Vaccine Adverse Reaction, Vaccine Response Impaired
Conditions
Keywords
SARS-CoV-2, COVID-19, gut microbiome, vaccine
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.
Interventions
BIOLOGICALCOVID-19 vaccine
Any vaccine for COVID-19
Sponsors
Persephone Biosciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine whether the microbiome composition can predict effectiveness of vaccine. | 6-12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identify correlations between microbiome composition and immune system response to the vaccine | 3-6 months | 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 |
| Track coronavirus variants of any individuals infected | 6-12 months | 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 |
| Build a library of samples and data for future research | 6-24 months | Samples will be stored and data saved in a HIPAA-compliant database. Samples will be linked to patient metadata |
Countries
United States
Outcome results
None listed