This study has completed. The information available is for reference only.

You Can Contribute to COVID-19 Immunity Research

Join in the Serimmune COVID-19 Study to help scientists understand the immune response to the virus.

What and Why

Our goal is to understand differences in personal immune response to infection by the COVID-19 virus, SARS-CoV-2. Each individual makes their own unique set of antibodies to SARS-CoV-2, and in this study we will investigate how these differences may be important for immunity, the duration of immunity, and for severity of symptoms.

How it Works

Enroll in the Study

To participate, you must meet the eligibility criteria, watch the consent video above and provide written consent by signing the Study Consent Form on DocuSign.

Answer Health Surveys

For every sample you provide, you will answer a short questionnaire about your health and medical history.

 

To protect your privacy, your medical information will be kept separate from any personal identifiers, and this information will not be shared with outside parties.

Provide a Blood Sample

Every 6 months we will mail you a sample collection kit, which you will use to collect your blood at home. Then you simply mail the sample to our lab in the pre-paid box provided.

Get Your COVID-19 Antibodies Report

Your blood sample will be analyzed in our laboratory and tested for antibodies against the COVID-19 virus, SARS-CoV-2.

 

For every sample you provide, you will receive a personalized report showing your unique antibody response to SARS-CoV-2 based on our technology, Serum Epitope Repertoire Analysis (SERA).

Additional Panels

In addition to the report on your antibodies against COVID-19, you also have the option of receiving an additional report on your antibody response against 5 Infectious Diseases (Lyme, Anaplasmosis, Babesiosis, Ehrlichiosis and Chagas Disease) and a marker of Celiac Disease (Deamidated Gliadin).

If you are interested in this additional report, you will need to complete the following:

  • New participants: You will have the option to opt-in when you answer the initial health survey.
  • Current participants: The option to opt-in is located on your personal profile page, on the study portal.

We Are Grateful for Your Participation In Our Study!

We are excited to share with you some of the scientific findings we are gathering on the immune response to SARS-CoV-2.

See the Data

About Serimmune’s COVID-19 Research

Researchers at Serimmune have mapped antibody specificities in SARS-CoV-2 infections back to their target epitopes. We have identified novel immune responses which may one day assist in the development of novel vaccines and therapeutics for this and other viruses.

Learn More

Frequently Asked Questions

About the Report

It will take approximately 4-6 weeks to receive your report once your sample arrives at our laboratory. Once your report is generated, you will receive an email with instructions for viewing your report.

A low antibody score does not mean that you do not have immunity to the virus. Antibodies are only one of several components that play a role in immunity. Even if your level of antibodies is not detectable by our tests, your antibody response is stored in your body and will be reactivated if you are exposed to the virus again. Additionally, although we use more than one test to measure SARS-CoV-2 antibodies, no test is 100% accurate.

The COVID vaccine targets an area of the SARS-CoV-2 virus called Spike glycoprotein. The natural infection score is determined by looking for antibodies to proteins that are not targeted by the vaccine (areas other than Spike glycoprotein). Some people do not make as many antibodies to these other proteins, so their response looks more like vaccination. Other people initially make antibodies to these other proteins, but they disappear more rapidly than antibodies to the Spike glycoprotein, so over time their response looks more like vaccination than natural infection.

We have been using the Delta variant for one of our tests and this may underestimate your antibody response to the Omicron variant. We have recently switched to using the Omicron variant for testing in order to ensure we are providing our participants with the most accurate results about their response to the circulating variant.

When our lab receives your sample, we run an IgG test first as it is the most informative test for our clinical study. The acute infection score is determined by running an IgM test. If there is not enough serum from your sample for the IgM test, our lab will report the score as N/A. Very few people in our clinical study are positive on the acute score, and rather than having you provide a second sample, we opted for an N/A result in the cases where there is insufficient sample volume to run both IgG and IgM.

Yes, we are very happy to collect another sample from you if you have received a booster shot. You can request another sample kit by emailing us at the address below. Please include the date you received the booster shot along with the maker. To allow enough time for changes to occur in your antibody response, we ask that you wait 2 weeks following your booster shot to collect another sample.

In order to calculate your total antibody score, our technology measures the amount of different antibodies you have to the virus based on the peptide motifs in our library to which the antibodies bind. These motifs mimic the natural binding sites of the antibodies in SARS-CoV-2 viral proteins. The amount of each motif is an approximation of the amount of each antibody present in your blood. We also use a conventional serology test, called an ELISA, which measures the amount of antibodies you have to the SARS-CoV-2 spike glycoprotein receptor binding domain (RBD). From these tests we calculate a composite score which indicates whether you have made antibodies to SARS-CoV-2 from either vaccination or natural infection.

