Johnson & Johnson is at work on an investigational COVID-19 vaccine candidate. That includes recruiting adult participants for Phase 3 clinical trials known as Ensemble. (Photo: Jnj.com)

The clinical research study of a COVID-19 vaccine candidate involving St. Jude Children’s Research Hospital and the University of Tennessee Health Science Center critically needs African Americans, the study’s leader says.

St. Jude and the University of Tennessee Health Science Center (UTHSC) have teamed up for the Ensemble Phase 3 clinical research study conducted by Janssen Pharmaceutical Companies of Johnson & Johnson.

The Ensemble clinical research studies are to “determine the safety and efficacy (whether it works) of an investigational vaccine for the prevention of COVID-19.” In Memphis, the studies are being conducted at St. Jude’s downtown medical complex.

The evaluation involves people 18 years of age or older.

To better gauge the safety and efficacy of the Janssen’s investigational COVID-19 vaccine, more African-American test subjects are critical to the trial, according to Dr. Aditya Gaur, who leads the study.

Dr. Aditya Gaur: “We look at data two years out to understand what is happening in both the short- and long-term.” (Courtesy photo)

“As of Friday, Dec. 11, we have recruited enough Caucasian participants for Ensemble,” said Gaur. “Now we need African American adults over 18, of various ages and ethnicities. People of color representing various races, including Latinx, are the only participants needed right now.”

Gaur said the African-American demographic is so important because it represents the community most at risk for COVID-19.

Ensemble is a collaboration of the Assistant Secretary for Preparedness and Response (ASPR), the Biomedical Advanced Research and Development Authority (BARDA), and the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH).

St. Jude is part of the NIAID-supported, COVID-19 Prevention Network (CoVPN). The hospital’s Infectious Disease Clinical Research Operations team is closely collaborating with the UTHSC’s Office of Clinical Research team and The Department of Internal Medicine Physicians to conduct the study.

“The Ensemble vaccine is being tested in 200 centers around the world,” said Gaur. “African Americans and Latinx are under-represented in the St. Jude study.”

According to Gaur, the Ensemble vaccine, much like the flu and measles vaccines, does not introduce the live virus into the body. But the body reacts in much the same way that it would in the event of coronavirus infection.

Gaur said participating in the process is simple, once a subject has been accepted to the study. At first contact, the prospective trial subject is asked some personal information and several health questions to initially determine eligibility.

An appointment is then made for the trial participant to take a nasal swab test. Blood will be taken for evaluation. An injection will then be administered of either the vaccine or a placebo (a salt-water solution).

After a short period, certain medical data is taken. Before leaving, researchers will upload an app to the subject’s phone, with consent. In the first year, the app will ask various questions about the person’s well-being every two weeks. In the second year, the app will make inquiries every two months.

“The test subjects will come in twice more to give blood and for researchers to see how the immune system is responding,” said Gaur. “We look at data two years out to understand what is happening in both the short- and long-term.”

The Ensemble vaccine is distinct from other COVID-19 vaccines because only one dose is required instead of two.

The study will include about 60,000 adult volunteers, including many who are older than 60, in the 200 designated global test sites. St. Jude and UTHSC are recruiting about 500 participants in the Memphis area.

Qualified participants will also be reimbursed for reasonable trial-related travel expenses to and from study visits.

Eligible individuals are:

  • Aged 18 years of age or older,
  • In stable health, and
  • Have not received a prior COVID-19 vaccine

Researchers are also interested in people who are more likely to be exposed to COVID-19, including:

  • People with underlying medical conditions;
  • People with greater chances of exposure at their job;
  • People who live or work in elder-care facilities;
  • People over age 65’
  • People who work in jails or prisons, and
  • People from racial and ethnic groups that have been impacted in greater numbers by the COVID-19 pandemic, including people who are African American/Black, Latinx, American Indian, Native Hawaiian, and Alaskan Native.

(More information about the trial is available at: www.ensemblestudy.com, or contact St. Jude Children’s Research Hospital directly, at: 901-595-3300.)