Quantifying the Immune Response and Level of Protection for Vaccines

In the second installment of an interview, members of the FlowMetric Life Sciences' leadership discuss how their technology might aid possible COVID-19 vaccine booster shots, how immunocompromised patients respond to vaccines, and other vaccines where their platform may be used.

One of the concerns within medical science is how long protection will last for the existing COVID-19 vaccines. More recently, there have been open discussions about the potential need for booster shots to provide further protection when immunity wanes.

Up until now, there has not been any technology that can measure immunity responses.

FlowMetric Life Sciences, Inc., just launched its VaxEffect platform. Renold Capocasale, CEO and founder of FlowMetric, and Grant Morgan, PhD, PMP, executive vice president for FlowMetric and general manager of VaxEffect, spoke this week on the platform, its clinical application, and future plans for immune response tests for other vaccines beyond COVID-19.

This is the second installment of the conversation with them. To view the first interview segment, click here.

The transcript has been edited for clarity and length.

Q: Could VaxEffect potentially help in identifying a time frame for COVID-19 booster shots?

Morgan: One of the aspects of the test that's really important is that we can do repeat testing. This will actually be timed very well with a lot of talking now about getting booster shots, either of the same vaccine you've received previously or potentially a different vaccine to see if that generates an additional immune response. What we think we'll be able to do is track over time the immune response to the vaccine and then provide that additional information to the health care provider as to when might be the right and optimum time to provide that booster to the patient.

Q: If a person registers as a low responder, what does that mean in practice?

Morgan: It's actually very interesting. For a low responder, there's a level of uncertainty as to whether there is a protective level of immune response against an exposure down the road to the virus. Right now, in the scientific community, we do not know what the correlate of protection is so what is the amount of antibodies you need to generate that protects you from further exposure to the virus? So that is not known yet, but there's a lot of research going on to understand what that correlate of protection is. The antibody test that we have, the VaxEffect immune response test, because it generates a quantitative response, we should be able to, in working with other health care providers, actually correlate the level of protection a person has and whether that should afford them protection to further exposure to the virus.

That’s something we think in the future, as more and more data [are] gathered, we will be able to offer to doctors and their patients as to whether—even if they have a weak immune response—is it sufficient to provide at least some partial protection to future exposure?

Q: Recent studies have sought to examine how immunocompromised patients, including patients with cancer, respond to the vaccine. How could VaxEffect help?

Morgan: What we're seeing with immunocompromised people, including people who have suffered from various different types of cancer, is that the immune response to the vaccine they receive is very varied. Some patients actually generate strong immune responses and, therefore, could be considered to be protected from the virus in going forward in their everyday lives.

But what they are seeing in both oncology specialties, but also for organ transplantation, diabetes, geriatric specialties, [is] that people have a reduced response to the vaccine they receive. And with regular serology tests not based on our platform of flow cytometry, they are actually getting results that say they are not generating any kind of immune response. But because the flow cytometry platform that we utilize for the VaxEffect test is so sensitive, we are actually able to identify a positive but weak immune response to the vaccine they received, which means there is a potential for a booster shot to actually increase that initial immune response that they generated.

VaxEffect is different to other tests on the market, specifically serology tests, in that a majority of them are over a very small dynamic range, which means that they can only give you really a qualitative result of ‘Yes, you've been infected or vaccinated and created an immune response,’ or ‘No, you haven't.’ The VaxEffect test, built with different technology on flow cytometry, is able to actually detect not only were you infected with the COVID-19 virus or created an immune response to the vaccine, but also the level of immune response that you were able to generate in response to either prior infection or to the vaccine.

Q: What is the status of VaxEffect?

Capocasale: The status of VaxEffect is that we just recently launched, and we are targeting VaxEffect to health care professionals in support of their patient needs addressing basic fundamental questions around how effective was the vaccination that they received against COVID-19. To date, we've tested over 1000 individuals either looking at their response to natural infection or their immune response to whatever vaccination they received for COVID-19.

Q: What is the key takeaway for clinicians?

Morgan: We believe the key takeaway for clinicians is an additional test, something that has never been used before or been available before, for doctors to inform their patients as to how well they've responded to the vaccine they received. So not just the simple, yes/no qualitative response to the vaccine we receive, but actually be able to inform their patients that they generated an immune response, which is similar or comparable to what others who have taken the test have generated. The doctor will also be able to offer a service where they can track that immune response over time and, therefore, make informed decisions about whether a patient would need a booster shot or should take extra precautions if their immune response was below what people believe is enough of an immune response for normal return back to everyday life.

Q: Is VaxEffect only for COVID-19?

Capocasale: VaxEffect is a platform that will have life beyond just COVID-19 vaccination immune response monitoring. It is a platform that will allow us to use the same technology and science to support basically any vaccine regimen that you receive. We anticipate, later this year, launching VaxEffect specifically for other vaccines such as Gardasil or Shingrix. We are excited at the prospect of patients having a much easier ability to monitor over time their vaccine immune response.

Quite simply, we believe the most important takeaway for clinicians for the VaxEffect platform is the alignment of unmet needs for the patient and their health care provider. We think it's really important for patients who have underlying conditions that may cause them extra risk for actually generating an immune response to have an easy, accessible, and highly communicative approach to their immune response to the vaccine.

For us, COVID-19 has been, obviously, an anxiety producing event for many people. To have a patient who doesn't really know more than yes/no where they stand, immunologically speaking, in response to a vaccination we think is important. It's peace of mind for both the physician and their patient, and it's actionable because we can monitor over time with easy-to-read data that is addressable by the physician to their patient. All of us have elderly parents who have received the vaccine. Wouldn’t it be great if you could show them, in quite easy terms, that they have generated an immune response [and] that they are protected? We all know individuals who are undergoing cancer therapeutic regimens that create immunodeficiency. For them, it's not just yes/no. For them, it's nice to see that they actually have generated some response. It brings hope.