[FG] Heininger UlrichHead of Research Unit Prof. Dr. med.Ulrich HeiningerOverviewMembersPublicationsProjects & CollaborationsProjects & Collaborations OverviewMembersPublicationsProjects & Collaborations Projects & Collaborations 8 foundShow per page10 10 20 50 A randomised controlled trial of adjunct corticosteroid therapy in hospitalised children with community acquired pneumonia (CAP): THE KIDS-STEP STUDY Investigator initiated clinical trials (IICT) Research Project | 3 Project MembersCommunity-acquired pneumonia (CAP) is a common reason for hospitalisation in childhood and represents a considerable socioeconomic burden. In hospitalised adults with CAP, we have shown a beneficial effect of short-term steroid treatment on time to clinical stability and on duration of hospital stay in a randomised controlled trial (RCT). These benefits in adults with CAP have been confirmed in a recent meta-analysis and appear to be independent of the aetiology of CAP. It is unclear if adjunct steroid treatment benefits children with CAP.Rationale: An intervention that shortens time to stability and discharge in childhood CAP would carry substantial socioeconomic benefits in terms of healthcare resource utilization as well as parental and child absenteeism from work and out-of-home activities, respectively. Based on our findings in adult patients with CAP, we expect a positive clinical effect of steroids also in children. So far, no large-scale RCTs have evaluated the effectiveness of oral steroids on patient-relevant or clinically relevant endpoints in childhood CAP. In particular, it is unclear whether clinical improvement in the short-term is offset by a mid-term increase in CAP recurrence. Aim of the study: The overall aim of the trial is to evaluate the impact of oral steroid treatment in children with CAP on outcomes that are of high importance for patients. Specifically, we aim to concurrently assess the effect of adjunct oral steroids in children hospitalised for CAP on clinical stability (efficacy) and CAP recurrence (safety).Objectives: The primary objective is to concurrently evaluate (i) whether treatment of children hospitalised for CAP with oral betamethasone is superior to placebo for clinical stability (defined as resolution of vital sign abnormalities in room air) within 48 hours of hospitalization; (ii) whether treatment of children hospitalised for CAP with oral betamethasone is noninferior to placebo for CAP-related readmissions to hospital within 28 days of randomisation. Other objectives include the evaluation of effects of oral betamethasone treatment (versus placebo) in children hospitalised for CAP on: duration of hospital stay; severity and duration of CAP symptoms; parental absence from work and/or child absence from routine out-of-home care or school; overall duration of antibiotic exposure and inpatient days; intensive care unit admissions; mortality; rate and severity of solicited clinical side effects and serious adverse events. Exploratory subgroup analyses are planned to evaluate the effect of age, initial antibiotic treatment, respiratory pathogen detected in initial nasopharyngeal swab and radiological evidence of CAP. Study Design: We propose a pragmatic randomised, controlled, patient-, care-giver-, investigator- and outcome-assessor blinded multicentre trial in 8 Swiss paediatric departments with two parallel groups (one active, one control; 1:1 ratio). Preschool and school-age children with moderate to severe CAP (defined clinically) requiring admission to hospital will be included. 700 patients will be randomised 1:1 to receive betamethasone (Betnesol®) (active group: 0.2 mg/kg/d in 1 daily dose for 2 days; control group: 2 days of placebo). The co-primary endpoints will be (i) the proportion of children who are clinically stable within 48 hours of randomisation; the proportion of children requiring CAP-related readmission to hospital within 28 days of randomisation. Significance: Any treatment associated with an increased likelihood of early clinical stability may lead to a higher proportion of children suitable for prompt discharge, in turn reducing the patient-relevant outcome of length of stay. This would likely lead to changes in paediatric CAP management in Switzerland (and similar high-income settings), especially if recurrence of moderate-severe CAP remained demonstrably low. VAESCO II SpAg4 Narcolepsy Research Project | 1 Project MembersAddressing the safety signal in a traditional case-control study including sampling and storage of blood and buccal swab samples for possible analysis of influenza specific antibodies, Trib2-specific antibodies, squalne specific antibodies, HLA-type and other possible genetic markers for narcolepsy VAESCO II SpAg3 European Vaccine Saftey Data Linkage Research Project | 1 Project MembersContinue efforts to develop a European Vaccine Safety Data linkage in current VAESCO partner countries with the long term aim to expand it to more member states. Blueprint for Global Vaccine Safety Research Project | 1 Project MembersWHO contract, SPHQ09- LOA-117 Activity 1.1 Survey