The expansion study is designed to understand how our responses to immune and inflammatory stressors, such as infections and vaccines, can influence our health and well-being over time. People who might appear similar in overall health status can often respond very differently to the same stress triggers – and these differences can shed light on future health trajectories. We plan to serially measure antibodies and other factors that can represent health trajectories that diverge over time. We are taking this approach to uncover scientific clues and make new discoveries that may guide us on how to maximize recovery from stress and improve longer-term health for all.

When our team founded the original CORALE study in March 2020, we hoped the pandemic might last a year or less. We focused our studies on illness susceptibility and resistance, and we built resources to support serial assessments, including repeat antibody testing, for up to 2 years. Recognizing the persistent effects of the pandemic, our team is now committed to studying how individuals and communities can recover from the pandemic and maintain health resilience over the longer term. We have now built resources that can support more frequent assessments, including repeat antibody testing, for up to 5 years or longer as needed. For this reason, this expansion study will minimize any added time commitment for original CORALE study participants while allowing the option for more frequent assessments, including antibody testing, for a longer period of time.

Due to operational logistics, the expansion study is currently only open for enrollment for employees and patients who are directly affiliated with the Cedars-Sinai Medical Center and associated medical networks. A limited number of enrolled participants who have moved out of the Los Angeles area may continue participation through remote health surveys and remote biosampling collection kits.

Our recent scientific reports are listed here and will be updated as new information is generated.

For additional questions about the study, you may email contact@embarc-study.org.

All participation and time commitment is completely voluntary. This study offers free blood draws and health surveys up to once a month for up to 5 years or longer. Each appointment for a blood draw (e.g. for antibody testing) takes up to 15 minutes to complete. Each electronic health survey takes up to 5 to 15 minutes to complete. Given the longitudinal nature of this study, our study team will contact you periodically to coordinate on-site appointments and provide reminders regarding electronic surveys. We may also keep in touch to check in on your health status following a serious illness or hospitalization. We may also contact you about the option for additional research assessments or studies, all of which will also be voluntary.

This study will provide to participants free testing and results for Qualitative IgG antibodies against SARS-CoV-2 nucleocapsid and Quantitative IgG antibodies against SARS-CoV-2 spike protein. We ask that participants who engage in antibody testing with returned results are willing to obtain a COVID-19 test (ideally a PCR nasopharyngeal swab) if returned results suggest recent infection or exposure to COVID. As part of the study, additional research diagnostics will be performed for which results will be used for research only. The information learned from this study may help many others in the future. Participants are not be paid for taking part in this research study.

The surveys are designed to collect information on sociodemographic, clinical, lifestyle, environmental, molecular, and other factors that can influence future health status. The surveys also collect information regarding changes in symptoms, medical history, medications, or exposures that can help us to understand how individuals respond from immunological stressors, such as infections and vaccines, over the short-term as well as over the long-term.

Organizations that may access your information for quality assurance and data analysis, only as needed, include: certified and approved study investigators and research staff, accrediting agencies (agencies that grant official certifications or educational institutions), organizations that sponsor the study (access is restricted to de-identified data only), safety monitors, and government and regulatory groups including the Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP), and the Institutional Review Board (IRB), which reviews protocols to protect people taking part in studies.

All research studies involve some risks. Risks or discomforts from this study are considered minimal. With respect to the survey portions of the study, you may feel uncomfortable about answering some questions and you can choose to skip answering any questions. With respect to biospecimen collection (e.g. blood draw) procedures, you may also experience some temporary discomfort from a finger prick or venipuncture. You can always choose to skip any biospecimen collection procedure now or in the future.

Participation in the study may be discontinued if funding for the study is reduced or discontinued, if the study is discontinued or suspended for any reason, if you do not follow the study procedures, and or if it is in your best interest to discontinue participation.

There is no cost to participating in this study. There will be no charge to you or your insurance company for your participation in this research study.

