About Us

Who we are

VACCELERATE is a clinical research network for the coordination and conduct of COVID-19 vaccine trials. The network is comprised of academic institutions from all over Europe: The consortium is led by the University Hospital Cologne, Germany, and currently includes 29 national partners in 18 EU-member states and 5 countries associated to the EU Horizon 2020 research programme.

VACCELERATE is funded by the European Commission's activities for future pandemic preparedness, the HERA Incubator, an instrument that was created in analogy to the United States' BARDA.

What we do

VACCELERATE offers expertise, services, resources and solutions to speed up existing and upcoming development programmes as well as market authorisations for new vaccines and vaccination strategies. The network serves as a single entry-point for all stakeholders in COVID-19 vaccine development (pharma, academia, European Commission, EMA, ECDC, national health authorities and others) for phase 2 and 3 trials in Europe. The network will address any research question of interest, such as vaccine efficacy in virus variants, trials in children, pregnant women, immuno-compromised patients, trials on combination of different vaccines etc. The establishment of a European Volunteer Registry for vaccine trials provides fast and efficient recruitment of trial participants (>37,000 volunteers in 15 countries: Austria, Belgium, Cyprus, Czech Republic, Germany, Greece, Ireland, Israel, Italy, Lithuania, Norway, Portugal, Spain, Sweden, Turkey, expansion to more countries ongoing).

VACCELERATE conducts capacity mapping of new clinical trial sites and laboratories with standardised methods and protocols, and provides standardised educational measures, training and quality management for harmonised vaccine trials. It already holds information on 484 clinical trial sites in 39 European countries. For details see the VACCELERATE Site Network. Harmonisation of data acquisition across all network sites enables open data exchange for valid data analysis.

Facts

  • 29 partners in 18 EU-member states and 5 countries associated to the EU Horizon 2020 research programme
  • Coordinated by University Hospital Cologne, Germany
  • Budget of € 12 Million
  • Top-up funding for three clinical trials: 14.5 M€
  • Funded by the European Union’s Horizon 2020 research and innovation programme
  • Duration 36 months
  • Start February 2021
  • Centralised information of currently 484 vaccine trial sites in 39 European countries on their capacity to perform vaccine trials
  • Volunteer registry active in 15 countries: Austria, Belgium, Cyprus, Czech Republic, Germany, Greece, Ireland, Israel, Italy, Lithuania, Norway, Portugal, Spain, Sweden, Turkey (>37,000 volunteers) 

Objectives

To provide the central platform serving as single entry-point for European stakeholders in vaccine development, by:

1. Establishing a consortium of vaccine development and clinical research excellence, with decision-making and communication structures identifying needs & delivering answers and solutions to stakeholders; and
2. Offering an open strategic forum for stakeholders from industry, SME, academia, EC, member states and public health authorities.

To build and expand a network of capable clinical trial sites and laboratories prepared to kick-start high quality phase 2 & 3 COVID-19 vaccine clinical trials in EU-member states and associated countries.

EUVAP

To ensure highest-quality data output for phase 2 & 3 vaccine trials by providing educational measures to clinical trial sites and laboratories.

ACADEMY

To provide access to clinical trial participants by establishing a registry for individuals volunteering to participate in phase 2 & 3 COVID-19 vaccine clinical trials.

VOLUNTEER-REGISTRY

To provide access to laboratory sites in Europe offering a comprehensive, standardised set of methods essential to phase 2 & 3 vaccine clinical trials.

Providing solutions for characteristic vaccine development issues during pandemics. To close gaps in public health knowledge on COVID-19 vaccines, and to improve knowledge transfer by providing access to harmonised data, protocols and assays that will speed up vaccine development and serve as blueprints for future pandemic preparedness.

To answer public health questions on COVID-19 vaccines that are unlikely to be addressed by vaccine developers, or in specific and as of yet under-represented populations and target groups.

VACCELERATE Projects

  1. EU-COVAT-1 AGED: A Multinational, Phase 2, Randomised, Adaptive Protocol to Evaluate Immunogenicity and Reactogenicity of Different COVID-19 Vaccines Administration in Older Adults (≥75) Already Vaccinated Against SARS-CoV-2
  2. EU-COVAT-2 BOOSTAVAC: An International Multicentre, Phase 2, Randomised, Adaptive Protocol to Determine the Need for, Optimal Timing of and Immunogenicity of Administering a 4th Homologous mRNA Vaccination Dose against SARS-CoV-2 in the General Population (18+ years) Already Vaccinated with the BNT162b2 Vaccine
  3. EU-COVPT-1 COVACC: A Phase 2, Comparative Randomised Trial to Evaluate the Impact of Reduced COVID‐19 mRNA Vaccination Regimen on Immunological Responses and Reactogenicity in Paediatric Subjects with Prior SARS‐CoV‐2 Immunity  
Visit „Volunteers“ for more information on the VACCELERATE Studies. 

VACCELERATE Work Packages

WP3 – Project Management & Network Coordination

Work package objectives:

WP3 comprises all managerial and coordinative activities that ensure VACCELERATE meets its self-defined six objectives and overall ambition. WP3 will ensure a swift implementation of structures and operational procedures required for successful management of the overall project, and ensures implementation of specific communication structures and procedures for coordinated management of stakeholder requests within the VACCELERATE network. WP3 guarantees that the VACCELERATE core principles of speed, inclusiveness and transparency are embraced throughout the project. The team of WP3 oversees risks with the potential to impact VACCELERATE and develops mitigation plans, within the scope of pandemic developments.

WP Lead & VACCELERATE Coordinator:

Prof. Oliver A. Cornely, MD

CECAD Cluster of Excellence University of Cologne, Center for Clinical Trials 
University Hospital Dep. I for Internal Medicine, Division of Infectious Diseases 
University Hospital, Cologne, Germany

 
 

WP4 – Communication & General Public Outreach

Work package objectives:

WP4 ensures appropriate, effective external communication about the VACCELERATE project. It is responsible for the dissemination of knowledge to the general public about COVID-19 (and future pandemic diseases). The team communicates the need and importance to conduct large vaccine trials and the benefits of vaccination and investigates the impact of vaccine hesitancy and vaccine confidence on willingness to participate in vaccine trials. WP4 further compiles educational material for specific populations and identifies any gaps in public information about COVID-19 vaccination and vaccine trials in Europe.

WP Leads:

Prof. Rebecca Jane Cox

Professor and head of the Influenza Centre, University of Bergen, Norway

Miriam Cohen Kandli, PhD

GCP/GVP, Inspectorate Unit, The Department of Clinical Trials, Ministry of Health, Israel

Work Package Results

The European Vaccine Initiative (EVI) developed an ‘Inventory and gap analysis report of existing public outreach material’ as part of VACCELERATE, the pan-European network for clinical trials of COVID -19 vaccines. This was done to identify and tackle existing gaps in public information material on COVID-19 vaccine trials in Europe, with special emphasis on identifying informational, promotional and educational material for underserved groups.

A team of reviewers at National University of Ireland Galway (NUIG) led by Pauline Meskell (University of Limerick) developed a protocol for a Cochrane Review (qualitative). The review aims to explore the factors associated with a person’s decision to take part in a pandemic or epidemic vaccine trial:

https://www.cochrane.org/MR000065/METHOD_factors-impact-recruitment-vaccine-trials-during-pandemic-or-epidemic-qualitative-evidence-synthesis

WP5 – Clinical Trial Site Capacity Building

Work package objectives:

WP5 aims to provide an infrastructure capable of rapidly implementing randomized controlled trials (RTCs) related to vaccine efficacy, safety and tolerability. The Site Network is VACCLERATE’s tool to enable Europe-wide mapping of clinical trial sites capable of conducting phase 2 & 3 COVID-19 vaccine trials. Therefore, the team evaluates current clinical study capacities, develops a mechanism for site selection and conducts site assessment based on past performance. WP5 defines minimum good quality standards and key performance indicators, and aims for harmonisation to international GCP standards by delivering educational courses for site personnel and developing Study Nurse courses.