of global vaccine safety stakeholders Perform a standardized survey among ministries of health, regulatory authorities, professional organizations, academic institutions and vaccine manufacturers. This qualitative survey will: a. Develop standardized questionnaire (Consultant with Working Group). b. Define selection criteria for survey recipients (Consultant with Collaborative Group). c. Develop the background document for interviewees (Consultant). d. Implement survey (Consultant). e. Analyse data (Consultant). f. Draft report (Consultant with Collaborative Group). g. Review the report (Project Advisory Committee). h. Finalize the report (Consultant with Collaborative Group). Activity 1.2 Report on Strengths-Weaknesses-Opportunities-Threats (SWOT) analysis of ongoing global and inter-country vaccine safety initiatives Description and assumptions: Several international projects designed to improve vaccine safety monitoring are ongoing, those projects are referred to in the proposal as "vaccine safety initiatives". There is, however, only limited understanding of the impact these initiatives currently have in the poorest countries. The purpose of the SWOT analysis is to describe the current structure and accomplishments of 10-15 of the most important of those initiatives and determine how these organizations can best serve the needs of the global effort, and propose roles and responsibilities. This analysis will be performed by a working group developing a set of criteria characterizing the strengths, weaknesses, opportunities and threats of 10 to 15 international vaccine safety initiatives. The initiatives that will be selected will have been identified through the survey from Activity 1.1 and will satisfy to explicit criteria of global relevance and previous accomplishments. This analysis will also consider the performance of WHO and UNICEF networks. SWOT questionnaires will be structured around the mission, expertise available, geographic reach, type of support provided, resources available and future prospects. Data collected will be analyzed to describe the level of impact for each dimension of coutries vaccine safety work and to identify the main gaps with respect to the currently available external support to country activities. Activities: 1. Develop the analytical criteria (Consultant with Collaborative Group). 2. Define selection criteria and identify the 10-15 most relevant initiatives (Consultant with Collaborative Group). 3. Survey the selected initiatives (Consultant). 4. Analyze the data through a working group (Consultant and Project Consultative Committee). 5. Draft the report Consultant. 6. Review of the report (Project Consultative Committee). 7. Finalize the report (Consultant with Collaborative Group). VAESCO II Project Research Project | 1 Project MembersGoal: Availability of high quality and timely information on the safety of human vaccines based on a concerted effort of European member states. General Objectives: 1. To promote good practices /decision making in vaccine safety assessment. 2. To facilitate and accelerate the cooperation between the responsible agencies in Europe. 3. To build capacity within the field of disease prevention by providing tools and models founded on evidence based practice. 4. To support the improvement of human health through the delivery of safe and effective vaccines. Specific Objectives: 5. To foster close collaboration in a network of agencies responsible to collect and collate information on AEFI in Europe. 6. To evaluate and implement a self assessment tool of national and regional vaccine safety monitoring systems. 7. To conduct collaborative post-licensure epidemiologic studies, investigating AEFI reported to responsible agencies in European Member States by use of a guidance document for causality assessment. 8. To prepare for a European Vaccine Safety Data Link (EVSD) by determining the scope, identifying available resources, exploring opportunities for synergistic collaboration, and conducting proof of principle studies. 9. To assess the background rates of clinical outcomes in specified target populations of newly introduced immunization programs in anticipation of coincidences between immunization and these outcomes. Deliverables 1. Evaluation of the VAESCO Self-assessment tool for AEFI reporting systems EU Member States. 2. Update of the VAESCO Self-assessment tool based on the above evaluation 3. Collaborative pilot studies assessing the causal relation between a given immunization and a predefined AEFI in EU Member States based on the VAESCO guidance for causality assessment. 4. An network of existing and new national and regional large linked data bases (EVSD) encompassing immunization and clinical outcome data in several EU Member States 5. Proof of principle studies evaluating opportunities and challenges of concerted collection, sharing, analysis and presentation of vaccine safety data within and across EU member states. 