What to Know About Johnson & Johnson's COVID-19 Vaccine Clinical Trial
As the COVID-19 pandemic continues to spike in the United States and around the world, the race is on to find effective vaccines that will prevent and stop the spread of the virus. Johnson & Johnson has one such vaccine in progress, and researchers are recruiting participants to get new treatments across the finish line.
Johnson & Johnson’s COVID-19 vaccine was developed based on technology it has used over the past 10 years to develop other vaccines. The company received U.S. government funding in March to move toward approval and production of its vaccine, along with several other COVID-19 vaccine candidates.
By July Johnson & Johnson began early testing for efficacy and safety before enrolling its first wave of patients in a phase 3 trial in September. The vaccine is now ready for a new phase 3 clinical trial to further test its effectiveness. This clinical trial, known as ENSEMBLE, needs up to 60,000 adult participants 18 and older of all genders and racial and ethnic groups around the world.
That’s where you might come in: Johnson & Johnson needs help enrolling patients in its ENSEMBLE clinical trial to keep moving forward with its COVID-19 vaccine research.
What to Know About Participating in a Clinical Trial
Njira Lugogo, M.D., medical director of the Clinical Research Unit at the University of Michigan and principal investigator for the ENSEMBLE trial, said in a recent interview she understands why patients may be uncertain about enrolling in a trial for a brand new COVID-19 vaccine. What can participants expect?
When you apply to enroll in a clinical trial, you’ll be asked screening questions to determine if you meet all the eligibility requirements, including questions about pre-existing conditions. Clinical trials have strict procedures to make sure you’re safe — and to make sure you completely understand the risks and procedures of the clinical trial.
If you’re enrolled in a phase 3 trial like ENSEMBLE, you will either be given the active, real vaccine or a placebo, inactive vaccine. Neither you or the researchers will know which. Called “blinding,” this process gives researchers an unbiased way to determine if a vaccine works.
Lugogo shared that many people want to know if their participation guarantees they will get the vaccine. Due to the nature of blinded clinical trials, unfortunately no. However, Lugogo said there’s a possibility if the vaccine receives FDA approval you may be able to get the vaccine earlier if you got the placebo during the clinical trial.
During the course of your trial participation, you’ll be followed closely for potential side effects as well as potential COVID-19 infection. For the ENSEMBLE trial, Lugogo said researchers will check in with you for two years as part of their ongoing work. This includes asking about any side effects and measuring how effective the vaccine is over time. Like any clinical trial, Lugogo expects some minor side effects from this COVID-19 vaccine.
“It’s important to remember that any vaccine has some associated risks,” she said. “Side effects are typically minor. For example, a sore, red arm; a slight fever; body aches or a headache. These are all part of the expected immune response that goes with vaccination.”
Who Will Be Enrolled in the Trial
Lugogo said the ENSEMBLE trial will include a diverse group of people that reflects the diversity of the actual population. This includes BIPOC patients and people over 65. While Lugogo said people over 65 are typically eager to participate, she knows BIPOC people may be wary of participating in investigational research.
“It’s understandable that people may be suspicious of clinical trials. We’ve found that the best way to help address this is to be as transparent as possible,” Lugogo said, adding:
We explain our safety protocols and what we know and don’t know about our investigational vaccine. We don’t want to overpromise or mislead people. … People respect our honesty, and that makes them more likely to consider participating.
Vaccine Development Is Moving Fast
People have expressed concern about the safety of a COVID-19 vaccine considering how fast research is moving. Typically it takes years to develop, test and get a new vaccine approved. However, the pandemic is a once-in-a-century health crisis. Because of this, Lugogo said global cooperation between stakeholders has made a big difference.
“The reason why research in vaccine development for the novel coronavirus has moved so fast is because so many groups — pharmaceutical companies, the federal government, research institutions — have come together in an unprecedented way to enable trials to push forward at a rapid pace,” she said.
All eyes are on the search for effective COVID-19 vaccines. Without clinical trial participants, these rapid, potentially life-saving investigations wouldn’t be possible. That’s why Lugogo encouraged anyone interested in participating in the Johnson & Johnson’s COVID-19 vaccine trial to see if they are eligible to enroll.
“It’s amazing to realize that our participation in clinical trials can contribute to the development of a treatment that has the potential to change a person’s quality of life,” Lugogo said. “The COVID-19 pandemic has so profoundly altered our lives, and this trial hits particularly close to home because I know I’m fighting for my loved ones, my colleagues and my patients.”
To find out if you’re eligible to participate in Johnson & Johnson’s phase 3 COVID-19 vaccine trial, head here.
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