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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 September 2021
• Main ID: NCT04639375
• Date of registration: 16/11/2020
• Prospective Registration: No
• Primary sponsor: E-MO Biology Inc
• Public title: Polio Vaccine (IPV) for SARS-CoV-2 and Prevention of Coronavirus Disease (COVID-19)
• Scientific title: 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)
• Date of first enrolment: November 15, 2020
• Target sample size: 300
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT04639375
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: John Andrews
• Affiliation: E-MO Biology Inc

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the
duration of the study

3. Male or female, aged 18-80

4. 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

5. In good general health with no active infectious disease as evidenced by medical
history and directed physical examination.

Exclusion Criteria:

1. Known allergic reactions to components of the polio vaccine

2. Febrile illness within 14 days

3. Positive for SARS-CoV-2 antigenemia at any time prior to screening1

4. Positive for SARS-CoV-2 antibodies at any time prior to screening1

5. Subjects with fever > 101o F at screening

6. 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

7. Treatment with an investigational drug or other intervention within the 90 days prior
to enrollment in this study

8. Inoculation with polio vaccine within the last 12 years

9. Women who are pregnant or breast feeding



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

SARS-CoV-2

Intervention(s)

Biological: Vaccinated with polio vaccine (IPV)

Primary Outcome(s)

Percentage of Subjects with Antibodies to SARS-CoV-2 RdRp following IPV Vaccination [Time Frame: Day 28]

Secondary Outcome(s)

Determination of neutralizing titer of antibodies raised to SARS-CoV-2 following vaccination with polio vaccine [Time Frame: Day 28]

Secondary ID(s)

EMO-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors