Hanna Rinta‐Kokko

Finnish Institute for Health and Welfare

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Arto A. Palmu

Finnish Institute for Health and Welfare

J. Pekka Nuorti

Tampere University

Jukka Jokinen

Finnish Institute for Health and Welfare

Hanna Nohynek

Finnish Institute for Health and Welfare

Kari Auranen

University of Turku

Maija Toropainen

Finnish Institute for Health and Welfare

Dorota Borys

GlaxoSmithKline (Belgium)

Terhi Kilpi

Finnish Institute for Health and Welfare

Lode Schuerman

GlaxoSmithKline (Belgium)

Esa Ruokokoski

Finnish Institute for Health and Welfare

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Finnish Institute for Health and Welfare

National Institutes of Health

University of Helsinki

Institute for Molecular Medicine Finland

European Centre for Disease Prevention and Control

Instituto de Salud Carlos III

Tampere University

Public Health Institute

GlaxoSmithKline (Belgium)

Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública

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Colonisation endpoints in Streptococcus pneumoniae vaccine trials

Vaccine (2013)

Kari Auranen Hanna Rinta‐Kokko David Goldblatt Hanna Nohynek Katherine L. O’Brien

Colonisation

10.1016/j.vaccine.2013.08.061

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Citations (55)

Indirect Impact of Ten-valent Pneumococcal Conjugate Vaccine Program on Reducing Antimicrobial Use and Tympanostomy Tube Placements in Finland

The Pediatric Infectious Disease Journal (2020)

Arto A. Palmu Hanna Rinta‐Kokko Hanna Nohynek J. Pekka Nuorti

Background: Acute otitis media (AOM) is the most common reason for antimicrobial use, and tympanostomy tube placement (TTP) is the most common reason for surgery requiring general anesthesia in children. Ten-valent pneumococcal conjugate vaccine (PCV10) was introduced in Finland in 2010 for infants. We evaluated the indirect impact of PCV10 on these surrogate otitis outcomes in unvaccinated children. Methods: Using before-after design, unvaccinated children ineligible for National Vaccination Program (born January 2006 to May 2010) were followed-up during 2012–2016 (target cohort, age 1.5–7 years). The target cohort was compared with an age- and season-matched unvaccinated reference cohort (born January 2000 to May 2004) during 2006–2010. Antimicrobial purchase data were obtained from the Social Insurance Institution of Finland benefits register. We assessed the relative reduction by generalized Cox regression for outpatient purchases of antibiotics recommended for treatment of AOM in the Finnish guidelines. Data on all TTP procedures were obtained from national hospital discharge register and Social Insurance Institution benefits register. Results: The rate of outpatient purchases of antimicrobials recommended for AOM was 51 in the unvaccinated reference cohort and 44/100 person-years in the unvaccinated target cohort; relative rate reduction was 14.7% [95% confidence interval: 14.0–15.3] and absolute rate reduction 7/100 person-years. The rates of TTP in the reference and target cohorts were 1.66/100 and 1.61/100 person-years, respectively. The relative rate reduction was 3.6% (0.7–6.5). Conclusions: Antimicrobial use and TTP procedures reduced in unvaccinated children after PCV10 introduction in infants. These indirect effects contribute to the savings in health care resource use for otitis and may also help in combating antimicrobial resistance.

Pneumococcal Conjugate Vaccine

Rate ratio

Tympanostomy tube

10.1097/inf.0000000000002696

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Citations (4)

Clostridioides difficile infections, recurrences, and clinical outcomes in real-world settings from 2015 to 2019: The RECUR England study

International Journal of Infectious Diseases (2024)

Subrata Ghosh Ana Antunes Hanna Rinta‐Kokko Elena Chaparova Sarah Lay‐Flurrie

To estimate the epidemiological and clinical burden of Clostridioides difficile infections (CDIs) and recurrences (rCDIs) in England.

Clostridioides

10.1016/j.ijid.2024.01.002

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Estimating excess mortality and economic burden of Clostridioides difficile infections and recurrences during 2015-2019: The RECUR England study

International Journal of Infectious Diseases (2024)

Subrata Ghosh Ana Antunes Hanna Rinta‐Kokko Elena Chaparova Sarah Lay‐Flurrie

ObjectiveTo generate real-world evidence on all-cause mortality and economic burden of Clostridioides difficile infections (CDIs) and recurrences (rCDIs) in England.MethodsWe conducted a cohort study using retrospective data from Clinical Practice Research Datalink linked to Hospital Episode Statistics. Patients diagnosed with CDI in hospital and community settings during 2015–2018 were included and followed for ≥1year. All-cause mortality was described at 6-, 12-, and 24-months. Healthcare resource usage (HCRU) and associated costs were assessed at 12-months of follow-up. A cohort of non-CDI patients, matched by demographic and clinical characteristics including Charlson Comorbidity Index score, was used to assess excess mortality and incremental costs of HCRU.ResultsAll-cause mortality among CDI patients at 6-, 12-, and 24-months was 15.87%, 20.37%, and 27.03%, respectively. A higher proportion of rCDI patients died at any point during follow-up. Compared with matched non-CDI patients, excess mortality was highest at 6-months with 1.81 and 2.53 deaths per 100 patient-months among CDI and ≥1 rCDI patients. Hospitalisations were the main drivers of costs, with an incremental cost of £1,209.21 per CDI patient. HCRU and costs increased with rCDIs.ConclusionsCDI poses a substantial mortality and economic burden, further amplified by rCDIs.

