Periodic Reporting for period 1 - VACCELERATE (VACCELERATE - European Corona Vaccine Trial Accelerator Platform)
Berichtszeitraum: 2021-01-28 bis 2022-07-27
The Coronavirus disease 2019 (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 580,940,852 reported cases and 6,423,296 associated deaths world-wide until 6 August 2022 (WHO EMRO | COVID-19 situation updates for week 31 (31 July–6 August 2022) | COVID-19 | Epidemic and pandemic diseases).
The most successful preventive measure against infections are vaccines such as vaccination against SARS-CoV-2. 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 nzmbers 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 is 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 an urgent need to leverage the EU response to COVID-19 to build, maintain and strengthen sustainable public health capacities for 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 vaccine trial performance.
VACCELERATE is to constitute 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 such as vaccination against SARS-CoV-2. 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 nzmbers 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 is 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 an urgent need to leverage the EU response to COVID-19 to build, maintain and strengthen sustainable public health capacities for 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 vaccine trial performance.
VACCELERATE is to constitute 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 first months of the project, the overall network infrastructure of VACCELERATE was established. This included the set-up and regular meetings of different boards, such as the Coordination Office, Coordination Board, Project Management Office, Ethics and Scientific Advisory Board, Clinical Trial Access Panel, and the nomination of National Coordinators for participating countries.
For further set up of the infrastructure, internal and external communication channels were put into place, incl. a website, information material for different stakeholder groups and educational & promotional material in many European languages. These aimed to not only inform experts of the existence of the network but also engage the general public.
Additionally, the VACCELERATE Site Network was established and numbers of registered clinical trial sites were increased by national recruitment efforts over Europe.
The VACCELERATE Volunteer Registry was established in 16 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, dedicated educational and promotional material designated for the general public was designed and distributed to increase awareness and knowledge about the importance of clinical trials and the Volunteer Registry.
Next to the Site Network and the Volunteer Registry, the partners have also developed standardised assays and protocols (e.g. master protocol), to facilitate clinical trial set-up and conduct and allow for data comparability and data sharing.
The goal of the project was not only to establish a network for vaccine trials in Europe, but also make it available for use by vaccine developers and other stakeholders. Therefore, numerous consultations and discussions with vaccine developers were held over the course of the first 18 months, 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 was asked to additionally develop its own vaccine clinical trials. Through intensive discussions and collaboration among the experts, VACCELERATE has succeeded in establishing three multinational vaccine clinical trials aiming to answer public health questions on COVID-19 vaccines in specific subpopulations or on vaccine dose schedules. The trials were still ongoing at the end of the first reporting period.
For further set up of the infrastructure, internal and external communication channels were put into place, incl. a website, information material for different stakeholder groups and educational & promotional material in many European languages. These aimed to not only inform experts of the existence of the network but also engage the general public.
Additionally, the VACCELERATE Site Network was established and numbers of registered clinical trial sites were increased by national recruitment efforts over Europe.
The VACCELERATE Volunteer Registry was established in 16 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, dedicated educational and promotional material designated for the general public was designed and distributed to increase awareness and knowledge about the importance of clinical trials and the Volunteer Registry.
Next to the Site Network and the Volunteer Registry, the partners have also developed standardised assays and protocols (e.g. master protocol), to facilitate clinical trial set-up and conduct and allow for data comparability and data sharing.
The goal of the project was not only to establish a network for vaccine trials in Europe, but also make it available for use by vaccine developers and other stakeholders. Therefore, numerous consultations and discussions with vaccine developers were held over the course of the first 18 months, 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 was asked to additionally develop its own vaccine clinical trials. Through intensive discussions and collaboration among the experts, VACCELERATE has succeeded in establishing three multinational vaccine clinical trials aiming to answer public health questions on COVID-19 vaccines in specific subpopulations or on vaccine dose schedules. The trials were still ongoing at the end of the first reporting period.
VACCELERATE aims at improving the development and evaluation of 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. 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 the end of the project, VACCELERATE will provide results from the three vaccine trials running on the platform. The EU-COVAT-1_AGED trial will be answering 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 the end of the project, VACCELERATE will provide results from the three vaccine trials running on the platform. The EU-COVAT-1_AGED trial will be answering 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.