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Vaccine Nov 2013Pneumococcal infections are a major cause of morbidity and mortality worldwide. Pneumococcal conjugate vaccines represent major progress in the prevention of invasive... (Comparative Study)
Comparative Study Meta-Analysis Review
Pneumococcal infections are a major cause of morbidity and mortality worldwide. Pneumococcal conjugate vaccines represent major progress in the prevention of invasive pneumococcal disease in the paediatric population. We performed a meta-analysis, in accordance with the PRISMA statement, in order to assess the immunogenicity and safety of 13-valent pneumococcal conjugate vaccines in infants. A literary search was conducted using electronic databases and specialized journals were searched manually. Inclusion criteria were: clinical trials with infants vaccinated with 13-valent pneumococcal conjugate, compared to 7-valent vaccine. We recorded the results in terms of the immunogenicity and safety of the vaccines. The quality of the studies included was assessed using the CASP and Jadad checklists. We included nine randomized clinical trials of 258 potentially relevant references in the meta-analysis. The studies included had high-moderate quality. Both vaccines were well tolerated in all groups of infants, and most local reactions and systemic events were of mild or medium intensity and typical of any injected vaccine. All studies included in the meta-analysis showed high immunogenicity for both pneumococcal vaccines in all tested serotypes. An anti-polysaccharide antibody concentration of ≥0.35 μg/mL was achieved in at least 89% of the infants. Our results suggest that the 13-valent pneumococcal conjugate vaccine has a similar safety profile, and is as effective as, the 7-valent vaccine in the prevention of invasive pneumococcal disease caused by the seven common serotypes, and could provide expanded protection against the six additional serotypes.
Topics: Antibodies, Bacterial; Drug-Related Side Effects and Adverse Reactions; Heptavalent Pneumococcal Conjugate Vaccine; Humans; Infant; Pneumococcal Infections; Pneumococcal Vaccines; Randomized Controlled Trials as Topic
PubMed: 24055349
DOI: 10.1016/j.vaccine.2013.09.008 -
The Pediatric Infectious Disease Journal Jan 2014Since second generation pneumococcal conjugate vaccines (PCVs) targeting 10 and 13 serotypes became available in 2010, the number of national policy makers considering... (Review)
Review
Since second generation pneumococcal conjugate vaccines (PCVs) targeting 10 and 13 serotypes became available in 2010, the number of national policy makers considering these vaccines has steadily increased. An important consideration for a national immunization program is the timing and number of doses-the schedule-that will best prevent disease in the population. Data on disease epidemiology and the efficacy or effectiveness of PCV schedules are typically considered when choosing a schedule. Practical concerns, such as the existing vaccine schedule, and vaccine program performance are also important. In low-income countries, pneumococcal disease and deaths typically peak well before the end of the first year of life, making a schedule that provides PCV doses early in life (eg, a 6-, 10- and 14-week schedule) potentially the best option. In other settings, a schedule including a booster dose may address disease that peaks in the second year of life or may be seen to enhance a schedule already in place. A large and growing body of evidence from immunogenicity studies, as well as clinical trials and observational studies of carriage, pneumonia and invasive disease, has been systematically reviewed; these data indicate that schedules of 3 or 4 doses all work well, and that the differences between these regimens are subtle, especially in a mature program in which coverage is high and indirect (herd) effects help enhance protection provided directly by a vaccine schedule. The recent World Health Organization policy statement on PCVs endorsed a schedule of 3 primary doses without a booster or, as a new alternative, 2 primary doses with a booster dose. While 1 schedule may be preferred in a particular setting based on local epidemiology or practical considerations, achieving high coverage with 3 doses is likely more important than the specific timing of doses.
Topics: Child, Preschool; Health Policy; Heptavalent Pneumococcal Conjugate Vaccine; Humans; Immunization Schedule; Infant; Infant, Newborn; Pneumococcal Infections; Pneumococcal Vaccines; United States; Vaccines, Conjugate
PubMed: 24336059
DOI: 10.1097/INF.0000000000000076 -
Prescrire International Jan 2011The 7-valent pneumococcal conjugate vaccine (4, 6B, 9V, 14, 18C, 19F, 23F) is the standard vaccine for the prevention of invasive pneumococcal infections in infants and... (Comparative Study)
Comparative Study
The 7-valent pneumococcal conjugate vaccine (4, 6B, 9V, 14, 18C, 19F, 23F) is the standard vaccine for the prevention of invasive pneumococcal infections in infants and children under 5 years of age. A 13-valent pneumococcal conjugate vaccine (with the addition of valences 1, 3, 5, 6A, 7F and 19A) has now been authorised to replace the 7-valent vaccine within the European Union. This new vaccine, adapted to recent epidemiological data on invasive pneumococcal infections, is supposed to cover at least 80% of pneumococcal infections in Europe. The protective potency of the 13-valent vaccine has not yet been tested in clinical trials. Clinical evaluation is based on two immunogenicity studies, in which the immunogenic potency of the 13-valent vaccine was similar to that of the 7-valent vaccine for their shared serotypes, but lower for serotypes 3, 6B and 9V. For these last two serotypes and for the new serotypes, the usual target antibody titre was reached after a booster injection. This was not the case for valence 3. * The vaccine used in immunogenicity studies did not contain polysorbate 80 (an excipient), and a non-inferiority study of the marketed vaccine containing polysorbate 80 was therefore conducted in 500 children. Non-inferiority was established for all 13 valences after the booster injection, but not for valences 6B and 23F after primary vaccination. According to the results of 10 studies, simultaneous administration of the 13-valent pneumococcal conjugate vaccine does not affect the immunogenicity of other vaccines generally administered before the age of 5 years. Other immunogenicity studies support the use of a variety of vaccine schedules for infants and children under 5 years of age who have not yet been vaccinated or who have started vaccination with the 7-valent vaccine. Increasing the number of valences in the vaccine from 7 to 13 led to no marked increase in local adverse effects (hypersensitivity, indurations, erythema) or systemic reactions (mainly fever, decreased sleep and irritability). In practice, replacing the 7-valent pneumococcal conjugate vaccine with the 13 valence vaccine could lead to a further reduction in the incidence of invasive pneumococcal infections. However, this remains to be confirmed by well-conducted epidemiological follow-up studies.
