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Ongoing projects

European Vaccines Hub for Pandemic Readiness: Europe’s Strategic Vaccine Development Initiative

This project aims to establish the European Vaccine Hub (EVH), a pan-European center dedicated to advancing public-health–relevant vaccine development.

The EVH project contributes to the development of an agreed set of pandemic-prototype vaccines and scalable technologies through a consortium of major EU Vaccine R&D institutions and manufacturers, ensuring effective coordination of national vaccine research programs. EVH aligns with the current international consensus on pandemic-vaccine development, leveraging insights from existing prototypes to enable the rapid selection and deployment of the most suitable vaccine candidates in an emerging pandemic.

EVH aims thus not only to create a reactive R&D system and knowledge hub linking powerful leading research institutions, but also initiate vaccine-development projects, refining relevant processes and procedures within its framework. The focus is on a select group of pathogens deemed critical for pandemic preparedness. From prototype design to clinical applications, the EVH drives innovation, enhance clinical evaluation capacities, and coordinate efforts with manufacturers while optimizing the digitalization of vaccine design and distribution processes.

The EVH consortium is composed of 11 Beneficiaries, 13 Affiliated and Associated entities, from 7 different countries, including leading EU organizations directly involved in vaccine development and in charge of pandemic preparedness in their own countries.

The project, started on 1st March 2025 with a duration of 4 years, has a total budget of more than €169 million, and is co-funded by the European Union.

Innovations to accelerate vaccine development and manufacture

Inno4vac is a new interdisciplinary project funded by the Innovative Medicines Initiative 2 (IMI2) focus on the design and application of new and highly advanced predictive models to allow a faster development and manufacturing of novel vaccines. It is coordinated by the European Vaccine Initiative, with the support from the Sclavo Vaccines Association as scientific coordination, and involves 41 partners from 11 different European countries, including 37 academic institutions and SMEs, as well as GSK, Sanofi Pasteur, CureVac and Takeda as industry partners.
Four main areas will be addressed by Inno4vac in an integrated manner:
(1) artificial intelligence will be used for in silico vaccine immune response and efficacy prediction;
(2) a modular computational platform will be developed for in silico modelling of vaccine bio-manufacturing and stability testing;
(3) new and improved controlled human infection models (CHIM) of influenza, Respiratory Syncytial Virus (RSV) and Clostridium difficile will be established to enable early vaccine efficacy evaluation, and
(4) novel cell-based human in vitro 3D models will be developed to reliably predict immune protection.

Further information at Inno4Vac project

PEDVAC-iNTS: Advancing Pediatric Vaccine Development Against Invasive Non-Typhoidal Salmonellosis

PEDVAC-iNTS is a collaborative research project on “Pediatric Phase I/II age de-escalation dose finding study of a vaccine against invasive non-typhoidal salmonellosis in sub-Saharan Africa”

PEDVAC-iNTS primary goal is to advance vaccine development for the use in the target population by conducting a pediatric PhaseI/II study in Ghana. The study builds on the efforts undertaken within Vacc-iNTS EC H2020 funded project, investigating vaccine safety and immunogenicity in healthy European adults. PEDVAC-iNTS evaluates additional vaccine lots using an age and dose escalation approach. Firstly, it will assess safety, in small cohorts of Ghanaian adults, children and infants, and subsequently define the optimal vaccine dose, in a larger infant cohort. Serological and transcriptomic analyses to profile the vaccine immune response are conducted. Additionally, antimicrobial susceptibility of iNTS-causing Salmonella strains, isolated in Ghana, is evaluated.

PEDVAC-iNTS is a public-private consortium of 7 partners from Europe and Ghana, involving experts from academic institutions, research institutes, small and medium-sized enterprises (SMEs) and non-profit organizations. The project, started on 1st March 2021 with a duration of 58 months, has a total budget of more than €5,6 million, and is part of the EDCTP2 programme supported by the European Union.

Further information at PEDVAC-iNTS – Vaccine for Non Tiphy Salmonella

Invasive non-typhoidal salmonellosis (iNTS) is an emerging bacterial neglected infectious disease that mainly affects children under 5 years of age and immunocompromised subjects. In 2017, iNTS was estimated to cause 59.100 deaths globally with an average case fatality rate of 14.5% (Lancet Infect Dis 2018-2019). The majority of cases are observed in sub-Saharan Africa, where iNTS is among the leading cause of community-acquired bloodstream infections. Salmonella enterica serovars Typhimurium and Enteritidis are the most commonly associated with invasive disease, causing 90% of cases (PLoS NTD 2017). There is no licensed vaccine against iNTS, and the emergence of antimicrobial-resistant strains is compromising efficacy of current affordable antimicrobials. High case fatality rates, difficult diagnosis and increasing antibiotic resistance strongly advocate for rapid development of an effective vaccine.