The value of the score may be influenced by many factors which may include: your age, how recently you were exposed or received the vaccine, whether you are taking any medicine that may compromise your immune system and, if you were naturally infected, the severity of your illness. We do not know how long a detectable immune response lasts. That is one of the primary aims of our study. If the antibodies in your blood decrease over time, or even if they become undetectable by our tests, this does not necessarily mean that you are no longer immune to the virus. Another goal of our study is to determine whether people become infected at some point after vaccination and whether that correlates with a decline in antibodies.

People that have been naturally infected with SARS-CoV-2 make antibodies to multiple different proteins contained in the virus. People who are vaccinated for SARS-CoV-2, however, will only make antibodies to the spike glycoprotein present in the vaccine. Our test can distinguish natural infection from vaccination by measuring an individuals’ antibodies to peptide motifs from SARS-CoV-2 proteins other than the spike glycoprotein. We have provided this score for people in case they wondered whether they had been naturally infected with COVID-19 during a previous illness, but had never been tested, or if people suspect that they might have COVID-19 whether or not they previously received a vaccine.

Occasionally, people who are naturally infected may have a weak response to non-spike proteins and their immune response may look more like a vaccinated person’s response. Additionally, people who were exposed several months previously may have a declining antibody response to the full virus and a subsequent vaccination may selectively enhance the antibody response to spike proteins. In these individuals, the response may also look more like vaccination than natural infection. The majority of the time, we can distinguish these two states.

Our test measures two different antibody isotypes present in the blood, IgG and IgM. The acute infection score is calculated by specifically measuring IgM antibodies in the blood. These particular IgM antibodies were detected in people with natural infection and are not present in people who have been vaccinated and so they are specific to infection. IgM antibodies are generally the first type to appear after infection and they are also the first to decline. The IgM antibody response varies amongst individuals and with the type of infection. For some types of infections, the IgM response can be prolonged for many months or even longer. From our studies in people naturally infected with COVID-19, the IgM response lasts for several months, however we have limited long term data. In this study, we hope to gain a better understanding about the kinetics of the IgM response to COVID-19.

There are two reasons why you may receive an acute antibody score of N/A

  1. The acute antibody test will not be run on individuals who have been vaccinated as they generally already have an antibody response due to vaccination; therefore, the acute antibody test will result as a weak score or negative score.
  2. If you were NOT vaccinated and your acute antibody test score is N/A, it is because there was not a sufficient amount of blood to run all of our tests. When this happens, we do not run the acute test.

We have screened over 500 COVID-19 cases spanning all disease severities and mapped the detected antibody specificities within each group. These maps showed that people with mild disease have fewer distinct antibody specificities compared with moderate and severe disease. Each person’s antibody response is unique, and the number or relative abundance of an individual’s antibodies doesn’t indicate greater or lesser immunity to the virus. Because of this unique and heterogeneous response, it is not possible to show a heat map of an average antibody response for any severity category. Instead, for each column, we are depicting the range of antibodies that we have identified within each disease severity category, or within vaccinated individuals.

There are some antibodies that are found at the same level across all groups, whereas other are present almost exclusively in moderate and/or severe COVID-19 cases. Within each of these columns, the darker the box, the more prevalent and/or more enriched that antibody species is in that severity group. We have provided these columns for reference and as the study progresses, we hope to understand whether the differences we have observed in our studies are representative of the larger population.

The primary value of the heat map for an individual is to visualize how your personal antibody response changes over time. For example, do some antibodies decrease while others remain? Does your global antibody response remain high for months or years? Does revaccination result in a greater boost of pre-existing immunity than was observed in the initial vaccination? Do people who get COVID-19 after having been previously naturally exposed or vaccinated have less severe cases overall?

We continually work to provide results that are meaningful to our participants and reflect the continuous change in your immune response. To that end, we always apply the latest data analysis algorithms to all of your data points (from your first sample to your current sample), so your most recent report will reflect the latest analysis method across all of your samples.

The antibody response varies in terms of how long it lasts depending on the infection and whether a person received treatment. Individuals who have been exposed to something in the past and then have either been treated or cleared the infection will likely have antibody levels drop over time.

