Vaccine Observation to Include All Communities for Equitable Science (VOICES)

VOICES: Vaccine Observation to Include All Communities for Equitable Science

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.

Study Overview

• Status: Terminated
• Conditions: Vaccine Adverse Reaction; Vaccine Response Impaired
• Intervention / Treatment: Biological: COVID-19 vaccine

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

• Study Contact: Name: Stephanie Culler, PhD; Phone Number: 7145950649; Email: sculler@persephonebiome.com
• Study Contact Backup: Name: Stephen Van Dien, PhD; Phone Number: 8582328733; Email: svandien@persephonebiome.com

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • Persephone Biosciences, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

It is anticipated that 10,000 subjects will be enrolled in this study. It is preferred that enrollment is balanced by sex; however, it is not required. All efforts will be made to provide racial/ethnic balance, with a goal of 50% underrepresented minorities.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Persephone Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; vaccine; COVID-19; gut microbiome
• Other Study ID Numbers: PB-2021-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No