Ole F. Olesen
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View article: Regulatory workshop on standardisation of clinical procedures, endpoints and data robustness of human challenge studies – A stakeholder meeting report
Regulatory workshop on standardisation of clinical procedures, endpoints and data robustness of human challenge studies – A stakeholder meeting report Open
Inno4Vac, a public-private partnership funded by the IMI2/EU/EFPIA Joint Undertaking (IMI2 JU), brings together academic institutions, SMEs, and pharmaceutical companies to accelerate and de-risk vaccine development. The project has made s…
View article: Boosting Vaccine Research: The 16-Year Journey of TRANSVAC Vaccine Infrastructure
Boosting Vaccine Research: The 16-Year Journey of TRANSVAC Vaccine Infrastructure Open
TRANSVAC represents a long-running effort to accelerate the development of novel vaccines by integrating institutions from across Europe under a single collaborative framework. This initiative has empowered the global vaccine community sin…
View article: Exploring the effects of time-restricted eating on body weight and associated cardiometabolic outcomes in South African women living with HIV (TESSA): protocol for a randomised controlled trial
Exploring the effects of time-restricted eating on body weight and associated cardiometabolic outcomes in South African women living with HIV (TESSA): protocol for a randomised controlled trial Open
Introduction We codesigned an intervention with a low-resourced community with the aim to investigate the effects of time-restricted eating (TRE) on changes in body weight and associated cardiometabolic outcomes in South African women livi…
View article: The AMR Accelerator: from individual organizations to efficient antibiotic development partnerships
The AMR Accelerator: from individual organizations to efficient antibiotic development partnerships Open
View article: Robust and persistent B-cell responses following SARS-CoV-2 vaccine determine protection from SARS-CoV-2 infection
Robust and persistent B-cell responses following SARS-CoV-2 vaccine determine protection from SARS-CoV-2 infection Open
Introduction A clear immune correlate of protection from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has not been defined. We explored antibody, B-cell, and T-cell responses to the third-dose vaccine and relation…
View article: Low Rates of Immunity among Medical Students and Residents in the Era of the Resurgence of Measles
Low Rates of Immunity among Medical Students and Residents in the Era of the Resurgence of Measles Open
Measles is a highly contagious viral disease spread through respiratory droplets. The number of reported cases increased worldwide in 2023, particularly in the European Region. Italy reported 213 cases in the first quarter of 2024, with mo…
View article: Perspectives of European Patient Advocacy Groups on Volunteer Registries and Vaccine Trials: VACCELERATE Survey Study
Perspectives of European Patient Advocacy Groups on Volunteer Registries and Vaccine Trials: VACCELERATE Survey Study Open
Background The VACCELERATE Pan-European Scientific network aims to strengthen the foundation of vaccine trial research across Europe by following the principles of equity, inclusion, and diversity. The VACCELERATE Volunteer Registry networ…
View article: Ethical approval for controlled human infectious model clinical trial protocols – A workshop report
Ethical approval for controlled human infectious model clinical trial protocols – A workshop report Open
Controlled Human Infectious Model studies (CHIM) involve deliberately exposing volunteers to pathogens. To discuss ethical issues related to CHIM, the European Vaccine Initiative and the International Alliance for Biological Standardizatio…
View article: Regulatory workshop on challenge strain development and GMP manufacture – A stakeholder meeting report
Regulatory workshop on challenge strain development and GMP manufacture – A stakeholder meeting report Open
Within the Innovative Health Initiative (IHI) Inno4Vac CHIMICHURRI project, a regulatory workshop was organised on the development and manufacture of challenge agent strains for Controlled Human Infection Model (CHIM) studies. Developers a…
View article: Fourth Controlled Human Infection Model (CHIM) meeting, CHIM regulatory issues, May 24, 2023
Fourth Controlled Human Infection Model (CHIM) meeting, CHIM regulatory issues, May 24, 2023 Open
Many aspects of Controlled Human Infection Models (CHIMs, also known as human challenge studies and human infection studies) have been discussed extensively, including Good Manufacturing Practice (GMP) production of the challenge agent, CH…
View article: Robust and Persistent B Cell Responses Following Third-Dose SARS-CoV-2 Vaccine Determine Protection from SARS-CoV-2 Infection
Robust and Persistent B Cell Responses Following Third-Dose SARS-CoV-2 Vaccine Determine Protection from SARS-CoV-2 Infection Open
View article: Placental Malaria: A Systematic Review and Meta-Analysis of Global Burden, Risk Factors, Maternal and Foetal Outcomes
Placental Malaria: A Systematic Review and Meta-Analysis of Global Burden, Risk Factors, Maternal and Foetal Outcomes Open
View article: Predicting the next pandemic: VACCELERATE ranking of the World Health Organization's Blueprint for Action to Prevent Epidemics
Predicting the next pandemic: VACCELERATE ranking of the World Health Organization's Blueprint for Action to Prevent Epidemics Open
Influenza, SARS-CoV, SARS-CoV-2, and Ebola virus were found to be the most concerning pathogens with pandemic potential, characterised by transmissibility through respiratory droplets and a reported history of epidemic or pandemic outbreak…
View article: The Challenges of Vaccine Trial Participation among Underserved and Hard-to-Reach Communities: An Internal Expert Consultation of the VACCELERATE Consortium
The Challenges of Vaccine Trial Participation among Underserved and Hard-to-Reach Communities: An Internal Expert Consultation of the VACCELERATE Consortium Open
Underserved and hard-to-reach population groups are under-represented in vaccine trials. Thus, we aimed to identify the challenges of vaccine trial participation of these groups in member countries of the VACCELERATE network. Seventeen Nat…
View article: 2356. Close correlation of RBD with Live Viral Neutralising Capacity Across Variants and Time Supports Use of RBD Thresholds to Predict Protective Host Immunity
