scholarly journals Evaluation of the indirect impact of the 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine in a cluster-randomised trial

PLoS ONE ◽  
2022 ◽  
Vol 17 (1) ◽  
pp. e0261750
Author(s):  
Hanna Rinta-Kokko ◽  
Arto A. Palmu ◽  
Esa Ruokokoski ◽  
Heta Nieminen ◽  
Marta Moreira ◽  
...  
Keyword(s):  
Haemophilus Influenzae ◽  
Conjugate Vaccine ◽  
Invasive Pneumococcal Disease ◽  
Vaccination Coverage ◽  
Indirect Effects ◽  
Pneumococcal Disease ◽  
Incidence Rates ◽  
Cluster Randomised ◽  
Indirect Impact ◽  
Catch Up

Background In the nation-wide double-blind cluster-randomised Finnish Invasive Pneumococcal disease trial (FinIP, ClinicalTrials.gov NCT00861380, NCT00839254), we assessed the indirect impact of the 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against five pneumococcal disease syndromes. Methods Children 6 weeks to 18 months received PHiD-CV10 in 48 clusters or hepatitis B/A-vaccine as control in 24 clusters according to infant 3+1/2+1 or catch-up schedules in years 2009―2011. Outcome data were collected from national health registers and included laboratory-confirmed and clinically suspected invasive pneumococcal disease (IPD), hospital-diagnosed pneumonia, tympanostomy tube placements (TTP) and outpatient antimicrobial prescriptions. Incidence rates in the unvaccinated population in years 2010―2015 were compared between PHiD-CV10 and control clusters in age groups <5 and ≥5 years (5―7 years for TTP and outpatient antimicrobial prescriptions), and in infants <3 months. PHiD-CV10 was introduced into the Finnish National Vaccination Programme (PCV-NVP) for 3-month-old infants without catch-up in 9/2010. Results From 2/2009 to 10/2010, 45398 children were enrolled. Vaccination coverage varied from 29 to 61% in PHiD-CV10 clusters. We detected no clear differences in the incidence rates between the unvaccinated cohorts of the treatment arms, except in single years. For example, the rates of vaccine-type IPD, non-laboratory-confirmed IPD and empyema were lower in PHiD-CV10 clusters compared to control clusters in 2012, 2015 and 2011, respectively, in the age-group ≥5 years. Conclusions This is the first report from a clinical trial evaluating the indirect impact of a PCV against clinical outcomes in an unvaccinated population. We did not observe consistent indirect effects in the PHiD-CV10 clusters compared to the control clusters. We consider that the sub-optimal trial vaccination coverage did not allow the development of detectable indirect effects and that the supervening PCV-NVP significantly diminished the differences in PHiD-CV10 vaccination coverage between the treatment arms.

scholarly journals Changes in invasive pneumococcal disease among adults living with HIV following introduction of 13-valent pneumococcal conjugate vaccine, 2008–2014

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S57-S58
Author(s):  
Miwako Kobayashi ◽  
William Adih ◽  
Jianmin Li ◽  
Ryan Gierke ◽  
Olivia M Almendares ◽  
...  
Keyword(s):  
Conjugate Vaccine ◽  
Invasive Pneumococcal Disease ◽  
Indirect Effects ◽  
Pneumococcal Conjugate Vaccine ◽  
Pneumococcal Disease ◽  
Census Data ◽  
People Living With Hiv ◽  
Childhood Immunization ◽  
Increased Risk ◽  
Living With Hiv

