Vaccine Observation to Include All Communities for Equitable Science

NCT04770649 | Terminated FDA Drug

• 1 other identifier: PB-2021-01
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

SARS-CoV-2; COVID-19; gut microbiome; vaccine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Identify correlations between microbiome composition and immune system response to the vaccine

  3-6 months

• Track coronavirus variants of any individuals infected

  6-12 months

• Build a library of samples and data for future research

  6-24 months

Study Arms (1)

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

Interventions

COVID-19 vaccine BIOLOGICAL

Any vaccine for COVID-19

COVID-19 vaccine recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Persephone Biosciences: lead

Study Sites (1)

Persephone Biosciences, Inc.

San Diego, California, 92121, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool and blood samples

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 25, 2021
• Study Start: April 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 5, 2024

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)