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Vaccine Aug 2016Invasive pneumococcal disease (IPD) and pneumonia are major causes of morbidity, especially in developing countries. While pneumococcal disease rates differences between... (Review)
Review
BACKGROUND
Invasive pneumococcal disease (IPD) and pneumonia are major causes of morbidity, especially in developing countries. While pneumococcal disease rates differences between various populations are well known, data are scarce regarding disparities in PCV impact on pneumococcal disease rates between populations living in the same country.
OBJECTIVE
The aim of this systematic literature review was to describe disparities in PCV impact between different populations.
METHODS
A systematic literature search was performed using the PubMed database. Studies evaluating pneumococcal disease rates at any age were included. The search was limited to articles written in English and published between 2000 and 2015. Independent extraction of articles was performed by two authors (NS, SB-S). Search terms included: pneumococcus, pneumococcal disease, IPD, pneumonia, PCV, pneumococcal vaccine, population, race, ethnicity, differences, and disparity. We defined resource-poor populations as African-Americans, Aboriginal, Alaska natives and Navajo native-Americans populations compared with the respective resource-rich populations, including White, non-Aboriginal, non-Alaska natives and general US population.
RESULTS
Eighteen articles meeting the selection criteria were identified; 17 regarding IPD and one regarding pneumonia. Nine articles compared IPD rates in African-Americans and Whites in the US, six compared Aboriginal and non-Aboriginal populations; two compared Alaska natives vs. non-native Alaskans in the US and one article compared Navajo native-Americans and general population in the US. Only minor difference where usually noted in the incidence rate ratios (IRRs) comparing pre- and post-PCV rates of IPD and pneumonia between resource rich and resource poor populations. In contrast, absolute rate reductions were higher in resource-poor compared with resource-rich populations.
CONCLUSION
While differences in IPD and pneumonia rates between resource-poor and resource-rich populations were decreased following PCV introduction, disparity is still apparent and is not fully eliminated in any of the studies. Younger (<2years) populations in resource-poor populations seem to benefit the most from PCV introduction.
Topics: Ethnicity; Healthcare Disparities; Humans; Incidence; Pneumococcal Infections; Pneumococcal Vaccines; Poverty; Vaccination
PubMed: 27443591
DOI: 10.1016/j.vaccine.2016.07.004 -
Vaccine Sep 2021Introduction of pneumococcal conjugate vaccines (PCVs), including the 13-valent PCV (PCV13), has considerably reduced pneumococcal disease burden. However, additional... (Randomized Controlled Trial)
Randomized Controlled Trial
A phase 3, randomized, double-blind study to evaluate the immunogenicity and safety of 3 lots of 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults 18 through 49 years of age.
INTRODUCTION
Introduction of pneumococcal conjugate vaccines (PCVs), including the 13-valent PCV (PCV13), has considerably reduced pneumococcal disease burden. However, additional serotypes not in PCV13 continue to present a substantial disease burden. The 20-valent PCV (PCV20) was developed to expand protection against pneumococcal disease beyond PCV13. As part of the phase 3 clinical development program, the current study assessed consistency of immune responses across 3 lots of PCV20 and described the safety profile of PCV20.
METHODS
This phase 3, randomized, multicenter, double-blind study of pneumococcal vaccine-naive adults 18-49 years of age randomized 1710 participants in a 2:2:2:1 ratio to receive 1 of 3 lots of PCV20 or PCV13. Immunogenicity was assessed through serotype-specific opsonophagocytic activity (OPA) titers before and approximately 1 month (28-42 days) after vaccination. Reported local reactions within 10 days, systemic events within 7 days, adverse events (AEs) within 30 days, and serious AEs (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination were evaluated.
RESULTS
Equivalence in immune responses (OPA geometric mean titers) for all 20 vaccine serotypes was demonstrated across the 3 PCV20 lots. Robust responses, assessed by OPA geometric mean fold rises, percentage of participants achieving ≥4-fold rises, and percentage of participants with OPA titers ≥lower limit of quantitation, were observed after PCV20. Reported rates of local reactions, systemic events, and AEs were similar between the pooled PCV20 lots and PCV13; most events were mild or moderate. Reported rates of SAEs and NDCMCs were low and similar between the PCV20 and PCV13 groups.