Abstract Background People living with HIV (PLHIV) are at increased risk of invasive pneumococcal disease (IPD). Introduction of 13-valent pneumococcal conjugate vaccine (PCV13) in children in 2010 reduced adult IPD burden (indirect effects). In 2012, PCV13 was recommended in series with 23-valent polysaccharide vaccine (PPSV23) for adults with immunocompromising conditions, including PLHIV. We evaluated changes in IPD incidence in adults ≥19 years old with and without HIV after PCV13 introduction for children in 2010 and for immunocompromised adults in 2012. PCV13 coverage for adults 19–64 years old with indications was 6% in 2014. Methods IPD cases, defined as pneumococcal isolation from sterile sites, were identified through CDC’s Active Bacterial Core surveillance, with counts projected nationally. HIV status was obtained from medical records. Isolates were serotyped by Quellung reaction or PCR and grouped into PCV13-types, PPV11-types (unique to PPSV23), or non-vaccine types. We estimated IPD incidence (cases per 100,000 people) using national case-based HIV surveillance (for PLHIV) or US Census data (for non-PLHIV) as denominators. We compared IPD incidence in 2011–12 and 2013–14 to the pre-PCV13 baseline (2008–09) by serotype groups. Results Overall IPD incidence at baseline was 354.0 for PLHIV and 15.5 for non-PLHIV. From baseline to 2013–14, IPD rates declined in both PLHIV (-36.3%; 95% CI: -38.8, -33.7%) and non-PLHIV (-27.3%; 95% CI: -28.2, -26.5%). The largest reductions were noted in PCV13-type IPD in both PLHIV (Figure 1) and non-PLHIV (Figure 2) for both periods (-46.8% for PLHIV and -45.9% for non-PLHIV in 2011–12; -60.3% for PLHIV and -65.8% for non-PLHIV in 2013–14). Overall IPD rates were 22.8 (95% CI: 22.2, 23.4) times as high in PLHIV compared with non-PLHIV at baseline, and 19.4 (95% CI: 18.8, 20.0) times as high in 2013–2014. Conclusion IPD rates declined significantly in both PLHIV and non-PLHIV during the study period due to reductions in PCV13-type IPD; however, IPD rates remained 20-fold in PLHIV compared with non-PLHIV. Similar magnitude reductions in PCV13-type IPD in both groups and low PCV13 coverage in immunocompromised adults suggest that most of the observed decline is due to PCV13 indirect effects from childhood immunization. Disclosures L. Harrison, GSK: Scientific Advisor, Consulting fee; W. Schaffner, Pfizer: Scientific Advisor, Consulting fee; Merck: Scientific Advisor, Consulting fee; Novavax: Consultant, Consulting fee; Dynavax: Consultant, Consulting fee; Sanofi-pasteur: Consultant, Consulting fee; GSK: Consultant, Consulting fee; Seqirus: Consultant, Consulting fee

scholarly journals Effectiveness of the 13-Valent Pneumococcal Conjugate Vaccine on Invasive Pneumococcal Disease in Greenland

Vaccines ◽  
2021 ◽  
Vol 9 (10) ◽  
pp. 1123
Author(s):  
Kristiana Alexandrova Nikolova ◽  
Mikael Andersson ◽  
Hans-Christian Slotved ◽  
Anders Koch
Keyword(s):  
Incidence Rate ◽  
Conjugate Vaccine ◽  
Invasive Pneumococcal Disease ◽  
Pneumococcal Conjugate Vaccine ◽  
Pneumococcal Disease ◽  
The Elderly ◽  
Incidence Rates ◽  
National Registry ◽  
Childhood Vaccination ◽  
Vaccination Program

The 13-valent pneumococcal conjugate vaccine (PCV13) was introduced in 2010 to the childhood vaccination program in Greenland. This study aimed to estimate the effectiveness of the PCV13 on the incidence of invasive pneumococcal disease (IPD) in children and in adults in Greenland. IPD cases from the pre-PCV13 period (January 1995–September 2010) were compared with the post-PCV13 period (September 2010–October 2020). Register data were collected from laboratory records, IPD reports, the national registry on admissions, and medical files. A total of 295 IPD cases were identified in the study period. Overall IPD incidence rate (IR) declined from the pre-PCV13 period to the post-PCV13 period (IR 23.3 to 15.3 per 100,000 person years). Overall IPD incidence among children decreased significantly, whereas overall IPD incidence among the elderly increased significantly. During the post-PCV13 period, the incidence of vaccine serotype (VT) IPD decreased in all ages, while the incidence of non-vaccine serotype (NVT) IPD increased. This increase was most substantial among elderly ≥60 years. In conclusion, the PCV13 has reduced incidence rates of IPD in Greenland. However, the increase in NVT IPD among the elderly is noteworthy, and sup-ports continued surveillance of IPD in the population of Greenland.

scholarly journals 1299. Epidemiology of Invasive Pneumococcal Disease (IPD) in the United States 2011-2019

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S737-S738
Author(s):  
Ryan Gierke ◽  
Monica M Farley ◽  
William Schaffner ◽  
Ann Thomas ◽  
Art Reingold ◽  
...  
Keyword(s):  
Conjugate Vaccine ◽  
Invasive Pneumococcal Disease ◽  
Pneumococcal Conjugate Vaccine ◽  
Pneumococcal Disease ◽  
The United States ◽  
Census Bureau ◽  
Incidence Rates ◽  
The Past ◽  
Vaccine Type ◽  
In Series

