WP1 - Project Management & Network Coordination


Work package objectives:

WP1 comprises all managerial and coordinative activities that ensure VACCELERATE meets its self-defined six objectives and overall ambition. WP1 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. WP 1 guarantees that the VACCELERATE core principles of speed, inclusiveness and transparency are embraced throughout the project. The team of WP1 oversees risks with the potential to impact VACCELERATE and develops mitigation plans, within the scope of pandemic developments.

WP Lead/Consortium Coordinator:


WP2 - Communication & General Public Outreach


Work package objectives:

WP2 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. WP2 further compiles educational material for specific populations and identifies any gaps in public information about COVID-19 vaccination and vaccine trials in Europe.


WP3 - Clinical Trial Site Capacity Building


Work package objectives:

WP3 aims to provide an infrastructure capable of rapidly implementing randomized controlled trials (RTCs) related to vaccine efficacy, safety and tolerability. The European Vaccine Trial Accelerator Platform (EUVAP) 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. WP3 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.


WP4 - 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 WP3 and WP6 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.


WP5 - Public Health Needs


Work package objectives:

The goal of WP5 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 WP5 will facilitate discussions on harmonisation of COVID-19 vaccine clinical trials.


WP6 - Immune Monitoring


Work package objectives:

WP6 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.


WP7 - Data Management, Standards & Sharing


Work package objectives:

WP7 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.


WP8 - Volunteer Registries


Work package objectives:

The overall objective of WP8 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. WP8 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.


SWG - Stakeholder Working Group


Objectives:

SWG will be an open forum that facilitates strategic discussions and identification of pressing unanswered public health needs. The SWG will moderate the necessary dialogue to make decisions regarding the future development of the VACCELERATE infrastructure in Europe, in order to avoid redundancies, promoting complementarities and facilitating cooperation. This will include in particular high level strategic recommendations on the specification for vaccine trials, making optimal use of the initiatives already developed at national, European, and international level. The SWG will be constituted from the existing Trial Coordination Board (TCB) Vaccines Working Group.

Further permanent members are the VACCELERATE Coordination Board, Clinical Trial Access Panel (CTAP) and further VACCELERATE participants as needed. The SWG is open for ad hoc attendance of representatives from (patient) interest groups, to put forward specific concerns and needs. The SWG will provide the multidisciplinary forum to enable alignment of COVID-19 vaccine development and testing strategies. The SWG will gather the European Medicines Agency (EMA) and national regulatory bodies, as well as the European Centre for Disease Prevention and Control (ECDC), and other relevant European and international actors (World Health Organisation (WHO), Coalition for Epidemic Preparedness Innovations (CEPI), European Vaccine Initiative (EVI), and Health Technology Assessment (HTA) organisations such as EUnetHTA, and EFPIA, as body of the pharmaceutical industry).

The reports produced by the SWG will promote the visibility and attractiveness of the VACCELERATE infrastructure for investigators and sponsors willing to test products, alone or in combination.


VACCELERATE Team