Vaccine Observation to Include All Communities for Equitable Science

Vaccine Adverse Reaction Clinical Trial

— VOICES  

Official title:

VOICES: Vaccine Observation to Include All Communities for Equitable Science

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04770649
• Other study ID #: PB-2021-01
• Status: Terminated
• Start date: April 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2021
• Source: Persephone Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vaccine Adverse Reaction
• Vaccine Response Impaired

Intervention

Biological:
• COVID-19 vaccine
Any vaccine for COVID-19

Locations

Country	Name	City	State
United States	Persephone Biosciences, Inc.	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Persephone Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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