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

NCT04639375 | Unknown Phase 4 FDA Drug

• 1 other identifier: EMO-001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects with Antibodies to SARS-CoV-2 RdRp following IPV Vaccination

  Percentage of all subjects vaccinated with IPV with antibodies to SARS-CoV-2 RdRp

  Day 28

Secondary Outcomes (1)

• Determination of neutralizing titer of antibodies raised to SARS-CoV-2 following vaccination with polio vaccine

  Day 28

Study Arms (1)

Vaccinated with polio vaccine (IPV)

EXPERIMENTAL

All subjects will receive polio vaccine: IPV as manufactured by Sanofi Pasteur for distribution in the United States

Biological: Vaccinated with polio vaccine (IPV)

Interventions

Vaccinated with polio vaccine (IPV) BIOLOGICAL

poliovirus vaccine (IPV) manufactured by Sanofi Pasteur for distribution in the United States

Vaccinated with polio vaccine (IPV)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 18-80
• Female subjects of child-bearing potential must have a negative pregnancy test (point-of-care dipstick) prior to being vaccinated and be willing to use an effective method of birth control from the time of entry into the study and for 30 days following vaccination
• In good general health with no active infectious disease as evidenced by medical history and directed physical examination.

You may not qualify if:

• Known allergic reactions to components of the polio vaccine
• Febrile illness within 14 days
• Positive for SARS-CoV-2 antigenemia at any time prior to screening1
• Positive for SARS-CoV-2 antibodies at any time prior to screening1
• Subjects with fever \> 101o F at screening
• Subjects who respond yes to any of the following question:
• Have you experienced any of the following symptoms in the past 48 hours (14):
• fever or chills
• cough
• shortness of breath or difficulty breathing
• fatigue
• muscle or body aches
• headache
• new loss of taste or smell
• sore throat

Sponsors & Collaborators

• E-MO Biology Inc: lead

Study Sites (1)

Rac Ii Md

National City, California, 91950, United States

Location

Study Officials

• John Andrews

  E-MO Biology Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 20, 2020
• Study Start: November 15, 2020
• Primary Completion: June 12, 2021
• Study Completion: June 12, 2022
• Last Updated: August 27, 2021

Record last verified: 2021-08

Locations

US (1)