Periodic Reporting for period 2 - VACCELERATE (VACCELERATE - European Corona Vaccine Trial Accelerator Platform)
Periodo di rendicontazione: 2022-07-28 al 2024-01-27
The COVID-19 pandemic is cause by infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and created an unprecedented burden for individuals and societies worldwide. Despite lockdowns in many countries and standstill of everyday life, the infection number reached hundred million cases and millions of associated deaths world-wide.
The most successful preventive measure against infections are vaccines. And although many millions of individuals have up to now been safely vaccinated, many public health questions remain unanswered, e.g. on long-term immune response, safety, and efficacy of COVID-19 vaccines in vulnerable populations or in face of increasing numbers of different SARS-CoV-2 variants.
Even though many clinical trials have been conducted and have proven the safety and efficacy of the developed vaccines, not many trials have been performed in Europe. Europe is thus much less attractive for vaccine developers and the European vaccine development landscape appears scattered, difficult to access and to navigate.
Europe has been lacking a strategic forum addressing urgent questions on COVID-19 vaccination and offering a single entry-point for public health authorities and vaccine developers to guide on COVID-19 clinical vaccine trials for Europe. There is still an urgent need to leverage the EU response to COVID-19 to build, maintain and strengthen sustainable public health capacities for future emergency pandemic preparedness.
VACCELERATE has been created to be the pan-European structure accelerating phase 2 & 3 clinical COVID-19 vaccine development, to connect and exploit the vast European expertise and channel this expertise to rapidly build a and provide a platform for also other vaccine trials for future pandemic preparedness.
VACCELERATE is constitutes as a preparedness network for large-scale phase 2 & 3 vaccine trials, to bring together the European expertise in vaccine trials into one network; to set up an ambitious infrastructure that will adequately prepare Europe for future epidemic and pandemic response in a wider context of emerging diseases.
The most successful preventive measure against infections are vaccines. And although many millions of individuals have up to now been safely vaccinated, many public health questions remain unanswered, e.g. on long-term immune response, safety, and efficacy of COVID-19 vaccines in vulnerable populations or in face of increasing numbers of different SARS-CoV-2 variants.
Even though many clinical trials have been conducted and have proven the safety and efficacy of the developed vaccines, not many trials have been performed in Europe. Europe is thus much less attractive for vaccine developers and the European vaccine development landscape appears scattered, difficult to access and to navigate.
Europe has been lacking a strategic forum addressing urgent questions on COVID-19 vaccination and offering a single entry-point for public health authorities and vaccine developers to guide on COVID-19 clinical vaccine trials for Europe. There is still an urgent need to leverage the EU response to COVID-19 to build, maintain and strengthen sustainable public health capacities for future emergency pandemic preparedness.
VACCELERATE has been created to be the pan-European structure accelerating phase 2 & 3 clinical COVID-19 vaccine development, to connect and exploit the vast European expertise and channel this expertise to rapidly build a and provide a platform for also other vaccine trials for future pandemic preparedness.
VACCELERATE is constitutes as a preparedness network for large-scale phase 2 & 3 vaccine trials, to bring together the European expertise in vaccine trials into one network; to set up an ambitious infrastructure that will adequately prepare Europe for future epidemic and pandemic response in a wider context of emerging diseases.
In the second reporting period (months 19-36) of the project, the overall network infrastructure of VACCELERATE was further expanded and solidified. The different boards, such as the Coordination Office, Coordination Board, Project Management Office, Ethics and Scientific Advisory Board, Clinical Trial Access Panel, and National Coordinators continued to meet on a regular basis and discussed latest developments of the COVID-19 pandemic, the progress of the different work package activities, the VACCELERATE vaccine trials and the future of VACCELERATE as a sustainable vaccine trial network for pandemic preparedness in Europe.
The external communication channels incl. a website, information material for different stakeholder groups and educational & promotional material in many European languages was kept up to date and published all results of the project. The external communications aimed to not only inform experts of the existence of the network but also engage the general public.
Additionally, the VACCELERATE Site Network was further advertised among European clinical trial sites and numbers of registered clinical trial sites continued to increase by national recruitment efforts over Europe.
The VACCELERATE Volunteer Registry was expanded to 26 countries and made available in the respective local languages to facilitate registration of volunteers throughout Europe and speed up recruitment in future vaccine trials. Furthermore, the dedicated educational and promotional material designated for the general public was further specified, translated and distributed to increase awareness and knowledge about the importance of clinical trials and the Volunteer Registry.
The goal of the project was not only to establish and maintain a network for vaccine trials in Europe, but also make it available for use by vaccine developers and other stakeholders. Therefore, also in the second reporting period numerous consultations and discussions with vaccine developers were held, providing expertise and support on vaccine clinical trial ideas, providing planned trials with clinical trial sites from the Site Network and aiding with subject recruitment by inviting participants from the Volunteer Registry.