Topics: Child, Preschool; European Union; Excipients; Humans; Immunization Schedule; Infant; Pneumococcal Infections; Pneumococcal Vaccines; Polysorbates; Vaccines, Conjugate
PubMed: 21462782
DOI: No ID Found -
Paediatric Drugs Feb 2012
Review
Topics: Animals; Humans; Pneumococcal Infections; Pneumococcal Vaccines; Randomized Controlled Trials as Topic; Research Report; Vaccines, Conjugate
PubMed: 22149553
DOI: 10.2165/11207010-000000000-00000 -
Aging Clinical and Experimental Research Jun 2009Pneumococcal disease in the elderly is a major concern emphasizing the need for prevention. The review focuses on a literature-based analysis of the efficacy ("does the... (Review)
Review
Pneumococcal disease in the elderly is a major concern emphasizing the need for prevention. The review focuses on a literature-based analysis of the efficacy ("does the vaccine works?") and/or the effectiveness ("does vaccination help older population?") of pneumococcal vaccines 14- or 23-valent (PPV23) in the elderly. In the setting of Streptococcus pneumoniae pneumonia, there is still no conclusive evidence decisively confirming the efficacy of pneumococcal vaccine against pneumococcal pneumonia in the elderly populations. However, the efficacy of pneumococcal vaccination has been demonstrated in the prevention of invasive pneumococcal disease (IPD) such as bacteremia, which is the main complication of pneumonia. In the setting of IPD in the elderly, analysis of the current literature provides evidence for both the efficacy and effectiveness of PPV23, but most of the clinical studies failed to demonstrate a substantial reduction in all-cause mortality rate. The community-acquired pneumonia guidelines in the industrialized countries include recommendations for pneumococcal vaccine by PPV23 for adults aged 65 years and over. Taking into account the preventive effect of PPV23 on IPD and the threat of a pandemic flu, the increase of PPV23 vaccination coverage in elderly patients should be strongly considered.
Topics: Aged; Humans; Pneumococcal Infections; Pneumococcal Vaccines; Pneumonia, Pneumococcal; Practice Guidelines as Topic; Vaccination
PubMed: 19571646
DOI: 10.1007/BF03324905 -
Atencion Primaria Sep 2002Estimate pneumococcal vaccine effectiveness in preventing Streptococcus pneumoniae illness in the elderly. (Comparative Study)
Comparative Study Meta-Analysis Review
AIM
Estimate pneumococcal vaccine effectiveness in preventing Streptococcus pneumoniae illness in the elderly.
DESIGN
Systematic review and meta-analysis. DATA SOURCE. MEDLINE, years 1964 to the 2000; EMBASE, from 1988 to the 2000; Cochrane Library, identified studies and previously published systematic reviews citations peruse, and contacts with field experts.
STUDY SELECTION
Clinical trials, cohort and case-control studies, published in Spanish, English or French, that estimated pneumococcal disease rates in vaccinated or not vaccinated elderly.
DATA EXTRACTION
The studies were valued independently by four investigators with predefined criteria of validity, such as results comparing rates of disease caused by serotypes included in the vaccine, random allocation, double blind design, included subjects pertaining to the same study base, and losses of less than 10% in clinical trials and 20% in observational studies.
RESULTS
Eight clinical trials considered the relative risk (RR) of pneumococcal pneumonia, three did not make estimations on pneumonia originated by serotypes included in the vaccine and only one study fulfilled all the inclusion criteria. Vaccinated versus not vaccinated pneumococcal pneumonia RR was 0.86 (95%CI, 0.24 to 2.99). Vaccine effectiveness was 14% (95%CI, -199 to 76%). Ten studies performed estimations on the effectiveness of the vaccine on invasive disease by vaccine serotypes. Of these, two clinical trials and two observational studies fulfilled the required quality criteria. RR of invasive disease was of 0.68 (95%CI, 0.39-1.18); vaccine effectiveness was 32% (95%CI, 18-61%).