This current phase of the expansion study is open to all Cedars Sinai employees or patients who are age 5 years or older and have an active Cedars Sinai medical record number. All eligible individuals are invited to enroll at this link. Family members of employees must also be age 5 years or older and have an active Cedars-Sinai medical record number to be eligible for the study. Enrollment of individuals under age 5 years is being considered for a future phase of the study. Interested individuals who are not currently affiliated with Cedars-Sinai can send us their name along with the name of the hospital or health system where they usually receive medical care. This information can be provided by entering information at this link or by emailing us at join@embarc-study.org along with the subject line: "future study". Individuals who are not currently affiliated with Cedars-Sinai may be considered for a future phase of the study.

You may enroll in the study by clicking on this link to the electronic consent form and intake survey. After completing the consent and intake survey, all participants are invited to schedule an appointment for initial blood draw at this link.

Any adult Cedars-Sinai employee or patient is eligible to enroll into the study at any time, regardless of vaccination status or timing.

We are offering up to monthly blood draws for all participants.

You can select an appointment time and location by clicking this link. If your preferred dates and times are full, you may elect to visit a blood draw station or contact us to find out if we may be able to accommodate a same-day walk-in appointment. Due to the high volume of visits, priority will be given to participants who have a pre-scheduled appointment.

If this will be your very first blood draw for either the EMBARC or CORALE study, please select "My first blood draw" from the drop-down menu on the scheduling site. If this will be a blood draw that is close in timing to a vaccine dose, please select "Blood draw before a vaccine dose: within 30 days" or "Blood draw after a vaccine dose: 14-21 days" from the drop-down menu on the scheduling site (even if this might be your first blood draw). If this will be a follow-up blood draw of any other type, not close in timing to a vaccine dose, please select "Follow-up blood draw" from the drop-down menu on the scheduling site. All blood draw visits are optional.

Each appointment confirmation email will provide a link to “Change/Cancel Appointment” that allows you to change your appointment date or time, as needed. You may also email any additional scheduling queries to us at contact@embarc-study.org.

For Cedars-Sinai employees and patients, the main site for clinical research visits including blood draw appointments is the Human Physiology Laboratory in the Steven Spielberg Building. Directions to this site are here. Due to operational logistics, we are currently able to conduct lab draws for employees and patients only at the main Cedars-Sinai Medical Center campus. If you live or work at a distance from the main campus, we are happy to accommodate any date and time that you may select for a blood draw appointment at the main campus that fits into your busy schedule. While some participants may be offered up to monthly laboratory testing, all blood draw visits are optional and you may contribute visits as your schedule allows. In addition, if you have any lab draws conducted with an affiliated Cedars-Sinai laboratory that sends samples to the central Cedars-Sinai campus for processing, we can try to locate the remnant samples in our central lab on your behalf and prepare these samples for antibody testing and other assays. If you would like to pursue this option, please let us know via email at least 3-5 days prior to your planned blood draw at the satellite site, so that our team can plan accordingly.

We are open for research clinic visits and blood draw appointments Monday through Thursday, 7:30 am to 4:00 pm, and Friday 7:30 am to 12:00 pm. Please note that we close earlier on Fridays to accommodate for same day biospecimen processing. The clinic site is also closed on holidays and for staff training days, as indicated in the online scheduling calendar.

We do accept a limited number of walk-in blood draw appointments for study participants. Due to the high volume of visits, priority will be given to participants who have a pre-scheduled appointment which can be made at this link.

Although we do not validate for parking, there is easily accessible parking in front of the clinical research site building where the first hour of parking is free. Directions and details can be found here.

Yes, to change or update your preferred email address for all study correspondence, please send us a note with this request to contact@embarc-study.org along with the subject line “change of email address”.

