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Indian Journal of Medical Microbiology 2019India is one among the four Asian countries with the greatest number of deaths due to pneumococcal infection among children under 5 years. pneumococcal conjugate vaccine...
India is one among the four Asian countries with the greatest number of deaths due to pneumococcal infection among children under 5 years. pneumococcal conjugate vaccine (PCV) has been introduced in a phased manner in five major Indian states. Ambiguity remains in choosing the appropriate type of PCV and optimum schedule with maximum effectiveness specific for each country. Here, we discuss the evidences with respect to serotype coverage, immunogenicity, reactogenicity and dosage schedule for introduction of PCV13 in India. In addition, the expected PCV impact and the challenges are detailed. PCV13 is expected to provide >75% serotype coverage for invasive pneumococcal disease (IPD) serotypes in Indian children combined with the replacement by nonvaccine serotypes which is unpredictable due to lack of complete data. Nasopharyngeal (NP) surveillance is easy, feasible and can replace IPD surveillance in resource-poor settings. Continuous IPD as well as NP surveillance in all the regions are necessary to assess the impact of PCV in India.
Topics: Age Factors; Female; Health Impact Assessment; Humans; Immunization Programs; Immunization Schedule; India; Male; Outcome Assessment, Health Care; Pneumococcal Infections; Pneumococcal Vaccines; Public Health Surveillance; Serogroup; Streptococcus pneumoniae; Vaccines, Conjugate
PubMed: 31745013
DOI: 10.4103/ijmm.IJMM_19_320 -
Journal of Immunology Research 2015Applications of the heptavalent pneumococcal conjugate vaccine (PCV7) in the pediatric immunization schedule have dramatically reduced the incidence of pneumococcal... (Review)
Review
Applications of the heptavalent pneumococcal conjugate vaccine (PCV7) in the pediatric immunization schedule have dramatically reduced the incidence of pneumococcal diseases in both vaccinated children and unvaccinated individuals of all ages. However, increased infections caused by non-PCV7 serotypes have been reported by several groups. To overcome this problem, new vaccines covering more serotypes including the emerging serotypes have been developed. The 13-valent pneumococcal conjugate vaccine (PCV13) currently covers the 7 PCV7 serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional serotypes 1, 3, 5, 6A, 7F, and 19A. After the first year of PCV13 applications in the immunization schedule in young children, global evaluation studies demonstrated that PCV13 provided a wider coverage and more effective prevention than PCV7 against invasive pneumococcal diseases (IPDs), mucosal pneumococcal diseases, and pneumococcal carriage. We reviewed the effects of PCV13 in the control of pneumococcal diseases in children based on previous studies.
Topics: Age Factors; Carrier State; Child; Child, Preschool; Heptavalent Pneumococcal Conjugate Vaccine; Humans; Incidence; Nasopharynx; Otitis Media; Outcome Assessment, Health Care; Pneumococcal Infections; Pneumococcal Vaccines; Pneumonia; Vaccination; Vaccines, Conjugate
PubMed: 26351648
DOI: 10.1155/2015/591580 -
Expert Review of Vaccines Mar 2012In view of the increasing licensure and use of pneumococcal conjugate vaccines, the relatively high cost, and growing issues with serotype emergence, there is a need to... (Review)
Review
In view of the increasing licensure and use of pneumococcal conjugate vaccines, the relatively high cost, and growing issues with serotype emergence, there is a need to re-evaluate the role of pneumococcal protein vaccines (PPVs) and pathways to their licensure. This paper summarizes the discussion and viewpoints from an expert meeting regarding the development of PPVs. A wide spectrum of pneumococcal vaccine researchers, developers, and regulators met to review the state of PPVs, identify research and development needs, and provide consensus opinions to support the introduction of new PPVs where possible. They also discussed clinical and regulatory aspects pertinent to these vaccines and generated a series of recommendations for moving the field forward.
Topics: Animals; Bacterial Proteins; Disease Models, Animal; Humans; Pneumococcal Infections; Pneumococcal Vaccines; Vaccines, Subunit; Virulence Factors
PubMed: 22380821
DOI: 10.1586/erv.12.5 -
Globalization and Health Jul 2016We analyzed an attempt to develop and clinically test a pneumococcal conjugate vaccine for the developing world, undertaken by public health institutions from the... (Review)
Review
We analyzed an attempt to develop and clinically test a pneumococcal conjugate vaccine for the developing world, undertaken by public health institutions from the Netherlands, Sweden, Denmark, Norway and Finland: the Dutch Nordic Consortium (DNC), between 1990 and 2000. Our review shows that the premature termination of the project was due less to technological and scientific challenges and more to managerial challenges and institutional policies. Various impeding events, financial and managerial challenges gradually soured the initially enthusiastic collaborative spirit until near the end the consortium struggled to complete the minimum objectives of the project. By the end of 1998, a tetravalent prototype vaccine had been made that proved safe and immunogenic in Phase 1 trials in adults and toddlers in Finland. The planned next step, to test the vaccine in Asia in infants, did not meet approval by the local authorities in Vietnam nor later in the Philippines and the project eventually stopped.The Dutch DNC member, the National Institute of Public Health and the Environment (RIVM) learned important lessons, which subsequently were applied in a following vaccine technology transfer project, resulting in the availability at affordable prices for the developing world of a conjugate vaccine against Haemophilus influenzae type b. We conclude that vaccine development in the public domain with technology transfer as its ultimate aim requires major front-end funding, committed leadership at the highest institutional level sustained for many years and a competent recipient-manufacturer, which needs to be involved at a very early stage of the development.At the national level, RIVM's policy to consolidate its national manufacturing task through securing a key global health position in support of a network of public vaccine manufacturers proved insufficiently supported by the relevant ministries of the Dutch government. Difficulties to keep up with high costs, high-risk innovative vaccine development and production in a public sector setting led to the gradual loss of production tasks and to the 2009 Government decision to privatize the vaccine production tasks of the Institute.
Topics: Clinical Trials as Topic; Denmark; Developing Countries; Finland; Humans; Institutional Management Teams; International Cooperation; Netherlands; Norway; Organizational Policy; Pneumococcal Vaccines; Sweden; Technology Transfer; Vaccination
PubMed: 27388678
DOI: 10.1186/s12992-016-0176-6 -
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 -
Clinical Microbiology and Infection :... Oct 2013Streptococcus pneumoniae-related infections are a major cause of morbidity and mortality in people of all ages worldwide. Pneumococcal vaccine development started in... (Review)
Review
Streptococcus pneumoniae-related infections are a major cause of morbidity and mortality in people of all ages worldwide. Pneumococcal vaccine development started in 1911 with a whole cell vaccine and more recently multivalent plain polysaccharide and polysaccharide conjugate vaccines have been developed. The recent vaccines rely on capsular polysaccharide antigens to induce serotype-specific immune responses. We summarize here the presentations on pneumococcal polysaccharide conjugate vaccine (conjugated to CRM197 carrier protein) given during the integrated symposium organized and funded by Pfizer International Operations during the 22nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) 31 March to 3 April 2012, London, UK. A dramatic reduction in the incidence of invasive pneumococcal diseases (IPD) due to vaccine serotypes (VST-IPD) has been reported since the introduction of a hepta-valent pneumococcal conjugate vaccine (PCV7). An indirect (herd) effect has been demonstrated to be associated with PCV7 infant vaccination programmes, with many studies reporting reductions in VST-IPD in populations that are not eligible for PCV7 vaccination. Since 2010, a 13-valent pneumococcal conjugate vaccine (PCV13) has been introduced into national immunization programmes and results from early surveillance suggest that this vaccine also has an impact on the serotypes unique to PCV13, as well as continuing to protect against the PCV7 serotypes. Data from a passive surveillance system in Europe in 2009, for instance, showed that the highest incidence of IPD remains in those aged >65 years and in children <5 years. PCV13 has now been licensed for vaccination of adults >50 years based on safety and immunogenicity data; an efficacy trial is being conducted. Regardless of previous pneumococcal vaccination status, if the use of 23-valent polysaccharide is considered appropriate, it is recommended to give PCV13 first. Novel immunization strategies remain the only practical means to reduce significantly the remaining global mortality and morbidity due to S. pneumoniae in adults.
Topics: Adult; Bacterial Proteins; Child; Europe; Humans; Immunization Programs; Pneumococcal Infections; Pneumococcal Vaccines; Polysaccharides, Bacterial; Population Surveillance; Streptococcus pneumoniae; Vaccination; Vaccines, Conjugate
PubMed: 24083785
DOI: 10.1111/1469-0691.12320 -
Value in Health Regional Issues Dec 2016To assess the efficacy, cost-effectiveness, immunogenicity, and safety related to the interchangeability between pneumococcal conjugate vaccines (PCVs) and vaccination... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
To assess the efficacy, cost-effectiveness, immunogenicity, and safety related to the interchangeability between pneumococcal conjugate vaccines (PCVs) and vaccination schedules in pediatric population.