CONCLUSIONS
Three different lots of PCV20 demonstrated robust and consistent immunogenicity. The safety and tolerability of PCV20 was acceptable and similar to that of PCV13. (Clinicaltrials.gov: NCT03828617).
Topics: Adolescent; Adult; Antibodies, Bacterial; Double-Blind Method; Humans; Middle Aged; Pneumococcal Infections; Pneumococcal Vaccines; Vaccines, Conjugate; Young Adult
PubMed: 34315611
DOI: 10.1016/j.vaccine.2021.07.004 -
The Pediatric Infectious Disease Journal Aug 2019Finnish studies have shown a significant impact of 10-valent pneumococcal conjugate vaccine (PCV10) on nonnotified clinically suspected invasive pneumococcal disease...
BACKGROUND
Finnish studies have shown a significant impact of 10-valent pneumococcal conjugate vaccine (PCV10) on nonnotified clinically suspected invasive pneumococcal disease (IPD). We used a similar vaccine probe design to estimate PCV7 and PCV13 impact in Australian children.
METHODS
Season and age-matched pre-PCV7 cohorts (born in 2002-2004) were compared with PCV7-early and PCV7-late, and PCV13-eligible cohorts. Using linked notification and hospitalization data, we calculated relative rate reductions (RRRs) and absolute rate reductions (ARRs) for notified IPD, and nonnotified clinically suspected IPD or unspecified sepsis (first hospitalization with an International Classification of Diseases 10th Revision-Australian Modification code: A40.3/G00.1/M00.1 or A40.9/A41.9/A49.9/G00/I30.1/M00, respectively).
RESULTS
Significant reductions in all outcomes were observed comparing PCV7-early and PCV7-late and PCV13-eligible to pre-PCV7 cohorts. RRRs were high for both notified and nonnotified clinically suspected IPD (range 71%-91%), but ARRs were lower for nonnotified (5-6/100,000 person-years) than for notified cases (59-70/100,000 person-years). RRRs for the combined outcome of nonnotified clinically suspected IPD or unspecified sepsis were lower at 21%-24% for PCV7-eligible cohorts and 36% for the PCV13-eligible cohort, but ARRs were considerable due to the high pre-PCV7 rates (ARR 37-31/100,000 person-years for PCV7-early and PCV7-late cohorts and 54/100,000 person-years for PCV13).
CONCLUSIONS
This study provides a quantitative estimate of the total burden of IPD preventable by PCV7 and PCV13 vaccination programs in Australia. ARRs (compared with prevaccination) were significant but smaller than in Finland (122/100,000 for the combined outcome) and longer-term follow-up is required to determine the additional impact of PCV13 above that seen for PCV7. Country-specific studies are needed to accurately estimate the burden of pneumococcal disease preventable by vaccination and cost-effectiveness of PCV vaccination programs.
Topics: Age Factors; Australia; Child; Child, Preschool; Female; Heptavalent Pneumococcal Conjugate Vaccine; Humans; Immunization Programs; Incidence; Male; Pneumococcal Infections; Pneumococcal Vaccines; Population Surveillance; Retrospective Studies; Vaccination; Vaccines, Conjugate
PubMed: 30985507
DOI: 10.1097/INF.0000000000002314 -
Vaccine Oct 2019Serotype 3 pneumococcal disease has not substantially declined at the population level after the routine introduction of 13-valent pneumococcal conjugate vaccine (PCV13)...
BACKGROUND
Serotype 3 pneumococcal disease has not substantially declined at the population level after the routine introduction of 13-valent pneumococcal conjugate vaccine (PCV13) into pediatric immunization programs across the globe. This epidemiological finding has generated debate regarding the effectiveness of PCV13 against serotype 3 disease. Evaluating PCV13 effectiveness against serotype 3 is especially critical in adults, where serotype 3 makes up an important amount of remaining pneumococcal disease.
METHODS
We performed a systematic review of the published literature to assess the direct effectiveness of PCV13 against serotype 3 community-acquired pneumonia (CAP) among adults. We then estimated overall vaccine effectiveness (VE) using a pooled analysis of the individual-level, raw data.
