The University is bringing new COVID-19 vaccine trials to New Haven, hoping both to build local community ties and to bolster its role as a leading research institution.
In late August, the Yale Center for Clinical Investigation began participating in a clinical trial for a coronavirus vaccine being developed by the pharmaceutical company Pfizer and has since administered the vaccine to 240 people. The University is also preparing for a January start to the Phase 3 trial of a separate vaccine developed by pharmaceutical company Merck.
As it approaches Phase 3, YCCI seeks to “engage minority populations in clinical trials, which is especially important because New Haven’s population is 27 percent Hispanic or Latino and 33 percent African American.” In their search for participants in vaccine trials, the center is reaching out specifically to ethnic and racial minorities in New Haven to ensure the vaccine can help those hit hardest by the pandemic.
To help with that effort, the YCCI has enlisted church leaders and members of Junta for Progressive Action — an organization that advances the social and economic environment of the Latinx community in New Haven — in an ambassador program.
“The relationship with Yale and the New Haven and surrounding community has blossomed due to the YCCI Ambassador program,” the Rev. Leroy O. Perry, pastor of the St. Stephens AME Zion Church and cultural ambassador to clinical research, wrote in an email to the News.
“A bridge between the community and Yale has been established,” Perry continued. “This bridge works to communicate the health needs and concerns of the community while helping [the] researcher establish trust in the community through the Cultural Ambassador.”
Onyema Ogbuagu, principal investigator for the trials, echoed that the YCCI and the New Haven community need to have a strong working relationship to be successful.
“It’s taken a lot of building of trust and strengthening relationships with community partners,” he said. “We both need each other.”
A combination of Yale’s scientific prowess and the YCCI Cultural Ambassadors Program draws pharmaceutical companies like Pfizer and Merck to the Elm City for their trials.
The trials, according to Yale New Haven Hospital Chief Medical Officer Thomas Balcezak, have a dual aim. Yale’s status as a leading research university allows for scientific discovery while also enabling members of the surrounding community to access therapies that may be effective but not yet approved or widely available.
Additionally, the city of New Haven, because of its diversity, is uniquely positioned to “meaningfully contribute to the advancement of science,” Balcezak told the News. He explained that if ethnic and racial minorities are not well represented in clinical trials, it can be challenging to know if the trial results can be extrapolated to the broader population. For its part, the Elm City’s demographics match those of the broader U.S. population more closely than those of any other U.S. metropolitan area, when taking into account age, educational attainment, race and ethnicity.
But there can be barriers to engaging these participants in clinical trials. Balcezak mentioned that historically, clinical trials have taken advantage of minority populations. In medicine today, many are less likely to be believed if they tell doctors they are in pain.
“We have learned that we must not forget the past, the Tuskegee Study, the Henrietta Lacks and the hundreds of other studies where Black people were used and abused for research,” Perry wrote in an email to the News. “It is because of such studies that research safe guards have been initiated. … And that is important for the community to be aware of if research is to be recruited in our communities.”
In earlier trials, people who have received Pfizer’s vaccine have produced the desired immune response. Now, the combined Phase 2/3 trial assesses whether the vaccine can protect people from the virus in a wider swath of the population, examining any rare side effects. The trial is unique, Ogbuagu said, because of its broad inclusion criteria. People as young as 12 years old can participate, and so can people with well-managed HIV and Hepatitis B or C.
The Pfizer trial has already enrolled 37,500 participants internationally, Ogbuagu said. The company has indicated it may seek regulatory approval as early as October.
Trial participants are given two doses of a vaccine, administered 21 days apart. They are randomly assigned to either receive a treatment or placebo. The second dose of the vaccine has already been administered to approximately 70 percent of participants in the Pfizer trial, Ogbuagu estimated.
The Pfizer trial is intended to be a two-year study where the vaccine’s effects on participants will be monitored closely. However, according to Ogbuagu, if there is early and overwhelming evidence of the vaccine’s efficacy, the Food and Drug Administration could grant the vaccine emergency use authorization much earlier.
The Pfizer vaccine uses a messenger RNA platform to prompt an immune response. The mRNA molecule then instructs cells to create a spike protein that closely resembles the one that SARS-CoV-2, the virus that causes COVID-19, uses to infect cells. This triggers the body’s immune response, enabling people to generate antibodies against the spike protein.
By contrast, the Merck vaccine will use a modified measles virus whose genome has been edited to express a spike protein that also closely resembles the one used by SARS-CoV-2. This will help prime the body’s immune system to fight off infection.
“It looks like coronavirus is going to be an easier virus to tackle with a vaccine than some of the tougher ones like HIV, HSV,” dean of the School of Public Health Sten Vermund said. “Coronavirus seems like it may be more like mumps or measles or polio where we are going to have an effective vaccine, that’s at least our best guess.”
There are currently 11 vaccines in Phase 3 trials, according to the New York Times coronavirus vaccine tracker.
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