Despite of the successful advances achieved to date in the fight against the COVID-19 pandemic with the development of vaccines and therapy, the worldwide propagation of SARS-CoV-2 has resulted in the rapid evolution of this virus and in the emergence of variants of concern (VOC) that may dampen the efficacy of the first generation vaccines. To tackle the challenges associated with the VOC, the CoVICIS program is proposing a global approach with a powerful state-of-the-art virologic and immunologic platforms coupled with large genomic surveillance studies and diverse cohorts in EU and SSA. This allows CoVICIS to contribute to the early identification of emerging VOC and address key unanswered questions regarding i) the susceptibility to infection with VOC after a prior infection in the setting of a long-COVID or after vaccination with different vaccines, ii) the risk posed by VOC in immunocompromised patients, and iii) the modalities of infection and immune responses in children. The diversity of the cohorts provides a unique opportunity to study virus evolution in different settings, where SARS-CoV-2-specific humoral and cellular immune responses are predicted to vary very significantly. Beyond the genomic surveillance, the ground-breaking research and innovation of the program is the characterization of virologic and immunologic properties of VOC and the identification of immune correlates of protection after disease or vaccination. CoVICIS’ ambitious goals are only achievable thanks to the existing population studies and cohorts funded by national and international public agencies and public-private partnerships, and the combined collective expertise of CoVICIS partners in the fields of epidemiology, genomics, virology, immunology, data science and public health.

Many HIV vaccine concepts and several efficacy trials have been conducted in the prophylactic and therapeutic fields with limited success. There is an urgent need to develop better vaccines and tools predictive of immunogenicity and of correlates of protection at early stage of vaccine development to mitigate the risks of failure. To address these complex and challenging scientific issues, the European HIV Vaccine Alliance (EHVA) program will develop a Multidisciplinary Vaccine Platform (MVP) in the fields of prophylactic and therapeutic HIV vaccines. The Specific Objectives of the MVP are to build up: 1.Discovery Platform with the goal of generating novel vaccine candidates inducing potent neutralizing and non-neutralizing antibody responses and T-cell responses, 2. Immune Profiling Platform with the goal of ranking novel and existing (benchmark) vaccine candidates on the basis of the immune profile, 3. Data Management/Integration/Down-Selection Platform, with the goal of providing statistical tools for the analysis and interpretation of complex data and algorithms for the efficient selection of vaccines, and 4. Clinical Trials Platform with the goal of accelerating the clinical development of novel vaccines and the early prediction of vaccine failure. EHVA project has developed a global and innovative strategy which includes: a) the multidisciplinary expertise involving immunologists, virologists, structural biology experts, statisticians and computational scientists and clinicians; b) the most innovative technologies to profile immune response and virus reservoir; c) the access to large cohort studies bringing together top European clinical scientists/centres in the fields of prophylactic and therapeutic vaccines, d) the access to a panel of experimental HIV vaccines under clinical development that will be used as benchmark, and e) the liaison to a number of African leading scientists/programs which will foster the testing of future EHVA vaccines through EDCTP

The highly integrated INCENTIVE consortium represents true partnership between Indian and European/US groups that addresses the global health and economic challenge posed by influenza infections, to reduce the worldwide burden resulting from outbreaks. INCENTIVE’s strategic goals are to provide seminal knowledge on the underlying mechanisms of poor responsiveness to influenza vaccines in vulnerable individuals and advance the development of two next generation universal influenza vaccines. This is achieved by pursing the following specific objectives: 1) address the current knowledge gap by performing comprehensive immunome profiling of responders and non-responders to licensed influenza vaccines in infants, children, adults and elderly in parallel phase IV trials in Europe and India to identify the underlying mechanisms of vaccine responsiveness in different vulnerable populations and ethnical groups; 2) advance the development of two next generation universal vaccines, including an antigen presenting cell-targeted nucleic acid vaccine up to proof-of-concept for vaccine efficacy in non-human primates, and a computationally-derived second generation COBRA (Computationally-Optimized Broadly-Reactive Antigens) vaccine up to clinical development, comprising a phase I trial in Europe, a phase II trial in India and efficacy studies using an influenza controlled human challenge model; 3) identify predictive biomarkers of responsiveness to vaccination to develop new diagnostics; 4) implement comprehensive technology transfer and harmonization activities for immunological analysis and data integration; and 5) perform a health systems and investment analysis, and discrete choice experiments to assess the suitability of the developed technologies for low- and middle-income countries and to identify potential downstream constraints that might affect uptake by health care systems.

The Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) pandemic has emerged as the largest global health threat to humanity in this century. According to the World Health Organisation Situation Report of March 28th 2020, 571,659 patients were diagnosed with Coronavirus Disease 2019 (COVID-19) and 26,493 deaths were reported globally. The wide spectrum of clinical symptoms, disease severity in high risk individuals, transmission efficiency and high mortality, raises an immediate need for vaccines or therapeutics. Given that the viral variant is new in the human population and emerged less than 4 months ago, there is no vaccine or approved therapies. The Corona Accelerated R&D in Europe (CARE) consortium is a coalition of 37 globally renowned academic institutions, pharmaceutical companies and non-profit research organizations who have committed to rapidly and efficiently address this emergent health threat, and the main objectives are: the development of therapeutics (i) to provide an emergency response towards the current COVID-19 pandemic by drug repositioning and (ii) to address the current and/or future coronavirus outbreaks by broad-spectrum small-molecule drug discovery and/or virus-neutralizing antibody discovery. To achieve this, a collection of repurposed drugs, focused libraries and small molecule libraries will be screened against SARS-CoV-2, other emerging SARS-CoV-2 clades and related coronavirus genera in phenotypic or target-based assays. A focused medicinal chemistry campaign will identify small-molecule hits, and Absorption, Distribution, Metabolism and Excretion (ADME), pharmacokinetic/pharmacodynamic (PK/PD), potency and safety of these therapeutic candidates will be assessed in vitro and in animal models. Virus-neutralizing monoclonal antibodies will be generated and further characterized. Immune markers will be identified contributing to the host immune responses to SARS-CoV-2 infections, and the correlation with clinical and virological outcomes will be determined. Finally, lead candidates will be advanced into Phase1 and Phase 2 clinical trials in humans. With this reactive response, the CARE consortium is dedicated to win the fight against coronavirus.