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Trial Tests Microbiome Effect on Covid-19 Vaccines

Microbiome graphic

(Tony Webster, Flickr)

11 Mar. 2021. A clinical trial is underway assessing the impact of gut microbes on immune responses generated by vaccines protecting against Covid-19 disease. The trial, known as Vaccine Observation to Include all Communities for Equitable Science, or Voices, is sponsored by biotechnology company Persephone Biosciences Inc. in San Diego.

Persephone Biosciences aims to improve the efficacy of drugs, including vaccines, by evaluating their interactions with microbial communities in the gut, also known as the microbiome. The microbiome, the collection of bacteria and other microorganisms found naturally in the body, particularly in the gut, is an emerging area of research and opportunity for therapies, including for diseases not usually associated with bacteria or the gut.

The company conducts large-scale observational studies, collecting data from participants throughout the U.S. over months at a time. Persephone uses the data to create databases from stool and blood samples, as well as participant health records, providing connections between gut microbes and the immune system. The company says it applies advanced analytics, including artificial intelligence, to find links between genomic properties, proteins, biomarkers, and microbial populations in the gut. Persephone says its findings can help drug developers create more precise treatments for disease, particularly cancer.

Research undertaken by Persephone Biosciences enrolls thousands of participants who provide specimen samples, as well data online over several months. While called clinical trials, they’re observational studies rather than randomized controlled clinical trials that test new treatments against a placebo or existing drugs.

Samples taken before and after vaccination

The Voices trial aims to track the impact of gut microbes on immune responses of individuals receiving one of the new vaccines authorized by Food and Drug Administration for protecting against Covid-19 disease. The study team is enrolling 10,000 participants, age 18 and older, in the U.S., beginning with a smaller pilot study in Southern California. The company says it’s particularly eager to enroll a gender-balanced participant sample, with half of the participants comprised of racial and ethnic minorities.

At the time of their enrollment, individuals should NOT have yet received a Covid-19 vaccine. After enrollment, participants are asked to provide stool and blood samples to Persephone Biosciences before receiving a Covid-19 vaccine, then provide specimens again after receiving the vaccine. Participants are also asked to complete online questionnaires every three months for a year. And if participants become infected with Covid-19, they’re asked to send in nasal swabs to Persephone. The company says it plans to compensate individuals for taking part in the study.

Persephone Biosciences says it will conduct whole genome sequencing and a metabolomic analysis to characterize the microbiome of individual participants, then correlate its microbial analysis to Covid-19 infections among participants after receiving their vaccines. The study team is also correlating its metabolomic analysis to immune system responses, as well as tracking the presence of any SARS-CoV-2 viral variants among infected participants. The company expects to store the specimen samples and data for further analyses if needed.

“The Voices study will provide new insight into how the human gut microbiome influences immune response to vaccination,” says Persephone Biosciences co-founder and CEO Stephanie Culler in a company statement released through Cision. Culler adds, “We anticipate possibly partnering with vaccine manufacturers and health care providers as the study evolves, to the mutual benefit of both parties.”

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