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BMC Pulmonary Medicine May 2016Invasive pneumococcal disease (IPD) and pneumococcal pneumonia are common and carry a significant morbidity and mortality. Current strategies to prevent pneumococcal... (Review)
Review
BACKGROUND
Invasive pneumococcal disease (IPD) and pneumococcal pneumonia are common and carry a significant morbidity and mortality. Current strategies to prevent pneumococcal disease are under review in the United Kingdom (UK). We conducted a systematic review to evaluate the burden of vaccine type adult pneumococcal disease specifically in the UK.
METHODS
A systematic review conducted and reported according to MOOSE guidelines. Relevant studies from 1990 to 2015 were included. The primary outcome was the incidence of vaccine type pneumococcal disease, focussing on the pneumococcal polysaccharide vaccine (PPSV), the 13-valent conjugate vaccine (PCV13) and the 7-valent conjugate vaccine (PCV7).
RESULTS
Data from surveillance in England and Wales from 2013/14 shows an incidence of 6.85 per 100,000 population across all adult age groups for IPD, and an incidence of 20.58 per 100,000 population in those aged >65 years. The corresponding incidences for PCV13 serotype IPD were 1.4 per 100,000 and 3.72 per 100,000. The most recent available data for community-acquired pneumonia (CAP) including non-invasive disease showed an incidence of 20.6 per 100,000 for adult pneumococcal CAP and 8.6 per 100,000 population for PCV13 serotype CAP. Both IPD and CAP data sources in the UK suggest an ongoing herd protection effect from childhood PCV13 vaccination causing a reduction in the proportion of cases caused by PCV13 serotypes in adults. Despite this, applying the incidence rates to UK population estimates suggests more than 4000 patients annually will be hospitalised with PCV13 serotype CAP and more than 900 will be affected by IPD, although with a trend for these numbers to decrease over time. There was limited recent data on serotype distribution in high risk groups such as those with chronic respiratory or cardiac disease and no data available for vaccine type (VT) CAP managed in the community where there is likely to be a considerable unmeasured burden.
CONCLUSION
The most recent available data suggests that VT pneumococcal disease continues to have a high burden in UK adults despite the impact of childhood PCV13 vaccination. IPD estimates represent only a fraction of the total burden of pneumococcal disease.
STUDY REGISTRATION
PROSPERO CRD42015025043.
Topics: Adult; Cost of Illness; England; Heptavalent Pneumococcal Conjugate Vaccine; Humans; Incidence; Pneumococcal Vaccines; Pneumonia, Pneumococcal; Vaccines, Conjugate; Wales
PubMed: 27169895
DOI: 10.1186/s12890-016-0242-0 -
Human Vaccines & Immunotherapeutics 2019Pneumococcal disease remains a public health priority in adults. Previous studies have suggested that administration of pneumococcal polysaccharide vaccine or... (Randomized Controlled Trial)
Randomized Controlled Trial
Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine compared to 13-valent pneumococcal conjugate vaccine in adults ≥65 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine.
BACKGROUND
Pneumococcal disease remains a public health priority in adults. Previous studies have suggested that administration of pneumococcal polysaccharide vaccine or pneumococcal conjugate vaccine within three years following receipt of PPV23 was associated with increased reactogenicity and reduced antibody titers in comparison to longer intervals. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) was evaluated in adults ≥ 65 years of age with prior history of PPV23 vaccination (V114-007; NCT02573181).
METHODS
A total of 250 adults who received PPV23 at least 1 year prior to study entry received a single dose of either PCV15 or PCV13 (125/arm) and were followed for safety for 14 days postvaccination. Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) geometric mean titers (GMTs) were measured immediately prior and 30 days postvaccination.
RESULTS
Safety profiles were comparable between PCV15 and PCV13 recipients. Following vaccination, serotype-specific antibody responses for the 13 shared serotypes were generally comparable between recipients of PCV15 and PCV13 for IgG GMCs, OPA GMTs, and geometric mean fold rises (GMFRs) and percentages of subjects with ≥ 4-fold-rise from baseline for both IgG and OPA. Recipients of PCV15 had numerically higher antibody responses than PCV13 for two serotypes unique to PCV15 (22F, 33F).
CONCLUSION
PCV15 was generally well tolerated and induced high levels of IgG and OPA antibodies to all 15 serotypes included in the vaccine when given as a single dose to adults ≥ 65 years of age previously vaccinated with PPV23.
