Stanford Medicine Participates in Johnson & Johnson COVID-19 Vaccine Trial

Stanford Medical Researchers Volunteer recruitment Participate in a Phase 3 trial of the Johnson & Johnson COVID-19 vaccine. If proven safe and effective, the vaccine may be approved by an emergency license by early 2021.

Researchers are cautiously optimistic about the future of vaccine development, partly due to the recent success of Pfizer and Moderna. As Johnson & Johnson vaccines are in clinical trials, we hope to increase the variety of vaccines that may be distributed worldwide.

According to Johnson & Johnson, 60,000 subjects across up to 215 global sites will be injected with an effective vaccine or placebo. news release.. According to Philip Grant, lead researcher and assistant professor of medicine, Stanford University will track 1,000 participants for safety and the development of infectious diseases over a two-year period. Participants who receive a placebo will be provided with a vaccine that is effective if the vaccine is proven effective before the lapse of two years.

According to Sumana Shashidhar, to evaluate the vaccine, researchers will track the side effects associated with the vaccine or placebo, the severity and number of COVID-19 cases, and the participants’ immune response to the vaccine over time. Shadshidar is a business clinical research manager at the Stanford Clinical Research Center in School of Medicine.

Vaccine development pipelines can take up to 10 years from discovery to approval, but Johnson & Johnson Accelerate the process.. Leveraging its subsidiary Janssen’s AdVac technology, it uses a shell of deactivated adenovirus to carry the genetic code of the harmless coronavirus spike protein to cells. When cells produce proteins, the body’s immune response is stimulated.

Johnson & Johnson combined Phase I and Phase II tests. This usually involves evaluating the vaccine in a small group of adults and determining the most effective dose, which is one step known as Phase 1 / 2a. Currently in Phase III, researchers will be vaccinated against a large group of healthy adults in areas where COVID-19 infection rates are predicted to be highest.

“The regulatory and launch process is condensed, but the phase timeline is [III] The study is pretty typical, “Grant wrote. Despite the rapid early stages, he showed confidence in the safety of the vaccine.

“Every vaccine we give is at risk. We inoculate 60,000 participants with the J + J vaccine, which gives us a robust data set related to safety,” Grant wrote. .. “That said, post-marketing data may still reveal very rare adverse events, but this potential risk is inferior to the risk of COVID-19 infection.”

Shasidar, who oversaw several COVID-19 studies, said he was confident in Stanford’s interdisciplinary team’s ability to handle this “scale and impact” study.

“In terms of coordination, we are conducting this trial like any other interventional clinical study trial,” she writes. “We follow the protocol, focus on participants from a scientific and safety perspective, and ensure that the team offers the best participant experience.”

The Johnson & Johnson vaccine is one of four vaccines currently in Phase III clinical trials in the United States. Pfizer And modern Last week, they reported that their mRNA vaccine candidates were 95% and 94.5% effective, respectively.

“It’s very encouraging that the immune response seen with these vaccines correlates with a high degree of clinical defense,” Grant wrote. “”[It] Make sure people expect many different platforms to work as well. “

The data are promising, but some logistics for distributing the vaccine are still under development.

According to Rhiju Das, an associate professor of biochemistry, mRNA vaccines are unlikely to allow mass vaccination of billions of people without stabilization.For stabilization Protect mRNA For chemical decomposition.

“Both Pfizer and Moderna mRNA vaccines must be shipped frozen,” Das said in a statement to The Daily. “Maybe you’ve seen an article explaining the logistical issues associated with the distribution of these drugs compared to influenza vaccinations that can be shipped in pre-filled syringes under standard refrigeration. . ”

CDC Advice to the facility To process large amounts of dry ice to store Pfizer vaccines at temperatures around -103 degrees Fahrenheit. Material hazards raise serious concerns about vaccine distribution, in addition to national supply shortages.

“Before COVID-19, scholars and the industry did not do basic research on the issue of mRNA stabilization,” Das wrote.

In Das’s lab, researchers Computational redesign The mRNA is folded into a well-structured package that can remain stable in syringe buffer. His research may improve future mRNA vaccines, but Das believes in the value of developing multiple types of vaccines.

“Some of the other vaccines currently being tested are single-dose and are easier to ship than mRNA vaccines,” Das wrote. “But imagine the evolution of the coronavirus. In that case, it is also advantageous to produce an mRNA vaccine that can be introduced quickly because the sequence can be changed and new doses can be used. [are] Manufacturing[d] On a time scale of a few weeks. ”

Johnson & Johnson vaccines are expected to be stable in 35.6-46.4 degrees Fahrenheit.. At the start of the Phase III trial in September, the company announced that it “does not require new infrastructure” for distribution.

Grant will review data from Johnson & Johnson by March or April, depending on participant enrollment speed and number of infections.

Contact Jodie Meng at jomeng’at’stanford.edu