July 6, 2021; Oslo, Norway: The Coalition for Epidemic Preparedness Innovations (CEPI) today announced that it will co-fund a study to assess the immune response to COVID-19 vaccination in patients aged 18 years or older who are immunosuppressed or who have received an organ transplant and are receiving immunosuppressive medication. CEPI will provide US$3.1 million (NOK26 million) in funding for this trial. An additional $3.6 million (NOK30 million) is provided by a consortium of leading Norwegian health organisations including the Norwegian Institute of Public Health, Diakonhjemmet Hospital, Akershus University Hospital, Haukeland University Hospital, Sørlandet Hospital Trust, Oslo University Hospital, and the Institute of Clinical Medicine at the University of Oslo. Oslo University Hospital will lead the study.

Study design

Study participants will include those who have received an organ transplant, patients with depleted levels of B-cells (ie, the immune cells responsible for producing antibodies), patients with immunodeficiency, patients with autoimmune disease (ie, when the immune system attacks the body’s own healthy cells), and patients receiving anti-inflammatory drugs (eg, anti-TNF biological treatment).

At least 6000 patients and 10000 healthy participants who have received two-doses of COVID-19 vaccine will be recruited in Norway. Vaccines will include those that are part of the Norwegian National Corona Immunization Program (currently the Pfizer-BioNTech and Moderna vaccines).

The primary aim of this study is to establish the level of adaptive immune responses to the COVID-19 vaccines in these populations, including B-cell and T-cell responses. An additional booster dose will be offered to participants in the intervention arm of the study who have low or no immune response to vaccination and will be monitored. Researchers will also assess the effects of different immunosuppressive medications on the immune responses to COVID-19 vaccination and which clinical parameters (ie, age, gender and T-cell responses) are associated with strong adaptive immunity and protection from severe COVID-19. Data for the study will also be gathered from various Norwegian population cohorts and health registries.

Importance of the study

COVID-19 vaccine efficacy has not been systematically tested on immunocompromised patients, who have the highest risk of developing severe COVID-19, despite tens of millions of people worldwide living with suppressed or compromised immune systems either due to underlying disorders or due to medications used in organ transplantation or to treat various co-morbidities.

Within this population, SARS-CoV-2 infection can persist for months, meaning they can shed infectious virus for longer periods of time. This persistent infection also provides additional opportunities for the virus to replicate and mutate, potentially leading to the emergence of novel variants.

Given the size of this potentially at-risk population, there is an urgent need to gather these data to guide national and global vaccinations strategies, such as COVAX—the global mechanism for equitable access to COVID-19 vaccines—and to optimise the management and care of immunocompromised patients around the world.

Filling the COVID-19 R&D gaps

Funding for this study forms part of CEPI’s $140 million (NOK1.16 billion) funding call to support clinical research gaps to expand access to COVID-19 vaccines. These gaps include assessment of the safety and effectiveness of COVID-19 vaccines in pregnant women, infants and children, and immunocompromised populations, as well as studies on booster doses, length of vaccine efficacy, ‘mix and match’ strategies, and dosing intervals.

This funding forms part of CEPI’s next 5-year plan, published in March, 2021, which aims to reduce or even eliminate the future risk of pandemics and epidemics. In view of the COVID-19 emergency, CEPI has brought forward its plans to develop vaccines that could protect against COVID-19 variants and multiple coronavirus species and is working to cut vaccine development timelines down to 100 days. CEPI’s efforts to compress vaccine development timelines to 100 days have been backed by the UK Government as part of its G7 presidency. The UK is also due to host a replenishment summit in 2022 to support CEPI’s programme of vaccine research and development, alongside manufacturing innovations.

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About CEPI

CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines against future epidemics. Prior to COVID-19 CEPI’s work focused on developing vaccines against Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever virus and Chikungunya virus – it has over 20 vaccine candidates against these pathogens in development. CEPI has also invested in new platform technologies for rapid vaccine development against unknown pathogens (Disease X).

During the current pandemic, CEPI initiated multiple programmes to develop vaccines against SARS-CoV-2 and its variants with a focus on speed, scale and access. These programmes leverage the rapid response platforms developed by CEPI’s partners prior to the emergence of COVID-19 as well as new collaborations. The aim is to advance clinical development of a diverse portfolio of safe and effective COVID-19 candidates and to enable fair allocation to these vaccines worldwide through COVAX.

CEPI’s 5-year plan lays out a $3.5 billion roadmap to compress vaccine development timelines to 100 days, develop a universal vaccine against COVID-19 and other Betacoronaviruses, and create a “library” of vaccine candidates for use against known and unknown pathogens. The plan is available at https://endpandemics.cepi.net.

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