CONCLUSIONS
No evidence was found supporting pneumococcal vaccine effectiveness to reduce or avoid S. pneumoniae disease in the elderly.
Topics: Adult; Age Factors; Aged; Aged, 80 and over; Case-Control Studies; Clinical Trials as Topic; Cohort Studies; Double-Blind Method; Humans; Middle Aged; Pneumococcal Vaccines; Pneumonia, Pneumococcal; Random Allocation; Risk
PubMed: 12372207
DOI: 10.1016/s0212-6567(02)79027-6 -
Expert Review of Vaccines Mar 2010
Review
Topics: Clinical Trials as Topic; Drug Approval; Europe; Humans; Immunization Schedule; Pneumococcal Infections; Pneumococcal Vaccines
PubMed: 20218848
DOI: 10.1586/erv.10.6 -
Drugs & Aging 2001The effective prevention of Streptococcus pneumoniae infection has a renewed priority in an era in which the emergence of antibacterial-resistant strains has the... (Review)
Review
The effective prevention of Streptococcus pneumoniae infection has a renewed priority in an era in which the emergence of antibacterial-resistant strains has the potential to further compromise efforts to reduce early mortality from invasive pneumococcal infection. Although the 23-valent pneumococcal polysaccharide (PPS) vaccine was approved in the US to prevent respiratory and invasive infection in the elderly and other high-risk populations, the protective efficacy of this vaccine for the growing population of adults aged >65 years remains controversial. The apparent effectiveness of pneumococcal immunisation in clinical studies of elderly adults has varied depending upon whether a reduction in pneumococcal colonisation, pneumonia, bacteraemia or death was used as an outcome. Clinical studies of vaccine efficacy to date suggest that the current pneumococcal vaccine is 56 to 81% effective at preventing invasive pneumococcal infection, and may have additive benefit to influenza vaccine in preventing community-acquired pneumonia, particularly in elderly adults with an increased risk of serious pneumonia requiring hospitalisation. Possible reasons for incomplete protection from pneumococcal infection after immunisation include infection with non-vaccine serotypes, inadequate or ineffective antibody responses, waning of antibody responses, or compromised nonhumoral host defences. Further studies are needed to determine whether: (i) elderly adults who respond poorly to the 23-valent pneumococcal vaccine can be identified prior to immunisation and targeted for study with improved pneumococcal vaccines; (ii) specific nutrient deficiencies can be identified and corrected to improve the immune responsiveness of elderly adults to the PPS vaccine; (iii) newer protein-conjugate or DNA pneumococcal vaccines may be more uniformly immunogenic for elderly adults; and (iv) whether smoking cessation reduces the risk of invasive pneumococcal infection in elderly adults.
Topics: Aged; Aged, 80 and over; Aging; Clinical Trials as Topic; Humans; Pneumococcal Infections; Pneumococcal Vaccines; Streptococcus pneumoniae; Treatment Outcome
PubMed: 11392439
DOI: 10.2165/00002512-200118050-00001 -
The Annals of Pharmacotherapy Dec 2011To review the immunogenicity, efficacy, and safety of the 13-valent pneumococcal conjugate vaccine (PCV13) for use in pediatric patients. (Review)
Review
OBJECTIVE
To review the immunogenicity, efficacy, and safety of the 13-valent pneumococcal conjugate vaccine (PCV13) for use in pediatric patients.
DATA SOURCES
A MEDLINE search (2000-September 2011) was conducted using the key words Streptococcus pneumoniae and pneumococcal conjugate vaccine for clinical trials, limited to studies conducted in humans and published in English.
STUDY SELECTION AND DATA EXTRACTION
Randomized, controlled, multicenter trials were reviewed and included to evaluate the safety and efficacy of PCV13. Literature on the epidemiology and pathology of pneumococcal infections and recommendations from the Advisory Committee on Immunization Practices (ACIP) were also reviewed.
DATA SYNTHESIS
PCV13 is approved for routine vaccination of all infants as a 4-dose series at age 2, 4, 6, and 12-15 months for children who previously received 1 or more doses of the 7-valent pneumococcal conjugate vaccine (PCV7), and for children with underlying medical conditions that increase their risk for pneumococcal disease or its complications. PCV13 has comparable immunogenicity to the serotypes common with PCV7 and also provides protection against 6 additional pneumococcal serotypes. PCV13 has also been shown to have a comparable adverse reaction profile to PCV7.
CONCLUSIONS
Based on published immunogenicity and safety data, as well as the recent recommendations by the ACIP for routine use in infants and indications for high-risk pediatric patients, PCV13 is a revised formulation of pneumococcal vaccine that should be included on pharmacy formularies.
Topics: Advisory Committees; Clinical Trials, Phase III as Topic; Humans; Multicenter Studies as Topic; Pediatrics; Pneumococcal Vaccines; Randomized Controlled Trials as Topic; Streptococcus pneumoniae; Vaccines, Conjugate
PubMed: 22045904
DOI: 10.1345/aph.1Q347 -
Deutsche Medizinische Wochenschrift... Aug 2013
Topics: Humans; Pneumococcal Infections; Pneumococcal Vaccines
PubMed: 23934594
DOI: 10.1055/s-0033-1343340