There are several ways to obtain an electronic copy of your COVID-19 vaccine records. If you have a hard copy record, you can take photo with your phone and email this to yourself or to our study staff at contact@embarc-study.org with the subject line: "vaccine record for upload". If you do not have a hard copy record, you can follow these steps below to sign up for a digital COVID-19 vaccine card: Go to https://myvaccinerecord.cdph.ca.gov/ Enter your first name, last name, and date of birth. Enter your mobile phone number OR e-mail address and create a 4-digit PIN. This will allow you to securely access your vaccine record. Check the box and click “Submit.” You should receive a text message or e-mail (depending on which you provided above) with a link to your vaccine record. This process usually takes a few minutes, though it can also take up to 24 hours. Click the link. You will be prompted to enter the PIN you created in step 4. You should be directed to your digital vaccine record. The record contains a QR code as well as your name, date of birth, vaccine date(s), and vaccine type(s). Please take a screenshot of your name, date of birth, vaccine date(s), and vaccine type(s). If you are completing this process for one of our research health surveys, please upload your vaccine directly in the survey if you received your vaccination outside of Cedars-Sinai Medical Center. If you have any trouble uploading your file into the survey form, please feel free to e-mail the screenshot to our secure e-mail address at contact@embarc-study.org.

Previous COVID-19 vaccines only targeted the original version of SARS-CoV-2, the virus that causes COVID-19. Since the original version was identified in January 2020, the virus has mutated. These mutations reduce the ability of previous vaccines to prevent infection or severe illness. For this reason, the new bivalent COVID-19 vaccine was updated to target both the original version of the virus and a recent mutated version of the virus. *The newly updated vaccines are called ‘bivalent’ as they target 2 versions of the virus.

Any person who has completed their initial COVID-19 vaccination series is eligible to receive a dose of the new bivalent vaccine made by Pfizer (if they are 12 years or older) or the new bivalent vaccine made by Moderna (if they are 18 years or older). Individuals may receive a dose of a new bivalent vaccine if it has been at least 2 months since completion of their initial COVID-19 vaccination series or 2 months since receiving a booster dose of the original vaccine. * Based on the FDA guidance, you do not need to have had at least one prior booster to receive the bivalent booster (monovalent vaccines are no longer approved for booster doses).

The FDA has communicated that they expect to approve new vaccine boosters for children age under 12 at some point in the mid-fall of 2022.

Not at all. Receiving a new bivalent COVID-19 vaccine dose is completely optional and not a condition of study eligibility. You are not required to obtain this vaccine booster to join or continue participating in the study. If you do decide to obtain any type of COVID vaccine now or in the future, we only ask that you notify us at contact@embarc-study.org (ideally along with a proof of vaccination) so that we may update your research records with the date and type of vaccine received.

No. Because we are an observational research study, we are involved only in diagnostic testing procedures (with return of certain validated results) and we are not directly involved in vaccine or medication administration procedures. Fortunately, the newly updated vaccine boosters are expected to be widely available in the community, including through local pharmacies, clinics, and county sites. We note that, at this time, the Cedars-Sinai Thalians Drive-Through is unable to reopen as a vaccine clinic for either patients or employees.

We will continue to offer optional blood draws every 30 days for serology testing regardless of your decision around obtaining the new bivalent COVID-19 vaccine. All participants who plan to receive the newly updated vaccine booster may schedule a pre-vaccine blood draw if it has been at least 30 days since their last blood draw. In addition, if you are interested in tracking the rise to peak antibody levels after vaccine, you may schedule a blood draw within 14 to 28 days after dose administration. All participation and time commitments made to obtain blood draws are completely voluntary.

All participants who plan to receive the optional newly updated vaccine booster may schedule a pre-vaccine blood draw if it has been at least 30 days since your last draw. All participants are also more than welcome to schedule a post-vaccine follow up blood draw at least 14 days after the booster. All participation and time commitments made to obtain blood draws are completely voluntary.

The new bivalent COVID-19 vaccines were authorized by a special FDA review panel that carefully reviewed the available data. The new vaccines are based on the original mRNA technology, with slight changes to allow for targeting the newer viral strains. This approach is considered similar to how the flu vaccine is updated every year to match the new flu strains that emerge during each new flu season. Other countries, including Canada and many European countries, have also authorized new bivalent COVID-19 vaccines that target the newer COVID-19 viral strains.

