Drive to get people to participate in Johnson & Johnson coronavirus vaccine trial kicks off at N.J. hospital – NJ.com

A recruitment drive to enroll participants for Johnson & Johnsons coronavirus virus vaccine trial kicked off Tuesday at Jersey Shore University Medical Center as the New Jersey-based company seeks to give the public another vaccination option.

Hackensack Meridian Health, New Jerseys largest health network, is enrolling volunteers in the double-blind trial, which will study the effectiveness of a two-dose regimen of J&Js experimental COVID-19 vaccine in up to 30,000 adults over age 18. Half of the participants will receive a placebo and the other half will receive the vaccine.

Meanwhile, Pfizer and Moderna are continuing to distribute approved vaccines to essential workers in New Jersey.

Its really important we have various vaccine options... Were trying to vaccinate the entire world population and so one company, two companies, three companies wont be able to produce enough vaccine to do that. The more companies that we have, the better it is for the world, said Dr. Ihor Sawczuk, president of Hackensack Meridian Healths Northern Market and the chief research officer of the network.

Over the past few weeks, thousands signed up to take part in the Phase 3 J&J trial and will have to undergo a pre-screening process. Two of those volunteers who passed the screening were given shots on Tuesday at the Monmouth County hospital.

J&J is also running a separate trial, which began in September, for a one-dose regimen involving 45,000 people. This new study will look at whether administering two doses of the vaccine has potential benefits for the duration of protection compared to one shot, Sawczuk said.

The shots are administered on day 1 and day 57 of participation, with the total study period being more than two years.

The J&J vaccine is an adenovirus-based shot, Sawczuk said. A segment of a gene that represents the spike protein of COVID-19 is inserted into an adenovirus, he said. That segment, when injected into our cells, produces messenger RNA which then becomes a protein our bodies recognize as foreign and develop antibodies against.

Its not COVID. Its an inactive form, but it stimulates our immune systems to develop antibodies against the spike protein so when they actually see the real one, well be able to protect ourselves, Sawczuk said.

Having another vaccine on the market approved by the FDA could be advantageous to different populations.

It is possible the J&J vaccine could be approved as a single-dose vaccine, as opposed to the two-dose Pfizer and Moderna vaccines. That could be important for a subset of the homeless population who arent easily able to get a follow-up shot, said Dr. David Kountz, Co-Chief Academic Officer and Hackensack Meridian Health and Associate Dean, Diversity and Equity, Hackensack Meridian School of Medicine.

The Pfizer vaccine also requires refrigeration at about -94 F in specialized freezers, resources often only available at large medical centers in more urban areas. Medical facilities in rural areas and less developed countries would benefit from a vaccine that is proven just as effective, but doesnt require those expensive freezers, said Dr. Ed Liu, chief of infectious diseases at Jersey Shore University Medical Center and principal investigator for the trial.

If other vaccines are just as effective or similarly effective and safe and dont require those refrigerations, that will be a benefit, said Liu.

The trial team is putting a focus on recruiting people of color, those with co-morbidities and individuals over the age of 60 to prove the vaccine is safe and effective for different groups, Kountz said.

People of color, and Black Americans in particular, are often underrepresented and hesitant to join scientific trials due to the history of racism in America in the medical field. Kountz pointed to the infamous Tuskegee Syphilis Experiment, in which 600 Black men involved in a study on syphilis were told they were getting free medical care but instead never given treatment for their disease.

He said staff have been doing outreach with community groups and religious leaders in order to enroll minority populations. Over the past few months, he and other team members have gone to numerous local churches to talk about the program in an effort to recruit people.

Enrollment for the Moderna Phase 3 trial at Hackensack University Medical Center earlier this year was 31.37% Hispanic or Latino, 26.8% white, 13.73% Asian and 8.5% Black or African American, according to data from Hackensack Meridian.

Liu says there are plans to put out more radio and TV spots about the trial and how to enroll.

Its critical. As a health network, weve done well... reaching out to diverse populations in New Jersey for the Moderna trial, but we can do better, Kountz said. And as a nation we can do better.

For more information about the trial, those interested can contact (551) 996-5977 or visit https://www.hackensackmeridianhealth.org/covid19/.

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Avalon Zoppo may be reached at azoppo2@njadvancemedia.com. Follow her on Twitter @AvalonZoppo.

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Drive to get people to participate in Johnson & Johnson coronavirus vaccine trial kicks off at N.J. hospital - NJ.com