6. Collaborative studies assessing the background rates of AEFI INYVAX - Optimisation of the development of poverty related diseases (PRD) vaccines by a transversal approach, addressing common gaps and challenges Research Project | 1 Project MembersA number of new vaccines are being developed against poverty-related infectious diseases of major public health importance at a global level. The development of these vaccines is facing the same kind of challenges and gaps, which still prevent: the establishment of readily accessible formulation and scale-up process development capacity for neglected disease vaccines. the establishment of a systematic approach for prioritising formulation of vaccine candidates using accepted pre-clinical criteria. the development of information-sharing tools to strengthen connections between the scientists, the developers and the clinical investigators. To address those challenges, the European vaccine community needs to establish a shared vision and goals and to identify the activities that could address some of the above-mentioned challenges. A cooperation between the different groups of PRD vaccine developers will bring innovative approaches for accelerating the development of effective vaccines. Among those challenges, several can be addressed through coordination across poverty related diseases, such as: Difficulties in accessing some technology platforms, such as synthetic peptides/recombinant proteins and expertise for GMP development, therefore allowing rational decisions to be made on the best industrial approach for pharmaceutical development. Difficulties in accessing certain know-how, such as lyophilisation and lack of formulation platforms accessible to academic groups. Difficulties in accessing some delivery platforms, such as adjuvants and virus-like particles for GMP development and/or to assess the quality and regulatory compliance of those platforms. Difficulties in harmonising the safety data collection. The insufficient number of trained scientists able to undertake leadership roles in vaccine development. Brighton Collaboration Standardizing case definitions for Adverse Events Following Immunization (AEFI) Research Project | 1 Project MembersThe Collaboration will develop standardized case definitions of AEFI, with particular relevance to pre-qualified vaccines including yellow fever, Japanese encephalitis, influenza, and rotavirus vaccines. It will develop 2-3 case definitions/year as prioritized by WHO. Deliverables 2009: The Collaboration will provide WHO with AEFI case definitions and guidelines for their global use for "Collection, analysis, and presentation of AEFI data", "diarrhea", "Guillain-Barré syndrome", and "Overall local reactions". Comparative Compliance with Supplementary and Basic Immunization Recommendations in Children 24 Months of Age in two Regions of Switzerland Research Project | 1 Project MembersNo data are available on the acceptance of the recently introduced supplementary immunizations in Switzerland. We therefore aim to assess the compliance with supplementary immunizations in comparison to basic immunizations in children 24 months of age in two regions of Switzerland, i.e., cantons of Basel-Stadt and Basel-Land (BS/BL) and Geneva (GE). 1 1 OverviewMembersPublicationsProjects & Collaborations
Projects & Collaborations 8 foundShow per page10 10 20 50 A randomised controlled trial of adjunct corticosteroid therapy in hospitalised children with community acquired pneumonia (CAP): THE KIDS-STEP STUDY Investigator initiated clinical trials (IICT) Research Project | 3 Project MembersCommunity-acquired pneumonia (CAP) is a common reason for hospitalisation in childhood and represents a considerable socioeconomic burden. In hospitalised adults with CAP, we have shown a beneficial effect of short-term steroid treatment on time to clinical stability and on duration of hospital stay in a randomised controlled trial (RCT). These benefits in adults with CAP have been confirmed in a recent meta-analysis and appear to be independent of the aetiology of CAP. It is unclear if adjunct steroid treatment benefits children with CAP.Rationale: An intervention that shortens time to stability and discharge in childhood CAP would carry substantial socioeconomic benefits in terms of healthcare resource utilization as well as parental and child absenteeism from work and out-of-home activities, respectively. Based on our findings in adult patients with CAP, we expect a positive clinical effect of steroids also in children. So far, no large-scale RCTs have evaluated the effectiveness of oral steroids on patient-relevant or clinically relevant endpoints in childhood CAP. In particular, it is unclear whether clinical improvement in the short-term is offset by a mid-term increase in CAP recurrence. Aim of the study: The overall aim of the trial is to evaluate the impact of oral steroid treatment in children with CAP on outcomes that are of high importance for patients. Specifically, we aim to concurrently assess the effect of adjunct oral steroids in children hospitalised for CAP on clinical stability (efficacy) and CAP recurrence (safety).Objectives: The primary objective is to concurrently evaluate (i) whether treatment