Clostridioides

10.1016/j.ijid.2024.02.010

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Effectiveness of pneumococcal Haemophilus influenzae protein D conjugate vaccine against pneumonia in children: A cluster-randomised trial

Vaccine (2018)

Terhi Kilpi Janne J. Jokinen Taneli Puumalainen Heta Nieminen Esa Ruokokoski

Pneumococcal conjugate vaccines have potential to prevent significant proportion of childhood pneumonia. Finnish Invasive Pneumococcal disease vaccine trial was designed to assess the vaccine effectiveness (VE) of the 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against several outcomes. We now report results for pneumonia.In this nationwide, cluster-randomised, double-blind trial, children younger than 19 months received PHiD-CV10 in 52 clusters or hepatitis vaccines as control in 26 clusters. Infants younger than 7 months at the first vaccination received either 3+1 or 2+1 vaccination schedule, children aged 7-11 months received 2+1, and those 12-18 months of age two-dose schedule. All hospitalizations and outpatient visits to hospital associated with ICD-10 codes compatible with pneumonia were identified through the National Care Register and 1-3 frontal chest X-ray images per event were collected. External readers who were unaware of the patients' vaccination status retrospectively interpreted the images. The evaluated outcomes were hospital-diagnosed, hospital-treated pneumonia as primary diagnosis, and radiologically confirmed pneumonia during the blinded, intention-to-treat follow-up period from the first vaccination to the end of 2011. Total VE was calculated as 1 minus rate ratio of all pneumonia episodes.47 366 children were enrolled from February 2009, to October 2010. VE against all episodes of hospital-diagnosed pneumonia was 27% (95% confidence interval [CI]: 14%, 38%), 32% (95% CI: 3%, 52%), and 23% (95% CI: -5%, 44%) in subjects enrolled at age <7, 7-11, and 12-18 months, respectively. Corresponding rate reductions were 3.4, 4.7, and 2.5 per 1000 person-years. VE estimates against pneumonia with alveolar consolidation or pleural effusion (WHO criteria) in the three cohorts were 45% (95% CI: 26%, 60%), 56% (95% CI: 14%, 77%), and 48% (95% CI: 2%, 73%), respectively.PHiD-CV10 vaccination remarkably reduced disease burden due to pneumonia in infants and young children.Main trial NCT00861380, nested carriage and otitis media trial NCT00839254 (ClinicalTrials.gov).

Pneumococcal Conjugate Vaccine

Conjugate

10.1016/j.vaccine.2018.08.020

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Impact and effectiveness of a conjugate vaccine against invasive pneumococcal disease in Finland - a modelling approach

Human Vaccines & Immunotherapeutics (2020)

Hanna Rinta‐Kokko Markku Nurhonen Kari Auranen

The evaluation of the public health impact of a vaccination program is essential in monitoring its policy relevance. Vaccine impact (VI) is usually assessed in a before-after design, in which data on disease burden without vaccination program is required from a historical reference period. It takes into account the indirect effects and therefore aims to describe the public health performance of the vaccination program in the population. Vaccine effectiveness (VE), measured in parallel settings, quantifies the benefit for an individual of being vaccinated but does not address the indirect effects of a vaccination program. The motivation of this paper is to gain insight into patterns of how VI and VE have manifested under large-scale use of a ten-valent pneumococcal conjugate vaccine in Finnish children. We construct a simple pseudo-dynamic model that mimics typical post-vaccination trends in the incidences of pneumococcal carriage and invasive disease in children when the proportion of vaccine-type carriage decreases. In the context of the model, we define the parameters of interest for VI and VE and explore how their expected values evolve over time. For comparison, we demonstrate the application of VI and VE estimation by using register data.

Pneumococcal Conjugate Vaccine

Carriage

10.1080/21645515.2020.1836918

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Citations (2)

Effectiveness of the 10-valent pneumococcal conjugate vaccine among girls, boys, preterm and low-birth-weight infants – Results from a randomized, double-blind vaccine trial

Vaccine (2019)

Heta Nieminen Hanna Rinta‐Kokko Janne J. Jokinen Taneli Puumalainen Marta Moreira