The aim of the Vacc-iNTS research project on “Advancing a GMMA-based vaccine against invasive non-typhoidal salmonellosis through Phase 1 trial in Europe and sub-Saharan Africa” is to advance the development of the iNTS-GMMA candidate vaccine against the invasive non-typhoidal salmonellosis (iNTS).

iNTS is an emerging bacterial neglected infectious disease responsible for a huge health and socioeconomic impact in sub-Saharan Africa. The Vacc-iNTS research project aims at bridging the gap between preclinical and early clinical development of a novel vaccine against iNTS. The iNTS-GMMA vaccine, based on the cost-effective GMMA technology, is composed of highly immunogenic outer membrane blebs used as antigen delivery system from the two most common African iNTS serotypes (Typhimurium and Enteritidis).

The objective of the Vacc-iNTS project is to conduct a Phase I study to demonstrate the safety and immunogenicity of the iNTS-GMMA candidate vaccine in healthy European and African adults, and to strengthen a collaborative network of iNTS experts to raise awareness of disease burden and favor vaccine deployment in limited-resource settings.

Vacc-iNTS is a consortium of 12 partners from 8 different countries, including iNTS-endemic countries, that involves experts from academic and research institutions. The project has a duration of 5 years and is funded by the European Commission for a total budget of 6 871 188.73 €.

For more detailed information, please visit the Vacc-iNTS website

Completed projects

The VSV-EBOVAC project, coordinated by SVA, aims to support the clinical development of a highly promising new Ebola vaccine candidate, the vesicular stomatitis virus (VSV)- vectored Zaire Ebola vaccine (VSV-ZEBOV). The World Health Organization (WHO) has identified VSV-ZEBOV as one of the three most promising Ebola vaccine candidates, and clinical trials are initiated mid 2014 in Europe and Africa.

The VSV-EBOVAC project is addressed to acquire new and critical knowledge of the innate and adaptive immune responses elicited in humans by VSV-ZEBOV vaccination, with specific emphasis on trancriptomics and metabolomics signatures. To this aim, it was constructed a consortium that brings together 12 leading international, both clinical and high tech, vaccine research institutes from 6 EU countries and USA as well as two African clinical sites. The partners provide including state-of-the art facilities and existing clinical vaccination research infrastructures that will work together to facilitate Ebola vaccine development.

This project proposes an ambitious program using cutting-edge technologies to perform an in depth characterization of the clinical samples harvested before/after VSV-ZEBOV immunization of 200 volunteers in Switzerland, Gabon and Kenya, and to extend the recently initiated clinical studies up to 12 months to identify the signatures and determinants of persistent immune responses. This will allow them to gather vital information on both the strength of the immune responses triggered by the vaccine and vaccine safety.

The VSV-EBOVAC project started in 1 of March of 2015, is a 3 year project and  received an IMI contribution of 3.9M€ and together with the funding provided by Wellcome Trust Foundation and funding to Swiss participants from the Swiss government brings the total contribution to 8M€.

for more information visit the VSV-EBOVAC website

The VSV-EBOPLUS collaborative research project on “Systems analysis of adult and pediatric responses to the VSV-ZEBOV Ebola vaccine” is aimed to decipher the immune and molecular signatures of adult and pediatric responses elicited by the rVSVrG-ZEBOV-GP vaccine, the only Ebola vaccine with demonstrated 100% protective efficacy in humans.

VSV-EBOPLUS will apply advanced cutting-edge technologies and systems vaccinology approaches to characterize the signatures of the responses to rVSVrG-ZEBOV-GP vaccination in clinical studies conducted in three different continents (Europe, Africa, US), in almost 1’000 adults, adolescents and children.

