Schurink-van 't Klooster, Tessa M; Donken, Robine; Schepp, Rutger M; van der Klis, Fiona R M; de Melker, Hester E(2018-11-26)
In this cohort study, we examined antibody levels and avidity after a two-dose schedule (0, 6 months) of the bivalent HPV-vaccine in girls routinely vaccinated in the Dutch HPV-vaccination program, up to 2 years following vaccination. A blood sample at 7, 12 and 24 months after the first dose and questionnaire data were collected (n = 56). HPV type-specific antibody concentrations (lU/ml) against seven types (HPV16/18/31/33/45/52/58) were assessed using a validated virus-like particles (VLP) multiplex immunoassay. Avidity was tested using a modification of this assay. Seropositivity for vaccine types HPV 16 and 18 was 100% up to month 24, but declined for HPV-types 31/33/45/52/58, although not statistically significant for HPV45. All Geometric Mean Concentrations (GMCs) declined by months 12 and 24, but remained high for HPV16/18. Between month 7 and 12, GMCs declined more for other types. High avidity antibodies were induced up to 24 months for vaccine types (75%, 76-78% and 81-82% at months 7, 12 and 24, respectively), but for other types antibody avidity was 16-29% at month 7, 20-32% at month 12 and 19-32% at month 24. GMCs declined over time for HPV-types 16/18/31/33/45/52/58, but remained high for vaccine-types HPV16/18 up to 24 months of follow-up. Antibody avidity was >75% for vaccine types but <35% for other HPV-types. Further follow-up of this cohort will provide insight into antibody and avidity kinetics over time.
Van de Burgwal, L H M; Ribeiro, C Dos S; Van der Waal, M B; Claassen, E(2018-11-26)
Continuing investments in vaccine innovation are insufficiently translated into market entries of novel vaccines. This innovation paradox is in part caused by stakeholders lacking complete understanding of the complex array of steps necessary for vaccine development and collaboration difficulties between the wide variety of stakeholders involved. Models providing cross-domain understanding can improve collaboration but currently lack both comprehensibility and granularity to enable a prioritized view of activities and criteria. Key opinion leaders (KOLs) were asked to contribute to the definition of a vaccine innovation cycle (VIC). In a first step, 18 KOLs were interviewed on the stages (activities and results) and gates (evaluation criteria and outcomes) of vaccine innovation. This first description of the VIC was subsequently validated and refined through a survey among 46 additional KOLs. The VIC identifies 29 distinct stages and 28 corresponding gates, distributed in ten different but integrated workstreams, and comprehensibly depicted in a circular innovation model. Some stage-gates occur at defined moments, whereas the occurrence and timing of other stage-gates is contingent on a variety of contextual factors. Yet other stage-gates continuously monitor internal and external developments. A gap-overlap analysis of stage-gate criteria demonstrated that 5 out of 11 criteria employed by vaccine developers correspond with criteria employed by competent (regulatory) authorities. The VIC provides a comprehensive overview of stage-gates throughout the value chain of vaccine innovation. Its cyclical nature highlights the importance of synchronizing with unmet needs and market changes, and conceptualizes the difference between incremental and radical vaccine innovation. Knowledge on the gap between internal and external criteria will enhance the viability of newcomers to the field. The VIC can be used by stakeholders to improve understanding and communication in forming collaborative alliances and consortia. Such a boundary-spanning function may contribute to the reduction of process inefficiencies, especially in public-private partnerships.
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