Topics: Aged; Antibodies, Bacterial; Double-Blind Method; Female; Humans; Immunization, Secondary; Immunoglobulin G; Male; Pneumococcal Infections; Pneumococcal Vaccines; Serogroup; Streptococcus pneumoniae; Vaccines, Conjugate
PubMed: 30427749
DOI: 10.1080/21645515.2018.1532250 -
JAMA Pediatrics Mar 2014An observational study found an increased risk of febrile seizure on the day of or 1 day after vaccination (days 0-1) with trivalent inactivated influenza vaccine (TIV)... (Clinical Trial)
Clinical Trial Observational Study
IMPORTANCE
An observational study found an increased risk of febrile seizure on the day of or 1 day after vaccination (days 0-1) with trivalent inactivated influenza vaccine (TIV) in the 2010-2011 season; risk was highest with simultaneous vaccination with TIV and 13-valent pneumococcal vaccine (PCV13) in children who were 6 to 23 months old. Text messaging is a novel method for surveillance of adverse events after immunization that has not been used for hypothesis-driven vaccine safety research.
OBJECTIVE
To prospectively evaluate whether children receiving TIV and PCV13 simultaneously had higher rates of fever on days 0 to 1 than those receiving either product without the other.
DESIGN, SETTING, AND PARTICIPANTS
Prospective observational cohort study of parents of children 6 to 23 months old recruited from 3 medical center-affiliated clinics in New York City from November 1, 2011, through April 5, 2012. A total of 530 of 614 eligible participants (86.3%) were enrolled. Parents were texted on the night of vaccination (day 0) and the 7 subsequent nights (days 1-7) to report their child's temperature. We used log-binomial regression to calculate adjusted relative risks (aRRs) and excess risk for fever on days 0 to 1, adjusted for age group, past influenza vaccination and simultaneous receipt of selected inactivated vaccines.
EXPOSURES
Receipt of TIV and/or PCV13.
MAIN OUTCOME(S) AND MEASURE(S)
Temperature of 38°C or higher on days 0 to 1 after vaccination.
RESULTS
On days 0 to 1, children receiving TIV and PCV13 simultaneously had higher rates (37.6%) of fever (temperature ≥38°C) than those receiving TIV (7.5%; aRR, 2.69; 95% CI, 1.30-5.60) or PCV13 (9.5%; aRR, 2.67; 95% CI, 1.25-5.66). The excess risk of fever after TIV and PCV13 was 20 and 23 per 100 vaccinations compared with TIV without PCV13 and PCV13 without TIV, respectively. Fever rates for days 2 to 7 were similar across groups. For days 0 to 1, 74.8% of the text messages were confirmed delivered; for another 9.0%, delivery status was unknown. Response rates were 95.1% and 90.9% for days 0 and 1 for confirmed delivered messages, respectively.
CONCLUSIONS AND RELEVANCE
Simultaneous TIV and PCV13 administration was associated with higher transient increased fever risk than administration of either vaccine without the other product. Text messaging to prospectively assess a specific vaccine adverse event has potential for enhancing prelicensure and postlicensure monitoring of adverse events after immunization and deserves further study.
TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT01467934.
Topics: Female; Fever; Humans; Infant; Influenza Vaccines; Influenza, Human; Male; New York City; Pneumococcal Vaccines; Prospective Studies; Reaction Time; Risk Factors; Text Messaging; Treatment Outcome
PubMed: 24395025
DOI: 10.1001/jamapediatrics.2013.4469 -
Clinical Microbiology and Infection :... Oct 2002Pneumococcal disease is now the leading cause of vaccine-preventable bacterial disease in children worldwide. Although a pneumococcal polysaccharide vaccine has been... (Review)
Review
Pneumococcal disease is now the leading cause of vaccine-preventable bacterial disease in children worldwide. Although a pneumococcal polysaccharide vaccine has been available for over three decades, its use has been limited due to poor immunogenicity in the most vulnerable children, aged less than 2 years. The prevalence of pneumococcal disease worldwide and the alarming global escalation of multiresistant strains of Streptococcus pneumoniae (pneumococcus) during the past decade have provided the impetus for the development and application of a new pneumococcal vaccine. The outstanding success of Haemophilus influenzae type b (Hib) conjugate vaccine in the control of invasive Hib disease is a reason to be optimistic that the pneumococcal conjugate vaccines will achieve similar results for the control of invasive pneumococcal disease. Remarkable efficacy against invasive pneumococcal disease with a seven-valent pneumococcal conjugate vaccine was demonstrated in infants and toddlers in the USA, and in February 2000 the first pneumococcal conjugate vaccine was licensed. Licensure and widespread use is likely to follow in other countries in which there is a need and the means to afford this live-saving vaccine. Active disease surveillance must be sustained globally, while active research, development of other multivalent conjugate formulations and the search for new candidate protein-based vaccines are in progress.