of children hospitalised for CAP with oral betamethasone is superior to placebo for clinical stability (defined as resolution of vital sign abnormalities in room air) within 48 hours of hospitalization; (ii) whether treatment of children hospitalised for CAP with oral betamethasone is noninferior to placebo for CAP-related readmissions to hospital within 28 days of randomisation. Other objectives include the evaluation of effects of oral betamethasone treatment (versus placebo) in children hospitalised for CAP on: duration of hospital stay; severity and duration of CAP symptoms; parental absence from work and/or child absence from routine out-of-home care or school; overall duration of antibiotic exposure and inpatient days; intensive care unit admissions; mortality; rate and severity of solicited clinical side effects and serious adverse events. Exploratory subgroup analyses are planned to evaluate the effect of age, initial antibiotic treatment, respiratory pathogen detected in initial nasopharyngeal swab and radiological evidence of CAP. Study Design: We propose a pragmatic randomised, controlled, patient-, care-giver-, investigator- and outcome-assessor blinded multicentre trial in 8 Swiss paediatric departments with two parallel groups (one active, one control; 1:1 ratio). Preschool and school-age children with moderate to severe CAP (defined clinically) requiring admission to hospital will be included. 700 patients will be randomised 1:1 to receive betamethasone (Betnesol®) (active group: 0.2 mg/kg/d in 1 daily dose for 2 days; control group: 2 days of placebo). The co-primary endpoints will be (i) the proportion of children who are clinically stable within 48 hours of randomisation; the proportion of children requiring CAP-related readmission to hospital within 28 days of randomisation. Significance: Any treatment associated with an increased likelihood of early clinical stability may lead to a higher proportion of children suitable for prompt discharge, in turn reducing the patient-relevant outcome of length of stay. This would likely lead to changes in paediatric CAP management in Switzerland (and similar high-income settings), especially if recurrence of moderate-severe CAP remained demonstrably low. VAESCO II SpAg4 Narcolepsy Research Project | 1 Project MembersAddressing the safety signal in a traditional case-control study including sampling and storage of blood and buccal swab samples for possible analysis of influenza specific antibodies, Trib2-specific antibodies, squalne specific antibodies, HLA-type and other possible genetic markers for narcolepsy VAESCO II SpAg3 European Vaccine Saftey Data Linkage Research Project | 1 Project MembersContinue efforts to develop a European Vaccine Safety Data linkage in current VAESCO partner countries with the long term aim to expand it to more member states. Blueprint for Global Vaccine Safety Research Project | 1 Project MembersWHO contract, SPHQ09- LOA-117 Activity 1.1 Survey of global vaccine safety stakeholders Perform a standardized survey among ministries of health, regulatory authorities, professional organizations, academic institutions and vaccine manufacturers. This qualitative survey will: a. Develop standardized questionnaire (Consultant with Working Group). b. Define selection criteria for survey recipients (Consultant with Collaborative Group). c. Develop the background document for interviewees (Consultant). d. Implement survey (Consultant). e. Analyse data (Consultant). f. Draft report (Consultant with Collaborative Group). g. Review the report (Project Advisory Committee). h. Finalize the report (Consultant with Collaborative Group). Activity 1.2 Report on Strengths-Weaknesses-Opportunities-Threats (SWOT) analysis of ongoing global and inter-country vaccine safety initiatives Description and assumptions: Several international projects designed to improve vaccine safety monitoring are ongoing, those projects are referred to in the proposal as "vaccine safety initiatives". There is, however, only limited understanding of the impact these initiatives currently have in the poorest countries. The purpose of the SWOT analysis is to describe the current structure and accomplishments of 10-15 of the most important of those initiatives and determine how these organizations can best serve the needs of the global effort, and propose roles and responsibilities. This analysis will be performed by a working group developing a set of criteria characterizing the strengths, weaknesses, opportunities and threats of 10 to 15 international vaccine safety initiatives. The initiatives that will be selected will have been identified through the survey from Activity 1.1 and will satisfy to explicit criteria of global relevance and previous accomplishments. This analysis will also consider the performance of WHO and UNICEF networks. SWOT questionnaires will be structured around the mission, expertise available, geographic reach, type of support provided, resources available and future prospects. Data collected will be analyzed to describe the level of impact for each dimension of coutries vaccine safety work and to identify the main gaps with respect to the currently available external support to country activities. Activities: 1. Develop the analytical criteria (Consultant with Collaborative Group). 