Abstract Background Thirteen-valent pneumococcal conjugate vaccine (PCV13) was recommended for U.S. children aged &lt; 5 years in February 2010 and recommended in series with 23-valent pneumococcal polysaccharide vaccine (PPSV23) for adults aged ≥ 65 years in 2014. PCV13 has led to dramatic reductions in invasive pneumococcal disease (IPD) burden. New, higher valency PCVs (PCV15, PCV20) are expected to be licensed for adults in late 2021. We examined remaining PCV13-type IPD among children and adults and assessed IPD burden potentially preventable through PCV15 and PCV20 use. Methods IPD cases (isolation of pneumococcus from sterile sites) were identified through CDC’s Active Bacterial Core surveillance during 1998–2019. Isolates were serotyped by Quellung or whole genome sequencing. Incidence rates (cases/100,000) were calculated using U.S. Census Bureau population denominators. Results After introduction of PCV13 in children, by 2013–2014, PCV13-type IPD declined 89% (from 15 to 2 cases/100,000) in children age &lt; 5 years and 67% (from 19 to 7 cases/100,000) in adults age ≥ 65 years. During 2014–2019, rates of PCV13-type IPD in children and adults remained stable. In 2018–2019, among children age &lt; 5 years, serotypes 3, 19F, 19A, and 6C accounted for most of the remaining PCV13-type IPD (46%, 32%, 14% and 4% respectively) (Figure 1). Among adults age ≥ 65 years, serotypes 3, 6C, 19A, and 19F accounted for most of the remaining PCV13-type IPD (62%, 12%, 10%, and 9% respectively) (Figure 1). During 2015–2019, rates of PCV15 and PCV20-type IPD have remained stable. In 2018–2019, among adults age ≥ 65 years, PCV15 non-PCV13-type IPD rates were 3.6 cases per 100,000 and accounted for 15% of all IPD. PCV20 non-PCV13-type IPD rates were 6.8 cases per 100,000 and accounted for 29% of all IPD (Figure 2). Among children age &lt; 5 years, PCV15 non-PCV13-type IPD rates were 1.6 cases per 100,000 and accounted for 17% of all IPD. PCV20 non-PCV13-type IPD rates were 2.8 cases per 100,000 and accounted for 39% of all IPD (Figure 2). Figure 1. Incidence rates of IPD among children &lt; 5 years old, by pneumococcal conjugate vaccine type and individual PCV13 serotypes, 2011–2019 Figure 2. Incidence rates of IPD among adults ≥ 65 years old, by pneumococcal conjugate vaccine type and individual PCV13 serotypes, 2011–2019 Conclusion Following the dramatic reductions after PCV13 introduction, PCV13-type IPD has remained stable during the past five years. There are opportunities to prevent an additional 30% IPD burden among adults through new PCV use. Disclosures William Schaffner, MD, VBI Vaccines (Consultant) Lee Harrison, MD, GSK, Merck, Pfizer, Sanofi Pasteur (Consultant)

Long-term Impact of Pneumococcal Conjugate Vaccines on Invasive Disease and Pneumonia Hospitalizations in Indigenous and Non-Indigenous Australians

2019 ◽  
Vol 70 (12) ◽  
pp. 2607-2615
Author(s):  
Kelley N Meder ◽  
Sanjay Jayasinghe ◽  
Frank Beard ◽  
Aditi Dey ◽  
Martyn Kirk ◽  
...  
Keyword(s):  
Indigenous People ◽  
Conjugate Vaccine ◽  
Invasive Pneumococcal Disease ◽  
Pneumococcal Conjugate Vaccine ◽  
Pneumococcal Disease ◽  
Laboratory Data ◽  
Community Acquired Pneumonia ◽  
Indirect Impact ◽  
Long Term Impact