WP Lead:

Dr. Patricia Bruijning-Verhagen

Associate Professor Infectious Diseases Epidemiology,                                            Julius Centre for Health Sciences and Primary Care, Department of Infectious Diseases Epidemiology                                                                                                      University Medical Centre Utrecht 

WP6 – Laboratory Site Capacity Building

Work package objectives:

The overall goal is to provide ‘state-of-the-art’ laboratory expertise for all vaccine clinical trials in VACCELERATE by building and maintaining a fully operational laboratory network with sites that can be selected for clinical studies with an external quality assessment. Tapping into LAB-Net, an IMI-funded infrastructure within the COMBACTE projects, VACCELERATE will provide access to a Europe-wide network of more than 800 laboratories in 41 countries. The team develops, validates and deploys detection assays for circulating and new SARS-CoV-variants during the clinical vaccination studies and validates and deploys next-generation tests. It provides together with WP5 and WP8 study-specific training to sites selected to participate in clinical studies and assists in finalising clinical protocols by adjusting SOPs, in line with the study objectives for standardised and harmonised sampling. The goal is to perform targeted and whole genome sequencing determination from specimens from vaccinated individuals developing respiratory symptoms. This provides information about evolution of the virus and enables identification of potential virulence markers, and emergence of markers of resistance to vaccination. This work will expand the existing PREPARE and RECOVER biobank with patient informed consent, well-characterised clinical samples collected in clinical vaccine trials for use in further studies.

WP Lead:

Prof. Herman Goossens

University of Antwerp, VAXINFECTIO, Laboratory of Medical Microbiology, Antwerp, Belgium

Work Package Results

Standard Operating Procedures (SOPs)

One aim of WP6 is to produce a standard set of Standard Operating Procedures (SOPs) that allow harmonisation of the laboratory procedures used in the VACCELERATE network to minimise the variation of the analytical assessments, standardising the measurements to facilitate the head-to-head comparison across different laboratories.
In the harmonization process of the laboratory assays, rigorous quality control (QC) and validation parameters are implemented to ensure the robustness, reproducibility, specificity, and sensitivity. Including the utilization of WHO/BIBSC biological controls/standards, which will allow the results to be expressed in International Standard Units where applicable.
In the overview you can find a list SOPs that were developed. These documents were developed for the VACCELERATE partners who can contact us to receive the full versions: info@vaccelerate.eu

WP7 – Public Health Needs

Work package objectives:

The goal of WP7 is to establish 1) a living document of completed, running, and planned clinical trials evaluating COVID-19 vaccines and 2) a living systematic review (with meta-analysis) of identified completed COVID-19 vaccine trials. The team will conduct a living monitoring of trial quality and transparency with a feedback to investigators and the community to improve future trials. It will additionally identify gaps in public health knowledge on COVID-19 vaccines and vaccination in general based on the systematic review and stakeholder involvement. By developing phase 2 & 3 master protocol templates based on identified gaps and harmonisation results, the work of WP7 will facilitate discussions on harmonisation of COVID-19 vaccine clinical trials.

WP Lead:

Dr. Jesús Frías Iniesta

Clinical Pharmacology Service, La Paz University Hospital- Idipaz & Department of Pharmacology, School of Medicine, Universidad Autonoma de Madrid, Spain

Work Package Results

Identifying and filling public health knowledge gaps in COVID-19 vaccine development has been deemed one of the key network objectives and included as one of the work streams within VACCELERATE. This work is based on close collaboration with other work streams within VACCELERATE, general public outreach and is anchored in a broad European and international dialogue about new COVID-19 vaccine clinical trials aiming to inform both ongoing and future studies through a living document of priority questions that reflects knowledge gaps and emerging priorities from the public health perspective.

In spring 2021, a stakeholder survey helped us identify a list of emerging and unanswered public health and clinical research questions in relation to vaccine safety, efficacy, vaccination schemes. A total of 89 responses to the stakeholder survey have been received, resulting in 148 submitted priority topics. Responses have been received from 23 countries across the EU but also associated countries via clinical sites registered in the EUVAP platform.

The survey replies have been grouped and compiled into a final list of 17 priority questions that are listed below.
From these findings 3 top public health priority questions for future COVID-19 trials have been identified in November 2021. 
The survey is repeated regularly. 

Further information and the full report can be found here:

https://chip.dk/Research/Studies/VACCELERATE/Report

https://www.chip-crf.info/redcap/surveys/?s=49RYXRWXTY 

https://chip.dk/Portals/0/files/VACCELERATE/VACCELERATE_WP7_D7.4_Report_w_appendixes_V1_11-11-2021.pdf

https://chip.dk/Portals/0/files/VACCELERATE/VACCELERATE_WP7_D7.6_Report_V1.0w_appendixes.pdf

https://chip.dk/Portals/0/files/VACCELERATE/VACCELERATE%20Public%20Health%20priority%20questions%20for%20future%20COVID-19%20vaccine%20trials%20-%202022FEB08.pdf

 

PRIORITY QUESTIONS IDENTIFIED BY VACCELERATE SURVEY

Vaccine administration 

  1. How can immunisation schedule (booster timing and number) and technologies (vaccine dose and type) be optimised to ensure maximum protection?
  2. What is the comparative advantage of heterologous vs. homogenic vaccination in terms of efficacy, safety and duration of protection?
  3. Can novel vaccines achieve non-inferiority efficacy and safety by non-parenteral route and possibly with only one dose?
  4. What should the vaccination strategy be for recovered patients?