2. Define selection criteria and identify the 10-15 most relevant initiatives (Consultant with Collaborative Group). 3. Survey the selected initiatives (Consultant). 4. Analyze the data through a working group (Consultant and Project Consultative Committee). 5. Draft the report Consultant. 6. Review of the report (Project Consultative Committee). 7. Finalize the report (Consultant with Collaborative Group). VAESCO II Project Research Project | 1 Project MembersGoal: Availability of high quality and timely information on the safety of human vaccines based on a concerted effort of European member states. General Objectives: 1. To promote good practices /decision making in vaccine safety assessment. 2. To facilitate and accelerate the cooperation between the responsible agencies in Europe. 3. To build capacity within the field of disease prevention by providing tools and models founded on evidence based practice. 4. To support the improvement of human health through the delivery of safe and effective vaccines. Specific Objectives: 5. To foster close collaboration in a network of agencies responsible to collect and collate information on AEFI in Europe. 6. To evaluate and implement a self assessment tool of national and regional vaccine safety monitoring systems. 7. To conduct collaborative post-licensure epidemiologic studies, investigating AEFI reported to responsible agencies in European Member States by use of a guidance document for causality assessment. 8. To prepare for a European Vaccine Safety Data Link (EVSD) by determining the scope, identifying available resources, exploring opportunities for synergistic collaboration, and conducting proof of principle studies. 9. To assess the background rates of clinical outcomes in specified target populations of newly introduced immunization programs in anticipation of coincidences between immunization and these outcomes. Deliverables 1. Evaluation of the VAESCO Self-assessment tool for AEFI reporting systems EU Member States. 2. Update of the VAESCO Self-assessment tool based on the above evaluation 3. Collaborative pilot studies assessing the causal relation between a given immunization and a predefined AEFI in EU Member States based on the VAESCO guidance for causality assessment. 4. An network of existing and new national and regional large linked data bases (EVSD) encompassing immunization and clinical outcome data in several EU Member States 5. Proof of principle studies evaluating opportunities and challenges of concerted collection, sharing, analysis and presentation of vaccine safety data within and across EU member states. 6. Collaborative studies assessing the background rates of AEFI INYVAX - Optimisation of the development of poverty related diseases (PRD) vaccines by a transversal approach, addressing common gaps and challenges Research Project | 1 Project MembersA number of new vaccines are being developed against poverty-related infectious diseases of major public health importance at a global level. The development of these vaccines is facing the same kind of challenges and gaps, which still prevent: the establishment of readily accessible formulation and scale-up process development capacity for neglected disease vaccines. the establishment of a systematic approach for prioritising formulation of vaccine candidates using accepted pre-clinical criteria. the development of information-sharing tools to strengthen connections between the scientists, the developers and the clinical investigators. To address those challenges, the European vaccine community needs to establish a shared vision and goals and to identify the activities that could address some of the above-mentioned challenges. A cooperation between the different groups of PRD vaccine developers will bring innovative approaches for accelerating the development of effective vaccines. Among those challenges, several can be addressed through coordination across poverty related diseases, such as: Difficulties in accessing some technology platforms, such as synthetic peptides/recombinant proteins and expertise for GMP development, therefore allowing rational decisions to be made on the best industrial approach for pharmaceutical development. Difficulties in accessing certain know-how, such as lyophilisation and lack of formulation platforms accessible to academic groups. Difficulties in accessing some delivery platforms, such as adjuvants and virus-like particles for GMP development and/or to assess the quality and regulatory compliance of those platforms. Difficulties in harmonising the safety data collection. The insufficient number of trained scientists able to undertake leadership roles in vaccine development. Brighton Collaboration Standardizing case definitions for Adverse Events Following Immunization (AEFI) Research Project | 1 Project MembersThe Collaboration will develop standardized case