SARS-CoV-2Phase 4NCT04639375
Polio Vaccine (IPV) for SARS-CoV-2 and Prevention of Coronavirus Disease (COVID-19)
A Phase 4 study testing Vaccinated with polio vaccine (IPV) in people with SARS-CoV-2, run by E-MO Biology Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- Vaccinated with polio vaccine (IPV)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2020to 12 Jun 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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.
Read the 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
- Being tested
- Vaccinated with polio vaccine (IPV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccinated with polio vaccine (IPV)Biological
poliovirus vaccine (IPV) manufactured by Sanofi Pasteur for distribution in the United States
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated with polio vaccine (IPV) | Experimental | All subjects will receive polio vaccine: IPV as manufactured by Sanofi Pasteur for distribution in the United States Receives: Biological: Vaccinated with polio vaccine (IPV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 28
Secondary outcomes (1)
Determination of neutralizing titer of antibodies raised to SARS-CoV-2 following vaccination with polio vaccine
Antibodies raised following IPV vaccination will be evaluated for neutralizing titer to both polio virus and SARS-CoV-2
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start15 Nov 2020
- Primary completion12 Jun 2021
- Study completion12 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- E-MO Biology Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Andrews, Study chair, E-MO Biology Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639375
- Sponsor's protocol ID
- EMO-001
- Status last verified
- Aug 2021
- First submitted
- 16 Nov 2020
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT04639375
- Acronym / sponsor ID
- EMO-001
- Conditions
- SARS-CoV-2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (actual)
- Lead sponsor
- E-MO Biology IncIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 12 Jun 2021 (actual)
- Study completion
- 12 Jun 2022 (estimated)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccinated with polio vaccine (IPV) | Experimental | Biological: Vaccinated with polio vaccine (IPV)All subjects will receive polio vaccine: IPV as manufactured by Sanofi Pasteur for distribution in the United States |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaccinated with polio vaccine (IPV)poliovirus vaccine (IPV) manufactured by Sanofi Pasteur for distribution in the United States | Biological | Vaccinated with polio vaccine (IPV) |
Primary outcome
Percentage of Subjects with Antibodies to SARS-CoV-2 RdRp following IPV Vaccination
Time frame: Day 28
Percentage of all subjects vaccinated with IPV with antibodies to SARS-CoV-2 RdRp
1 secondary outcome
Determination of neutralizing titer of antibodies raised to SARS-CoV-2 following vaccination with polio vaccine
Time frame: Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Andrews study chair
E-MO Biology Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vaccinated with polio vaccine (IPV) in people with SARS-CoV-2, run by E-MO Biology Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects with Antibodies to SARS-CoV-2 RdRp following IPV Vaccination (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.