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The Senior Care Pharmacist Apr 2023To review the current literature available regarding the efficacy and safety of the 20-valent l vaccine in older people and summarize the current recommendation for use... (Review)
Review
To review the current literature available regarding the efficacy and safety of the 20-valent l vaccine in older people and summarize the current recommendation for use in this patient population. PubMed was searched using the following terms: (PCV20 [Title] or 20-valent [Title] or 20-valent conjugate vaccine [Title]) and English (Language). The current recommendations from the Advisory Committee on Immunization Practices and manufacturer package inserts were also reviewed. Nine articles on 20-valent vaccine were identified based on the above search terms. Those selected for inclusion were randomized control trials including primary or subgroup analysis of PCV20 in older people. Two randomized controlled trials have assessed the immunogenicity and safety of PCV20 in adults 65 years of age and older, one in a population previously vaccinated with PPSV23 and one in a vaccine-naive population. Both trials demonstrated PCV20 elicited a robust immune response one month after vaccination. PCV20 was well-tolerated with adverse events similar to earlier vaccine formulations. The simplified vaccine regimen of a singular PCV20 vaccination offers a compelling advancement. Longer-term studies are needed to show if PCV20 will improve vaccination rates and reduce morbidity and mortality.
Topics: Aged; Humans; Pneumococcal Vaccines; Streptococcus pneumoniae; Vaccination; Vaccines, Conjugate
PubMed: 36949560
DOI: 10.4140/TCP.n.2023.148 -
Expert Review of Vaccines 2016Streptococcus pneumoniae is a leading cause of illness and death in adults. A polysaccharide vaccine has been available for over 30 years, but despite significant use,... (Review)
Review
Streptococcus pneumoniae is a leading cause of illness and death in adults. A polysaccharide vaccine has been available for over 30 years, but despite significant use, the public health impact of this vaccine has been limited. The 13-valent pneumococcal conjugate vaccine (PCV13) has been licensed by the US Food and Drug Administration and other international regulatory authorities with the assumption that induction of a T cell-dependent immune response and noninferior immunogenicity to vaccine antigens when compared with the polysaccharide vaccine would be important to satisfy a significant unmet medical need. PCV13 efficacy against vaccine-type pneumococcal community-acquired pneumonia was confirmed in a large randomized controlled trial in older adults and its use is now increasingly recommended globally.
Topics: Adult; Community-Acquired Infections; Humans; Pneumococcal Vaccines; Pneumonia, Pneumococcal; Randomized Controlled Trials as Topic; United States; Vaccines, Conjugate
PubMed: 26651847
DOI: 10.1586/14760584.2016.1132171 -
The Cochrane Database of Systematic... 2001Infection with Streptococcus pneumoniae is an important cause of pneumonia and other serious illnesses, particularly amongst those with certain high-risk medical... (Review)
Review
BACKGROUND
Infection with Streptococcus pneumoniae is an important cause of pneumonia and other serious illnesses, particularly amongst those with certain high-risk medical conditions such as asthma. Although pneumococcal vaccine is routinely advocated for people with asthma, there is uncertainty about the evidence base that underpins this recommendation.
OBJECTIVES
To determine the efficacy of pneumococcal vaccine in reducing mortality or morbidity from pneumococcal disease in asthmatics.
SEARCH STRATEGY
Randomised controlled trials were identified using the Cochrane Airways Group's register derived from MEDLINE, EMBASE, and CINAHL electronic databases and hand searched respiratory journals and meeting abstracts.
SELECTION CRITERIA
Randomised controlled trials, with or without blinding, in which pneumococcal vaccine has been compared with placebo or no treatment in people with clinician diagnosed asthma.
DATA COLLECTION AND ANALYSIS
Two reviewers independently reviewed all abstracts and full papers of all articles of potential relevance were retrieved. Methodological quality was rated using the Cochrane approach and the Jadad rating scale. Data extraction was performed by one reviewer and checked independently by a second. We planned to perform quantitative analyses of outcomes on an intention-to-treat basis, where possible.
MAIN RESULTS
Of the three papers retrieved, only one satisfied the inclusion criteria and the methodological quality of this study was low (unblinded and inadequate allocation concealment). None of the data could be aggregated in a meta-analysis. Comparisons in a sub-set of 30 asthmatic children prone to recurrent episodes of otitis media, showed that pneumococcal vaccination decreased the incidence of acute asthma exacerbations from 10 to 7 (per child per year).
REVIEWER'S CONCLUSIONS
This review found very limited evidence to support the routine use of pneumococcal vaccine in people with asthma. A randomised trial of vaccine efficacy in children and adults with asthma is needed.
Topics: Asthma; Humans; Pneumococcal Vaccines; Pneumonia, Pneumococcal
PubMed: 11687018
DOI: 10.1002/14651858.CD002165 -
The Cochrane Database of Systematic... 2002Infection with Streptococcus pneumoniae is an important cause of pneumonia and other serious illnesses, particularly amongst those with certain high-risk medical... (Review)
Review
BACKGROUND
Infection with Streptococcus pneumoniae is an important cause of pneumonia and other serious illnesses, particularly amongst those with certain high-risk medical conditions such as asthma. Although pneumococcal vaccine is routinely advocated for people with asthma, there is uncertainty about the evidence base that underpins this recommendation.
OBJECTIVES
To determine the efficacy of pneumococcal vaccine in reducing mortality or morbidity from pneumococcal disease in asthmatics.
SEARCH STRATEGY
Randomised controlled trials were identified using the Cochrane Airways Group's register derived from MEDLINE, EMBASE, and CINAHL electronic databases and hand searched respiratory journals and meeting abstracts.
SELECTION CRITERIA
Randomised controlled trials, with or without blinding, in which pneumococcal vaccine has been compared with placebo or no treatment in people with clinician diagnosed asthma.
DATA COLLECTION AND ANALYSIS
Two reviewers independently reviewed all abstracts and full papers of all articles of potential relevance were retrieved. Methodological quality was rated using the Cochrane approach and the Jadad rating scale. Data extraction was performed by one reviewer and checked independently by a second. We planned to perform quantitative analyses of outcomes on an intention-to-treat basis, where possible.
MAIN RESULTS
Of the three papers retrieved, only one satisfied the inclusion criteria and the methodological quality of this study was low (unblinded and inadequate allocation concealment). None of the data could be aggregated in a meta-analysis. Comparisons in a sub-set of 30 asthmatic children prone to recurrent episodes of otitis media, showed that pneumococcal vaccination decreased the incidence of acute asthma exacerbations from 10 to 7 (per child per year). A further search conducted in September 2001 did not yield any further studies.
REVIEWER'S CONCLUSIONS
This review found very limited evidence to support the routine use of pneumococcal vaccine in people with asthma. A randomised trial of vaccine efficacy in children and adults with asthma is needed.
Topics: Asthma; Humans; Pneumococcal Vaccines; Pneumonia, Pneumococcal; Randomized Controlled Trials as Topic
PubMed: 11869626
DOI: 10.1002/14651858.CD002165 -
Vaccine Dec 2016Pneumococcal conjugate vaccines (PCVs) are highly effective in preventing pneumococcal invasive disease (IPD) due to serotypes included in the vaccines. The risk of... (Review)
Review
BACKGROUND
Pneumococcal conjugate vaccines (PCVs) are highly effective in preventing pneumococcal invasive disease (IPD) due to serotypes included in the vaccines. The risk of vaccine-type IPD in immunised children (i.e. vaccine failure) has not been systematically assessed in countries with established PCV programmes.
METHODS
We undertook a systematic review of the English literature published from January 2000 to April 2016 to evaluate the vaccine schedule, risk factors, serotype distribution, clinical presentation and outcomes of vaccine failure in children vaccinated with the 7-valent (PCV7), 10-valent (PCV10), and 13-valent (PCV13) vaccines. Data sources included MEDLINE, EMBASE, Cochrane library, and references within identified articles.
RESULTS
We identified 1742 potential studies and included 20 publications involving 7584 participants in children aged ⩽5year-olds: 5202 received 2 doses followed by a booster in 10 studies, (68.6%), 64 (0.8%) received 3 doses without a booster in 2 studies, and 2318 received a 3+1 schedule (30.6%) in 8 studies. A total of 159 vaccine failure cases were identified, representing 2.1% [95% CI: 1.8-2.4%] of the reported IPD cases. Most studies did not report clinical characteristics or outcomes. Among eight studies reporting comorbidities, 33/77 patients (42.9%) had an underlying condition. The main serotypes associated with vaccine failure were 19F (51/128 cases with known serotype; 39.8%), 6B (33/128; 25.8%), and 4 (10/128; 7.8%). Only five studies reported patient outcomes, with a crude case fatality rate of 2.4% (2/85; 95%CI: 0.3-8.5%).
CONCLUSION
Pneumococcal conjugate vaccines have been implemented in national immunisation programmes for more than a decade, yet there are only a few studies reporting vaccine failure. PCV failure is rare, irrespective of vaccine or schedule. Co-morbidity prevalence was high amongst vaccine failure cases but case fatality rate was relatively low. There is a need for more systematic reporting vaccine failure cases in countries with established pneumococcal vaccination programmes.
Topics: Heptavalent Pneumococcal Conjugate Vaccine; Humans; Incidence; Infant; Pneumococcal Infections; Pneumococcal Vaccines; Treatment Failure; Vaccines, Conjugate
PubMed: 27838066
DOI: 10.1016/j.vaccine.2016.10.050 -
Microbial Pathogenesis Sep 2018Despite the fact that pneumococcal conjugate vaccines (PCVs) have significantly reduced the rate of invasive pneumococcal diseases through the use of vaccine serotypes,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Despite the fact that pneumococcal conjugate vaccines (PCVs) have significantly reduced the rate of invasive pneumococcal diseases through the use of vaccine serotypes, infection with Streptococcus pneumoniae remains a major public health hazard. Serotype-independent vaccines that are economically viable species of common protein antigens such as whole-cell vaccines (WCVs) are needed. Considering the ongoing debate about the effectiveness of WCVs, a systematic literature review and meta-analysis was carried out to determine the efficacy of WCVs against colonization in mice.
MATERIAL AND METHODS
A systematic review was undertaken of published studies on the protection (colonized/uncolonized) of whole cell pneumococcal vaccine in mice. The search terms used were "whole cell vaccine" and "Streptococcus pneumoniae" in PubMed, Google Scholar, Embase, Web of Science and Scopus engines. Data was extracted from original publications and a meta-analysis was performed on studies divided into sub-groups by the number of inoculations, type of sample, type of adjuvant, time of sampling, design of study and quality of study.
RESULTS
Ten eligible articles published from 2000 to 2016 were included in this review. The meta-analysis was performed on eight out of 10 studies and demonstrated that the estimated pooled risk ratios (RRs) for comparison of colonization between the vaccinated and unvaccinated mice for outcomes 1 and 2 were 0.18 and 0.24, respectively. Lower RRs were observed in sub-groups that were inoculated with vaccines three times, those using cholera toxin (CT) adjuvants and those obtained as tracheal specimens from the mice.
CONCLUSIONS
The best protocol for use of a WCV is its application with CT adjuvant administered intranasally in three inoculations at doses of 10⁸ CFU. Further studies performed under similar conditions to obtain accurate results on the effectiveness of this vaccine are recommended.
Topics: Adjuvants, Immunologic; Administration, Intranasal; Animals; Disease Models, Animal; Mice; Pneumococcal Infections; Pneumococcal Vaccines; Vaccines, Inactivated
PubMed: 29908308
DOI: 10.1016/j.micpath.2018.06.026 -
Journal of Infection and Chemotherapy :... Jun 2013Streptococcus pneumoniae is a major human pathogen responsible for the majority of bacterial pneumonia cases as well as invasive pneumococcal diseases with high... (Review)
Review
Streptococcus pneumoniae is a major human pathogen responsible for the majority of bacterial pneumonia cases as well as invasive pneumococcal diseases with high mortality and morbidity. Use of conjugate vaccines targeting the pneumococcal capsule has dramatically reduced the incidence of invasive diseases, and there are active efforts to further improve the conjugate vaccines. However, in children new pneumococcal vaccines can no longer be tested with placebo-based clinical trials because effective vaccines are currently available. Thus, vaccine studies must depend on surrogate markers of vaccine efficacy. Although traditional antibody levels (e.g., ELISA) are useful as a surrogate marker of protection, they have limitations, and a bioassay measuring the capacity of antibodies to opsonize pneumococci has been developed. This opsonophagocytosis assay (OPA) replicates the in vivo mechanism of antibody protection and should therefore better reflect protection by vaccine-induced antibodies. Technical improvements of OPA have made this bioassay rapid, multiplexed, and practical for analyzing small samples including those from children. Strong correlations between ELISA and OPA have been observed in many studies of young children. However, poor correlations have been found in some important clinical situations (such as determination of protection by cross-reactive antibodies) and populations (such as elderly adults and immunodeficient patients). In these settings, OPA has become a useful supplementary measure of pneumococcal vaccine immunogenicity. Current efforts to standardize OPA will further expand its uses.
Topics: Antibodies, Bacterial; Biomarkers; Cytological Techniques; Enzyme-Linked Immunosorbent Assay; Humans; Opsonin Proteins; Phagocytosis; Pneumococcal Vaccines; Streptococcus pneumoniae; Vaccines, Conjugate
PubMed: 23657429
DOI: 10.1007/s10156-013-0601-1 -
The Annals of Pharmacotherapy Sep 2002To review the immunogenicity, efficacy, and safety of the heptavalent conjugated pneumococcal vaccine (PCV7). (Review)
Review
OBJECTIVE
To review the immunogenicity, efficacy, and safety of the heptavalent conjugated pneumococcal vaccine (PCV7).
DATA SOURCES
A MEDLINE search (1993-August 2001) of research limited to humans published in the English language was conducted.
STUDY SELECTION
Findings from randomized, controlled, multicenter trials were reviewed. Literature regarding epidemiology, control, and treatment of invasive pneumococcal diseases in different populations and the Advisory Committee on Immunization Practices recommendations were also reviewed.
DATA SYNTHESIS
PCV7 administered to infants aged 2, 4, and 6 months, with a booster dose at 12-15 months, has been shown to be immunogenic. It decreases the incidence of invasive pneumococcal disease; individual data on bacteremia and meningitis are unavailable. Findings from clinical trials showed that invasive pneumococcal disease caused by vaccine serotypes was reduced by 87%, 58%, and 62% for children <1 year, <2 years, and <5 years of age, respectively, after introduction of routine vaccine use. The overall incidence of acute otitis media did not decrease significantly. However, culture-confirmed episodes and episodes due to pneumococcal serotypes included in the vaccine were reduced. The vaccine was immunogenic in children with sickle cell disease, but its efficacy in preventing invasive pneumococcal diseases remains unclear. Although immunogenicity and efficacy trials are lacking, the vaccine is recommended for Alaskan Native or American Indian children between 24 and 59 months of age, and for children with underlying conditions such as HIV infection, AIDS, other immunocompromising conditions, and chronic illnesses. At the manufacturer's list price of 58 dollars/dose, PCV7 is not projected to be cost-effective after 4 doses. Postmarketing analysis evaluating immunogenicity and efficacy in the excluded population may favorably change this.
CONCLUSIONS
Based on published efficacy and immunogenicity data, pharmacy formularies should include PCV7.
Topics: Carrier State; Child; Clinical Trials as Topic; Costs and Cost Analysis; Diphtheria Toxoid; Humans; Pneumococcal Infections; Pneumococcal Vaccines; Polysaccharides; Vaccines, Conjugate
PubMed: 12196061
DOI: 10.1345/aph.1A048 -
Expert Review of Vaccines Jan 2020: Serotype replacement - a consequence of polysaccharide vaccine use - will continue to drive the inclusion of new serotypes on conjugate vaccines, increasing production... (Review)
Review
: Serotype replacement - a consequence of polysaccharide vaccine use - will continue to drive the inclusion of new serotypes on conjugate vaccines, increasing production complexity and costs, and making an already expensive vaccine less accessible to developing countries, where prevalence is higher and resources available for health systems, scarcer. Serotype-independent formulations are a promising option, but so far they have not been successful in reducing colonization/transmission.: Protein-based and whole-cell vaccine candidates studied in the past 30 years. Challenges for serotype-independent vaccine development and alternative approaches.: Clinical trials performed so far demonstrated the importance to establish more reliable animal models and better correlates of protection. Defining appropriate endpoints for clinical trials of serotype-independent vaccine candidates has been a challenge. Inhibition of colonization has been evaluated, but concern on the extent of bacterial elimination is still a matter of debate. Challenges on establishing representative sites for clinical trials, sample sizes and appropriate age groups are discussed. On a whole, although many challenges will have to be overcome, establishing protein-based antigens as serotype-independent vaccines is still the best alternative against the huge burden of pneumococcal diseases in the world.
Topics: Animals; Antigens, Bacterial; Bacterial Proteins; Humans; Pneumococcal Infections; Pneumococcal Vaccines; Serogroup; Vaccines, Conjugate
PubMed: 31903805
DOI: 10.1080/14760584.2020.1711055 -
Human Vaccines Oct 2011The thirteen valent pneumococcal conjugate vaccine (PCV13, Prevenar 13(TM)) is the broader coverage successor to the highly effective seven valent vaccine (PCV7,... (Review)
Review
The thirteen valent pneumococcal conjugate vaccine (PCV13, Prevenar 13(TM)) is the broader coverage successor to the highly effective seven valent vaccine (PCV7, Prevenar(TM)) which has reduced rates of pneumococcal disease in many countries. Despite the success of PCV7, pneumococcal disease due to non-PCV7 serotypes remains a threat in many settings, in particular many developing countries with a high burden of pneumococcal disease where serotype 1 and 5 are among the most common serotypes. Disease due to certain non-PCV7 serotypes, in particular serotype 19A has also begun to increase in incidence in countries with widespread use of PCV7. PCV13 consists of thirteen pneumococcal capsular polysaccharides individually conjugated to the diphtheria-derived protein carrier CRM(197). In addition to serotypes 4, 6B, 9V, 14, 18C, 19F and 23F included in PCV7, PCV13 also includes serotypes 1, 3, 5, 6A, 7F and 19A. PCV13 was licensed on the basis of non-inferiority trials and has proved to be at least as safe and effective as PCV7. PCV13 replaced PCV7 in the childhood immunisation schedules of the USA and UK in 2010 and is being rolled out to an increasing number of developing countries during 2011. Here we review the current literature regarding this vaccine, describing safety, efficacy, global serotype coverage and use and future directions.
Topics: Developing Countries; Humans; Pneumococcal Infections; Pneumococcal Vaccines; Prevalence; Serotyping; Streptococcus pneumoniae; United Kingdom; United States; Vaccination
PubMed: 21941097
DOI: 10.4161/hv.7.10.16794