UCLH doses first patient in the world in Covid-19 antibody trial

UCLH has opened a new vaccine research centre with two clinical trials testing a long-acting antibody combination treatment to protect against Covid-19.

Researchers in the STORM CHASER study led by UCLH virologist Dr Catherine Houlihan have recruited the first participant in the world to the study.

They believe the antibody or LAAB, known as AZD7442 and developed by AstraZeneca, may offer immediate and long-term protection to people who have been recently exposed to the SARS-CoV-2 virus, to prevent them developing Covid-19.

Dr Houlihan, also of UCL Infection & Immunity, said: “We know that this antibody combination can neutralise the virus, so we hope to find that giving this treatment via injection can lead to immediate protection against the development of Covid-19 in people who have been exposed – when it would be too late to offer a vaccine.”

The other study, PROVENT, is looking at use of AZD7442 in people who may not respond to vaccination (for instance where someone has a compromised immune system) or are at increased risk of Covid-19 infection due to factors such as age and existing conditions. UCLH infectious diseases consultant Dr Nicky Longley is leading the UCLH portion of PROVENT.

Dr Longley said: “We will be recruiting people who are older or in long-term care, and who have conditions such as cancer and HIV which may affect the ability of their immune system to respond to a vaccine. We want to reassure anyone for whom a vaccine may not work that we can offer an alternative which is just as protective.”

Antibodies are protein molecules that the body produces to help fight infections. Monoclonal antibodies are artificially produced in a laboratory and designed as possible medical treatments. They are designed to be injected directly into the body, unlike vaccines which ‘train’ the immune system itself to produce antibodies.

The LAABs have been engineered with AstraZeneca’s proprietary half-life extension technology to increase the durability of the therapy for six to 12 months following a single administration. The combination of two LAABs is also designed to reduce the risk of resistance developed by the SARS-CoV-2 virus.

In both PROVENT and STORM CHASER, researchers will assess whether the treatment reduces the risk of developing Covid-19 and/or reduces the severity of infection compared to placebo.

Key participant groups in the STORM CHASER trial will include healthcare workers, students who live in group accommodation, and patients who are exposed to anyone with the SARS-CoV-2 virus which causes Covid-19, as well as residents of long-term care facilities and industrial/military settings.

Both trials are taking place at the newly-created Vaccine Research Centre at UCLH, which opened this month to help accelerate the development of new vaccines and treatments during the Covid-19 pandemic.

The centre, which operates under the patronage of the National Institute for Health Research (NIHR) UCLH Biomedical Research Centre and the UCLH Research Directorate, represents an extension of the existing NIHR UCLH Clinical Research Facility (CRF) led by Professor Vincenzo Libri.

Professor Libri is also a professor at the UCL Queen Square Institute of Neurology and a principal investigator on the Oxford/AstraZeneca vaccine trial. He provides oversight of all Covid-19 vaccine/preventative treatment trials at UCLH.

These two trials will also be supported by the Camden Health Evolution (CHE) GP Federation, a group of nine practices and 75,000 patients. Led by Dr Harpreet Sood and CHE Federation chair, Dr Daniel Beck, this partnership provides a new and unique collaboration between UCLH and local GPs, supporting efficient running of both studies, particularly in relation to the management of trial participants that develop Covid-like symptoms during their participation.

As licensed vaccines become available to qualifying trial participants, a mechanism will be put in place to enable them to safely leave the study if deemed medically beneficial. Being a trial participant in one of the studies will not delay the process of receiving a vaccination and should not prevent patients being involved in other studies if they do develop an illness related to Covid-19.

Professor Libri said: “Both STORM CHASER and PROVENT are crucial to finding a solution to this pandemic. At UCLH we are committed to protecting all our patients from Covid-19, including those who may not have optimal responses to vaccines, therefore it is important that we test as many approaches as possible to find effective treatments for everybody. The opening of our new Vaccine Research Centre will help to propel our fight against the virus, meet our aspiration to save as many lives as possible, and ensure a return to normality.”

UCLH chief executive Professor Marcel Levi said: “I am proud of our staff for getting these important studies off the ground and I am immensely grateful to all those involved for working so hard for our community. The recent progress on vaccines is hugely welcome, and developing these additional treatments will be vital to ensure everyone in society can be offered protection against Covid-19.”

UCLH director of research Professor Bryan Williams said: “This is a great example of the NHS at its best. As well as delivering care for patients, UCLH is also undertaking the type of world-leading and ground-breaking research we champion as a research hospital and NIHR Biomedical Research Centre.”

NIHR Joint National Specialty Lead for Infection Professor Andrew Ustianowski said: “We have had very encouraging data on Covid-19 vaccines. What we don't yet have, but need, are interventions in the post-exposure setting. STORM CHASER is exploring the use of a combination of monoclonal antibodies given intramuscularly in those who have been exposed to SARS-CoV-2 – a setting where vaccination would not have time to work and we have no other proven therapies to date. This makes STORM CHASER an important study that may have a large impact on our ability to control this infection.

Professor Ustianowski, who is also the chief investigator of both studies, said: “Today's announcement shows once again the UK's ability to set up world-leading research into Covid-19. It is a credit not only to the research team involved, but the thousands of people at the NIHR and the NHS who have delivered Covid vaccine research in ground-breaking time.”

AstraZeneca Executive Vice President, BioPharmaceuticals Research & Development, Mene Pangalos said: “AZD7442 has the potential to be an important preventative and therapeutic medicine against Covid-19, focusing on the most vulnerable patients. This work complements our vaccine development programme. The STORM CHASER trial in particular is a unique approach, with enrolment initiated on site following the identification of a confirmed case to halt the spread of Covid-19 in the facility or community. We offer our appreciation and gratitude to everyone involved in these trials, from the scientists, researchers and clinicians, to the trial participants and study sites, as we all work together to help end this pandemic.”

NHS England national medical director Professor Stephen Powis said: “The continuing contribution of the NHS to pioneering global efforts to fight Covid-19 is remarkable. These two clinical trials are an important addition to testing new therapeutic approaches, as antibody treatments may offer an alternative to patient groups who cannot benefit from a vaccine, such as immunocompromised patients. I also welcome the spirit of enterprise and innovation which has led the NIHR to support an NHS hospital trust to lead on these important trials.”