Vaccine Observation to Include All Communities for Equitable Science

Overview

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

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2022

Interventions

  • 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

Primary 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

Secondary Measures

  • 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

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Persephone Biosciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Stephanie Culler, PhD, 7145950649, sculler@persephonebiome.com

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