Vaccination in immunocompromised 

  1. What is the vaccine efficacy and are there other immunological correlates of protection than antibodies in various immunocompromised groups?
  2. How can immunisation schedule (booster timing and number) and technologies (vaccine dose and type) be optimised for the immunocompromised group to ensure maximum protection?

Pediatric vaccination 

  1. What is the efficacy and the specific immune response to the vaccine in children, including immunocompromised pediatric population?
  2. What are the long-term safety considerations of vaccination in children?
  3. What is the relationship in terms of protection between vaccination and immuno-mediated diseases such as MIS-C?

Long-term protection and immunity 

  1. How long does immunity (humoral-cellular) last after vaccination with current vaccines?
  2. Are currently available vaccines effective against SARS-CoV-2 variants in the short- and long-term and is there a need to develop new vaccine to protect against the VOCs?
  3. What is the best measure of protective immunity after vaccination at the individual level and when after vaccination should it be taken?

Protection against new variants 

  1. Are currently available vaccines effective against SARS-CoV-2 variants in the short- and long-term and is there a need to develop new vaccine to protect against the VOCs?

Long-term vaccine safety/side effects 

  1. What are the long-term adverse side effects of vaccination in terms of vaccine-related or vaccine-induced diseases (autoimmune, oncologic, fertility etc.)?

Infection transmission prevention 

  1. Are current vaccines and vaccine strategies effective in preventing SARS-CoV-2 transmission?

Public health/policy 

  1. How can awareness of and confidence in vaccine programmes be improved to address vaccine hesitancy and misinformation with focus on specific population groups?
  2. How can wide-scale global vaccination coverage be ensured within reasonable timelines, especially in resource-limited settings?

In November 2021 a new survey was circulated among the VACCELERATE Consortium focused on the revision of the initial list of priority questions identified in D7.4 First report on unanswered COVID-19 vaccines and vaccination priority questions for future trials was finalised in September 2021.

The survey aimed to rank the list of the 17 priority questions and identify the top 3 most important unanswered questions for potential upcoming COVID-19 vaccines clinical trials to address as well as collect any new emerging questions. Below you can find the list of the top 3 priority questions identified by the survey respondents. 

1. How can immunisation schedule (booster timing and number) and technologies (vaccine dose and type) be optimised to ensure maximum protection (incl. immunocompromised groups)?

2. How can awareness of and confidence in vaccine programmes be improved to address vaccine hesitancy and misinformation with focus on specific population groups?

3. How long does immunity (humoral-cellular) last after vaccination with current vaccines?

Proposed new priority questions for future COVID-19 vaccine studies (March 2022)

WP8 – Immune Monitoring

Work package objectives:

WP8 will focus on compiling, and establishing a comprehensive catalogue of standardised immunological and genetic assays for COVID-19 vaccines that can be rolled out across the network. This enables a direct comparison of results from different laboratories which in turn facilitates the design and implementation of multi-site clinical trials. The catalogue will include standardised assay protocols for humoral, cellular, mucosal immune monitoring, and assays for genetic variants. The team aims to align and standardise protocols, reagents, and standards (such as international antibody standards from NIBCS) with other major initiatives and networks such as CEPI’s consortium of centralised COVID-19 labs, WHO’s ACT Accelerator and NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV). The team will also review available scientific data to identify and prioritise additional immune monitoring assays that should be developed in the future.