definitions of AEFI, with particular relevance to pre-qualified vaccines including yellow fever, Japanese encephalitis, influenza, and rotavirus vaccines. It will develop 2-3 case definitions/year as prioritized by WHO. Deliverables 2009: The Collaboration will provide WHO with AEFI case definitions and guidelines for their global use for "Collection, analysis, and presentation of AEFI data", "diarrhea", "Guillain-Barré syndrome", and "Overall local reactions". Comparative Compliance with Supplementary and Basic Immunization Recommendations in Children 24 Months of Age in two Regions of Switzerland Research Project | 1 Project MembersNo data are available on the acceptance of the recently introduced supplementary immunizations in Switzerland. We therefore aim to assess the compliance with supplementary immunizations in comparison to basic immunizations in children 24 months of age in two regions of Switzerland, i.e., cantons of Basel-Stadt and Basel-Land (BS/BL) and Geneva (GE). 1 1
A randomised controlled trial of adjunct corticosteroid therapy in hospitalised children with community acquired pneumonia (CAP): THE KIDS-STEP STUDY Investigator initiated clinical trials (IICT) Research Project | 3 Project MembersCommunity-acquired pneumonia (CAP) is a common reason for hospitalisation in childhood and represents a considerable socioeconomic burden. In hospitalised adults with CAP, we have shown a beneficial effect of short-term steroid treatment on time to clinical stability and on duration of hospital stay in a randomised controlled trial (RCT). These benefits in adults with CAP have been confirmed in a recent meta-analysis and appear to be independent of the aetiology of CAP. It is unclear if adjunct steroid treatment benefits children with CAP.Rationale: An intervention that shortens time to stability and discharge in childhood CAP would carry substantial socioeconomic benefits in terms of healthcare resource utilization as well as parental and child absenteeism from work and out-of-home activities, respectively. Based on our findings in adult patients with CAP, we expect a positive clinical effect of steroids also in children. So far, no large-scale RCTs have evaluated the effectiveness of oral steroids on patient-relevant or clinically relevant endpoints in childhood CAP. In particular, it is unclear whether clinical improvement in the short-term is offset by a mid-term increase in CAP recurrence. Aim of the study: The overall aim of the trial is to evaluate the impact of oral steroid treatment in children with CAP on outcomes that are of high importance for patients. Specifically, we aim to concurrently assess the effect of adjunct oral steroids in children hospitalised for CAP on clinical stability (efficacy) and CAP recurrence (safety).Objectives: The primary objective is to concurrently evaluate (i) whether treatment of children hospitalised for CAP with oral betamethasone is superior to placebo for clinical stability (defined as resolution of vital sign abnormalities in room air) within 48 hours of hospitalization; (ii) whether treatment of children hospitalised for CAP with oral betamethasone is noninferior to placebo for CAP-related readmissions to hospital within 28 days of randomisation. Other objectives include the evaluation of effects of oral betamethasone treatment (versus placebo) in children hospitalised for CAP on: duration of hospital stay; severity and duration of CAP symptoms; parental absence from work and/or child absence from routine out-of-home care or school; overall duration of antibiotic exposure and inpatient days; intensive care unit admissions; mortality; rate and severity of solicited clinical side effects and serious adverse events. Exploratory subgroup analyses are planned to evaluate the effect of age, initial antibiotic treatment, respiratory pathogen detected in initial nasopharyngeal swab and radiological evidence of CAP. Study Design: We propose a pragmatic randomised, controlled, patient-, care-giver-, investigator- and outcome-assessor blinded multicentre trial in 8 Swiss paediatric departments with two parallel groups (one active, one control; 1:1 ratio). Preschool and school-age children with moderate to severe CAP (defined clinically) requiring admission to hospital will be included. 700 patients will be randomised 1:1 to receive betamethasone (Betnesol®) (active group: 0.2 mg/kg/d in 1 daily dose for 2 days; control group: 2 days of placebo). The co-primary endpoints will be (i) the proportion of children who are clinically stable within 48 hours of randomisation; the proportion of children requiring CAP-related readmission to hospital within 28 days of randomisation. Significance: Any treatment associated with an increased likelihood of early clinical stability may lead to a higher proportion of children suitable for prompt discharge, in turn reducing the patient-relevant outcome of length of stay. This would likely lead to changes in paediatric CAP management in Switzerland (and similar high-income settings), especially if recurrence of moderate-severe CAP remained demonstrably low.