The Serimmune tick-borne disease tests were developed to detect an active or recent infection. If you have previously received a positive result and have been treated for a tick-borne disease, your antibodies may have declined to a level that is undetectable using our test.

The deamidated gliadin test looks for antibodies to wheat proteins that are present in people with Celiac disease. Individuals who do not know they have Celiac and who eat products containing gluten may have higher levels of these antibodies. If you, however, have been previously diagnosed with Celiac disease and are on a gluten-free diet, you may have low or undetectable levels of these antibodies. This does not mean that you do not have Celiac disease.

About the Study

The Serimmune COVID-19 Immunity study “Human antibody repertoire profiling for sero-surveillance of SARS-CoV-2 and other emerging pathogens” is intended to investigate personal immune response to infection by SARS-CoV-2 virus. Each individual makes their own unique set of antibodies to COVID-19, this study investigates how these differences may impact an individual’s experience with the disease.

Serimmune has a proprietary technology for assessing immune response and the personal antibodies made by an individual. This technology, Serum Epitope Repertoire Analysis or SERA, allows us to measure the antibodies present in a specimen and map them back to specific locations, or epitopes, on the virus. We will use SERA to better understand your specific antibody response.

No, we are unable to provide letters of exemption from the COVID-19 vaccine for participation in this clinical study.

This means that you agree to contribute your information to the Serimmune research study. As a participant, we will ask you to do a few things. We have summarized the most important ones below.

You will be asked to:

  1. Complete an informed consent document that will provide you details on the study and your participation in it. This is very important.
  2. Enroll through our website and complete a short health assessment.
  3. Provide a blood sample using a home collection kit for analysis.
  4. Provide additional samples from time to time or following infection with SARS-CoV-2.

If you have more questions, you can contact us at the email below.

You are consenting to allow researchers to use your blood and associated health information to better understand the human antibody response to COVID-19 and other emerging novel and seasonal pathogens. We encourage participants to remain in the study for the full five-year period, however you may opt out at any time.

The assay we will perform is not intended to be used as a clinical diagnostic test. If you have had exposure to the SARS-CoV-2 virus, the research assay is designed to characterize the antibody profiles that we see against the virus and track how they develop over time.

  1. Meet these eligibility requirements:
    • You are over 18 years old and live in the United States.
    • You are willing to provide blood samples using a home collection kit.
    • You are willing to complete an online medical history questionnaire every time you provide a sample.
  2. Watch a video that explains the study.
  3. Sign the Study Consent Form.
  4. Register in the online study portal.

You do not need to have been diagnosed with COVID-19 to participate in the study. We will run your sample and provide you with the results. If you are exposed in the future, this will tell us about your specific immune response.

If you are infected during the study, focus on getting well. Approximately two weeks after your symptoms started, we would appreciate a sample to test for your antibody response to this recent infection.

If you would like to provide this additional sample, you may request a blood collection kit by emailing us at the address below.

Our technology may be able to tell you about your specific immune response to the vaccine and how it differs from the immune response to the native virus.

Email Serimmune at the address below for additional information.

We hope to better understand the antibodies that individuals make to SARS-CoV-2 and how this may be important for immunity, the duration of immunity, and for severity of symptoms.

Your personal identifying data will never be shared with third parties without your explicit consent; however, we may utilize your de-identified results in our research and technology development. A de-identified result is not traceable back to you personally. If you consent to participate in this study, we may only share your de-identified individual data and population level data with our research collaborators. Our collaborators are obligated to maintain strict levels of confidentiality for all data and will not have access to your personal identifiers.

All our data, when brought into our computing ecosystem, are disconnected from your contact and identifying information. Data are coded with a unique sample identifier (a sample ID) that does not contain any personal identifying information.

Our research is performed in a secure computing environment with access restricted to research scientists and system administrators. Our computers and servers are procedurally, electronically and physically protected and monitored and are monitored for unauthorized activity.

Your sample will be analyzed on Serimmune’s proprietary platform SERA or Serum Epitope Repertoire Analysis. Your sample may be stored frozen until the end of the study for re-analysis.

Absolutely. We are interested in the antibodies you may have made in response to infection.

Yes, this study is being conducted under oversight by WCG IRB study #1297772.

The Serimmune Study Webinar Q&A

Answers to questions from The Serimmune Study, Evaluating Antibody Response to SARS-CoV-2 and Other Pathogens Over Time

We developed the Babesia panel in collaboration with Mayo clinic and the samples they provide were positive for B. microti. We would like to expand our panels as cohorts become available and B. duncani would be a great addition.

