VOICES: Vaccine Observation to Include All Communities for Equitable Science
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| COVID-19 vaccine recipients 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
Any vaccine for COVID-19
|
Outcome Measures
Primary Outcome Measures
- Determine whether the microbiome composition can predict effectiveness of vaccine. [6-12 months]
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
Secondary Outcome Measures
- Identify correlations between microbiome composition and immune system response to the vaccine [3-6 months]
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
- Track coronavirus variants of any individuals infected [6-12 months]
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
- Build a library of samples and data for future research [6-24 months]
Samples will be stored and data saved in a HIPAA-compliant database. Samples will be linked to patient metadata
Eligibility Criteria
Criteria
Inclusion Criteria:
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Men or women who are ≥ 18 years old and expecting to receive the SARS-CoV-2 vaccine within the next 30 days.
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Subjects who are able to provide written informed consent.
Exclusion Criteria:
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Subjects with known HIV, Hepatitis A, Hepatitis B, Hepatitis C, or SARS-CoV-2 infection within 4 weeks of vaccination
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Subjects without the mental capacity to complete either a written or online questionnaire, alone or with assistance, or make sound decisions
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Women who are pregnant, plan on becoming pregnant, or are nursing.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Persephone Biosciences, Inc. | San Diego | California | United States | 92121 |
Sponsors and Collaborators
- Persephone Biosciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PB-2021-01