RESULTS
Two published studies met inclusion criteria. One was a randomized controlled trial conducted in the Netherlands and published in 2014. The other was a recently-published case-control study conducted in Louisville, Kentucky that used a test-negative design (TND). We also identified a third TND study conducted in Argentina that was recently presented as a conference abstract but is not yet published. All three studies were conducted in adults aged ≥65 years. PCV13 VE against serotype 3 hospitalized CAP was 52.5% (95%CI: 6.2-75.9%) from the pooled analysis of individual-level data from all three studies. Results were similar if the unpublished estimate was excluded (serotype 3 VE = 53.6% [95%CI: 6.7-76.9%]). No heterogeneity was observed.
CONCLUSIONS
Currently-available evidence, although limited to three studies, suggests that PCV13 provides direct protection against serotype 3 hospitalized CAP in adults aged ≥65 years.
Topics: Adult; Argentina; Case-Control Studies; Humans; Kentucky; Netherlands; Pneumococcal Infections; Pneumococcal Vaccines; Pneumonia, Pneumococcal; Randomized Controlled Trials as Topic; Research Design; Serogroup; Streptococcus pneumoniae; Vaccine Potency; Vaccines, Conjugate
PubMed: 31522807
DOI: 10.1016/j.vaccine.2019.08.059 -
Expert Review of Vaccines Mar 2020: Pneumococcal diseases (including pneumonia, meningitis and sepsis) are among the leading vaccine-preventable causes of death in under-5-year-olds. Pneumococci are also... (Review)
Review
: Pneumococcal diseases (including pneumonia, meningitis and sepsis) are among the leading vaccine-preventable causes of death in under-5-year-olds. Pneumococci are also one of the main bacterial pathogens associated with acute otitis media (AOM). Infant immunization programs with pneumococcal conjugate vaccines (PCVs) have led to stark reductions in pneumococcal disease rates.: We summarized the development of the pneumococcal non-typeable protein D-conjugate vaccine (PHiD-CV) and evidence of its protective effect in children, since its licensure one decade ago. We highlighted the most recent data from post-licensure studies on invasive pneumococcal disease (IPD), pneumonia and AOM and from health economic evaluations. We present results from a model estimating PHiD-CV's impact on pneumococcal-related deaths.: Recent data from post-licensure studies confirm the previously demonstrated positive impact of PHiD-CV on IPD, pneumonia, AOM and AOM-related interventions (e.g., antibiotic use). Despite the success of infant PHiD-CV (and other PCV) programs, pneumococcal diseases still pose a substantial public health burden. Further reducing this burden will require improving access to currently available PCVs, increasing vaccination coverage and addressing the remaining burden due to non-vaccine serotypes. Future availability of lower-cost PCVs, PCVs with a broader serotype coverage and serotype-independent vaccines may contribute to this.
Topics: Child, Preschool; Humans; Infant; Otitis Media; Pneumococcal Infections; Pneumococcal Vaccines; Vaccination; Vaccination Coverage; Vaccines, Conjugate
PubMed: 32195602
DOI: 10.1080/14760584.2020.1738226 -
Vaccine May 2024The current recommendation for the elderly is to receive both a single dose 23-valent pneumococcal polysaccharide vaccine (PPSV-23) and an annual inactivated influenza...
BACKGROUND
The current recommendation for the elderly is to receive both a single dose 23-valent pneumococcal polysaccharide vaccine (PPSV-23) and an annual inactivated influenza vaccine. There is a lack of post-marketing safety studies on concomitant vaccination using real-world data. We aimed to evaluate the safety of administering PPSV-23 and influenza vaccine concomitantly versus sequentially.
METHODS
We performed a retrospective cohort study using a linked database that combines vaccination registry from the Korea Disease Control and Prevention Agency and claims data from the National Health Insurance Service. The study population included all those aged over 65 who received PPSV-23 at least once from Jan 1, 2016, to Dec 31, 2020. This study evaluated the 16 prespecified events of interest. Concomitant vaccination was defined as receiving both PPSV-23 and influenza vaccine on the same day. For sequential vaccination, we defined it as receiving influenza vaccination during the period from 30 to 365 days prior to the date of PPSV-23 injection. We performed 1:4 propensity score matching and estimated adjusted incidence rate ratio (aIRR) with a 95 % confidence interval (CI) using conditional Poisson regression.
