UC San Diego Well being might be a take a look at web site for a 3rd, main Part III scientific trial to evaluate a vaccine candidate for SARS-CoV-2, the novel coronavirus that causes COVID-19.
Sponsored by Janssen Prescription drugs Corporations of Johnson & Johnson, the trial will recruit as much as 60,000 contributors at websites in the USA, Brazil, Chile, Colombia, Mexico, Peru, Argentina, Philippines, South Africa and Ukraine to check a single-dose investigational vaccine injection. Dubbed ENSEMBLE, the trial in San Diego formally launches October 7, 2020.
False shade scanning electron micrograph of SARS-CoV-2 virus, which causes COVID-19. Photograph credit score: NIAID
Just like the
Moderna and
AstraZeneca COVID-19 vaccine trials already underway at UC San Diego Well being and elsewhere, the Janssen trial might be a randomized, double-blind, placebo-controlled examine. It’ll assess the efficacy, security and immunogenicity (the power to impress an immune response) of the investigational drug Advert.26-COV2.S.
The Janssen trial employs an older, well-tested vaccine improvement strategy: A deactivated widespread chilly virus is modified to hold the SARS-CoV-2’s attribute spike protein, which the virus makes use of to enter host cells. This vaccine “vector” is injected, and the presence of the spike protein prompts the human immune system to create neutralizing antibodies to dam the focused pathogen, basically rendering subsequent exposures to the coronavirus as non-infectious.
“The Janssen vaccine technique builds upon their in depth expertise utilizing the identical vaccine platform for a lot of different infectious ailments, together with HIV, Ebola and malaria,” stated
Susan Little, MD, professor of drugs at UC San Diego Faculty of Medication and principal investigator of the UC San Diego trial. “No important issues of safety have been recognized in research of greater than 90,000 folks utilizing this similar vaccine platform for different infectious ailments.”
In late-July, researchers revealed on-line pre-clinical information within the journal
Nature displaying {that a} single injection of Advert.26-COV2.S produced a “strong immune response” in rhesus macaques. In different phrases, it generated ranges of neutralizing antibodies that gives near- or full safety from COVID-19 infections within the lungs of the monkeys.
The early findings had been encouraging sufficient for Janssen to right away announce the launch a two-year-long Part I/IIa first-in-human scientific trial in the USA and Belgium. Interim, non-peer-reviewed outcomes of that examine, revealed September 25, 2020 on the preprint web site
medRxiv, discovered that security and immunogencicity supported additional scientific improvement.
Participation Protocol
The Part III ENSEMBLE trial at UC San Diego Well being will recruit an estimated 2,000 contributors. Half of the contributors will obtain a single injection of the Advert.26-COV2.S investigational vaccine and the opposite half will obtain a placebo; all might be commonly monitored for indicators of an infection and COVID-19 over the following two years. Qualifying contributors have to be 18 or older and in moderately good well being.
Susan Little, MD, professor of drugs at UC San Diego Faculty of Medication and principal investigator of the UC San Diego trial.
Like the opposite trials, researchers are particularly eager about contributors at elevated threat of SARS-CoV-2 an infection as a result of the place they stay (greater neighborhood unfold of the virus), age or private circumstances, equivalent to working in important jobs like first responders, well being care, upkeep, building, grocery shops or assisted dwelling services.
There may be an emphasis upon participation in underserved communities, notably these of shade, which have proven greater charges of each hospitalization and demise as a result of COVID-19. In keeping with the newest out there information from the County of San Diego’s
Health and Human Services Agency, the countywide charge of SARS-CoV-2 an infection is 1,442 circumstances per 100,000 inhabitants. Within the southern half of the county, nonetheless, the speed is measurably greater: Chula Vista — 2,207; Imperial Seaside — 2,189; Nationwide Metropolis — 2,598.
To allow simpler entry to the examine in these communities, UC San Diego trial coordinators have contracted with Nationwide Metropolis to determine a testing location in trailers that might be arrange within the car parking zone of Toyon Park. The location is scheduled to function via October 2022. Further outreach efforts are deliberate.
“Many communities of shade are experiencing greater charges of hospitalization associated to COVID-19 than are noticed in White, non-Hispanic folks,” stated Little. “It is vital that these communities are represented in COVID-19 vaccine scientific trials in order that we perceive if the vaccine will work effectively inside these teams.”
The Janssen trial is a part of the Nationwide Institutes of Well being’s (NIH)
COVID-19 Prevention Network (CoVPN) and
Operation Warp Speed, a program sponsored by the U.S. Division of Well being and Human Providers, with a aim to ship 300 million doses of a secure, efficient vaccine for COVID-19 by finish of yr or early 2021. Presently, Operation Warp Pace has now dedicated a reported $8 billion to improvement and/or buy of various vaccines underneath investigation by AstraZeneca, Moderna, Janssen/Johnson & Johnson, Pfizer/BioNTech SE, NovaVax, Merck and Sanofi/GSK, the final a European-based partnership.
Belgium-based Janssen Pharmaceutica was bought by the American well being conglomerate Johnson & Johnson in 1961. Janssen opened a 122,000-square-foot life sciences facility in San Diego in 2012; Johnson & Johnson has maintained a analysis middle in within the area for greater than 20 years. Each entities have had lengthy and assorted analysis collaborations with UC San Diego.
For extra details about collaborating within the Janssen trial at UC San Diego, go to
www.covidvaccinesd.com or name 619-742-0433.
For info on different COVID-19 scientific trials at UC San Diego, go to
clinicaltrials.ucsd.edu/covid-19.
