COVID-19 vaccine clinical trials are coming to Wichita. Here’s what you need to know

Several COVID-19 vaccine clinical trials are coming to the Wichita area, and are currently recruiting healthy adult volunteers. It’s welcome news for many, as coronavirus cases continue to rise in Sedgwick County and across the country.

David Shelly, a Wichita resident and Spanish teacher at East High, was excited to volunteer.

“The current situation with COVID-19 is frustrating for everybody,” he said. “I’d like to get a vaccine that would become generally available, so that we can really get some of that quality of life back that we’re missing.”

The Alliance for Multispeciality Research, formerly Heartland Research Associates, is recruiting volunteers for multiple COVID-19 vaccine clinical trials at its Wichita East, Wichita West, and Newton locations. Even more trials could be on the way soon, as researchers continue to roll out new candidate COVID-19 vaccines.

Clinical trials are a crucial step in making a COVID-19 vaccine publicly available, though as with any medical trial, participation is not without some risk.

The COVID-19 vaccine race

Vaccines teach your body to recognize a viral invader so that you can build the antibodies necessary to fight the disease before you get infected. Older vaccines did so using the virus itself, which was modified to be inactive or weakened so that it couldn’t cause illness.

Modern vaccine development efforts aim to train your immune system by introducing just one distinctive part of the virus.

Dr. Terry Klein, a medical director at AMR leading the COVID-19 vaccine clinical trials, likens the new technology to teaching your immune system to recognize the novel coronavirus just by its coat sleeve, rather than its whole body.

“We haven’t done live vaccine preparation for years,” Klein said.

Most potential COVID-19 vaccines focus on one specific part of the novel coronavirus: the spike protein on the exterior of the virus forming its recognizable “crown.” The spike protein is also the part of the virus that binds to human cells, facilitating its invasion and eventual takeover of your body’s cellular machinery.

Pharmaceutical research groups have taken different approaches to safely delivering the spike protein into the human body.

Some vaccines, such as one being developed by Novavax, contain pieces of the spike protein itself.

Others, called genetic vaccines, introduce DNA or mRNA (DNA’s genetic middleman) encoding the spike protein’s structure. Companies including Moderna, Inovio, Pfizer, and the German company BioNTech, are all pursuing genetic vaccines.

Another approach uses a modified kind of adenovirus — one of the viruses responsible for the common cold — to deliver the protein. This modified adenovirus produces the spike protein inside your body, but is engineered so that it can’t get you sick. AstraZeneca and Johnson & Johnson are both testing adenovirus-based vaccines.

These newer vaccine technologies, particularly genetic vaccines, are faster to develop and easier to manufacture on a large scale than traditional whole-virus methods. If a genetic vaccine against COVID-19 succeeds in clinical trials and is approved by the Food and Drug Administration, it would be the first ever genetic vaccine licensed for human use.

Clinical trials – how a new vaccine gets to the market

Before being licensed for public distribution, all vaccines go through rigorous evaluation in both a laboratory and clinical setting.

Before testing in humans is even considered, researchers conduct extensive laboratory testing. Vaccine candidates are tested in cells in the lab, as well as in animals such as mice, to ensure that they do not cause any major side effects, such as organ failure, and to ensure they will stimulate an immune response.

The goal of human trials is to determine if a vaccine is both safe and effective. Before testing can begin, researchers must draft a detailed plan, which then must be approved by both the FDA and an independent review board.

Specific clinical trial protocols vary, but they typically involve a placebo control group, meaning that some participants will receive a placebo instead of the vaccine. The results of the group receiving the placebo are compared to the results of the group receiving the vaccine. Studies involving placebos are almost always double-blind, meaning that neither researchers nor the participants know who received the vaccine and who received the placebo, which maintains the integrity of the study.

Pharmaceutical companies partner with local clinical research firms who do not have a financial stake in the vaccine’s success, like AMR, to conduct the human clinical trials. The data is monitored by another independent safety committee, called a data and safety monitoring board, who can stop the trial at any time if the clinical data suggests the vaccine is unsafe.

In the first phase of a clinical trial, safety is a top concern. Between 10-100 healthy adult volunteers receive the vaccine, and their health is closely monitored, sometimes with overnight stays in the hospital for observation. Blood samples are typically collected to test levels of several different antibodies – a sign that the vaccine is working as hoped.

After the vaccine is deemed safe from major side effects, phase two can begin. In a phase two trial, up to a few hundred participants will receive the vaccine. For the next several months, participants will check in with the clinic with phone calls or visits on a weekly or monthly basis.

