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Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in HIV-infected adults in the era of highly active antiretroviral therapy: analysis stratified by CD4 T-cell count.

ABSTRACT: HIV-infected patients are 30- to 100-fold more susceptible to invasive pneumococcal diseases than are healthy adults. Pneumococcal vaccination may be the best way to decrease the large pneumococcal disease burden, but the optimal timing of vaccination is still unclear. In this study, HIV-infected subjects aged ≥18 years were recruited and divided into 2 age-matched groups: group 1 (subjects with CD4 T-cell count ≥350 cells/µL) and group 2 (CD4 T-cell count <350 cells/µL). Multiplex opsonophagocytic killing assay was used to compare immunogenicity after immunization with 13-valent pneumococcal conjugate vaccine (PCV13). Among 70 subjects, 67 (group 1, N = 34; group 2, N = 33) were available for the assessment of immunogenicity and safety. With respect to the post-vaccination geometric mean titer (GMT) ratios, the non-inferiority criteria were not met. Post-vaccination GMTs were significantly lower in group 2 compared to group 1 for all 4 pneumococcal serotypes (5, 6B, 18C, and 19A) tested. PCV13 was safe and well tolerated in HIV-infected patients irrespective of immune status. In conclusion, PCV13 showed significantly inferior immunogenicity among HIV-infected patients with CD4 T-cell count <350 cells/µL compared to those with a higher CD4 T-cell count.

SUBMITTER: Song JY

PROVIDER: S-EPMC7012181 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectiveThe Ministry of Health (MOH), Mongolia, is considering introducing 13-valent pneumococcal conjugate vaccine (PCV13) in its national immunization programme to prevent the burden of disease caused by Streptococcus pneumoniae. This study evaluates the cost-effectiveness and budget impact of introducing PCV13 compared to no PCV vaccination in Mongolia.MethodsThe incremental cost-effectiveness ratio (ICER) of introducing PCV13 compared to no PCV vaccination was assessed using an age-stratified static multiple cohort model. The risk of various clinical presentations of pneumococcal disease (meningitis, pneumonia, non-meningitis non-pneumonia invasive pneumococcal disease and acute otitis media) at all ages for thirty birth cohorts was assessed. The analysis considered both health system and societal perspectives. A 3+0 vaccine schedule and price of US$3.30 per dose was assumed for the baseline scenario based on Gavi, the Vaccine Alliance's advance market commitment tail price.ResultsThe ICER of PCV13 introduction is estimated at US$52 per disability-adjusted life year (DALY) averted (health system perspective), and cost-saving (societal perspective). Although indirect effects of PCV have been well-documented, a conservative scenario that does not consider indirect effects estimated PCV13 introduction to cost US$79 per DALY averted (health system perspective), and US$19 per DALY averted (societal perspective). Vaccination with PCV13 is expected to cost around US$920,000 in 2016, and thereafter US$820,000 every year. The programme is likely to reduce direct disease-related costs to MOH by US$440,000 in the first year, increasing to US$510,000 by 2025.ConclusionIntroducing PCV13 as part of Mongolia's national programme appears to be highly cost-effective when compared to no vaccination and cost-saving from a societal perspective at vaccine purchase prices offered through Gavi. Notwithstanding uncertainties around some parameters, cost-effectiveness of PCV introduction for Mongolia remains robust over a range of conservative scenarios. Availability of high-quality national data would improve future economic analyses for vaccine introduction.

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Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in HIV-infected adults in the era of highly active antiretroviral therapy: analysis stratified by CD4 T-cell count.

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