UC San Diego Health has joined the third major Phase 3 clinical trial assessing the efficacy and safety of a COVID-19 vaccine candidate. Now they have joined the study sponsored by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. With 60,000 participants, sites span the world from the United States and Brazil to Chile, Columbia, Mexico, Peru, the Philippines, and others. The “ENSEMBLE” trial comes to San Diego starting October 7, 2020. The other two pivotal trials currently at the San Diego trial site organization include Moderna and AstraZeneca, the latter of which is on hold. The investigational product, Ad.26-CoV2.S, a deactivated common cold virus modified to target SARS-CoV-2 specific spike protein, is injected. The hope is that the spike’s presence protein elicits the proper response from the human immune system: delivering neutralizing antibodies to block the virus. As some demographic groups such as African Americans and Hispanics face much higher risks for infection, UCSD has creatively established mobile site locations in working-class districts in San Diego’s South County.
COVID-19 in San Diego
COVID-19, like in many other communities, hits some demographic groups harder than others. For example, minority groups falling under the category of African American, Hispanic, and others, such as Native Americans and the elderly and those struggling with co-morbidities, face a graver risk with COVID-19.
Front-line workers—those employed in health care, first responders, construction, assisted living facilities, and the like—face a higher risk than professionals or others that can work remotely.
Scott LaFee for UC San Diego Health reveals that the pattern of COVID-19 infection is not distributed equally. For example, according to San Diego Health and Human Services Agency data, the countywide rate of COVID-19 infection equals 1,442 cases per 100,000. However, in the southern sections of San Diego County, home to more working-class districts with higher concentrations of Hispanics and Blacks, the COVID-19 infection rates are markedly higher, such as in Chula Vista (2,207), Imperial Beach (2,189), and National City (2,598).
Positive Preclinical Data
Published in Nature in late July, researchers revealed that a single injection of the vaccine led to a “robust immune response” in rhesus macaques, generating positive responses leading to near-complete or complete protection from SARS-CoV-2 infections in the lungs of the primates. Janssen found the findings strong enough to launch a Phase 1/2 clinical trial in Belgium. Moreover, Mr. LaFee reports interim, non-peer-reviewed results of the study were published in late September, uploaded to preprint server medRxiv. The safety and immunogenicity results merited more research.
Participation at UCSD Trial Site
Qualifying participants must be 18 or older and in reasonable health. UCSD will seek to recruit an estimated 2,000 participants, with half of the individuals receiving a sole injection of the Ad.26-COV2.S investigational vaccine, and the other a placebo. The UCSD study team, led by Dr. Little, will monitor the participants.
Trials to the Community
Showcasing a growing trend in COVID-19 clinical trials, investigators are bringing the study to the community and even the household. As it is traditionally more difficult to recruit and enroll minority study participants, study teams are organizing themselves to be more flexible and accessible. For example, in the ENSEMBLE study, UCSD has established a link with local cities and communities, such as National City, where trailers will be set up in the parking lot of Toyon Park, reports Mr. LaFee.
The goal here is to connect with community residents and educate them about the risks of COVID-19 while educating them about clinical trials, their importance, and potential benefits for all. Moreover, if the vaccine candidate increases the odds of eluding infection, it cannot hurt to participate, especially for those individuals at greater risk.
This setup is similar to one planned for the AstraZeneca (AZD1222) trial in Los Angeles, with no delay due to the UK’s safety incident. In that study, the University of Southern California (USC) partnered with the City of Vernon Public Health to bring the COVID-19 vaccine study to the industrial town where a number of COVID-19 outbreaks have occurred.
UCSD Principal Investigator Point of View
Susan Little, MD, professor of medicine at UC San Diego School of Medicine and Principal Investigator for this study, commented, “The Janssen vaccine strategy builds upon their extensive experience using the same vaccine platform for many other infectious diseases, including HIV, Ebola, and malaria.” She continued, reported Scott LaFee for UC San Diego Health, “No significant safety issues have been identified in studies of more than 90,000 people using the same vaccine platform for other infectious diseases.”
Susan Little, MD, professor of medicine at UC San Diego School of Medicine and Principal Investigator
Call to Action: If you are based in San Diego and want to participate in the Janssen trial, check out the website or call 619-742-0422. For information about other COVID-19 clinical trials at UC San Diego, visit clinicaltrials.ucsd.edu/covid-19