NCT04639375

Polio Vaccine (IPV) for SARS-CoV-2 and Prevention of Coronavirus Disease (COVID-19)

A Proof-of-concept Study of Poliovirus Vaccine (IPV) Activity to Induce an Immune Response That Cross-reacts With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: E-MO Biology Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

A total of 300 healthy volunteers between the ages of 18 and 80 with no previous history of COVID-19 will be entered into the study and will receive IPV by injection on Day 1. Blood specimens collected pre-inoculation will be tested for cross-reactivity to poliovirus and SARS-CoV-2 by Western blot. An additional specimen will be collected on Day 28 post-inoculation and, likewise tested for cross-reactivity to poliovirus and SARS-CoV-2. The number of subjects with an immune response to SARS-CoV-2 antigens following inoculation with IPV will be summarized.

Detailed description

A total of 300 healthy volunteers between the ages of 18 and 80 with no previous history of COVID-19 will be entered into the study and will receive IPV by injection on Day 1. Blood specimens collected pre-inoculation will be tested for cross-reactivity to poliovirus and SARS-CoV-2 by Western blot. An additional specimen will be collected on Day 28 post-inoculation and, likewise tested for cross-reactivity to poliovirus and SARS-CoV-2. If the results from this study demonstrate that polio vaccine induces an immune response against both the immunogen (poliovirus) and SARS-CoV-2, the study may be amended after consultation with the Center for Biologics evaluation and research (CBER), to enroll an additional 275 subjects. Expansion of the original cohort will be stratified by age and race/ethnicity. The number of subjects with an immune response to SARS-CoV-2 antigens following inoculation with IPV will be summarized. Vaccination for poliomyelitis is part of routine childhood vaccination. Only IPV has been administered in the United States since the year 2000 as a series of 4 inoculations in childhood inducing an immunity which, although protective for years, wans over time and is, for the most part, undetectable in adults unless a booster is administered. United States residents are advised to receive a booster prior to travelling to countries where polio disease remains endemic. Inactivated vaccines against RNA viruses (including Poliovirus and coronavirus) induce an immune response that recognizes the non-structural antigens of the inactivated viral particle. There is extensive homology between Poliovirus and SARS-CoV-2 RNA-dependent-RNA-polymerase (RdRp) both within the coding regions and illustrated in the 3-dimensional modeling. The homology between the viral epitopes may be sufficient such that adults who receive a polio booster develop an immune response that cross-reacts with SARS-CoV-2. Consequently, the neutralizing activity of antibodies raised to SARS-CoV-2 RdRp will be evaluated.To evaluate and characterize the immune response to SARS-CoV-2 elicited in adults by IPV. Primary Objective: To evaluate whether an immune response to SARS-CoV-2 RdRp is induced in adults receiving a booster inoculation of IPV. Secondary Objectives:: To evaluate the neutralizing activity of antibodies raised to SARS-CoV-2 RdRp This is a single-site study in a clinic in San Diego California that routinely diagnoses and manages patients with COVID-19.

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	Vaccinated with polio vaccine (IPV)	poliovirus vaccine (IPV) manufactured by Sanofi Pasteur for distribution in the United States

Timeline

• Start date: 2020-11-15
• Primary completion: 2021-06-12
• Completion: 2022-06-12
• First posted: 2020-11-20
• Last updated: 2021-08-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study