VAESCO II SpAg4 Narcolepsy Research Project | 1 Project MembersAddressing the safety signal in a traditional case-control study including sampling and storage of blood and buccal swab samples for possible analysis of influenza specific antibodies, Trib2-specific antibodies, squalne specific antibodies, HLA-type and other possible genetic markers for narcolepsy
VAESCO II SpAg3 European Vaccine Saftey Data Linkage Research Project | 1 Project MembersContinue efforts to develop a European Vaccine Safety Data linkage in current VAESCO partner countries with the long term aim to expand it to more member states.
Blueprint for Global Vaccine Safety Research Project | 1 Project MembersWHO contract, SPHQ09- LOA-117 Activity 1.1 Survey of global vaccine safety stakeholders Perform a standardized survey among ministries of health, regulatory authorities, professional organizations, academic institutions and vaccine manufacturers. This qualitative survey will: a. Develop standardized questionnaire (Consultant with Working Group). b. Define selection criteria for survey recipients (Consultant with Collaborative Group). c. Develop the background document for interviewees (Consultant). d. Implement survey (Consultant). e. Analyse data (Consultant). f. Draft report (Consultant with Collaborative Group). g. Review the report (Project Advisory Committee). h. Finalize the report (Consultant with Collaborative Group). Activity 1.2 Report on Strengths-Weaknesses-Opportunities-Threats (SWOT) analysis of ongoing global and inter-country vaccine safety initiatives Description and assumptions: Several international projects designed to improve vaccine safety monitoring are ongoing, those projects are referred to in the proposal as "vaccine safety initiatives". There is, however, only limited understanding of the impact these initiatives currently have in the poorest countries. The purpose of the SWOT analysis is to describe the current structure and accomplishments of 10-15 of the most important of those initiatives and determine how these organizations can best serve the needs of the global effort, and propose roles and responsibilities. This analysis will be performed by a working group developing a set of criteria characterizing the strengths, weaknesses, opportunities and threats of 10 to 15 international vaccine safety initiatives. The initiatives that will be selected will have been identified through the survey from Activity 1.1 and will satisfy to explicit criteria of global relevance and previous accomplishments. This analysis will also consider the performance of WHO and UNICEF networks. SWOT questionnaires will be structured around the mission, expertise available, geographic reach, type of support provided, resources available and future prospects. Data collected will be analyzed to describe the level of impact for each dimension of coutries vaccine safety work and to identify the main gaps with respect to the currently available external support to country activities. Activities: 1. Develop the analytical criteria (Consultant with Collaborative Group). 2. Define selection criteria and identify the 10-15 most relevant initiatives (Consultant with Collaborative Group). 3. Survey the selected initiatives (Consultant). 4. Analyze the data through a working group (Consultant and Project Consultative Committee). 5. Draft the report Consultant. 6. Review of the report (Project Consultative Committee). 7. Finalize the report (Consultant with Collaborative Group).