Abstract Background Universal pneumococcal conjugate vaccine (PCV) programs began in Indigenous Australian children in 2001 and all children in 2005, changing to 13-valent PCV (PCV13) in 2011. We used laboratory data for invasive pneumococcal disease (IPD) and coded hospitalizations for noninvasive pneumococcal community-acquired pneumonia (PnCAP) to evaluate long-term impact. Methods Annual incidence (per 100 000 population) was calculated for age-specific total IPD, PCV13 non–7-valent PCV (PCV7) serotypes, and PnCAP by Indigenous status. Incidence in the pre–universal PCV7 (2002–2004), early PCV7 (2005–2007), pre-PCV13 (2008 to mid-2011), and post-PCV13 (mid-2011 to 2016) periods was used to calculate incidence rate ratios (IRRs). Results In the total population, all-age incidence of IPD declined from 11.8 pre-PCV7 to 7.1 post-PCV13 (IRR, 0.61 [95% confidence interval {CI}, .59–.63]) but for PnCAP declined among ages &lt;1 year (IRR, 0.34 [95% CI, .25–.45]) and 1–4 years (IRR, 0.50 [95% CI, .43–.57]) but increased significantly among age ≥5 years (IRRs, 1.08–1.14). In Indigenous people, baseline PCV13 non-PCV7 IPD incidence was 3-fold higher, amplified by a serotype 1 epidemic in 2011. By 2015–2016, although incidence of IPD and PnCAP in children aged &lt;5 years decreased by 38%, neither decreased in people aged ≥5 years. Conclusions Fifteen years post-PCV and 5 years post-PCV13, direct and indirect impact on IPD and PnCAP differed by age and between Indigenous and non-Indigenous people, with potential implications for long-term PCV impact in comparable settings. Fifteen years after pneumococcal conjugate vaccine (PCV) introduction and 5 years post-PCV13, direct and indirect impact on invasive pneumococcal disease and pneumococcal community-acquired pneumonia differed by age and between Indigenous and non-Indigenous people, with potential implications for long-term PCV impact in comparable settings.

scholarly journals Direct and Indirect Impact of 13-valent Pneumococcal Conjugate Vaccine (PCV13) on Invasive Pneumococcal Disease (IPD) Among Children and Adults in the U.S.

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S66-S67 ◽  
Author(s):  
Tamara Pilishvili ◽  
Ryan Gierke ◽  
Monica Farley ◽  
William Schaffner ◽  
Ann Thomas ◽  
...  
Keyword(s):  
Invasive Pneumococcal Disease ◽  
Indirect Effects ◽  
Pneumococcal Disease ◽  
Age Groups ◽  
Polysaccharide Vaccine ◽  
Direct And Indirect Effects ◽  
Vaccine Type ◽  
Indirect Impact ◽  
In Series ◽  
The U.S

Abstract Background In February 2010, PCV13 was introduced for routine use among children aged &lt; 5 years. In June 2012, PCV13 was recommended for use in series with 23-valent polysaccharide vaccine (PPSV23) for adults ≥19 years with select medical conditions, and in August 2014, for all adults ≥65 years. We evaluated the direct and indirect effects of PCV13 6 years post-introduction on invasive pneumococcal disease (IPD). Methods IPD cases (isolation of pneumococcus from sterile sites) were identified among residents of Active Bacterial Core surveillance (ABCs) sites during July 2007–June 2016. Isolates were serotyped by Quellung, PCR, or whole genome sequencing and classified as PCV13 or non-vaccine type (NVT). Incidence changes were estimated as percent changes (one minus rate ratio) and 95% confidence intervals (95% CI) between pre-PCV13 (2007–2009) and two post-PCV13 periods (July 2014–June 2015 and July 2015–June 2016). Results ABCs identified 31,190 IPD cases between 2007 and 2015, with 2,750 cases among children &lt;5 years and 10,930 among those ≥65 years. During the two post-PCV13 periods, overall IPD rates were 33%-62% lower relative to 2007–2009 among all age groups, including &lt;5 years and ≥65 years (Figure). Significant reductions in PCV13-type IPD incidence were observed for all age groups during both post-PCV13 periods, with incidence 84% (q95% CI 78, 88%) and 68% (95% CI 63, 73%) lower in 2015–2016 among children &lt; 5 years and adults ≥65 years, respectively. PCV13-type IPD reductions were driven by serotypes 19A and 7F. IPD due to non-vaccine types also declined significantly among children &lt; 5 years (−27%, 95% CI –42, –9%) and adults ≥65 years (-24%, 95% CI –34, –14%). PCV13-type IPD incidence did not differ significantly between the two post-PCV13 periods. Conclusion IPD incidence declined among children and adults in the U.S. following PCV13 introduction among children. The lack of difference in PCV13 rates between 2014–2015 and 2015–2016 suggests no measurable early impact of PCV13 introduction among adults ≥65 years. To date, we found no evidence of significant replacement disease with non-PCV13 types. Further work is needed to explain reductions in non-vaccine type disease observed in the post-PCV13 era. Disclosures W. Schaffner, Pfizer: Scientific Advisor, Consulting fee; Merck: Scientific Advisor, Consulting fee; Novavax: Consultant, Consulting fee; Dynavax: Consultant, Consulting fee; Sanofi-pasteur: Consultant, Consulting fee; GSK: Consultant, Consulting fee; Seqirus: Consultant, Consulting fee; L. Harrison, GSK: Scientific Advisor, Consulting fee

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