The vaccine, developed by Oxford University and AstraZeneca, is called AZD1222 and has successfully gone through earlier smaller phase 1 and 2 trials. The phase 3 trial is designed to determine whether two doses of the vaccine can prevent symptomatic COVID-19. The study aims to enroll 30,000 volunteers across the United States and more than 250 at UCLA.
This vaccine does not contain a live SARS-CoV-2 virus and cannot give a person COVID-19. If the results from the trial are positive, the vaccine could be made available to the public to prevent disease.
Recruitment for the trial has resumed following a brief pause after the FDA, the independent Data and Safety Monitoring Board, and AstraZeneca reviewed a possible adverse reaction seen in a trial participant in the United Kingdom. The FDA and independent regulators reviewed all safety data from trials globally (around 18,000 participants) and concluded it is safe to resume the phase 3 trial. It is not unusual that in large scale phase 3 trials, some participants will become unwell, and every case has to be evaluated to ensure the careful assessment of safety.
"The safety of our volunteers and participants is the first priority of everyone working on this trial across the nation and locally here in Los Angeles," said Dr. Raphael Landovitz, the trial's lead researcher at UCLA and co-director of UCLA's Center for HIV Identification, Prevention and Treatment Services. "Having a safe and effective vaccine is critical to ending the pandemic. We are looking forward to getting this trial underway so that we can find a vaccine for everyone, and especially those that have been most impacted by COVID-19. Help Stop COVID LA is an opportunity for the Los Angeles community to be a part of the solution to help end this pandemic. We hope everyone who is at risk for COVID-19 or its complications will consider if volunteering for this trial is right for them."
To be eligible, a volunteer cannot have previously tested positive for COVID-19. Volunteers are assigned at random to receive the investigational vaccine or a placebo (saline injection). The trial is blinded, meaning the participants and the investigators will not know who receives the vaccine. Of the volunteers enrolled, two-thirds will get the study vaccine and one-third will get a placebo or harmless injection. This allows researchers to compare outcomes in the vaccine group against the placebo group. In the two years that follow, researchers will monitor all study volunteers for the development of symptomatic COVID-19 and for any side effects of the vaccine.
UCLA is part of the COVID-19 Prevention Network (CoVPN) participating in the phase 3 trial. The network, supported by the National Institute of Allergy and Infectious Diseases (NIAID), aims to enroll thousands of volunteers in large-scale clinical trials testing a variety of investigational vaccines and monoclonal antibodies intended to protect people from COVID-19.
UCLA is recruiting volunteers who reside in the greater Los Angeles area, primarily including members of the Black, Latinx, Asian/Pacific Islander, and Native American communities that have been disproportionately affected by COVID-19 and are at high-risk for severe disease. This also includes:
To find out more and sign up to volunteer please visit www.helpstopcovid.la
SOURCE UCLA Health
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