WP Leads:

Prof. Jean-Daniel Lelièvre

Institut national de la santé et de la recherche médicale (INSERM), France

 

Prof. Ole F. Olesen

European Vaccine Initiative (EVI), Germany

Work Package Results and Protocols

Flow Cytometry based-Live SARS-CoV-2 Micro-Neutralisation assay
Dr. Virginie Gautier, Associate professor in Virology, Centre for Experimental Pathogen Host Research (CEPHR), School of Medicine, University College Dublin (UCD), Ireland

Protocol for Cellular Immune Response Assays (Institute of Health Carlos III)
Dr. Jordi Ochando

Protocol for Humoral Immune Response Assays (University of Bergen)
Prof. Rebecca Jane Cox Brokstad

Protocol for the Collection and Handling of Biological Materials
WP4

Anti-Sars-Cov-2 (Spike, Nucleocapsid and RBD) IgG Protocol for MSD Platform
Alejandro Abner Garcia Leon (UCD Dublin School of Medicine)

Protocol on the Preparation of PBMCs
WP4

Protocol on Whole Blood Processing
(WP4)

Protocol on Sample Handling (WP4)

WP9 – Data Management, Standards & Sharing

Work package objectives:

WP9 aims to develop a data management toolbox to be able to propose standardised data management services, promoting interoperability of data across vaccine trials using the VACCELERATE network. This maximises the speed and efficiency of study setup, for example by promoting a standardised set of outcomes, data items and data collection instruments. It additionally maximises the efficiency of data collection, promoting data collection protocols that can be shared between different vaccine trials, using a single data collection system. The team aims to maximise the ‘FAIRness’ and thus the scientific value of the generated data, by 1) ensuring it is well described by metadata, 2) promoting the deposition of data and documents into repositories, and 3) promoting de-identification and other data preparation steps, as well as 4) ensuring data is as inter-operable as possible.

WP Lead:

Dr. Jacques Demotes

Director General of ECRIN,                                                                                              European Clinical Research Infrastructure Network (ECRIN), France

WP10 – Volunteer Registries

Work package objectives:

The overall objective of WP10 is the design and implementation of an EU-wide, dynamic, harmonised, and sustainable Volunteer Registry for phase 2 & 3 vaccines clinical trials with an initial focus on the COVID-19 pandemic, and for the future expansion to any forthcoming European epidemic/pandemic. It will be built on the recently established German Volunteer Registry and is currently expanding to four other countries, with 12 other countries on the way. WP10 strives to expand volunteer registries from healthy individuals to patients in specific sub-groups which is an essential resource for the identification of eligible volunteers for phase 2 & 3 vaccine clinical trials and can also be used to facilitate access to populations underrepresented in current vaccine trials. The added values of VACCELERATE for vaccine developers lie in the specific expertise needed for vaccine trials, combined with access to volunteers with or without co-morbidities, in- and out-patient settings, and the capacity to enrol a high number of participants in a short period of time.

WP Lead:

Zoi Dorothea Pana, MD, MSc, PhD

Lecturer in Pediatrics,                                                                                                  Subspecialty Epidemiology, Infection Control and Prevention (EUC, CY), European University of Cyprus (EUC); Ministry of Health (CY), Cyprus

Work Package Results

The Volunteer Registry is available for different countries and in several local languages. More countries are joining. More than 37,000 volunteers already registered.

Countries active in the volunteer registry

Countries in activation process

Countries with translations in process

Countries with translations in process

More information and registration on the Volunteer Registry Website.

Work Package 10 developed a large variety of promotional materials including posters, brochures, flyers, videos, educational cards and puzzles for children. All of these were translated to different languages. You can find all materials in all languages on the website of the VACCELERATE Volunteer Registry. 

Videos

You can watch the videos created by WP10 here: https://vaccelerate.eu/videos/. More videos on VACCELERATE topics can be found on our YouTube channel. You can download the promotional material here: https://www.dropbox.com/sh/hfaom2vslyqa1nh/AACRgKHKhcxlM0xVvASMvAQ9a?dl=0.

Posters

Flyers

This flyer is also available in Czech, French, German Greek, Hebrew, Italian, Portugese and Spanish.

Brochures

This brochure is also available in Czech, French, German, Greek, Hebrew, Italian and Spanish.

Educational Cards

A total of 5 sets of educational cards were designed, each including a QR code linked with a URL (web address) on one side and additional text and characters on the other. The URL can be a website (e.g. https://www.vaccelerate.eu/) and/or selected videos from trustful sources (i.e. WHO, UNICEF, EUPATI, European vaccination portal, COVAX, GAVI) and produced animation videos from WP10.   

