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.
Full Title of Study: “VOICES: Vaccine Observation to Include All Communities for Equitable Science”
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: December 2022
- Biological: COVID-19 vaccine
- Any vaccine for COVID-19
Arms, Groups and Cohorts
- 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.
Clinical Trial Outcome Measures
- Determine whether the microbiome composition can predict effectiveness of vaccine.
- Time Frame: 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
- Identify correlations between microbiome composition and immune system response to the vaccine
- Time Frame: 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
- Time Frame: 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
- Time Frame: 6-24 months
- Samples will be stored and data saved in a HIPAA-compliant database. Samples will be linked to patient metadata
Participating in This Clinical Trial
- 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Persephone Biosciences
- Provider of Information About this Clinical Study
- Overall Contact(s)
- Stephanie Culler, PhD, 7145950649, firstname.lastname@example.org
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