VSV-EBOPLUS is a public-private consortium of 11 partners from 8 different countries involving experts from academic and research institutions, clinical sites (Switzerland, Gabon, USA) and the rVSVrG-ZEBOV-GP vaccine manufacturer. The project, of the duration of 5 years, has a total budget of more than €15 million, and it is funded by the Innovative Medicines Initiative 2 (IMI 2) Joint Undertaking.

for more information visit the VSV-EBOPLUS website

Standardisation and development of assays for assessment of influenza vaccine correlates of protection

The human influenza virus is the causative agent of one of the most important infectious diseases in the world, causing frequent (seasonal) epidemics as well as pandemics, both of which cause significant morbidity and mortality worldwide. Influenza virus infects all age groups but children and adults over the age of 65 are most at risk of severe morbidity and mortality. Vaccination is recommended for these age groups. Vaccination remains the most effective method to control seasonal infections and the most important strategy to prepare for a possible pandemic. Despite the development and licensure of influenza vaccines along with clinical evidence of their ability to protect against influenza, the potential correlates of protection induced by these vaccines are still not fully elucidated

The availability of a tool-box of standardised, validated serological assays for human influenza vaccines, agreed and used by key parties in the private and in the public sector will have tremendous impact on the R&D process globally, and will pave the way for future investigation and definition of correlates of protection for these vaccines.

The FLUCOP project started March 2015 with a five year duration ending February 2020. The total budget is of €13,999,164 with equal contribution from the IMI and European Federation of Pharmaceutical Industries and Associations (EFPIA).

for more information visit the FLUCOP website

Advanced Immunization Technologies

Aditec is a collaborative research programme that aims to accelerate the development of novel and powerful immunisation technologies for the next generation of human vaccines. Funded from the European Union’s Seventh Programme, DG Health, scientists from 13 countries and 42 research partners from some of the most competitive European research groups from universities, research institutions and biotech companies together with top US groups on systems biology and adjuvants have come together to work on different aspects of vaccination, from basic research, new technologies to clinical trials and public health.

The main goal of the ADITEC project is to produce the necessary knowledge to develop new and powerful technologies for the next generation of vaccines. This requires an approach where diverse but complementary scientific disciplines and technologies meet.

The highly innovative project will lead to safer and more effective vaccines. We see a future where vaccines will be administered in novel manners without needles. The formulations will be optimized for different age groups because we know that new-borns sometimes need other vaccines than elderly. We will discover what the different needs are for men and women, how we can improve formulations for people with chronic diseases. All new insights and technologies will be shared with partners around the world so, in the future, we are better able to combat devastating diseases.

for more detailed information, please visit the ADITEC website

Innovation Partnership for a European Roadmap

IPROVE aims to drive current EU research efforts towards the establishment of a clear vision of the priority innovations and technologies necessary to address infectious and non-infectious threats of importance not only to global public health, but also to today’s key EU health challenges (e.g. ageing population, healthcare-associated infections, high chronic disease incidence, low levels of prevention awareness, and suboptimal use of existing cost-effective vaccines across the lifespan). The roadmap will explore how the wealth of expertise available across academia, industry, SMEs, public health institutes, and regulatory bodies can be pooled and leveraged to overcome fragmentation and removal of bottlenecks to the timely translation of breakthrough research into innovative vaccines. The project will look at the entire innovation chain, from discovery to delivery, including interventions necessary to improve education curricula, perception and awareness.

The project ended in March 2016.

The “Innovation Partnership for a Roadmap on Vaccines in Europe” (IPROVE) Consortium – financed under the EU 7th Framework Programme (FP7) – on March 16th, 2016 launched a vision for vaccine research and innovation in Europe over the next 20 years.

The roadmap, which is the first of its kind, was launched during a special European Parliament event that took place on the 16th of March and was hosted by MEPs Francoise Grossetête, Cristian-Silviu Busoi and Markus Ferber. Key opinion leaders in the field of vaccine research and development attended the event including representatives from the European Commission, the European Parliament, European Union Member States and a broad representation of the vaccines community including academia, industry, civil society and regulatory bodies.

The IPROVE roadmap will inform strategic decisions on the priorities for future vaccine investment in innovation and technological development at European Union and individual Member State level. Through a bottom-up approach involving all key stakeholders in the European vaccine field, the strategy aims to overcome fragmentation and remove bottlenecks to translation of breakthrough research into innovative vaccines.

Following a two year consultation period, the plan covers the critical areas of intervention relevant to the entire innovation value chain, defines priorities and makes recommendations to support and accelerate research in vaccines, to help steer European competitiveness in this field for the delivery and benefit of innovative prophylactic and therapeutic vaccines.