RESULTS
Of the 2,885,144 elderly patients who received PPSV-23 vaccination at least once from Jan 1, 2016, to Dec 31, 2020, a total 87,899 were included in the concomitant vaccination group and 1,200,091 were included in the sequential vaccination group. After adjusting for confounders, the concomitant group exhibited a significantly lower risk of allergic reactions (aIRR: 0.71, 95 % CI: 0.58-0.87), neuritis (aIRR: 0.72, 95 % CI: 0.57-0.91), and pneumonia (aIRR: 0.85, 95 % CI: 0.80-0.90), while demonstrating significantly higher risks of paralysis (aIRR: 1.63, 95 % CI: 1.05-2.52) compared to the sequential group.
CONCLUSIONS
Concomitant administration of PPSV-23 and influenza vaccine in the elderly was not associated with a higher risk of most prespecified adverse events (AEs) compared to sequential vaccination. This study supports the safety of concomitant administration of PPSV-23 and influenza vaccine.
Topics: Humans; Influenza Vaccines; Pneumococcal Vaccines; Female; Aged; Male; Retrospective Studies; Aged, 80 and over; Influenza, Human; Republic of Korea; Vaccination; Pneumococcal Infections
PubMed: 38641496
DOI: 10.1016/j.vaccine.2024.03.078 -
Vaccine Jul 2022Children with cochlear implants are at increased risk of invasive pneumococcal disease, with national and international guidelines recommending additional pneumococcal...
Children with cochlear implants are at increased risk of invasive pneumococcal disease, with national and international guidelines recommending additional pneumococcal vaccines for these children. This study aimed to examine the pneumococcal immunization status and rate of invasive pneumococcal disease in children with cochlear implants at a tertiary paediatric hospital over a 12-year period. Additionally, the impacts of vaccination reminders and a dedicated immunization clinic on pneumococcal vaccination rates were assessed. This quality improvement study included 200 children who had received a cochlear implant through the Children's Hearing Implant Program at a tertiary paediatric hospital servicing the state of Western Australia. The majority of children (88%) were not up to date with additionally recommended pneumococcal vaccinations. Over the 12-year study period, 2% of children developed invasive pneumococcal disease associated with cochlear implant infections. Generic and personalized electronic immunization reminders improved pneumococcal vaccine up-take in this paediatric cochlear implant setting from 12% (19/153) at baseline to 49% (75/153, p < 0.0001) post implementation. The value of a nurse-led dedicated immunization clinic was also demonstrated with all children (42/42, 100%) up to date with Prevenar13 and the majority (34/42, 81%) up to date with Pneumovax23 post initiation of this referral pathway. These data support the expansion of this model to other medically-at-risk paediatric groups that have been highlighted consistently to be under-vaccinated.
Topics: Child; Cochlear Implantation; Cochlear Implants; Humans; Pneumococcal Infections; Pneumococcal Vaccines; Quality Improvement; Vaccination
PubMed: 35718588
DOI: 10.1016/j.vaccine.2022.06.022 -
Expert Review of Vaccines Feb 2017Safety and reactogenicity data were reviewed following 10 years of experience with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate... (Review)
Review
Safety and reactogenicity data were reviewed following 10 years of experience with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in clinical development and from post-licensure settings. Analyses of pooled clinical trial data and post-marketing reports provided an overview of its safety profile and allowed assessment of rare adverse events that might not have been identified previously. The safety of PHiD-CV was also evaluated in children at higher risk for pneumococcal infection (preterm and HIV-infected or HIV-exposed infants), for different vaccination schedules and co-administered pediatric vaccines, and with a focus on special categories of adverse events (febrile convulsions, apnea, Kawasaki disease and sudden deaths). Following the distribution of over 235 million doses, PHiD-CV has been well tolerated when co-administered with other pediatric vaccines to children aged less than 5 years from diverse ethnic and geographic backgrounds. Detailed examination of various aspects has confirmed its favorable benefit: risk profile.
Topics: Clinical Trials as Topic; Drug-Related Side Effects and Adverse Reactions; Haemophilus Infections; Humans; Pneumococcal Infections; Pneumococcal Vaccines; Product Surveillance, Postmarketing; Retrospective Studies
PubMed: 26954689
DOI: 10.1586/14760584.2016.1164044 -
Vaccine Aug 2017We conducted a case-control study to elucidate associations between pneumonia in elderly individuals and 23-valent pneumococcal polysaccharide vaccine (PPSV23) and...