Most experts believe the new bivalent COVID-19 vaccine will be more effective against the newer viral strains that are currently causing most new COVID-19 cases. The hope is that these new vaccines will offer broader and better immunity to the newer viral strains. The FDA and CDC review committees have expressed no concerns about the safety of the new bivalent COVID-19 vaccine given that the design is similar to the original vaccines.

The CDC advises that anyone who has had COVID-19 can obtain a dose of the new bivalent COVID-19 vaccine approximately 90 days after their symptoms started or 90 days from when they first received a positive test. The CDC also notes people may want to consider sooner or later timing based on personal risk for developing severe COVID-19 illness and how high the transmission rates are where you live.

You may receive the new bivalent vaccine at least two months after your last COVID-19 booster.

The side effect profile for the new vaccines is expected to be similar to those of the prior mRNA vaccines. Many people who had reactions to prior vaccine doses tend to have fewer reactions to each subsequent dose, although some people have experienced the opposite. You may want to consider the timing of receiving the new vaccine based on your personal experience with prior vaccines.

Not to worry, you will receive another vaccine card when you get your next vaccine/booster. For anyone who has more than one vaccine card, we recommend taking a picture of all your vaccine records for safe keeping. You may also staple your cards together to help keep them in the same location.

Not at all. We are an observational research study and do not discourage or prevent participation in other clinical studies including clinical trials. However, we do ask participants to notify us at contact@embarc-study.org if your participation in any other clinical study or trial involves receiving any vaccines or treatments for COVID-19, so that we may keep your research records as up to date as possible.

Cedars-Sinai employees are able to obtain easy access COVID-19 testing via the drive through site at Thalians. To schedule if you have symptoms, click on: https://csmc.service-now.com/ehscovidassessment or email: groupcovidemployeetesting@cshs.org To schedule if you have no symptoms, click on: https://csmc.service-now.com/thalianscovidtesting Cedars-Sinai patients can obtain COVID-19 testing via their Cedars-Sinai physician or urgent care by clicking here: https://www.cedars-sinai.org/programs/urgent-care.html

Our research team sends all collected blood samples to the Abbott research laboratories on a weekly schedule, with results returned within 4 to 6 weeks following the date of blood draw. After we receive your results, we will email them directly to the email address that you provided. Please note that these results will not be uploaded into the CS-Link EPIC electronic medical records system. There are a few reasons why results are not returned more quickly. Many commercially available assays provide qualitative results (present vs absent) which can be returned faster. Our research assays provide quantitative results (numeric values representing antibody levels), which can offer more detailed information on changes over time and the extent to which higher antibody levels may represent response to infection versus response to vaccine or response to both. However, these more detailed antibody measurements take longer to run. In addition, because our assays are being performed in a state-of-the-art research laboratory, the samples need to be batched shipped to the research laboratory where all sample assays undergo research grade quality control and quality assurance procedures prior to the return of results.

Although antibody levels may be lower or higher in some people compared to others, any value above the reference cutoff is considered to be a “positive” value. There are some people who will have a positive value appear earlier or later in relation to the timing of their prior vaccination dose, and some people whose positive value appears after two or more doses instead of one dose. Ongoing studies are being conducted to understand how even having a low antibody level measured after receiving vaccine does not necessarily mean that the immune system has not responded favorably to the vaccination.

Although the level of an antibody response to vaccination may be somewhat correlated to effectiveness of the vaccine, this link is uncertain and an area of ongoing research.

There is currently no established “normal” range for antibody levels, in part because antibody levels measured in the blood can vary in relation to many factors. For any antibody level that is above the reference cutoff that was provided, this level can be considered to be a “positive” value representing presence of antibodies.

Our partner laboratory does not currently provide more specific or detailed measures of antibody levels at present. Some specialized antibody measures require ongoing investigation before they can be considered sufficiently validated for reporting back to participants and being subject to potential interpretation within a clinical context. If any additional testing results become available and are considered appropriate for returning to participants, we will let all study participants know.