The IPROVE roadmap focuses on seven main thematic topics of consultation;

  1. Vaccine R&D
  2. Therapeutic Vaccines
  3. Production and Manufacturing
  4. Infrastructures
  5. Vaccine SME needs
  6. Training
  7. Communications and Acceptance of Vaccination

Please see and download the roadmap at: iprove-roadmap.eu/

Vaccine against Typhoid Fever for Developing Countries

Typhoid is one of the most devastating infectious diseases in developing countries. More than 21 million people get infected worldwide and over 200,000 die every year, with more than 90% of the disease burden being in Asia. In areas at high endemicity, epidemiological data show high disease incidence in young children, indicating that children below 2 years of age should be targeted for vaccination.
 

Unfortunately vaccines currently available for adults do not provide a high level of protection, providing a short-lived protection and, most importantly, they are not effective in small children.
A vaccine against typhoid effective in small children, which could be administered concomitantly with EPI vaccines, at an affordable price is one of the most needed vaccines in the developing countries, especially in Asia.
The Sclavo Vaccines Association is for the first time making possible a collaboration between the Regione Toscana, Siena University Hospital, the University of Siena and the humanitarian vaccine initiative Novartis Vaccine Institute for Global Health: together they will face the great challenges generated by the denial of rightful access to vaccines for every human being. This collaborative project is further explained below.

Project status

The Typhoid Vaccine project supported by the Association has been conceived to protect small children that today are the age class most vulnerable to the deadly consequences of the disease.

The vaccine uses the Vi polysaccharide Salmonella Typhi antigen conjugated with a protein carrier that has the potential to elicit T-cell mediated immunological memory and can effectively be used to immunize infants in developing countries.

The Vaccine has completed Phase 2 clinical trials in India, Pakistan and the Philippines showing that Vi-CRM197 is safe and immunogenic in endemic populations of all ages. Given at 9 months of age, concomitantly with measles vaccine, Vi-CRM197 shows a promise for potential inclusion in EPI schedules of countries endemic for typhoid. Study results have also been published on Lancet.

The vaccine will be produced and made available in Low Income Countries through Biological E, a manufacturer located in India, the country with the highest number of children dying for Typhoid Fever.

European Vaccine Research and Development Infrastructure

TRANSVAC2 is the follow-up project to its successful predecessor project TRANSVAC, the European Network of Vaccine Research and Development funded under FP7. The TRANSVAC2 consortium comprises a comprehensive collection of leading European institutions that propose to further advance with the previous initiative towards the establishment of a fully operational and sustainable European vaccine R&D infrastructure. TRANSVAC2 will support innovation for both prophylactic and therapeutic vaccine development based on a disease-overarching and one-health approach, thereby optimising the knowledge and expertise gained during the development of both human and animal vaccines. This will be achieved by bridging the translational gap in biomedical research, and by supporting cooperation between public vaccine R&D institutions of excellence, related initiatives and networks in Europe, and industrial partners. TRANSVAC2 will complement and integrate with existing European research infrastructures in both the public and private sectors. TRANSVAC2 will function as leverage and innovation catalyst between all stakeholders involved in vaccine R&D in Europe and -by providing integrated and overarching vaccine R&D services- will contribute to the development of effective products to address European and global health challenges, to controlling the burden and spread of infectious diseases, and reinforce the economic assets represented by vaccine developers in Europe.
The impact of TRANSVAC2 will be maximised by two external advisory bodies. An independent Scientific & Ethics Advisory Committee will provide recommendations surrounding scientific-technical and ethical issues, whereas the coordination of TRANSVAC2 with other related initiatives and the further promotion of the long-term stability of a European vaccine R&D infrastructure will be supported by a Board of Stakeholders comprising representatives of policy and decision makers, industry associations and European infrastructures.

Further information at TRANSVAC2: Improving and Accelerating Vaccine Development in Europe

Design study for an European vaccine infrastructure

Through the TRANSVAC infrastructure, state-of-the-art scientific-technical services, technical training, and innovative research and development are currently providing very significant support to European vaccine researchers and developers.

TRANSVAC-DS builds on the outstanding success and lessons learned from TRANSVAC and during the two-year project duration will further explore and prepare the establishment of a stable and truly sustainable European vaccine infrastructure. The main objective and output of TRANSVAC-DS is the preparation of a conceptual design report that will describe in detail the maturity of the vaccine infrastructure concept and be the basis for the establishment of a permanent and sustainable vaccine infrastructure of direct relevance to and benefit for Europe and further afield. As part of the design report, a five-year business plan will be delivered together with an implementation plan that will guide the further establishment of a sustainable European vaccine infrastructure.

Further information at https://www.transvac.org/transvac-ds