2356. Close correlation of RBD with Live Viral Neutralising Capacity Across Variants and Time Supports Use of RBD Thresholds to Predict Protective Host Immunity Open
Background Although SARS-CoV-2 neutralising antibodies protect against severe COVID-19, whether circulating IgG titres reflect underlying host capacity to neutralise wild type (WT) and variants of concern (VOC) and what IgG threshold refle…
View article: 2338. Robust and Persistent B Cell Responses Following Third Dose SARS-CoV-2 Vaccine Determine Protection from COVID-19
2338. Robust and Persistent B Cell Responses Following Third Dose SARS-CoV-2 Vaccine Determine Protection from COVID-19 Open
Background The immunological memory to SARS-CoV-2 (SCV-2) vaccination has multiple components, with robust antibody (Ab) and B cell responses demonstrated post vaccination. The extent and persistence of T cell responses to vaccination rema…
View article: Distinct receptor binding domain IgG thresholds predict protective host immunity across SARS-CoV-2 variants and time
Distinct receptor binding domain IgG thresholds predict protective host immunity across SARS-CoV-2 variants and time Open
View article: Vaccine Hesitancy among Healthcare Workers in Europe: A Systematic Review
Vaccine Hesitancy among Healthcare Workers in Europe: A Systematic Review Open
This study analyzes vaccine hesitancy (VH) among healthcare workers (HCWs) in 15 European countries. We have undertaken a systematic review by synthesizing data from 46 articles (between 2015 and 2022) encompassing 55,612 subjects. Despite…
View article: Potential business model for a European vaccine R&D infrastructure and its estimated socio-economic impact
Potential business model for a European vaccine R&D infrastructure and its estimated socio-economic impact Open
Background Research infrastructures are facilities or resources that have proven fundamental for supporting scientific research and innovation. However, they are also known to be very expensive in their establishment, operation and mainten…
View article: Measles vaccine uptake among Italian medical students compared to the pre-COVID-19 era
Measles vaccine uptake among Italian medical students compared to the pre-COVID-19 era Open
The COVID-19 pandemic has severely affected health systems worldwide and raised the issue of vaccine hesitancy. In 2022, the World Health Organization reported an outbreak of measles infection among people over 20 years of age in the Europ…
View article: Enhancing Public Health Communication Regarding Vaccine Trials: Design and Development of the Pan-European VACCELERATE Toolkit
Enhancing Public Health Communication Regarding Vaccine Trials: Design and Development of the Pan-European VACCELERATE Toolkit Open
Background The pan-European VACCELERATE network aims to implement the first transnational harmonized and sustainable vaccine trial Volunteer Registry, being a single entry point for potential volunteers of large-scale vaccine trials across…
View article: Vaccination rates in Europe are not associated with online media intensity
Vaccination rates in Europe are not associated with online media intensity Open
To map the public information about COVID-19 vaccines and vaccine trials in Europe, we have compiled an inventory of online communication materials from official sources (e.g., governments, public agencies, and NGOs) via directed online re…
View article: Proceedings of the 14th Annual Conference on the Science of Dissemination and Implementation in Health
Proceedings of the 14th Annual Conference on the Science of Dissemination and Implementation in Health Open
Background:Annually, over 600,000 adults served in U.S. trauma centers (≥ 20%) develop posttraumatic stress disorder (PTSD) and/or depression in the first year after injury.American College of Surgeons guidelines strongly recommend screeni…
View article: VACCELERATE Volunteer Registry: A European study participant database to facilitate clinical trial enrolment
VACCELERATE Volunteer Registry: A European study participant database to facilitate clinical trial enrolment Open
The VACCELERATE Volunteer Registry is an active single-entry point for European residents interested in COVID-19 clinical trials participation in 12 countries (i.e., Austria, Cyprus, Germany, Greece, Ireland, Lithuania, Norway, Portugal, S…
View article: Funders' Perspectives on Supporting Implementation Research in Low- and Middle-Income Countries
Funders' Perspectives on Supporting Implementation Research in Low- and Middle-Income Countries Open
We identify and discuss 7 approaches for funders to contemplate when considering support for implementation research in low- and middle-income countries.
View article: VACCELERATE: Volunteer Registry: A European Study Participant Database to Facilitate Clinical Trial Enrolment
VACCELERATE: Volunteer Registry: A European Study Participant Database to Facilitate Clinical Trial Enrolment Open
View article: A Mechanism for Reviewing Investments in Health Research Capacity Strengthening in Low- and Middle-Income Countries
A Mechanism for Reviewing Investments in Health Research Capacity Strengthening in Low- and Middle-Income Countries Open
More than 40 agencies that fund health research capacity strengthening in low- and middle-income countries (LMICs) participate in the ESSENCE Health Research initiative, which has established a mechanism for reviewing and coordinating thei…
View article: World RePORT: a database for mapping biomedical research funding
World RePORT: a database for mapping biomedical research funding Open
In response to the 1990s HIV/AIDS pandemic ravaging sub-Saharan Africa, global research funders expanded portfolios in the region and massively increased HIV/AIDS research investments. This support has grown substantially over time but wit…
View article: It is not enough that we require data to be shared; we have to make sharing easy, feasible and accessible too!
It is not enough that we require data to be shared; we have to make sharing easy, feasible and accessible too! Open
► The sharing of health data, including clinical trial data, is required more and more often by research publishers, regulatory agencies, ethics committees and funding bodies.► Despite these requirements, there are currently no clear stand…
View article: Biomedical Research Investments in Africa: An Analysis from the World RePORT Database
Biomedical Research Investments in Africa: An Analysis from the World RePORT Database Open