SAN DIEGO, March 11, 2021 /PRNewswire/ -- Persephone Biosciences Inc., a privately held, data-driven microbiome-focused biotechnology company, today announced the initiation of the VOICES clinical study to determine the impact of gut microbiome composition and function on the immune system and efficacy of COVID-19 vaccination.
VOICES (Vaccine Observation to Include all Communities for Equitable Science) is a non-interventional, single-site study that will enroll up to 10,000 people in the U.S. being administered a COVID-19 vaccine (i.e., any vaccine currently authorized for emergency or other use in the U.S. by the Food and Drug Administration (FDA) as well as any that may be authorized for emergency or other use in the U.S. during the course of the VOICES study). The study is vaccine agnostic and will collect both blood and stool samples prior to and following subjects being vaccinated for the SARS CoV-2 virus, with the goal of identifying and determining specific gut microbiota and the metabolic processes that are involved in optimal immune response and function. Next-generation sequencing technologies will be used to examine samples from participants who subsequently contract COVID-19 after vaccination, to accurately analyze failure data and take account of and track coronavirus variants.
Persephone Biosciences is committed to diversity inclusion within the study, with a goal of balanced gender enrollment as well as 50% ethnic and racial minorities, as those populations have been disproportionately adversely impacted by COVID-19. The study will begin with an initial pilot study of a few hundred adults, and scale to over 10,000 participants nationwide using a decentralized clinical trial approach. Study participants will be able to donate both stool and blood samples remotely.
"The VOICES study will provide new insight into how the human gut microbiome influences immune response to vaccination. While we are studying the COVID-19 vaccine specifically, we also believe that there will be read-through to other vaccination programs that could ultimately lead to precision vaccinations as a new frontier of precision medicine, as well as therapeutics targeting the microbiome to improve vaccine response," said Stephanie Culler, CEO and Co-founder of Persephone Biosciences. "We anticipate possibly partnering with vaccine manufacturers and healthcare providers as the study evolves, to the mutual benefit of both parties. Following the initial pilot study, we hope to publish early data in a relevant scientific publication or present at an appropriate congress."
Eligible subjects will provide two samples each of blood and stool, one prior to and one following administration of any COVID-19 vaccine. Follow-up questionnaires will be provided at 3, 6, 9 and 12 months to determine if they have contracted COVID-19 or have experienced any adverse effects of the vaccine. Participants that have contracted COVID-19 will be asked for additional sample donation for viral sequencing.
The official title of the VOICES study is: "Vaccine Observation to Include all Communities for Equitable Science". The objective of this study is to collect samples each of blood and stool from subjects being vaccinated for the SARS-CoV-2 virus. These samples will be analyzed to determine the impact of gut microbiome composition and function on the immune system and efficacy of the vaccination. More information about this study can be found at NCT04770649.
About Persephone Biosciences:
Persephone Biosciences, a Y Combinator company, takes a novel approach to improving the efficacy of existing therapies, leveraging the systemic impact of the gut microbiome on the human immune system. Persephone's technology platform is based on population-scale observational clinical trials, advanced genomics and immunology techniques and machine learning to understand the impact of gut microbes on patient prognosis and immune system function. The results are used to design precision immunotherapies utilizing synthetic biology and companion diagnostics for unmet needs.
Persephone Biosciences is a JLABS @ San Diego resident and part of BLUE KNIGHT™, a joint initiative between Johnson & Johnson Innovation – JLABS and the Biomedical Advanced Research and Development Authority, a component of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services. This collaboration aims to stimulate innovation and incubation of technologies that improve health security and response through companies focused on public health threats and emerging infectious diseases.
For more information, visit www.persephonebiosciences.com.
Dr. Stephanie Culler
CEO and Co-founder
Persephone Biosciences, Inc.
Gilmartin Group, LLC.
Evan Wicker, Ph.D.
Russo Partners, LLC
Olipriya Das, Ph.D.
Russo Partners, LLC
SOURCE Persephone Biosciences