METHODS
Systematic searches were conducted in December 2010 and April 2015 for economic evaluations in MEDLINE, EMBASE, LILACS, and Cochrane Central Register of Controlled Trials. Web sites and databases from medical societies, experts, and associations related to the topic, proceedings or congressional annals, and doctoral theses were also searched. No language or temporal restriction was applied. We included randomized controlled trials, economic evaluations, and systematic reviews evaluating antibody response, cost-effectiveness, and effectiveness of PCVs' interchangeability. A Strengthening the Reporting of Observational Studies in Epidemiology-based checklist was used to assess the risk of bias in observational studies and a Cochrane approach for experimental/quasi-experimental studies. Pairs of reviewers independently selected (through the Web-based Early Reviewer Organizer Software), assessed the quality, and extracted the data of the studies. Discrepancies were resolved by consensus. We planned to perform meta-analysis whenever appropriate.
RESULTS
Forty-six of 202 studies were included. There was no direct information available on the interchangeability between PCVs. The immunogenicity and safety between the 10-valent PCV (PCV10) and the 7-valent PCV were similar when both vaccines were coadministered with other routine pediatric vaccines. PCV10 and 13-valent PCV (PCV13) were consistently more cost-effective than 7-valent PCV.
CONCLUSIONS
There was no direct comparative information available on the interchangeability among PCVs, but they have pretty similar immunogenicity and safety. PCV10 versus PCV13 cost-effectiveness varied according to price, indirect effects, and indirect costs. PCV10 gains more quality-adjusted life-years because of the prevention of more frequent yet less severe events such as otitis media, and PCV13 prevents less frequent but more costly events such as invasive diseases.
Topics: Child; Cost-Benefit Analysis; Humans; Otitis Media; Pneumococcal Infections; Pneumococcal Vaccines; Vaccination; Vaccines, Conjugate
PubMed: 27986195
DOI: 10.1016/j.vhri.2015.12.001 -
PloS One 2017Routine vaccination of elderly people against pneumococcal diseases is recommended in many countries. National guidelines differ, recommending either the 23-valent... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Routine vaccination of elderly people against pneumococcal diseases is recommended in many countries. National guidelines differ, recommending either the 23-valent polysaccharide vaccine (PPV23), the 13-valent conjugate vaccine (PCV13) or both. Considering the ongoing debate on the effectiveness of PPV23, we performed a systematic literature review and meta-analysis of the vaccine efficacy/effectiveness (VE) of PPV23 against invasive pneumococcal disease (IPD) and pneumococcal pneumonia in adults aged ≥60 years living in industrialized countries.
METHODS
We searched for pertinent clinical trials and observational studies in databases MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews. We assessed the risk of bias of individual studies using the Cochrane Risk of Bias tool for randomized controlled trials and the Newcastle-Ottawa Scale for observational studies. We rated the overall quality of the evidence by GRADE criteria. We performed meta-analyses of studies grouped by outcome and study design using random-effects models. We applied a sensitivity analysis excluding studies with high risk of bias.
RESULTS
We identified 17 eligible studies. Pooled VE against IPD (by any serotype) was 73% (95%CI: 10-92%) in four clinical trials, 45% (95%CI: 15-65%) in three cohort studies, and 59% (95%CI: 35-74%) in three case-control studies. After excluding studies with high risk of bias, pooled VE against pneumococcal pneumonia (by any serotype) was 64% (95%CI: 35-80%) in two clinical trials and 48% (95%CI: 25-63%) in two cohort studies. Higher VE estimates in trials (follow-up ~2.5 years) than in observational studies (follow-up ~5 years) may indicate waning protection. Unlike previous meta-analyses, we excluded two trials with high risk of bias regarding the outcome pneumococcal pneumonia, because diagnosis was based on serologic methods with insufficient specificity.
CONCLUSIONS
Our meta-analysis revealed significant VE of PPV23 against both IPD and pneumococcal pneumonia by any serotype in the elderly, comparable to the efficacy of PCV13 against vaccine-serotype disease in a recent clinical trial in elderly people. Due to its broader serotype coverage and the decrease of PCV13 serotypes among adults resulting from routine infant immunization with PCV13, PPV23 continues to play an important role for protecting adults against IPD and pneumococcal pneumonia.
