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

Status unconfirmed · Phase 4

Conditions studied: SARS-CoV-2

In brief

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.

Key facts

Study ID

NCT04639375

Run by

E-MO Biology Inc

People needed

300

Starts

2020-11-15

Expected to finish

2022-06-12

Last updated by the study team

2021-08-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

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
• congestion or runny nose
• nausea or vomiting
• diarrhea
• Treatment with an investigational drug or other intervention within the 90 days prior to enrollment in this study
• Inoculation with polio vaccine within the last 12 years
• Women who are pregnant or breast feeding

Where it is running

• Rac Ii Md — National City, California, United States

Full record on ClinicalTrials.gov

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