Clinical trial NCT04770649: Vaccine Observation to Include All Communities for Equitable Science
Official title: VOICES: Vaccine Observation to Include All Communities for Equitable Science
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Vaccine Response Impaired
Vaccine Adverse Reaction
Keywords: SARS-CoV-2
COVID-19
gut microbiome
vaccine
Lead sponsor: Persephone Biosciences
Sponsor class: INDUSTRY
First posted: 2021-02-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Determine whether the microbiome composition can predict effectiveness of vaccine.
timeFrame: 6-12 months
Secondary outcomes:
measure: Identify correlations between microbiome composition and immune system response to the vaccine
timeFrame: 3-6 months
measure: Track coronavirus variants of any individuals infected
timeFrame: 6-12 months
measure: Build a library of samples and data for future research
timeFrame: 6-24 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Persephone Biosciences, Inc.
state: California
Study officials:
References: