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The Pediatric Infectious Disease Journal Aug 2017Pneumococcal infections are the leading cause of vaccine-preventable death in children. In June 2015, the 13-valent pneumococcal conjugate vaccine (PCV13) was introduced...
BACKGROUND
Pneumococcal infections are the leading cause of vaccine-preventable death in children. In June 2015, the 13-valent pneumococcal conjugate vaccine (PCV13) was introduced in the Portuguese Immunization Program. We evaluated the cost-effectiveness of children vaccinated with PCV13 versus no vaccination for preventing pneumococcal diseases.
METHODS
A cohort simulation model for 2014 Portuguese newborns was used, considering a lifetime horizon and existence of herd effect on adults. Model outcomes measured life years gained, direct and indirect healthcare costs and net benefits considering &OV0556;20,000 per life years gained. PCV13 clinical effectiveness rate by serotype covered was assumed similar to PCV7. Patients' resource use was based on 2014 diagnostic-related group database and experts' opinion, while national legislation and official drug cost database were the main sources for unitary costs. Univariate sensitivity analyses were conducted to assess results' effectiveness.
RESULTS
In base case scenario, PCV13 was a dominant strategy, being associated with better health outcomes and lower costs. In a lifetime, a total of 6238 infections (excluding acute otitis media) and 130 deaths were averted, with a total saving of &OV0556;397,217 ($432,966). Net benefits were estimated above &OV0556;28 million ($30 million). Results were robust in all sensitivity analyses, with positive net benefits, except when herd effect was excluded.
CONCLUSIONS
Vaccination of children with PCV13 starting in their first year of life is a cost-effective intervention with the potential to save costs to the Portuguese health system and to provide health gains by reducing the burden of pneumococcal disease in the vaccines and through the herd effect of this vaccine.
Topics: Child, Preschool; Cost-Benefit Analysis; Humans; Immunization; Incidence; Infant; Models, Immunological; Pneumococcal Infections; Pneumococcal Vaccines
PubMed: 28288018
DOI: 10.1097/INF.0000000000001587 -
Expert Review of Pharmacoeconomics &... Feb 2014The 23-valent pneumococcal polysaccharide vaccine is known to be economically reasonable in adults. With the 13-valent pneumococcal conjugate vaccine (PCV13) now... (Comparative Study)
Comparative Study
The 23-valent pneumococcal polysaccharide vaccine is known to be economically reasonable in adults. With the 13-valent pneumococcal conjugate vaccine (PCV13) now available, the question is whether 23-valent pneumococcal polysaccharide vaccine offers sufficient protection in adults compared with PCV13. Our cost-effectiveness analyses favor adult PCV13 use, but results depend largely on assumptions regarding PCV13 effectiveness in preventing non-bacteremic pneumococcal pneumonia and on herd immunity effects from childhood PCV13 use, neither of which are well characterized at present. An ongoing randomized trial of adult PCV13 use and future surveillance data should clarify these issues for some population groups, but in others, such as the immunocompromised, modeling that rigorously accounts for uncertainty can and should be used to assist policymakers in their decisions.
Topics: Adult; Age Factors; Cost-Benefit Analysis; Humans; Immunity, Herd; Immunocompromised Host; Pneumococcal Vaccines; Pneumonia, Pneumococcal; Vaccination
PubMed: 24329002
DOI: 10.1586/14737167.2014.868312 -
The Cochrane Database of Systematic... Apr 2009Bronchiectasis is increasingly recognized as a major cause of respiratory morbidity especially in developing countries. Even in affluent countries, bronchiectasis is... (Review)
Review
BACKGROUND
Bronchiectasis is increasingly recognized as a major cause of respiratory morbidity especially in developing countries. Even in affluent countries, bronchiectasis is increasingly seen in some community subsections (e.g. Aboriginal communities) and occurs as a comorbidity and disease modifier in respiratory diseases such as chronic obstructive pulmonary disease (COPD). Respiratory exacerbations in people with bronchiectasis are associated with reduced quality of life, accelerated pulmonary decline, hospitalisation and even death. Conjugate pneumococcal vaccine is part of the routine infant immunisation schedule in many countries. Current recommendations for additional pneumococcal vaccination include children and adults with chronic suppurative disease.
OBJECTIVES
To evaluate the effectiveness of pneumococcal vaccine as routine management in children and adults with bronchiectasis in (a) reducing the severity and frequency of respiratory exacerbations and (b) pulmonary decline.
SEARCH STRATEGY
The Cochrane Register of Controlled Trials (CENTRAL), the Cochrane Airways Group Specialised Register, MEDLINE and EMBASE databases were searched by the Cochrane Airways Group. Pharmaceutical manufacturers of pneumococcal vaccines were also contacted. The latest searches were performed in November 2008.
SELECTION CRITERIA
All randomised controlled trials that utilised pneumococcal vaccine on children and adults with bronchiectasis. All types of pneumococcal vaccines were included.
DATA COLLECTION AND ANALYSIS
Results of searches were reviewed against pre-determined criteria for inclusion. No eligible trials were identified and thus no data was available for analysis. One small non-randomised controlled trial in children was reported.
MAIN RESULTS
One randomised controlled open label study in 167 adults with chronic lung disease (bronchiectasis and other diseases associated with bronchiectasis) compared 23-valent pneumococcal (PV) and influenza vaccine with influenza vaccine alone (control group). The study found a significant reduction in acute infective respiratory exacerbations in the PV group compared to the control group, OR=0.48 (95%CI 0.26, 0.88); number needed to treat to benefit = 6 (95%CI 4, 32) over 2-years. There was however no difference in episodes of pneumonia between groups and no data on pulmonary decline was available. In another study, a benefit in elimination of Strep. pneumoniae in the sputum was found in a non-randomised trial in children but no clinical effect was described.
AUTHORS' CONCLUSIONS
Current but limited evidence support the use of 23-valent pneumococcal vaccine as routine management in adults with bronchiectasis. Circumstantial evidence also support the use of routine 23-valent pneumococcal vaccination in children with bronchiectasis. Further randomised controlled trials examining the efficacy of this intervention using various vaccine types in different age groups are needed. There is no data on the efficacy of pneumococcal vaccine on pulmonary decline. With the lack of evidence in how often the vaccine should be given, it is recommended that health providers adhere to national guidelines.
Topics: Adult; Bronchiectasis; Child; Humans; Pneumococcal Infections; Pneumococcal Vaccines; Respiration Disorders
PubMed: 19370631
DOI: 10.1002/14651858.CD006316.pub3 -
Vaccine Nov 2015Use of the pneumococcal conjugate vaccines among children in the US since 2000 has dramatically reduced pneumococcal disease burden among adults. Significant... (Review)
Review
Use of the pneumococcal conjugate vaccines among children in the US since 2000 has dramatically reduced pneumococcal disease burden among adults. Significant vaccine-preventable morbidity and mortality from pneumococcal infections still remains, especially among older adults. The US Advisory Committee on Immunization Practices (ACIP) has recently recommended the routine use of both pneumococcal conjugate (PCV13) and polysaccharide vaccines (PPSV23) for adults ≥65 years. These recommendations were based on the remaining burden of illness among adults and the importance of non-bacteremic pneumonia prevention in light of new evidence confirming the efficacy of PCV13 to prevent pneumococcal pneumonia among older adults. This paper reviews the evidence that led the ACIP to make recommendations for PCV13 and PPSV23 use among adults, and highlights potential gaps to be addressed by future studies to inform adult vaccination policy. The changing epidemiology of invasive pneumococcal disease and pneumonia should be closely monitored to evaluate the effectiveness and continued utility of the current vaccination strategy, and to identify future directions for pneumococcal disease prevention among older adults.
Topics: Adult; Advisory Committees; Aged; Aged, 80 and over; Health Policy; Humans; Pneumococcal Vaccines; Pneumonia, Pneumococcal; United States; Vaccination; Vaccines, Conjugate
PubMed: 26116257
DOI: 10.1016/j.vaccine.2015.05.102 -
Expert Review of Vaccines Nov 2020We assessed the safety and immunogenicity of 2 + 1 infant regimens initiated with the 13-valent pneumococcal conjugate vaccine (PCV13) and completed with the... (Comparative Study)
Comparative Study Randomized Controlled Trial
Can two different pneumococcal conjugate vaccines be used to complete the infant vaccination series? A randomized trial exploring interchangeability of the 13-valent pneumococcal conjugate vaccine and the pneumococcal non-typeable protein D-conjugate vaccine.
We assessed the safety and immunogenicity of 2 + 1 infant regimens initiated with the 13-valent pneumococcal conjugate vaccine (PCV13) and completed with the pneumococcal non-typeable protein D-conjugate vaccine (PHiD-CV). This partially blinded study randomized 6-12-week-old infants to receive two-dose priming and a booster (at ages 2, 4, 12-15 months) with: PCV13 at priming and PHiD-CV at boosting (PPS); PCV13 then PHiD-CV at priming and PHiD-CV at boosting (PSS); or PHiD-CV at priming and boosting (SSS control). All analyses were descriptive, i.e., no statistical significance tests were done. The total vaccinated cohort at priming comprised 294 infants. Grade 3 adverse events were reported after 8.7% (PPS), 11.4% (PSS), and 16.9% (SSS) of primary doses (primary objective). No serious adverse events were considered vaccination-related. For most PHiD-CV serotypes, observed percentages of children reaching antibody concentrations ≥0.2 µg/mL and opsonophagocytic activity (OPA) titers above cutoffs were similar across groups 1 month post-priming and post-booster. Observed geometric mean antibody concentrations and OPA titers were lower for some PHiD-CV serotypes with the mixed regimens than with PHiD-CV only, especially for PSS. However, no tests of statistical significance were performed. Immunogenicity of the two mixed PCV13/PHiD-CV regimens seemed mostly similar to that of a PHiD-CV-only series, although observed antibody GMCs and OPA GMTs for some PHiD-CV serotypes were lower. No safety concerns were raised. The clinical relevance of the observed differences is unknown. ClinicalTrials.gov: NCT01641133.
Topics: Cohort Studies; Female; Humans; Immunization, Secondary; Immunogenicity, Vaccine; Infant; Male; Pneumococcal Infections; Pneumococcal Vaccines; Serogroup; Vaccination
PubMed: 33297773
DOI: 10.1080/14760584.2020.1843431 -
International Journal of Molecular... Dec 2016Community-acquired pneumonia (CAP) places a considerable burden on society. A substantial number of pediatric and adult CAP cases are due to but fortunately there are... (Review)
Review
Community-acquired pneumonia (CAP) places a considerable burden on society. A substantial number of pediatric and adult CAP cases are due to but fortunately there are effective vaccines available that have a significant impact on CAP-related medical, social, and economic problems. The main aim of this paper is to evaluate the published evidence concerning the impact of pneumococcal vaccines on the prevention of CAP in children and adults. Available data indicate that pneumococcal conjugate vaccines (PCVs) are effective in children, reducing all-cause CAP cases and bacteremic and nonbacteremic CAP cases. Moreover, at least for PCV7 and PCV13, vaccination of children is effective in reducing the incidence of CAP among adults. Recently use of PCV13 in adults alone or in combination with the pneumococcal polysaccharide vaccine has been suggested and further studies can better define its effectiveness in this group of subjects. The only relevant problem for PCV13 is the risk of a second replacement phenomenon, which might significantly reduce its real efficacy in clinical practice. Protein-based pneumococcal vaccines might be a possible solution to this problem.
Topics: Community-Acquired Infections; Humans; Mass Vaccination; Pneumococcal Vaccines; Pneumonia, Pneumococcal
PubMed: 28029140
DOI: 10.3390/ijms18010030 -
Lancet (London, England)Pneumonia is estimated to cause 2 million deaths every year in children. Streptococcus pneumoniae is the most important cause of severe pneumonia. We aimed to assess the... (Clinical Trial)
Clinical Trial Randomized Controlled Trial
Efficacy of nine-valent pneumococcal conjugate vaccine against pneumonia and invasive pneumococcal disease in The Gambia: randomised, double-blind, placebo-controlled trial.
BACKGROUND
Pneumonia is estimated to cause 2 million deaths every year in children. Streptococcus pneumoniae is the most important cause of severe pneumonia. We aimed to assess the efficacy of a nine-valent pneumococcal conjugate vaccine in children.
METHODS
We undertook a randomised, placebo-controlled, double-blind trial in eastern Gambia. Children age 6-51 weeks were randomly allocated three doses of either pneumococcal conjugate vaccine (n=8718) or placebo (8719), with intervals of at least 25 days between doses. Our primary outcome was first episode of radiological pneumonia. Secondary endpoints were clinical or severe clinical pneumonia, invasive pneumococcal disease, and all-cause admissions. Analyses were per protocol and intention to treat.
FINDINGS
529 children assigned vaccine and 568 allocated placebo were not included in the per-protocol analysis. Results of per-protocol and intention-to-treat analyses were similar. By per-protocol analysis, 333 of 8189 children given vaccine had an episode of radiological pneumonia compared with 513 of 8151 who received placebo. Pneumococcal vaccine efficacy was 37% (95% CI 27-45) against first episode of radiological pneumonia. First episodes of clinical pneumonia were reduced overall by 7% (95% CI 1-12). Efficacy of the conjugate vaccine was 77% (51-90) against invasive pneumococcal disease caused by vaccine serotypes, 50% (21-69) against disease caused by all serotypes, and 15% (7-21) against all-cause admissions. We also found an efficacy of 16% (3-28) against mortality. 110 serious adverse events arose in children given the pneumococcal vaccine compared with 131 in those who received placebo.
INTERPRETATION
In this rural African setting, pneumococcal conjugate vaccine has high efficacy against radiological pneumonia and invasive pneumococcal disease, and can substantially reduce admissions and improve child survival. Pneumococcal conjugate vaccines should be made available to African infants.
Topics: Child, Preschool; Female; Gambia; Humans; Immunization Schedule; Incidence; Infant; Male; Pneumococcal Infections; Pneumococcal Vaccines; Pneumonia, Pneumococcal; Vaccines, Conjugate
PubMed: 15794968
DOI: 10.1016/S0140-6736(05)71876-6 -
Vaccine Mar 2007This paper summarizes the discussion and viewpoints from a recent meeting regarding the use of animal models for pneumococcal protein vaccines. A wide spectrum of...
This paper summarizes the discussion and viewpoints from a recent meeting regarding the use of animal models for pneumococcal protein vaccines. A wide spectrum of workers in this field met to discuss the animal species to be used in models, the approach of passive and active protection, the characteristics of challenge pneumococcal strains, inducing disease syndromes by a variety of routes of challenge, the determination of specific endpoints to assess effectiveness, the correlates of protection and other details of experimental design and analysis. Vaccine regulatory aspects were discussed. The document concludes with a series of questions that remain to be investigated.
Topics: Animals; Humans; Models, Animal; Pneumococcal Infections; Pneumococcal Vaccines
PubMed: 17034908
DOI: 10.1016/j.vaccine.2006.09.021 -
Vaccine May 2017Conserved pneumococcal proteins are potential candidates for inclusion in vaccines against pneumococcal diseases. In the first part of a two-part study, an... (Randomized Controlled Trial)
Randomized Controlled Trial
Efficacy of a novel, protein-based pneumococcal vaccine against nasopharyngeal carriage of Streptococcus pneumoniae in infants: A phase 2, randomized, controlled, observer-blind study.
BACKGROUND
Conserved pneumococcal proteins are potential candidates for inclusion in vaccines against pneumococcal diseases. In the first part of a two-part study, an investigational vaccine (PHiD-CV/dPly/PhtD-30) containing 10 pneumococcal serotype-specific polysaccharide conjugates (10VT) combined with pneumolysin toxoid and pneumococcal histidine triad protein D (30μg each) was well tolerated by Gambian children. Part two, presented here, assessed the efficacy of two PHiD-CV/dPly/PhtD formulations against pneumococcal nasopharyngeal carriage (NPC) prevalence in infants.
METHODS
In this phase 2, randomized, controlled, observer-blind trial, healthy infants aged 8-10weeks, recruited from a peri-urban health center, were randomized (1:1:1:1:1:1) into six groups. Four groups received PHiD-CV/dPly/PhtD (10 or 30μg of each protein), PHiD-CV, or 13-valent pneumococcal conjugate vaccine at ages 2-3-4months (3+0 infant schedule) and two groups PHiD-CV/dPly/PhtD-30 or PHiD-CV at 2-4-9months (2+1 infant schedule). The primary objective was impact on non-10VT NPC at ages 5-9-12months. Secondary objectives included confirmatory analysis of protein dose superiority and safety/reactogenicity. Impact on pneumococcal NPC acquisition, bacterial load, and ply and phtD gene sequencing were explored.
RESULTS
1200 infants were enrolled between June 2011 and May 2012. Prevalences of pneumococcal (60-67%) and non-10VT (55-61%) NPC were high at baseline. Across all post-vaccination time points, efficacy of PHiD-CV/dPly/PhtD-10 and PHiD-CV/dPly/PhtD-30 against non-10VT NPC (3+0 schedule) was 1.1% (95% CI -21.5, 19.5) and 2.1% (-20.3, 20.3), respectively; efficacy of PHiD-CV/dPly/PhtD-30 (2+1 schedule) was 0.5% (-22.1, 18.9) versus PHiD-CV. No differences were observed in pneumococcal NPC acquisition, clearance, or bacterial load. Both protein-based vaccines elicited immune responses to pneumococcal proteins.
CONCLUSIONS
In this high carriage prevalence setting, inclusion of pneumococcal proteins in the PHiD-CV/dPly/PhtD investigational vaccine had no impact on pneumococcal NPC in infants, regardless of protein dose or schedule. Future evaluations will assess its impact against pneumococcal disease endpoints.
FUNDING
PATH, GlaxoSmithKline Biologicals SA. ClinicalTrials.gov identifier NCT01262872.
Topics: Bacterial Load; Bacterial Proteins; Carrier State; Dose-Response Relationship, Immunologic; Female; Gambia; Humans; Infant; Male; Nasopharynx; Pneumococcal Infections; Pneumococcal Vaccines; Single-Blind Method; Streptococcus pneumoniae; Treatment Outcome
PubMed: 28389097
DOI: 10.1016/j.vaccine.2017.03.071 -
MMWR. Recommendations and Reports :... Dec 2010On February 24, 2010, a 13-valent pneumococcal polysaccharide-protein conjugate vaccine (PCV13 [Prevnar 13, Wyeth Pharmaceuticals Inc., marketed by Pfizer Inc.]) was...
Prevention of pneumococcal disease among infants and children - use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine - recommendations of the Advisory Committee on Immunization Practices (ACIP).
On February 24, 2010, a 13-valent pneumococcal polysaccharide-protein conjugate vaccine (PCV13 [Prevnar 13, Wyeth Pharmaceuticals Inc., marketed by Pfizer Inc.]) was licensed by the Food and Drug Administration (FDA) for prevention of invasive pneumococcal disease (IPD) caused among infants and young children by the 13 pneumococcal serotypes covered by the vaccine and for prevention of otitis media caused by serotypes also covered by the 7-valent pneumococcal conjugate vaccine formulation (PCV7 [Prevnar, Wyeth]). PCV13 contains the seven serotypes included in PCV7 (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and six additional serotypes (serotypes 1, 3, 5, 6A, 7F, and 19A). PCV13 is approved for use among children aged 6 weeks-71 months and supersedes PCV7, which was licensed by FDA in 2000. This report summarizes recommendations approved by the Advisory Committee on Immunization Practices (ACIP) on February 24, 2010, for the use of PCV13 to prevent pneumococcal disease in infants and young children aged <6 years. Recommendations include 1) routine vaccination of all children aged 2-59 months, 2) vaccination of children aged 60-71 months with underlying medical conditions, and 3) vaccination of children who received ≥1 dose of PCV7 previously (CDC. Licensure of a 13-valent pneumococcal conjugate vaccine [PCV13] and recommendations for use among children-Advisory Committee on Immunization Practices [ACIP], 2010. MMWR 2010;59:258-61). Recommendations also are provided for targeted use of the 23-valent pneumococcal polysaccharide vaccine (PPSV23, formerly PPV23) in children aged 2-18 years with underlying medical conditions that increase their risk for contracting pneumococcal disease or experiencing complications of pneumococcal disease if infected. The ACIP recommendation for routine vaccination with PCV13 and the immunization schedules for children aged ≤59 months who have not received any previous PCV7 or PCV13 doses are the same as those published previously for PCV7 (CDC. Preventing pneumococcal disease among infants and young children: recommendations of the Advisory Committee on Immunization Practices [ACIP]. MMWR 2000;49[No. RR-9]; CDC. Updated recommendation from the Advisory Committee on Immunization Practices [ACIP] for use of 7-valent pneumococcal conjugate vaccine [PCV7] in children aged 24-59 months who are not completely vaccinated. MMWR 2008;57:343-4), with PCV13 replacing PCV7 for all doses. For routine immunization of infants, PCV13 is recommended as a 4-dose series at ages 2, 4, 6, and 12-15 months. Infants and children who have received ≥1 dose of PCV7 should complete the immunization series with PCV13. A single supplemental dose of PCV13 is recommended for all children aged 14-59 months who have received 4 doses of PCV7 or another age-appropriate, complete PCV7 schedule. For children who have underlying medical conditions, a supplemental PCV13 dose is recommended through age 71 months. Children aged 2-18 years with underlying medical conditions also should receive PPSV23 after completing all recommended doses of PCV13.
Topics: Adolescent; Child; Child, Preschool; Humans; Immunization Schedule; Infant; Pneumococcal Infections; Pneumococcal Vaccines; Product Surveillance, Postmarketing; Serotyping; Streptococcus pneumoniae; United States
PubMed: 21150868
DOI: No ID Found