The University College London Hospitals (UCLH) NHS Trust announced on Friday that it is running the trials at a new vaccine research center.
Both trials are examining AZD7442, a long-acting antibody (LAAB) combination developed by AstraZeneca.
The first study, called STORM CHASER, is examining whether the antibody can provide immediate and long-term protection to people recently exposed to the SARS-CoV-2 virus.
“We know that this antibody combination can neutralize 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,” said study leader UCLH virologist Dr. Catherine Houlihan in a press release from the hospital.
STORM CHASER had recruited 10 people as of Friday. Key participants will include healthcare workers, students in group housing, patients exposed to anyone with the virus, residents of long-term care facilities and those in industrial or military settings.
THE SECOND study, called PROVENT, is examining whether people who may not respond to the vaccine, including immuno-compromised people, or at-risk groups, such as the elderly or those with preexisting conditions, may be helped by AZD7442, even prior to exposure.
“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," said UCLH infectious diseases consultant Dr. Nicky Longley, the head of the study. "We want to reassure anyone for whom a vaccine may not work that we can offer an alternative, which is just as protective.”
Both UCLH studies will examine whether AZD7442 reduces the risk of developing COVID-19 and/or reduces the severity of the infection compared to a placebo.
Trial participants will be able to safely leave the study in order to get licensed vaccines if it is deemed medically beneficial, according to UCLH.
Antibodies are produced by the body to help fight infections. Monoclonal antibodies are artificially produced in laboratories for possible medical treatments in patients already infected with the virus and could provide protection before exposure as well.
While vaccines train the body over a matter of weeks to produce its own antibodies, antibody injections skip that step, aiming to provide immediate protection against viruses.
AZD7442 is a combination of two LAABs derived from recovering patients that were discovered by Vanderbilt University Medical Center and then licensed to AstraZeneca, according to the company, which then optimized the LAABs with half-life extension in order to increase the durability of the therapy for six to 12 months. The combination is also designed to reduce the risk of resistance developed by the virus.
In pre-clinical experiments published in Nature, the LAABs in AZD7442 were shown to block the novel coronavirus from binding with host cells, protecting against infection.
UCLH'S NEW Vaccine Research Center, which opened in December, is operating under the patronage of the National Institute of Health Research (NIHR) UCLH Biomedical Research Center and the UCLH Research Directorate, and represents an extension of the NIHR UCLH Clinical Research Facility led by Prof. Vincenzo Libri.
Libri is also a principal investigator on the Oxford/AstraZeneca vaccine trial and provides oversight of all COVID-19 vaccine/preventative treatment trials.
“Both STORM CHASER and PROVENT are crucial to finding a solution to this pandemic," said Libri. "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 Center 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,” he said.While the treatments are currently only being trialed in London, the study will eventually expand to multiple sites in the US and the UK.
Mene Pangalos, AstraZeneca's executive vice president of BioPharmaceuticals Research & Development, stated in the UCLH release that AZD7442 “has the potential to be an important preventative and therapeutic medicine against COVID-19, focusing on the most vulnerable patients."
"The STORM CHASER trial in particular is a unique approach, with enrollment initiated on site following the identification of a confirmed case to halt the spread of COVID-19 in the facility or community," Pangalos said. "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.”
Antibody treatments have been evaluated since nearly the beginning of the pandemic.
In May, the Israel Institute for Biological Research (IIBR) completed a groundbreaking scientific development, identifying an antibody that neutralizes the coronavirus.
The Defense Ministry stated at the time that the breakthrough appeared to be the first to meet three key parameters: The antibody is monoclonal, new and refined, and contains an exceptionally low proportion of harmful proteins; the institute has demonstrated the ability of the antibody to neutralize the novel coronavirus; and the antibody was specifically tested on the aggressive coronavirus.In October, a team of researchers from Tel Aviv University announced that they had developed an antibody cocktail against COVID-19 that could provide natural immunity for possibly up to several months.
Maayan Jaffe-Hoffman, Anna Ahronheim and Idan Zonshine contributed to this report.