1st set of educational cards

Educational aim: increase literacy for vaccine trials, trial registries, participation in vaccine trials, trial process and participant process in trials
Trustful source: EUPATI tool
Target population: all citizens above 12 years of age
Second page QR code the link below for each question from EUPATI tool
Total Number of cards: 25 

2nd set of educational cards

Educational aim: increase literacy on COVID-19 vaccination and mRNA vaccines
Target group age: all citizens above equal 12 years of age
Trusted source: European vaccination portal (EVI)
Front page QR code: https://www.vaccelerate.eu/volunteer-registry/index.html
Second page QR code: the link below for each question from EVI
Total Number of cards: 10

3rd set of educational cards

Educational aims: increase literacy on vaccine development, vaccine approval process, safety monitoring and awareness against vaccine misinformation
Target group age: all citizens above equal 12 years of age
Trusted source: European Vaccination portal (EVI) and ECDC
Front page QR code https://www.vaccelerate.eu/volunteer-registry/index.html
Second page QR code the link below for each question
Total number of cards: 7 

4th set of educational cards

Educational aims: increase awareness and information about the VACCELERATE Volunteer Registry
Target group age: all citizens irrespectively of age
Trusted source: VACCELERATE site (https://vaccelerate.eu/)
Front page: QR code with the animation by the Graphic Designer on the slogan “be the missing piece”
Second page: at the other page QR code with the link of the vaccelerate volunteer registry
(https://www.vaccelerate.eu/volunteer-registry/index.html)
Total Number of cards: 4

5th set of educational cards

Educational aims: increase literacy on COVID-19 vaccination, increase awareness for COVID-19 vaccine equity and utilitarianism
Target group age: all citizens irrespectively of age
Trusted source: WHO/ COVAX/ UNICEF/ GAVI
Front page QR code https://www.vaccelerate.eu/volunteer-registry/index.html
Second page QR code: the link below for each question
Total Number of cards: 12 

Puzzles

WP11 – Immunogenicity of mRNA-based Booster Vaccination Doses in Elderly 

Work package objectives:

The key objective for WP11, together with WP12, is the set-up of the master protocol trial platform “A multinational Phase 2, Randomised, Evaluator-Blinded, Adaptive Master Protocol to Evaluate the Impact of Different COVID-19 Vaccine Booster Strategies in Adults Already Vaccinated Against SARS-CoV-2” and the conduct of two respective subtrials run on the platform. The overarching primary objective is the evaluation of the immune response against wild-type SARS-CoV-2 following different mRNA-based COVID-19 vaccine booster strategies in the adult population. As overarching secondary objectives, safety of COVID-19 booster vaccines as well as the humoral immune response against SARS-CoV-2 variants of concern (VOCs).

The two trials are anticipated to be conducted at up to 24 clinical trial sites in up to eight European countries. All samples will be analysed in selected central lab(s) in Europe.

WP Lead:

Prof. Oliver A. Cornely, MD

CECAD Cluster of Excellence University of Cologne, Center for Clinical Trials 
University Hospital Dep. I for Internal Medicine, Division of Infectious Diseases 
University Hospital, Cologne, Germany

WP12 – Requirement and Optimal Timing of mRNA-based Booster Vaccination Doses in Adults

Work package objectives:

The key objective for WP11, together with WP12, is the set-up of the master protocol trial platform “A multinational Phase 2, Randomised, Evaluator-Blinded, Adaptive Master Protocol to Evaluate the Impact of Different COVID-19 Vaccine Booster Strategies in Adults Already Vaccinated Against SARS-CoV-2” and the conduct of two respective subtrials run on the platform. The overarching primary objective is the evaluation of the immune response against wild-type SARS-CoV-2 following different mRNA-based COVID-19 vaccine booster strategies in the adult population. As overarching secondary objectives, safety of COVID-19 booster vaccines as well as the humoral immune response against SARS-CoV-2 variants of concern (VOCs).

The two trials are anticipated to be conducted at up to 24 clinical trial sites in up to eight European countries. All samples will be analysed in selected central lab(s) in Europe.

WP Lead:

Prof. Patrick Mallon, MD

Professor of Microbial Diseases, UCD School of Medicine and Consultant in Infectious Diseases, St Vincent's University Hospital, University College Dublin, Ireland

WP13 – COVID-19 mRNA vaccination regimen in children aged 12-16 years

Work package objectives:

While children are much less affected by the (severe) consequences of SARS-CoV-2 infection, paediatric vaccination may prove relevant to maintain low community transmission when lifting non-pharmaceutical interventions. The objective of WP13 is to set-up and conduct paediatric COVID-19 vaccine trials that help inform optimal COVID-19 vaccination strategies in children and adolescents.

