EL CENTRO, CA - October 27, 2020 - AstraZeneca trial will recruit up to
30,000 participants, with a goal to develop and confirm an effective vaccine
to prevent COVID-19 by end of year.
UC San Diego researchers are collaborating with El Centro Regional Medical
Center (ECRMC) in the Imperial Valley, which has been hard-hit by the
pandemic, to create a subsite of the trial. UC San Diego Health will be
part of a second, massive clinical trial to assess the safety, efficacy
and immunogenicity of a vaccine designed to protect against SARS-CoV-2,
the novel coronavirus that causes COVID-19.
Like the Moderna clinical trial, which launched in late-July, the Phase
III national AstraZeneca study will recruit up to 30,000 participants
at multiple sites across the country. The trial arm at UC San Diego will
involve an estimated 1,600 participants, with particular outreach intended
for underserved communities. The UC San Diego trial is slated to begin
October 30, 2020.
“The virus has dealt a devastating blow to both the medical and financial
well-being of the region,” said Chris Tomaszewski, MD, chief medical
officer at ECRMC. “A successful vaccine trial — our target
is more than 1,000 participants — will give hope as we stop the
spread of this disease in such a vulnerable community.”
“The SARS-CoV-2 pandemic has disproportionately impacted communities
of color across the United States,” said Susan Little, MD, professor
of medicine at UC San Diego School of Medicine and principal investigator
of the UC San Diego trial. “These vehicles will help our research
team bring vaccine trial opportunities to high-burden communities that
might otherwise be underserved.”
The trial is sponsored by the National Institutes of Health’s (NIH)
COVID-19 Prevention Network (CoVPN) and is part of Operation Warp Speed,
a program sponsored by the U.S. Department of Health and Human Services,
with a goal to deliver 300 million doses of a safe, effective vaccine
for COVID-19 by end of year or early 2021. Currently, Operation Warp Speed
has now committed a reported $8 billion to development and/or purchase
of different vaccines under investigation by AstraZeneca, Moderna, Janssen/Johnson
& Johnson, Pfizer/BioNTech SE, NovaVax, Merck and Sanofi/GSK, the
last a European-based partnership.
The latest vaccine, known as AZD1222, is a collaboration between the pharmaceutical
giant AstraZeneca and Oxford University, both based in the United Kingdom.
It is made from a weakened version of an adenovirus (which causes the
common cold) derived from chimpanzees and modified so it cannot replicate
in humans. Little said the approach is similar to the strategy used safely
in previous human vaccine trials for prevention of Middle East Respiratory
Syndrome, a coronavirus closely related to COVID-19.
The virus contains the full-length structural surface glycoprotein of SARS-CoV-2
that gives the novel coronavirus its characteristic spikes. These spikes
are used by the virus to fuse with host cell membranes. When the adenovirus
binds to host cells, the SARS-CoV-2 genetic material it contains prompts
an immune response and ideally, the development of neutralizing antibodies.
Neutralizing antibodies are part of the body’s adaptive immune system.
By interfering with how pathogens, such as viruses, bacteria and microbial
toxins, interact with host cells, the antibodies can render pathogens
In data published in
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31604-4/fulltext researchers found that the vaccine was generally well tolerated in Phase
I/II trials, with the most common adverse effects being temporary pain,
fever, muscle ache, headache, chills, fatigue or malaise. These effects
were less frequent after the second dose and less frequent in trial participants
who were pre-treated with Tylenol.
Preliminary findings found that study participants receiving two vaccines
28 days apart developed fewer vaccine side effects (than those receiving
one vaccine) and all developed SARS-CoV-2-specific neutralizing antibody
responses. Additionally, AZD1222 vaccines have generated production of
immune cells called T cells, which are important for long-lived immunity.
The Phase III AZD1222 trial will be randomized, double-blind and placebo-controlled
— the gold standard for clinical trials. Up to 30,000 participants
will be recruited, spread across 81 sites. Two-thirds of the participants
will receive the test vaccine, given as two injections with the second
shot 28 days after the first. The other third will receive two injections
of a saline placebo on the same timetable.
Qualifying participants must be 18 or older and be in reasonably good health.
They must be at increased risk of SARS-CoV-2 infection due to where they
live (higher community spread of the virus) or personal circumstances,
such as working in essential jobs like first responders, health care,
maintenance, construction, grocery stores or assisted living facilities.
The study is scheduled to last for two years, with seven scheduled study
visits to monitor participants’ health and well-being. Participants
will be asked to monitor for symptoms of COVID-19, such as fever, shortness
of breath, cough, headache and loss of sense of taste. Participants are
asked to contact study coordinators immediately if they develop symptom(s)
suggestive of COVID-19 that persist for a day or more — at which
time they will be tested for SARS-CoV-2. Participants who develop COVID-19
while on study will wear an armband device that measures temperature,
blood oxygen saturation, respiratory rate and heart rate to assess their
well-being for up to 28 days. They will provide blood and nasal samples
during the scheduled study visits.
For information on other COVID-19 clinical trials at ECRMC, visit
https://www.covidvaccineiv.com/ call 760-339-4085.
Media Contact: Shiloh Williams, 803-804-7893,