Topics: Adolescent; Adult; Child; Child, Preschool; Drug Resistance, Bacterial; Humans; Middle Aged; Nasopharyngeal Diseases; Pneumococcal Infections; Pneumococcal Vaccines; Polysaccharides, Bacterial; Streptococcus pneumoniae; Treatment Outcome; Vaccines, Conjugate
PubMed: 12390280
DOI: 10.1046/j.1469-0691.2002.00424.x -
BMJ Open Dec 2023To determine the evidence for non-specific effects of the Pneumococcal and Haemophilus influenza vaccine in children aged 5 years and under.
OBJECTIVE
To determine the evidence for non-specific effects of the Pneumococcal and Haemophilus influenza vaccine in children aged 5 years and under.
DATA SOURCES
A key word literature search of MEDLINE, EMBASE, The Cochrane Central Register of Controlled Trials, the European Union Clinical Trials Register and ClinicalTrials.gov up to June 2023.
STUDY ELIGIBILITY CRITERIA
Randomised controlled trials (RCTs), quasi-RCT or cohort studies.
PARTICIPANTS
Children aged 5 or under.
STUDY APPRAISAL AND SYNTHESIS METHODS
Studies were independently screened by two reviewers, with a third where disagreement arose. Risk of bias assessment was performed by one reviewer and confirmed by a second. Results were tabulated and a narrative description performed.
RESULTS
Four articles were identified and included in this review. We found a reduction in hospitalisations from influenza A (44%), pulmonary tuberculosis (42%), metapneumovirus (45%), parainfluenza virus type 1-3 (44%), along with reductions in mortality associated with pneumococcal vaccine. No data on the Haemophilus vaccine was found.
CONCLUSIONS AND IMPLICATIONS
In this systematic review, we demonstrate that there is a reduction in particular viral infections in children aged 5 years and under who received the 9-valent pneumococcal conjugate vaccine which differ from those for which the vaccine was designed to protect against. While limited studies have demonstrated a reduction in infections other than those which the vaccine was designed to protect against, substantial clinical trials are required to solidify these findings.
PROSPERO REGISTRATION NUMBER
CRD42020146640.
Topics: Child; Humans; Haemophilus Vaccines; Pneumococcal Vaccines; Influenza, Human; Streptococcus pneumoniae; Cohort Studies
PubMed: 38101831
DOI: 10.1136/bmjopen-2023-077717 -
Journal of Internal Medicine Nov 2009Streptococcus pneumoniae is an important cause of morbidity and mortality worldwide. There are three established approaches to anti-pneumococcal vaccination: capsular... (Review)
Review
Streptococcus pneumoniae is an important cause of morbidity and mortality worldwide. There are three established approaches to anti-pneumococcal vaccination: capsular polysaccharide pneumococcal vaccine (PPV), protein-polysaccharide conjugate pneumococcal vaccine (CPV) and protein-based pneumococcal vaccine (PBPV). At present, only a 23-valent PPV for use in adults and a seven-valent CPV for use in infants are available in clinical practice. This study reviews available data on the efficacy of the available vaccines in different age groups and disease presentations, and the advantages and shortcomings of each type of vaccine, including future perspectives. Special attention is given to controversies regarding the efficacy of PPV against pneumonia in adults and its protective effects against myocardial infarction.
Topics: Adult; Aged; Aged, 80 and over; Child; Child, Preschool; Humans; Middle Aged; Myocardial Infarction; Pneumococcal Infections; Pneumococcal Vaccines; Vaccines, Conjugate
PubMed: 19754854
DOI: 10.1111/j.1365-2796.2009.02149.x -
Human Vaccines & Immunotherapeutics 2015Streptococcus pneumoniae is an important pathogen causing invasive diseases such as sepsis, meningitis, and pneumonia. Vaccines have become the most effective way to... (Randomized Controlled Trial)
Randomized Controlled Trial
Immunogenicity and safety of a 23-valent pneumococcal polysaccharide vaccine in Chinese healthy population aged >2 years: A randomized, double-blinded, active control, phase III trial.