WP Lead:

Dr. Patricia Bruijning-Verhagen

Associate Professor Infectious Diseases Epidemiology                                            Julius Centre for Health Sciences and Primary Care, Department of Infectious Diseases Epidemiology
University Medical Centre Utrecht 

Our WP Leads about their Work Packages:

VACCELERATE Work Package Leads 2022

Meet the VACCELERATE Work Package Leaders: https://www.youtube.com/watch?v=0xDxa5a0K9A

Coordination Office Cologne, Germany

VACCELERATE National Coordinators

VACCELERATE National Coordinators 2022

Meet the VACCELERATE National Coordinators for each participating country: https://www.youtube.com/watch?v=ilVsI0erlHI&t=1s

VACCELERATE Project Managers

VACCELERATE Partner Portraits – Get to know the team behind

FAQ: Frequently Asked Questions

Consortium Qs & WP3 – Project Management & Network Coordination

What kind of trials do you run?

We run phase 2 and phase 3 vaccine trials, with hundreds to thousands of participants with an initial focus on the COVID-19 pandemic, and for the future expansion to any forthcoming European epidemic/pandemic.
We aim primarily at specific trials closing knowledge gaps rapidly especially in populations underrepresented in current vaccine trials (children, pregnant or breast-feeding women, individuals with comorbidities, immunosuppression, or allergies).

Why do we need more clinical trials when we already have 4 approved vaccines?

More technologies should be tested and operational in case of new virus variants in addition to improving vaccine handling & distribution and trials in underrepresented populations.

How are Member States involved?

In order to grow the existing site network within the Site Network, National Coordinators of each Member State are the key. They have been selected by their peers based on their clinical trial expertise, representation, and responsiveness. National Coordinators are the VACCELERATE Member State ambassadors and will encourage the enrolment of additional sites in their respective countries and will identify pre-existing national networks of clinical trial sites that should be offered to align with VACCELERATE.

How does VACCELERATE interact with authorities, e. g. EMA, ECDC, or WHO, and sponsors of clinical trials?

VACCELERATE will bring together stakeholders, including public health authorities, vaccine developers, clinical trial sites and laboratories, and existing study networks across Europe into one VACCELERATE network. Through the Site Network, VACCELERATE has already matched sponsors and clinical sites in several countries for ongoing phase 2 & 3 COVID-19 vaccine clinical trials. Once VACCELERATE is operational as the European single entry-point for vaccine developers, many further collaborations are expected to follow. These will focus on COVID-19 for now but will expand to vaccines against other diseases in the future.

WP4 – Communication & General Public Outreach

How will VACCELERATE ensure all vulnerable groups are included in clinical trials & also to overcome vaccine hesitancy?

VACCELERATE will develop targeted information packages which will be available in all European languages. These are adapted to the intended population i.e. cartoon videos for children. Vaccine hesitancy will be addressed through systematic reviews of available information and specific and clear information material to dispel myths about vaccines and clinical trials.

WP5 – Clinical Trial Site Capacity Building

What is the added value of a European clinical trials network?

A permanent vaccine trials network across Europe ensures an adequately prepared infrastructure to rapidly initiate vaccine studies across different vaccine types, as well as age- and patient-groups. The network is of critical value for the conduct of such randomized controlled trials (RCTs) on vaccine efficacy, safety and tolerability within a relevant timeframe to guide evidence-based vaccine development.

Explain how the decisions / prioritisation is done

When a vaccine developer seeks clinical trial sites for a new clinical trial, the VACCELERATE team is contacted to identify sites that match the required selection criteria such as study phase, geographical area, enrolment capacity, trial experience, etc. The VACCELERATE team notifies matching sites about the study which have previously provided their profile through the Site Network. In the future, this will be routed through the respective National Coordinators, to maintain an overview at country level.

WP6 – Laboratory Site Capacity Building

What is the added value of a European laboratory network?

A fully operational laboratory network is essential to support the clinical studies. In Europe, such a network has been built in more than 40 countries, with support from the European Commission. Labs will be trained study-specifically to achieve standardised and harmonised sampling and to deploy next-generation diagnostic methods.

