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Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against invasive pneumococcal disease: A cluster randomised trial

Department of Vaccination and Immune Protection, National Institute for Health and Welfare, Tampere, Finland. Electronic address: .
The Lancet (Impact Factor: 45.22). 11/2012; 381(9862). DOI: 10.1016/S0140-6736(12)61854-6
Source: PubMed

ABSTRACT Vaccine effectiveness of pneumococcal conjugate vaccines against culture-confirmed invasive pneumococcal disease has been well documented. In the Finnish Invasive Pneumococcal disease (FinIP) trial, we reported vaccine effectiveness and absolute rate reduction against laboratory-confirmed invasive pneumococcal disease (confirmation by culture or antigen or DNA detection irrespective of serotype). Here, we assessed vaccine effectiveness of PHiD-CV10 against clinically suspected invasive pneumococcal disease in children by use of diagnoses coded in hospital discharge registers.

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    • "This is in line with our previous findings that a 2- dose schedule induced a reduction in carriage and present findings on timing of the booster dose. PCV7 has been replaced by a ten-valent (PCV10) or thirteenvalent (PCV13) pneumococcal conjugate vaccine [42] [43] [44]. Many studies have shown that the immunogenicity induced by PCV10 and PCV13 against the 7 serotypes present in PCV7 is comparable to the response to PCV7 [45] [46], therefore our findings in this study are expected to be also applicable to the new conjugate vaccines. "
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    ABSTRACT: The seven-valent pneumococcal conjugate vaccine (PCV7) has been introduced in most high-income countries, although with differences in age, timing and number of primary doses before 6 months of age and presence and timing of a booster vaccination. The objective was to determine and compare the IgG antibody levels and functionality of IgG responses (avidity and opsonophagocytoses) at 1 and 2 years of age following 2 primary doses with a booster at 11 or 24 months of age. Children received PCV7 at 2 and 4 months (2-dose group), or at 2, 4 and 11 months (2+1-dose group), or no PCV7 (controls) before 1 year of age. All children received a PCV7 dose at 24 months of age. At the age of 12 months, the 2+1-dose group had higher IgG levels and functional antibody levels, compared to the 2-dose group for all serotypes, but at 25 months the difference between the 2-dose and 2+1 dose groups had disappeared for most serotypes. The kinetics of opsonophagocytic antibodies were in line with the specific IgG antibody levels for most serotypes, although differences between the 2-dose and the 2+1-dose group were more pronounced in OPA activity as compared to the IgG levels especially at the age of 24 months. Delaying the booster dose from 11 months to 24 months after 2 primary series doses resulted in significantly higher OPA GMTs one month after the booster dose. This must, however, be balanced against the risk of leaving children unboosted between the age of 11 and 24 months at a time when disease risk is still high. Local decisions about the timing of a booster dose should also take into account vaccine coverage and the indirect herd effect in a well vaccinated population. Trial registration clinicaltrials.gov Identifier: NCT00189020.
    Vaccine 10/2013; 31(49). DOI:10.1016/j.vaccine.2013.09.073 · 3.49 Impact Factor
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    • "Local data [2] Incidence of pneumococcal otitis media per 1,000 58 (up to 60 mo) Prymula et al. [3] IPD vaccine efficacy 83% (7-valent PCV and 10-valent PCV) Black et al. [4] 83% (10-valent PCV) Palmu et al. [5] Vaccine efficacy against suspected pneumococcal pneumonia 20.5% (7-valent, 10-valent, and 13-valent PCV) Black et al. [6] All-cause otitis media vaccine efficacy 6% (7-valent PCV and 13-valent PCV) Eskola et al. [7] Pneumococcal otitis media vaccine efficacy 41.4% (10-valent PCV) Prymula et al. 2006 [3] Reduction in vaccine effectiveness over time Decrease at a rate of 2% every 6 mo; reduced by 18% at 60 mo Extrapolated from Heath et al. [8] Serotype coverage 38% (7-valent), 61% (10-valent), 74% (13-valent) Erdem and Sener [9] Costs In-hospital cost of treating meningitis US $1,000 (UK ¼ US $7,628) [1] National Burden of Disease Study [10] and Turel et al. [2] In-hospital cost of treating bacteremia/septicemia US $500 (UK ¼ US $4,254) [1] In-hospital cost of treating suspected pneumococcal pneumonia US $40 (UK ¼ US $497) [1] Cost of treating a case of otitis media US $30 (UK ¼ US $118) [1] Following meningitis, cost of treating: deafness US $9,696 (UK ¼ US $96,960) [1] focal neurological deficit US $2,4613 (UK ¼ US $24,230) [1] chronic seizures US $758 (UK ¼ US $7,592) [1] Cost of a death US $160 (UK ¼ US $17,600) [1] Mortality Average of 1,879 deaths per year (24 per 100,000 population younger than age 5 y) of which 1,855 pneumonia-related and 24 IPD-related "
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    ABSTRACT: Pneumococcal infection is an important and preventable cause of morbidity and mortality. The Turkish government introduced 7-valent pneumococcal conjugate vaccine (PCV) into the national immunization program in 2009. This suggests that replacing 7-valent PCV with a higher-valent version could at least maintain "standard of care" if not improve it, and that it could be affordable. The aim of this analysis was to assess the potential direct cost-effectiveness of 13-valent PCV in Turkey, a country with a birth cohort of 1.4 million, against a "no vaccine" state, against the default 7-valent PCV state, and against a 10-valent PCV state, using a published cohort model with a 5-year horizon. The cost per life-year gained is below the 1 × per-capita gross domestic product threshold across large changes in key input parameters, indicating that the model is stable and suggesting that any PCV would be very cost-effective in a Turkish national pediatric immunization schedule.
    Value in Health 07/2013; 16(5):755-9. DOI:10.1016/j.jval.2013.03.1632 · 2.89 Impact Factor
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    ABSTRACT: The ten-valent pneumococcal conjugate vaccine (PCV10) was introduced into the Finnish National Vaccination Program (NVP) in September 2010 with a 2+1 schedule (3, 5, 12 months) without catch-up vaccinations. We evaluated the direct and indirect effects of PCV10 on invasive pneumococcal disease (IPD) among children ≤5 years of age during the first three years after NVP introduction. We conducted a population-based, observational follow-up study. The cohort of vaccine-eligible children (all children born June 1, 2010 or later) was followed from 3 months of age until the end of 2013. For the indirect effect, another cohort of older children ineligible for PCV10 vaccination was followed from 2011 through 2013. Both cohorts were compared with season- and age-matched reference cohorts before NVP introduction. National, population-based laboratory surveillance data were used to compare culture-confirmed serotype-specific IPD rates in the vaccine target and reference cohorts by using Poisson regression models. The overall IPD rate among vaccine-eligible children was reduced by 80% (95%CI 72 to 85); the reduction in vaccine-type IPD was 92% (95%CI 86 to 95). However, a non-significant increase in non-vaccine type IPD was observed. During 2012-2013, we also observed a 48% (95%CI 18 to 69) reduction in IPD among unvaccinated children 2 to 5 years of age, which was mostly attributable to the ten vaccine serotypes. This is the first population-based study investigating the impact of PCV10 introduction without prior PCV7 use. A substantial decrease in IPD rates among vaccine-eligible children was observed. A smaller and temporally delayed reduction among older, unvaccinated children suggests that PCV10 also provides indirect protection against vaccine-type IPD. Changes in serotype distribution warrant continuous monitoring of potential increases in non-vaccine serotypes.
    PLoS ONE 03/2015; 10(3):e0120290. DOI:10.1371/journal.pone.0120290 · 3.23 Impact Factor
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