Several studies have shown differences in susceptibility to infections and immune response to vaccines by sex. Prematurely born infants are at higher risk for pneumococcal diseases, with lower effectiveness for some vaccines compared to term infants. We have reported the effectiveness of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) on several endpoints in the Finnish Invasive Pneumococcal disease (FinIP) vaccine trial. Now, we present the results of a post-hoc analysis evaluating PHiD-CV10 effectiveness in subgroups by sex, gestational age, and birth weight. The FinIP trial was a phase III/IV cluster-randomized, double-blind trial. Infants enrolled < 7 months of age received PHiD-CV10 in two thirds of clusters (3 + 1 or 2 + 1 schedule) and hepatitis B vaccine as control in remaining third. Outcome data included invasive pneumococcal disease, pneumonia, tympanostomy tube placements, and antimicrobial purchases collected through national, routinely used health registers. Negative binomial model was used in the incidence and vaccine effectiveness estimation, and differences in incidences between subgroups were tested among control children. Of the 30,527 infants enrolled 51% were boys. The incidences of hospital-diagnosed pneumonia and otitis-related outcomes were higher among boys in control groups. There were no significant sex differences in the vaccine effectiveness estimates. Altogether, 1519 (5%) infants were born before 37th gestational week. The incidences of pneumonia outcomes were higher among premature infants when compared to term infants. The vaccine effectiveness estimates among preterm infants were not statistically significant except for antimicrobial purchases, but all point estimates were at the same level among preterm infants as among term infants. There was no significant difference between 2 + 1 and 3 + 1 schedules in any of the subgroups analysed. PHiD-CV10 had a similar effectiveness in both sexes, and seemed to be protective in preterm infants. Trial registration: ClinicalTrials.gov NCT00861380 and NCT00839254

Pneumococcal Conjugate Vaccine

10.1016/j.vaccine.2019.05.033

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Citations (10)

Effectiveness of 10-valent pneumococcal conjugate vaccine estimated with three parallel study designs among vaccine-eligible children in Finland

Vaccine (2019)

Hanna Rinta‐Kokko Kari Auranen Maija Toropainen J. Pekka Nuorti Hanna Nohynek

Pneumococcal Conjugate Vaccine

10.1016/j.vaccine.2019.11.049

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Citations (11)

Estimating Strain‐Specific and Overall Efficacy of Polyvalent Vaccines Against Recurrent Pathogens From a Cross‐Sectional Study

Biometrics (2013)

Kari Auranen Hanna Rinta‐Kokko M. Elizabeth Halloran

Summary Evaluating vaccine efficacy for protection against colonization with bacterial pathogens is an area of growing interest. Colonization of the nasopharynx is an asymptomatic carrier state responsible for person‐to‐person transmission. It differs from most clinical outcomes in that it is common, recurrent, and observed only in its prevalent state. To estimate rates of acquisition and clearance of colonization requires repeated active sampling of the same individuals over time, an expensive and invasive undertaking. Motivated by feasibility constraints in efficacy trials with colonization endpoints, investigators have been estimating vaccine efficacy from cross‐sectional studies without principled methods. We present two examples of vaccine studies estimating vaccine efficacy from cross‐sectional data on nasopharyngeal colonization by Streptococcus pneumoniae (pneumococcus). This study presents a framework for defining and estimating strain‐specific and overall vaccine efficacy for susceptibility to acquisition of colonization ( ) when there is a large number of strains with mutual interactions and recurrent dynamics of colonization. We develop estimators based on one observation of the current status per study subject, evaluate their robustness, and re‐analyze the two vaccine trials. Methodologically, the proposed estimators are closely related to case–control studies with prevalent cases, with appropriate consideration of the at‐risk time in choosing the controls.

Vaccine efficacy

10.1111/j.1541-0420.2012.01826.x

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Citations (18)

Effectiveness of the 10-valent pneumococcal conjugate vaccine among girls, boys, preterm and low-birth-weight infants - Results from a randomized, double-blind vaccine trial

WOS (2019)

Heta Nieminen Hanna Rinta‐Kokko Janne J. Jokinen Taneli Puumalainen Marta Moreira

Abstract Background Several studies have shown differences in susceptibility to infections and immune response to vaccines by sex. Prematurely born infants are at higher risk for pneumococcal diseases, with lower effectiveness for some vaccines compared to term infants. We have reported the effectiveness of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) on several endpoints in the Finnish Invasive Pneumococcal disease (FinIP) vaccine trial. Now, we present the results of a post-hoc analysis evaluating PHiD-CV10 effectiveness in subgroups by sex, gestational age, and birth weight. Methods The FinIP trial was a phase III/IV cluster-randomized, double-blind trial. Infants enrolled  Results Of the 30,527 infants enrolled 51% were boys. The incidences of hospital-diagnosed pneumonia and otitis-related outcomes were higher among boys in control groups. There were no significant sex differences in the vaccine effectiveness estimates. Altogether, 1519 (5%) infants were born before 37th gestational week. The incidences of pneumonia outcomes were higher among premature infants when compared to term infants. The vaccine effectiveness estimates among preterm infants were not statistically significant except for antimicrobial purchases, but all point estimates were at the same level among preterm infants as among term infants. There was no significant difference between 2 + 1 and 3 + 1 schedules in any of the subgroups analysed. Conclusion PHiD-CV10 had a similar effectiveness in both sexes, and seemed to be protective in preterm infants. Trial registration: ClinicalTrials.gov NCT00861380 and NCT00839254

Pneumococcal Conjugate Vaccine

Premature birth

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