VAESCO II Project Research Project | 1 Project MembersGoal: Availability of high quality and timely information on the safety of human vaccines based on a concerted effort of European member states. General Objectives: 1. To promote good practices /decision making in vaccine safety assessment. 2. To facilitate and accelerate the cooperation between the responsible agencies in Europe. 3. To build capacity within the field of disease prevention by providing tools and models founded on evidence based practice. 4. To support the improvement of human health through the delivery of safe and effective vaccines. Specific Objectives: 5. To foster close collaboration in a network of agencies responsible to collect and collate information on AEFI in Europe. 6. To evaluate and implement a self assessment tool of national and regional vaccine safety monitoring systems. 7. To conduct collaborative post-licensure epidemiologic studies, investigating AEFI reported to responsible agencies in European Member States by use of a guidance document for causality assessment. 8. To prepare for a European Vaccine Safety Data Link (EVSD) by determining the scope, identifying available resources, exploring opportunities for synergistic collaboration, and conducting proof of principle studies. 9. To assess the background rates of clinical outcomes in specified target populations of newly introduced immunization programs in anticipation of coincidences between immunization and these outcomes. Deliverables 1. Evaluation of the VAESCO Self-assessment tool for AEFI reporting systems EU Member States. 2. Update of the VAESCO Self-assessment tool based on the above evaluation 3. Collaborative pilot studies assessing the causal relation between a given immunization and a predefined AEFI in EU Member States based on the VAESCO guidance for causality assessment. 4. An network of existing and new national and regional large linked data bases (EVSD) encompassing immunization and clinical outcome data in several EU Member States 5. Proof of principle studies evaluating opportunities and challenges of concerted collection, sharing, analysis and presentation of vaccine safety data within and across EU member states. 6. Collaborative studies assessing the background rates of AEFI
INYVAX - Optimisation of the development of poverty related diseases (PRD) vaccines by a transversal approach, addressing common gaps and challenges Research Project | 1 Project MembersA number of new vaccines are being developed against poverty-related infectious diseases of major public health importance at a global level. The development of these vaccines is facing the same kind of challenges and gaps, which still prevent: the establishment of readily accessible formulation and scale-up process development capacity for neglected disease vaccines. the establishment of a systematic approach for prioritising formulation of vaccine candidates using accepted pre-clinical criteria. the development of information-sharing tools to strengthen connections between the scientists, the developers and the clinical investigators. To address those challenges, the European vaccine community needs to establish a shared vision and goals and to identify the activities that could address some of the above-mentioned challenges. A cooperation between the different groups of PRD vaccine developers will bring innovative approaches for accelerating the development of effective vaccines. Among those challenges, several can be addressed through coordination across poverty related diseases, such as: Difficulties in accessing some technology platforms, such as synthetic peptides/recombinant proteins and expertise for GMP development, therefore allowing rational decisions to be made on the best industrial approach for pharmaceutical development. Difficulties in accessing certain know-how, such as lyophilisation and lack of formulation platforms accessible to academic groups. Difficulties in accessing some delivery platforms, such as adjuvants and virus-like particles for GMP development and/or to assess the quality and regulatory compliance of those platforms. Difficulties in harmonising the safety data collection. The insufficient number of trained scientists able to undertake leadership roles in vaccine development.
Brighton Collaboration Standardizing case definitions for Adverse Events Following Immunization (AEFI) Research Project | 1 Project MembersThe Collaboration will develop standardized case definitions of AEFI, with particular relevance to pre-qualified vaccines including yellow fever, Japanese encephalitis, influenza, and rotavirus vaccines. It will develop 2-3 case definitions/year as prioritized by WHO. Deliverables 2009: The Collaboration will provide WHO with AEFI case definitions and guidelines for their global use for "Collection, analysis, and presentation of AEFI data", "diarrhea", "Guillain-Barré syndrome", and "Overall local reactions".
Comparative Compliance with Supplementary and Basic Immunization Recommendations in Children 24 Months of Age in two Regions of Switzerland Research Project | 1 Project MembersNo data are available on the acceptance of the recently introduced supplementary immunizations in Switzerland. We therefore aim to assess the compliance with supplementary immunizations in comparison to basic immunizations in children 24 months of age in two regions of Switzerland, i.e., cantons of Basel-Stadt and Basel-Land (BS/BL) and Geneva (GE).