To determine if the vaccine seems to be working, blood samples are collected from participants and antibody levels are measured. Additionally, participants are monitored for the development of any COVID-19 symptoms or a positive COVID-19 swab test. Phase two trials typically last for at least several months, and often up to a year. However, the phase two trial period may be shorter for COVID-19 vaccines.

A vaccine candidate that is determined to be safe and likely effective can then enter phase three, a large trial with up to 30,000 volunteers across the country.

Phase three trials ask the billion-dollar question: Does the vaccine work for a large group of people in a variety of environments?

As in phase two, vaccine effectiveness is determined by measuring blood antibody levels and monitoring participants for COVID-19 symptoms. Clinical researchers also continue to assess the vaccine’s safety by monitoring participants for any side effects. The main difference between a phase two and phase three clinical trial is that phase 3 involves more participants who are monitored for a longer period of time, potentially up to several years.

Because of the urgency of the COVID-19 pandemic, the length of each phase may be shorter than normal, and review of the data may be expedited so that the next phase can begin as soon as a vaccine candidate passes the prior phase.

Despite the speed, clinical researchers are adamant that safety corners are not being cut. The legal process of approving a vaccine remains the same, and all clinical trials are still being strictly overseen by the FDA and third-party review boards.

Currently, a phase 3 vaccine trial is planned for the AMR Wichita East, Wichita West, and Newton locations, and a phase 2 vaccine trial is planned at the Newton location.

Because of confidentiality agreements, AMR can’t say publicly which vaccines they are testing in the Wichita area or the companies involved.

The risks

If you are chosen to participate in a vaccine clinical trial, you will be informed which specific vaccine you will potentially receive, the company producing it, how long the study is expected to take, how often you will have to follow up with the clinic, and any other requirements for the study. You will also be informed of any known potential risks or side effects of the experimental vaccine.

This practice is called informed consent, and is required by federal law. Informed consent also requires that participants be told about any new risks discovered as the trial progresses, and can choose to opt out at any time.

Common side effects of vaccination include muscle soreness at the injection site, a low fever, and headaches. Allergic reactions are also a risk if you have an allergy to any of the vaccine’s components; you may be asked about or tested for allergies in order to determine your eligibility.

Because whole-virus vaccines are not currently being tested in the US, participating in a clinical vaccine trial does not put participants at risk for exposure to COVID-19 from the vaccine itself.

“The chance of you getting COVID by getting a COVID vaccine is zero,” Klein said.

Volunteers will never be intentionally exposed to the novel coronavirus in order to test immunity, which clinical researchers say would be a severe breach in medical ethics.

The effectiveness of the vaccine is instead determined by measuring antibodies in blood samples and by carefully monitoring volunteers for any COVID-19 symptoms throughout the trial period. These data are compared to the data of volunteers receiving a placebo vaccine.

The benefits

The main benefit of participating in a COVID-19 vaccine trial is potentially having early access to a vaccine. However, potential volunteers should remember that some participants will receive a placebo instead of the vaccine, and you won’t know which treatment you received until after the trial ends.

All participants should still wash their hands frequently, wear a mask while in public, and continue to follow CDC guidance to prevent their exposure to COVID-19.

In Dr. Kevin Ault’s experience, most people participate in clinical trials out of altruism, rather than for immunity.

“My experience in people volunteering for clinical trials is that they really do it out of the goodness of their heart. They want to help their fellow human beings,” said Ault, a professor at the Kansas University Medical Center who researches human papillomavirus vaccines.

In this case, helping a fellow human being also means contributing to a historic medical effort to combat the COVID-19 pandemic.

“We say that we’re trying to help each other and trying to support each other,” said Shelly, the East High teacher who volunteered. “This is one way we can do that.”

Who is eligible?

Adults in good health may be eligible to participate in current or future COVID-19 vaccine studies. At least one of the studies planned for the Wichita area is specifically recruiting healthy adults employed in high-risk fields, such as health care, and grocery store workers.

Some clinical trials are scheduled to begin in the next few weeks. Additional vaccine trials are expected to begin throughout the next year as more potential coronavirus vaccines are developed and move into clinical trials.

If you are interested in volunteering for a vaccine clinical trial, but unsure if it is right for you, talk to your primary healthcare provider.

More information is available on the Heartland Research website.

This story was originally published July 14, 2020 at 5:01 AM.