Vaccine Observation to Include All Communities for Equitable Science

Study Overview
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Brief Summary
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VOICES is a longitudinal, prospective, observational study that will enroll up to 10,000 subjects of diverse racial backgrounds being administered an emergency use authorized COVID-19 vaccine, for collection and analysis of stool and blood samples. It has recently been shown that the gut microbiome, the collection of microbes that line our GI tract, play a significant role in vaccine immune response and severe complications from COVID-19. The identification of biomarkers may aid in predicting response to vaccination and are critical towards improving vaccine-induced immunity. These real-world patient derived biomarkers could be used as interventional targets for the design of innovative adjuvant co-therapies that can boost an effective immune response to the vaccine, enhancing efficacy for a broader population, including those at most risk. Subjects who meet the entry criteria will provide two samples each of blood, one prior to and one following vaccine administration. Follow-up questionnaires will be sent at 3, 6, 9, and 12 months to determine if participants have contracted COVID-19 or have experienced any adverse effects of the vaccine. Nasal swab samples will also be collected from participants that have contracted COVID-19. The samples will be analyzed to determine the impact of gut microbiome composition and function on the immune system and vaccine efficacy.

Official Title
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VOICES: Vaccine Observation to Include All Communities for Equitable Science

Conditions
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Vaccine Response Impaired, Vaccine Adverse Reaction

Intervention / Treatment
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* Biological: COVID-19 vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women who are ≥ 18 years old and expecting to receive the SARS-CoV-2 vaccine within the next 30 days. Subjects who are able to provide written informed consent. Exclusion Criteria: Subjects with known HIV, Hepatitis A, Hepatitis B, Hepatitis C, or SARS-CoV-2 infection within 4 weeks of vaccination Subjects without the mental capacity to complete either a written or online questionnaire, alone or with assistance, or make sound decisions Women who are pregnant, plan on becoming pregnant, or are nursing.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 vaccine recipients<br>Subjects who have an appointment to receive a COVID-19 vaccine, and are able to provide samples prior to and after their first vaccine dose. | Biological: COVID-19 vaccine<br>* Any vaccine for COVID-19<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine whether the microbiome composition can predict effectiveness of vaccine. | Whole genome sequencing and metabolomics will be used to characterize the patient's microbiome, and whether there is any correlation with subjects who contract COVID-19 post-vaccination | 6-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify correlations between microbiome composition and immune system response to the vaccine | Immune cell profile and cytokine analysis will be performed on the blood samples to characterize the patient's immune phenotype, and determine how it correlates to microbiome composition | 3-6 months | 
| Track coronavirus variants of any individuals infected | Any subject who contracts COVID-19 after vaccination will provide a nasal swab, which will be subject to viral sequencing to determine whether vaccinated individuals are more susceptible to certain variants | 6-12 months | 
| Build a library of samples and data for future research | Samples will be stored and data saved in a HIPAA-compliant database. Samples will be linked to patient metadata | 6-24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccine, SARS-CoV-2, COVID-19, gut microbiome