Effectiveness of 23-valent pneumococcal polysaccharide vaccine and seasonal influenza vaccine for pneumonia among the elderly - Selection of controls in a case-control study.
We conducted a case-control study to elucidate associations between pneumonia in elderly individuals and 23-valent pneumococcal polysaccharide vaccine (PPSV23) and seasonal influenza vaccine (influenza vaccine). Here, we examined selection of controls in our study using an analytic epidemiology approach. The study period was from October 1, 2009 through September 30, 2014. Cases comprised ≥65-year-old patients newly diagnosed with pneumonia. For every case with pneumonia, two patients with other diseases (one respiratory medicine, one non-respiratory medicine) who were sex-, age-, visit date- and visit hospital-matched were selected as controls. Odds ratios (ORs) and 95% confidence intervals (CIs) of vaccination for pneumonia were calculated using conditional logistic regression model. Similar analyses were also conducted based on the clinical department of controls. Analysis was conducted in 234 cases and 438 controls. Effectiveness of pneumococcal vaccination or influenza vaccination against pneumonia was not detected. Proportions of either vaccination in controls were greater among respiratory medicine (pneumococcal vaccine, 38%; influenza vaccine, 55%) than among non-respiratory medicine (23%; 48%). Analysis using controls restricted to respiratory medicine showed marginally significant effectiveness of pneumococcal vaccination (OR, 0.59; 95%CI, 0.34-1.03; P=0.064) and influenza vaccination (0.64; 0.40-1.04; 0.072). However, this effectiveness might have been overestimated by selection bias of controls, as pneumonia cases are not necessarily respiratory medicine patients. In the analysis using controls restricted to non-respiratory medicine, OR of pneumococcal vaccination for pneumonia was close to 1, presumably because the proportion of pneumococcal vaccination was higher in cases than in controls. Because pneumococcal vaccine was not routinely administered during the study period, differences in recommendations of vaccination by physician in different clinical departments might have greatly affected vaccination proportions. When we select controls, we should consider the background factors (underlying diseases, clinical department, etc.) which affect physicians' recommendation of vaccination.
Topics: Aged; Aged, 80 and over; Case-Control Studies; Control Groups; Female; Hospitalization; Humans; Influenza Vaccines; Male; Odds Ratio; Pneumococcal Vaccines; Pneumonia, Pneumococcal; Pneumonia, Viral; Research Subjects; Seasons; Vaccination; Vaccine Potency
PubMed: 28818473
DOI: 10.1016/j.vaccine.2017.07.005 -
Biometrics Mar 2024To infer the treatment effect for a single treated unit using panel data, synthetic control (SC) methods construct a linear combination of control units' outcomes that...
To infer the treatment effect for a single treated unit using panel data, synthetic control (SC) methods construct a linear combination of control units' outcomes that mimics the treated unit's pre-treatment outcome trajectory. This linear combination is subsequently used to impute the counterfactual outcomes of the treated unit had it not been treated in the post-treatment period, and used to estimate the treatment effect. Existing SC methods rely on correctly modeling certain aspects of the counterfactual outcome generating mechanism and may require near-perfect matching of the pre-treatment trajectory. Inspired by proximal causal inference, we obtain two novel nonparametric identifying formulas for the average treatment effect for the treated unit: one is based on weighting, and the other combines models for the counterfactual outcome and the weighting function. We introduce the concept of covariate shift to SCs to obtain these identification results conditional on the treatment assignment. We also develop two treatment effect estimators based on these two formulas and generalized method of moments. One new estimator is doubly robust: it is consistent and asymptotically normal if at least one of the outcome and weighting models is correctly specified. We demonstrate the performance of the methods via simulations and apply them to evaluate the effectiveness of a pneumococcal conjugate vaccine on the risk of all-cause pneumonia in Brazil.
Topics: Humans; Models, Statistical; Pneumococcal Vaccines; Computer Simulation; Treatment Outcome; Biometry; Data Interpretation, Statistical
PubMed: 38819307
DOI: 10.1093/biomtc/ujae055