Streptococcus pneumoniae is an important pathogen causing invasive diseases such as sepsis, meningitis, and pneumonia. Vaccines have become the most effective way to prevent pneumococcal infections. This phase III trial was designed to evaluate the immunogenicity and safety of a 23-valent pneumococcal polysaccharide vaccine in Chinese healthy population aged >2 years. We conducted a randomized, double-blinded, active-controlled, multicenter trial in which 1660 healthy population (>2 years of age) were randomly assigned in a 1 : 1 ratio to receive 2 intramuscular doses of either the treatment vaccine or the active control vaccine, PNEUMOVAX 23. The surveillance period was 30 days. The primary end point was the 2-fold increase rate of anti-pneumococcal antibody for all 23 included serotypes in each group. In the intention-to-treat cohort, the 2-fold increase rate of anti-pneumococcal antibody for 23 included serotypes varied from 62.47% to 97.01% in the treatment group, and from 51.49% to 95.77% in the control group. According to -10% non-inferiority margin and 95% confidence intervals of rate difference, almost all included serotypes of the treatment group reached non-inferiority to control group except for serotype 6B, the lower limit of rate difference of which was -10.00%, equal to the non-inferiority margin. The 2-fold increase rates of anti-pneumococcal antibody were significantly higher in the treatment group for serotype 2, 3, 4, 10A, 11A and 20. Furthermore, for all 23 serotypes, IgG geometric mean concentrations (GMCs) at day 30 were significantly higher in treatment group for serotype 2, 3, 4, 9 V, 10A, 11A, 15 B, 18C, 19 A, 22 F and 33 F. Higher geometric mean fold increase (GMFI) were also observed in the treatment group correspondingly. Serious adverse events occurred in 3 of 830 participants in the treatment group (0.36%) and 2 of 830 participants in the control group (0.24%). No death occurred during the trial. The frequencies of both solicited and unsolicited adverse events (AEs) were small lower in the treatment group (34.34% vs 35.66% for solicited AEs, 4.34% vs 5.42% for unsolicited AEs). Both vaccines were well tolerated and most AEs were mild or moderate in intensity. The newly vaccine was well tolerated and immunologically non-inferior to the active control vaccine PNEUMOVAX 23 for all 23 vaccine serotypes in the Chinese population (>2 years of age).
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antibodies, Bacterial; Asian People; Child; Child, Preschool; Double-Blind Method; Drug-Related Side Effects and Adverse Reactions; Female; Healthy Volunteers; Humans; Injections, Intramuscular; Male; Middle Aged; Pneumococcal Vaccines; Streptococcal Infections; Treatment Outcome; Young Adult
PubMed: 26083953
DOI: 10.1080/21645515.2015.1055429 -
Journal of the Formosan Medical... Jul 2006Pneumococcal infection causes high morbidity and mortality in children. Prevention of pneumococcal diseases by effective vaccination is an urgent need. This study...
BACKGROUND/PURPOSE
Pneumococcal infection causes high morbidity and mortality in children. Prevention of pneumococcal diseases by effective vaccination is an urgent need. This study evaluated the safety and immunogenicity of heptavalent pneumococcal conjugate (7VPnC) vaccine (serotypes 4, 6B, 9V, 14, 18C, 19F, 23F) booster dose administered at 15-20 months of age in Taiwanese toddlers.
METHODS
Fifty-eight healthy Taiwanese toddlers who were primed with three doses of the 7VPnC vaccine in infancy received a booster dose in an open-label, noncomparative trial. Routine oral polio vaccine and diphtheria toxoid, tetanus toxoid, and pertussis vaccine were administered concomitantly. Surveillance for safety was conducted after vaccination. Antibody concentration to each of the seven pneumococcal serotypes was measured before and 1 month after the booster dose.
RESULTS
Mild to moderate local reactions were common (45-50%). Fever, fussiness, restlessness, and loss of appetite were the most frequent systemic reactions (31-50%). Before the booster dose of vaccine, 68% (for serotype 18C) to 100% (for serotype 14) of subjects had antibody concentrations >or= 0.2 microg/mL to different pneumococcal serotypes. After the booster dose, the geometric mean concentration of IgG increased significantly (p < 0.001) for all seven serotypes indicating the induction of immunologic memories. Ninety-eight percent of the toddlers had antibody concentration >or= 0.2 microg/mL against all serotypes after the booster.
CONCLUSION
The 7VPnC vaccine containing the prevalent serotypes in Taiwan is safe and effective in boosting immunity against pneumococcal disease in Taiwanese children.
Topics: Antibodies, Bacterial; Female; Heptavalent Pneumococcal Conjugate Vaccine; Humans; Immunization, Secondary; Infant; Male; Meningococcal Vaccines; Pneumococcal Vaccines; Safety; Serotyping; Streptococcus pneumoniae
PubMed: 16877233
DOI: 10.1016/S0929-6646(09)60148-0 -
The Pediatric Infectious Disease Journal Jan 2014Pneumonia is the leading cause of morbidity and mortality among children <5 years of age globally. Pneumococcal conjugate vaccines (PCVs) are known to provide protection... (Review)
Review
BACKGROUND
Pneumonia is the leading cause of morbidity and mortality among children <5 years of age globally. Pneumococcal conjugate vaccines (PCVs) are known to provide protection against vaccine serotype pneumococcal pneumonia; uncertainty exists regarding the optimum PCV dosing schedule.
