 3332 AEFI cases following PCV13, with a reporting rate of 17.58/10000 doses. Of the reported AEFI, 652 were serious AEFI cases and the reporting rate was 3.44 for serious AEFI. The reporting rate of fever was the highest among all the clinical diagnosis (7.39/10000 doses). The positive signals were obtained for injection site reaction (ROR-1.96SE: 1.55), hypotonic hyporesponsive episode (HHE) (ROR-1.96SE: 1.62) and febrile seizure (ROR-1.96SE: 1.52). Conclusion The present results supported previous observations that the PCV13 administered as the four-dose schedule was generally well tolerated in Chinese infants as we did not identify any new/unexpected safety concern from the NAEFISS during a four-year time period.

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Section: Introductionmentioning

confidence: 98%

Surveillance of adverse events following immunization of 13-valent pneumococcal conjugate vaccine among infants, in Zhejiang province, China

Pan

Chen

et al. 2022

Human Vaccines & Immunotherapeutics

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“…To enable more appropriate preventative health measures. Guidelines from the Advisory Committee on Immunization Practices (ACIP) and Infectious Disease Society of America (IDSA) state that immunocompromised patients, including those with PIs, have different requirements for vaccinations [ 14 , 15 ]. Identification of PIs enables more timely vaccinations and prevention of illness.…”

Section: Introductionmentioning

confidence: 99%

Reducing Delays in Diagnosing Primary Immunodeficiency Through the Development and Implementation of a Clinical Decision Support Tool: Protocol for a Quality Improvement Project

Kumar¹,

Zetumer²,

Swee³

et al. 2022

JMIR Res Protoc

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Background Primary immunodeficiencies (PIs) are a set of heterogeneous chronic disorders characterized by immune dysfunction. They are diagnostically challenging because of their clinical heterogeneity, knowledge gaps among primary care physicians, and continuing shortages of clinically trained immunologists. As a result, patients with undiagnosed PIs are at increased risk for recurrent infections, cancers, and autoimmune diseases. Objective The aim of this research is to develop and implement a clinical decision support (CDS) tool for the identification of underlying PIs. Methods We will develop and implement a CDS tool for the identification of underlying PIs among patients who receive primary care through a health care provider at the University of Iowa Hospitals and Clinics. The CDS tool will function through an algorithm that is based on the Immune Deficiency Foundation’s 10 Warning Signs for Primary Immunodeficiency. Over the course of a year, we will use Lean Six Sigma principles and the Define, Measure, Analyze, Improve, and Control (DMAIC) framework to guide the project. The primary measure is the number of newly diagnosed PI patients per month. Secondary measures include the following: (1) the number of new patients identified by the CDS as being at high risk for PI, (2) the number of new PI cases in which immunoglobulin replacement or rotating antibiotics are started, (3) the cost of evaluation of each patient identified by the CDS tool as being at high risk for PIs, (4) the number of new consults not diagnosed with a PI, and (5) patient satisfaction with the process of referral to the Immunology Clinic. Results This study was determined to not be Human Subjects Research by the Institutional Review Board at the University of Iowa. Data collection will begin in August 2021. Conclusions The development and implementation of a CDS tool is a promising approach to identifying patients with underlying PI. This protocol assesses whether such an approach will be able to achieve its objective of reducing diagnostic delays. The disciplined approach, using Lean Six Sigma and the DMAIC framework, will guide implementation to maximize opportunities for a successful intervention that meets the study’s goals and objectives as well as to allow for replication and adaptation of these methods at other sites. International Registered Report Identifier (IRRID) PRR1-10.2196/32635

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“…These vaccines use either a polysaccharide capsular antigen alone (PPV) or conjugated to a carrier protein (PCV) [ 6 ]. The current PPV (Pneumovax23) consists of pneumococcal polysaccharide antigens covering 23 serotypes and stimulates a T-cell independent antibody response resulting in no immunological memory [ 7 ]. PCV13 (Prevenar) covers against the serotypes in PCV7 (4, 6B, 9V, 14, 18C, 19F, and 23F) and serotypes 1, 3, 5, 6A, 7F and 19A.…”

Section: Introductionmentioning

confidence: 99%

“…PCV10 covers against serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F and uses Haemophilus influenzae Protein D, tetanus toxoid, or diphtheria toxoid as the carrier proteins depending on the capsular antigen. Importantly, PCV stimulates a T-cell-dependent response [ 7 , 8 ].…”

Section: Introductionmentioning

confidence: 99%

“…The sequence of vaccination with PCV13 initially followed by PPV23 has been shown to provide a better response to the pneumococcal serotypes included in both vaccines [ 12 ]. A systematic review of 30 publications including 2406 subjects identified the PCV13 vaccine to be safe and largely well tolerated [ 7 ]. Specifically, it concluded that concerns of immunogenicity and safety were not supported and should not form a barrier to vaccinating immunocompromised hosts.…”

Section: Introductionmentioning

confidence: 99%

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Pneumococcal Vaccination in Immunocompromised Hosts: An Update

2021

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Infections with the pathogen, Streptococcus pneumoniae, are a common cause of morbidity and mortality worldwide. It particularly affects those at the extremes of age and immunocompromised individuals. Preventing pneumococcal disease is paramount in at risk individuals, and pneumococcal vaccination should be offered. Here, we discuss the role of pneumococcal vaccination in specific groups of immunocompromised hosts.

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Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine in patients with immunocompromising conditions: a review of available evidence

Cited by 8 publications

References 56 publications

Surveillance of adverse events following immunization of 13-valent pneumococcal conjugate vaccine among infants, in Zhejiang province, China

Surveillance of adverse events following immunization of 13-valent pneumococcal conjugate vaccine among infants, in Zhejiang province, China

Reducing Delays in Diagnosing Primary Immunodeficiency Through the Development and Implementation of a Clinical Decision Support Tool: Protocol for a Quality Improvement Project

Pneumococcal Vaccination in Immunocompromised Hosts: An Update

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