How will VACCELERATE monitor new variants?

Exhaustive etiologic diagnosis will be performed on the samples collected from patients included in the vaccination trials. Subsequently, we will perform targeted and whole genome sequencing providing information about evolution of the virus, enable identification of potential virulence markers, and emergence of markers of resistance to vaccination. Sequencing data will feed into the European COVID-19 Data Platform.

WP7 – Public Health Needs

What public health needs does VACCELERATE address?

VACCELERATE will:

  • continuously monitor COVID-19 trial quality and results to improve future trials.
  • answer gaps in public health knowledge on COVID-19 vaccines and vaccination in general.
  • will give us information for future vaccine trials.
  • will work on answering vaccination questions related to ethnicity and gender issues, as well as for other populations such as paediatric, pregnant, breast feeding, and patients with specific comorbidities, immunosuppression, or allergies.
  • will aim to close other gaps, such as the utility of COVID-19 vaccine combinations, the length of immunity or the influence of certain virus mutations on vaccine efficacy.
What are the groups where clinical trials are needed most?

Children, immunosuppressed patients, chronic diseases, the extremes of age, pregnant or breast-feeding women.

WP8 – Immune Monitoring

What are the added values of immune monitoring in VACCELERATE?

A1: Standardisation of neutralising antibody assays: Phase 3 clinical trials have shown the efficacy of several candidates. However, at present the protective immunological correlates (biomarker) are not precisely determined. Neutralising antibodies appear to be good candidates but the lack of standardisation for this assay makes it difficult to compare one assay to another. This standardisation will be one of the objectives of VACCELERATE, thus allowing comparison between different vaccines and also in the study of the response against the different variants.

A2: Standardisation of the T-cell response: The human immune response consists of two distinct elements, namely an antibody response and a cellular (or T-cell) immune response. Remarkably, both immune responses appear important to elicit a strong and lasting protection against the virus. However, the T-cell response is much less analysed at present, although it could be one of the important elements to be stimulated with future vaccine candidates. This is because the parts of the virus that stimulate the T-cell response are different from those that induce antibody responses, and therefore variants are unlikely to have the same impact on the antibody and the T-cell response. The T-cell response is therefore a key element in understanding, together with the antibody response, to determine the clinical response to the variants. The standardisation of this assay and its comparison from one clinical trial to another seems indispensable, and could pave the way for a more intelligent use of vaccines and combination of different vaccines in the future.

A3: Standardisation of the mucosal immune response: This response is currently poorly studied even though it is the key element allowing to analyse the protection not only against the disease (end point of phase 3 clinical trials) but also against the infection and therefore against transmission. The analysis of the mucosal immune response and its standardisation are therefore essential elements in defining effective vaccine strategies at the collective level.

A4: Harmonisation with global initiatives: There are currently a large number of clinical trials ongoing around the world. Each of these have their own unique properties and many use slightly different methods for analysing the immune responses. Developing a standardised and validated set of immune monitoring assays for COVID-19 vaccine trials in VACCELERATE can put Europe in a strong position for global standardisation and collaboration in this area.

WP9 – Data Management, Standards & Sharing

How will the network make the best possible use of the clinical trial data?

VACCELERATE will offer services promoting harmonised data collection and management, both in terms of content (clinical outcomes) and of data standards, making data from multiple trials interoperable and available for secondary analyses. It will also promote data sharing solutions compliant with the European regulations, hosted by the EU COVID-19 Data Portal.

WP10 – Volunteer Registries

What is the added value of the Volunteer Registry in VACCELERATE?

The three main pillars of the VACCELERATE EU consortium are SPEED- TRANSPARENCY- INCLUSIVENESS. The overall objective is the design and implementation of an EU-wide, dynamic, harmonised, and sustainable Volunteer Registry for phase 2 & 3 vaccine clinical trials with an initial focus on the COVID-19 pandemic, and for the future expansion to any forthcoming European epidemic/pandemic. The Registry can be used to facilitate access to populations underrepresented in current vaccine trials. Not all European countries have implemented such an infrastructure, so the consortium will strive to expand volunteer registries, from healthy individuals to patients in specific sub-groups. Thus, added values of VACCELERATE for vaccine developers lie in the specific expertise needed for vaccine trials, combined with access to volunteers with or without co-morbidities, in- and out-patient settings, and the capacity to enrol a high number of participants in a short period of time.