NCT04770649

Vaccine Observation to Include All Communities for Equitable Science

VOICES: Vaccine Observation to Include All Communities for Equitable Science

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: Persephone Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vaccine Response Impaired
• Vaccine Adverse Reaction

Interventions

Type	Name	Description
BIOLOGICAL	COVID-19 vaccine	Any vaccine for COVID-19

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-02-25
• Last updated: 2024-04-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study