To our knowledge, the vaccines that are available in the US are exclusively spike-based. There are other vaccines in clinical trials outside the US that use the whole virion, notably QazCovid-in.

We will need to look at the data more closely to be able to make an educated comment. Different subgroups broken down by sex or age have shown differential responses to infection or the development of autoimmunity and there are a lot of hypotheses as to why this might be. We will be investigating this further in our study.

The antibody response that we detect is highly dependent upon time after exposure to either vaccine or natural infection. The antibody response drops off fairly dramatically via our test after an average of about 6 months, even if people have had multiple stimuli. If it has been less than 6 months and there is no evidence of natural infection or vaccination, this individual would be an outlier result in our study, but we have observed examples of this occurring.

The infection status is based exclusively on our test result. It can miss some people that have been naturally infected because they did not make a strong, conserved antibody response to non-spike proteins, or the response was fleeting and disappeared before testing occurred.

Yes, we do look for autoantibodies. We are interested in whether we can identify any autoantibodies in ME/CFS and/or Long Covid. Autoantibodies can be harder to find for technical reasons, but we do already have panels for some autoantibodies in our platform and we are interested in adding more.

Antibodies to other proteins seem to drop off more rapidly, so that if some time has passed, your report may indicate vaccination even if you had a natural infection most recently. Each antibody may have different kinetics, and some may increase over time while others decrease.

The heat map values for each antibody are calculated based on our roughly 500 prepandemic controls (i.e., never exposed to Covid). We calculate the mean and standard deviation of motif enrichment for each in the negative control population where enrichment is the number of observations of a particular motif in the peptide data/the number expected by random chance based on the size of our library.

The heat map values for each motif are z-scores based on this control set (z-score is the number of standard deviations above the mean of the controls). We consider a z-score of 4 to be a positive result (4 standard deviations above the mean of the negative controls). Our heat maps have the exact z-scores for each motif, but we bucketed the values on the participant heat maps for simplicity. Light purple is 3.5- 10 standard deviations, medium purple is 10.001-35, dark purple is 35.001, and up. Negatives are below 3.5. Participants make a different set of individual antibodies to the virus, so some people have negative scores for many of the antibodies.

The exception is the top band which is the Receptor Binding Domain of Spike. We can’t parse out the individual antibody specificities for this domain, so this is a polyclonal test and almost everyone has that band.

We have only officially had the study running for 1.5 years and do not have enough data yet to look for people with long periods of no exposure from either infection or vaccination to evaluate what happens to their antibody levels. In our study, it is unusual for high levels of spike antibodies to remain after 12 months of no exposure, but we need to get more data to understand the significance.

Yes, an individual’s overall antibody response tends to fall off between 3 months to a year post exposure. Some individuals’ antibodies remain detectable after a year but are usually significantly decreased relative to the acute period of infection or right after vaccination. This is relatively consistent with the literature and the cadence of recommended boosting.

It can, but individuals can also make antibodies that cross react with these epitopes. We have set the natural infection score so that the other protein epitopes are 99% specific. That means that 1 in 100 people could have a miss classification if they have only a single band in the other category. If they have more than a single band, the specificity goes up, i.e., the classifier is more accurate.

People make antibodies that can cross-react with SARS-CoV-2 epitopes and false positives may rarely occur. We have tried to set the specificity of our algorithm very high to prevent this, but this occurs even with established clinical tests. If there are many bands in the other protein category, the likelihood that a person had a natural infection is very high because it is very unlikely that a person will make many different antibodies that cross react with distinct regions of the SARS-CoV-2 virus.

In a way, yes, although some people with natural infections post-vaccine still produce antibodies to other viral proteins. Since your body has already made an antibody to that region of the virus, it can rapidly produce more when it sees the virus again.

Yes, that’s correct. Other proteins include nucleocapsid, NSP8, and a few motifs that don’t map, but don’t show up in vaccinated people, so we know they are directed toward other viral proteins.

We are not yet sure of any significance. The top band on the heat map is not actually from a single antibody as there are many different antibody specificities that contribute. So even if you only have the top band, you still have many antibodies.

Many people only have a few bands on the heat map. We are curious about whether some bands co-segregate with specific populations (e.g., Long Covid) and even more curious about people that do not have antibodies to that top band since it is the target of most neutralizing antibodies (i.e., antibodies that clear the virus).