METHODS
We conducted a systematic review of studies published from 1994 to 2010 (supplemented post hoc with studies from 2011) documenting the effect of PCV dosing schedules on clinical and radiologically confirmed pneumonia, pneumococcal pneumonia and empyema among children of ages targeted to receive vaccine. Data on 2- and 3-dose schedules were included. Percent change of pneumonia incidence rates from baseline to most recent year post-PCV introduction was calculated.
RESULTS
We identified 42 primary citations that evaluated PCV schedules and pneumonia. Thirty-seven (88%) were from North America, Europe or Australia; 37 (88%) evaluated PCV7 and 1 (2%) PCV10. Two studies (both observational) compared multiple schedules within the study. We found evidence of reduced clinical and radiologically confirmed pneumonia incidence for all schedules, including 2+1 (1 nonrandomized trial, 5 observational studies), 3+0 (5 randomized trials, 2 observational studies) and 3+1 (5 clinical trials, 24 observational studies) schedules. The magnitude of disease impact did not differ among schedules. Evidence for impact on pneumococcal pneumonia and empyema varied.
CONCLUSIONS
All schedules (2+1, 3+0 and 3+1) reduced clinical and radiologically confirmed pneumonia. Quantifying differences in pneumonia disease impact between schedules was difficult due to heterogeneity among studies in design, case definition and population. These findings support World Health Organization recommendations for 3-dose schedules administered as either 3+0 or 2+1 regimens. Pneumonia impact data are still needed on expanded serotype PCV products, developing country settings and the role for a booster dose.
Topics: Child, Preschool; Heptavalent Pneumococcal Conjugate Vaccine; Humans; Immunization Schedule; Infant; Observational Studies as Topic; Pneumococcal Vaccines; Pneumonia, Pneumococcal; Randomized Controlled Trials as Topic; Vaccines, Conjugate
PubMed: 24336056
DOI: 10.1097/INF.0000000000000082 -
The Pediatric Infectious Disease Journal Jan 2014Pneumococcal conjugate vaccines (PCV) reduce nasopharyngeal carriage of vaccine type (VT) pneumococci, an important driver of vaccine programs' overall benefits. The... (Review)
Review
BACKGROUND
Pneumococcal conjugate vaccines (PCV) reduce nasopharyngeal carriage of vaccine type (VT) pneumococci, an important driver of vaccine programs' overall benefits. The dosing schedule that best reduces carriage is unclear.
METHODS
We performed a systematic review of English language publications from 1994 to 2010 (supplemented post hoc with studies from 2011) reporting PCV effects on VT carriage to assess variability in effect by dosing schedule.
RESULTS
We identified 32 relevant studies (36 citations) from 12,980 citations reviewed. Twenty-one (66%) evaluated PCV7; none used PCV10 or PCV13. Five studies evaluated 2 primary doses and 13 three primary doses. After the first year of life, 14 evaluated 3-dose primary series with PCV booster (3+1), seven 3 doses plus 23-valent polysaccharide booster "3+1PPV23," five "3+0," four "2+1," three "2+1PPV23" and two "2+0." Four studies directly compared schedules. From these, 3 primary doses reduced VT carriage more than 2 doses at 1-7 months following the series (1 study significant; 2 borderline). In a study, the 2+1 schedule reduced VT carriage more than 2+0 at 18, but not at 24 months of age. One study of a 23-valent pneumococcal polysaccharide vaccine booster showed no effect. All 16 clinical trials with unvaccinated controls and 11 observational studies with before-after designs showed reduction in VT carriage.
CONCLUSIONS
The available literature demonstrates VT-carriage reduction for 2+0, 2+1, 3+0 and 3+1 PCV schedules, but not for 23-valent pneumococcal polysaccharide vaccine booster. Comparisons between schedules show that 3 primary doses and a 2+1 schedule may reduce carriage more than 2 primary doses and a 2+0 schedule, respectively.
Topics: Carrier State; Heptavalent Pneumococcal Conjugate Vaccine; Humans; Immunization Schedule; Infant; Nasopharynx; Pneumococcal Infections; Pneumococcal Vaccines; Vaccines, Conjugate
PubMed: 24336057
DOI: 10.1097/INF.0000000000000083