Next to the network establishment, the consortium continued to work on its own vaccine clinical trials. Through intensive discussions and collaboration among the experts, VACCELERATE has succeeded in establishing and conducting three multinational vaccine clinical trials aiming to answer public health questions on COVID-19 vaccines in specific subpopulations or on vaccine dose schedules. Two of the three trials were still ongoing at the end of the second reporting period.
The external communication channels incl. a website, information material for different stakeholder groups and educational & promotional material in many European languages was kept up to date and published all results of the project. The external communications aimed to not only inform experts of the existence of the network but also engage the general public.
Additionally, the VACCELERATE Site Network was further advertised among European clinical trial sites and numbers of registered clinical trial sites continued to increase by national recruitment efforts over Europe.
The VACCELERATE Volunteer Registry was expanded to 26 countries and made available in the respective local languages to facilitate registration of volunteers throughout Europe and speed up recruitment in future vaccine trials. Furthermore, the dedicated educational and promotional material designated for the general public was further specified, translated and distributed to increase awareness and knowledge about the importance of clinical trials and the Volunteer Registry.
The goal of the project was not only to establish and maintain a network for vaccine trials in Europe, but also make it available for use by vaccine developers and other stakeholders. Therefore, also in the second reporting period numerous consultations and discussions with vaccine developers were held, providing expertise and support on vaccine clinical trial ideas, providing planned trials with clinical trial sites from the Site Network and aiding with subject recruitment by inviting participants from the Volunteer Registry.
Next to the network establishment, the consortium continued to work on its own vaccine clinical trials. Through intensive discussions and collaboration among the experts, VACCELERATE has succeeded in establishing and conducting three multinational vaccine clinical trials aiming to answer public health questions on COVID-19 vaccines in specific subpopulations or on vaccine dose schedules. Two of the three trials were still ongoing at the end of the second reporting period.
VACCELERATE aims at improving the development and evaluation of not only COVID-19 vaccines in Europe and providing a sustainable vaccine trial platform in Europe. During a pandemic, timely evaluation of vaccines to reduce the number of hospitalised patients and associated morbidity and mortality is of utmost importance. VACCELERATE aims to accelerate vaccine development, serves as a point of contact for various stakeholders, and provides a platform for conducting vaccine trials for both big pharmaceutical companies and smaller (academic) initiatives during a pandemic but also for future pandemic preparedness. It focuses on inclusion of vaccine trial sites in the Site Network, making it an important pillar of the vaccine network, but also on harmonisation of quality standards, access to laboratories and expertise, open data sharing, and facilitation of trial participant recruitment. VACCELERATE aims to standardise protocols and data, to increase comparability between trials, address scientific questions, and enhance pandemic preparedness. The network’s vision is to contribute to the long-term readiness for future pandemics and collaborate with existing infrastructures for sustainability.
The establishment of the Volunteer Registry has shown that having a database of people interested in participating in clinical trials increases the speed of recruitment enormously. Not only can the database be pre-filtered using the trial’s inclusion criteria (e.g. age, comorbidities, previous vaccinations), but can also be used to invite participants with little effort via email, that live in close distance to the clinical trial site.
Additionally, it became clear that there is a general misconception of clinical trials and the participation in a trial. Therefore, the produced educational material was greatly needed to inform the general public of procedures in clinical trial and the participation within.
Until project end, VACCELERATE will provide results from the three vaccine trials running on the platform. The EU-COVAT-1_AGED trial has answered the public health question whether a fourth COVID-19 vaccination of elderly people (75 years and older) is sufficient to increase antibody production and keep them on a sufficient level. EU-COVAT-2_BOOSTAVAC will deliver answers on the best spacing of booster doses for COVID-19 vaccination, and EU-COVPT-1_CoVacc will provide results on vaccination in children that have already been infected with COVID-19 prior to vaccination. With results from these three clinical trials, VACCELERATE will answer pressing public health questions that can impact the vaccination policies in Europe.
The establishment of the Volunteer Registry has shown that having a database of people interested in participating in clinical trials increases the speed of recruitment enormously. Not only can the database be pre-filtered using the trial’s inclusion criteria (e.g. age, comorbidities, previous vaccinations), but can also be used to invite participants with little effort via email, that live in close distance to the clinical trial site.
Additionally, it became clear that there is a general misconception of clinical trials and the participation in a trial. Therefore, the produced educational material was greatly needed to inform the general public of procedures in clinical trial and the participation within.
Until project end, VACCELERATE will provide results from the three vaccine trials running on the platform. The EU-COVAT-1_AGED trial has answered the public health question whether a fourth COVID-19 vaccination of elderly people (75 years and older) is sufficient to increase antibody production and keep them on a sufficient level. EU-COVAT-2_BOOSTAVAC will deliver answers on the best spacing of booster doses for COVID-19 vaccination, and EU-COVPT-1_CoVacc will provide results on vaccination in children that have already been infected with COVID-19 prior to vaccination. With results from these three clinical trials, VACCELERATE will answer pressing public health questions that can impact the vaccination policies in Europe.