We are still working on analysis of the Long Covid cohort. There are a lot of factors that must be controlled (Long Covid first, then vaccine vs. vice versa, timing etc…) before we can draw any definitive conclusions.

No. The differences between those groups are not significant.

Certainly, however, we do not have a large enough number of people in this category. If these people share triggers with the Long Covid group then we would see that, but if they have separate reasons for their illness, we will need at least 10 people to try to do discovery.

The top band on the heat map stays positive for longer than the other bands. That is because it is generated from many different antibodies to the Receptor Binding Domain of spike, not a single antibody. People that haven’t had a vaccine or infection within the last 6 months often only have this band.

We are unable to determine who has never gotten Covid. Someone may have had Covid long before they joined the study, and their antibody response may have waned below detection. If someone is in the study and gives a sample every 6 months, we may be able to tell that they have never gotten Covid if they also haven’t been vaccinated.

This refers to the fact that there were more people that were Receptor Binding Domain negative in the Long Covid group. If we separate the groups into those that had also been vaccinated and those that have not, there is still a greater fraction of Long Covid that were RBD negative in both groups.

Every antibody epitope (band on the heat map) has some level of cross-reactivity in a normal population. This means that people can have antibodies unrelated to Covid that are similar and bind to similar sequences in SARS-CoV-2 but are from another organism. We take this into account with our algorithm to try to prevent misclassification, but it is not perfect. It is possible for people to have bands, especially weak bands, in the other protein category on the heat map, but not have had Covid.

For people on a gluten free diet that have Celiac disease, their antibody levels to deamidated gliadin tend to be lower and may be undetectable.

The changes in the natural infection score, if it is below the cutoff for natural infection, are not significant. These fluctuate to a small are all within the negative range and don’t have any practical meaning.

You can have antibodies that cross react with Lyme disease epitopes or proteins. This is actually very common even with clinically diagnostic tests (some conditions or diseases are known to cause false positive results). People with scores that are around the cutoff generally have a greater likelihood of being false positives. This is very unlikely for people with high scores and lots of different antibodies to Lyme.

We would like to be able to add more panels to the additional report as the study progresses. This requires IRB approval and documentation of panel performance, and this process takes time.

We don’t have a clear point after which we stop detecting antibodies, but we know if people are treated, they will not remain positive by our test for a long time post treatment.

We aren’t physicians and we base the Long Covid on self-reporting. From what we do see, it is certainly possible that someone had Long Covid, but no longer has detectable antibodies. It is also possible that they have a similar condition with overlapping symptoms.

There are so many different symptoms associated with Long Covid. We would like to be able to break out these subgroups and look for trends. We will make sure that we are capturing this on our questionnaire.

If you were exposed and treated, depending on the amount of time that has passed, we may not be able to detect antibodies anymore. Antibody response varies depending upon the type of infection, how soon it was treated, and how long it has been since treatment.

Data is preliminary, but we think this is an interesting finding. Importantly, the majority (~80%) of Long Covid patients have antibody signals and scores that are very similar to the general population and are not distinguishable from those patients who do not report Long Covid symptoms. The shifts presented are pushed lower by a subset of the Long Covid patients with very low or indetectable antibody signals.

We know IVIg interferes with our test, but we haven’t done a time course to see how long it interferes. We can tell when people have IVIg in their blood based on some of our panels, but would have to test empirically to know the exact timing.

Just as a reminder, our panels are for research use only. We have done a lot of work to ensure their accuracy, but every test has a false negative and false positive rate. For Chagas disease, people generally get exposed and often are asymptomatic, but the parasite persists, so a positive result doesn’t necessarily indicate recent exposure. Exposure may have occurred many years ago. The panel has >99.9% sensitivity and a similarly high specificity. Once you are infected, the antibodies persist if you don’t receive treatment. So those results are pretty definitive (<1 in 1000 false positive).

For the tick-borne diseases, if you are exposed and receive treatment, the antibodies decline and may be undetectable over time. We don’t generally pick up infections that are from a year or further if someone has been treated and cleared these infections.

Conversely, the antibodies may be very low at the beginning of the infection, or you may only have IgM antibodies which aren’t included on the additional report, so our test won’t detect exposure. In short, a strong positive result for tick-borne disease using our platform is pretty definitive, but a negative result doesn’t mean that you were never exposed.

We are looking for autoantibodies in subgroups. There are complexities with identifying these and adding them to our panels because of the heterogeneity of the immune response in autoimmune disease, but we hope to be able to add these to our additional panels over the course of the study.