Topics: Age Factors; Aged; Aged, 80 and over; Clinical Trials as Topic; Female; Humans; Male; Odds Ratio; Outcome Assessment, Health Care; Pneumococcal Infections; Pneumococcal Vaccines; Streptococcus pneumoniae
PubMed: 28061505
DOI: 10.1371/journal.pone.0169368 -
Human Vaccines & Immunotherapeutics 2016All currently available Streptococcus pneumoniae (Spn) vaccines have limitations due to their capsular serotype composition. Both the 23-valent Spn polysaccharide... (Review)
Review
All currently available Streptococcus pneumoniae (Spn) vaccines have limitations due to their capsular serotype composition. Both the 23-valent Spn polysaccharide vaccine (PPV) and 7, 10, or 13-valent Spn conjugate vaccines (PCV-7, 10, -13) are serotype-based vaccines and therefore they elicit only serotype-specific immunity. Emergence of replacement Spn strains expressing other serotypes has consistently occurred following introduction of capsular serotype based Spn vaccines. Furthermore, capsular polysaccharide vaccines are less effective in protection against non-bacteremic pneumonia and acute otitis media (AOM) than against invasive pneumococcal disease (IPD). These shortcomings of capsular polysaccharide-based Spn vaccines have created high interest in development of non-serotype specific protein-based vaccines that could be effective in preventing both IPD and non-IPD infections. This review discusses the progress to date on development of Spn protein vaccine candidates that are highly conserved by all Spn strains, are highly conserved, exhibit maximal antigenicity and minimal reactogenicity to replace or complement the current capsule-based vaccines. Key to development of a protein based Spn vaccine is an understanding of Spn pathogenesis. Based on pathogenesis, a protein-based Spn vaccine should include one or more ingredients that reduce NP colonization below a pathogenic inoculum. Elimination of all Spn colonization may not be achievable or even advisable. The level of expression of a target protein antigen during pathogenesis is another key to the success of protein based vaccines.. As with virtually all currently licensed vaccines, production of a serum antibody response in response to protein based vaccines is anticipated to provide protection from Spn infections. A significant advantage that protein vaccine formulations can offer over capsule based vaccination is their potential benefits associated with natural priming and boosting to all strains of Spn. One of the most universal and comprehensive approaches of identifying novel vaccine candidates is the investigation of human sera from different disease stages of natural infections. Antigens that are robustly reactive in preliminary human serum screening constitute a pathogen-specific antigenome. This strategy has identified a number of Spn protein vaccine candidates that are moving forward in human clinical trials.
Topics: Animals; Antigens, Bacterial; Bacterial Proteins; Clinical Trials as Topic; Drug Discovery; Drug Evaluation, Preclinical; Humans; Pneumococcal Vaccines; Streptococcus pneumoniae
PubMed: 26539741
DOI: 10.1080/21645515.2015.1052198 -
Canadian Family Physician Medecin de... Sep 2019To describe the burden of pneumococcal disease and associated risk factors in the Canadian adult population, delineate available pneumococcal vaccines and associated... (Review)
Review
OBJECTIVE
To describe the burden of pneumococcal disease and associated risk factors in the Canadian adult population, delineate available pneumococcal vaccines and associated efficacy and effectiveness data, and review current pneumococcal vaccine recommendations and community-acquired pneumonia (CAP) prevention strategies in Canada.
QUALITY OF EVIDENCE
Pneumococcal vaccination guidelines from the Canadian National Advisory Committee on Immunization in 2013 and 2016 constitute level III evidence for CAP prevention in the Canadian adult population.
MAIN MESSAGE
It is recommended that immunosuppressed adults of all ages receive the 13-valent pneumococcal conjugate vaccine (PCV13) (grades A and B recommendations). In 2016, the National Advisory Committee on Immunization also recommended that all adults aged 65 years and older receive PCV13 (grade A recommendation) on an individual basis, followed by the 23-valent pneumococcal polysaccharide vaccine (grade B recommendation). This update is based on a large clinical study that demonstrated PCV13 efficacy against vaccine-type CAP in this population.
CONCLUSION
Physicians should focus on improving pneumococcal vaccination rates among adults, which remain low. Vaccination with PCV13 should also be considered for adults with chronic conditions, whose baseline risk is often higher than that for healthy individuals aged 65 years and older.
Topics: Advisory Committees; Canada; Community-Acquired Infections; Humans; Immunization Schedule; Pneumococcal Vaccines; Pneumonia, Pneumococcal; Practice Guidelines as Topic; Streptococcus pneumoniae; Vaccines, Conjugate
PubMed: 31515311
DOI: No ID Found