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NCT03922061 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Safety, Reactogenicity and Immunogenicity of Fractional-dose Inactivated Polio Vaccine (fIPV) Given Intradermally With Double Mutant Enterotoxigenic Escherichia Coli Heat Labile Toxin (dmLT) Adjuvant
A Phase 1 study, sponsored by University of Vermont.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT03922061 is a Phase 1 study that has completed, run by University of Vermont. The registered enrollment target is 29 participants.
The verdict
NCT03922061, a Phase 1 study, has completed, sponsored by University of Vermont.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
Polio is a serious disease that can cause paralysis and death. It is caused by a virus and can be prevented by vaccine. The World Health Organization's (WHO) Global Polio Eradication Initiative is trying to get rid of all polio disease around the world. Researchers want to help by testing a new vaccine. In many countries, people are vaccinated with oral polio vaccine (OPV) given by mouth during childhood. OPV is good at giving immunity (protection from polio) in the body and the gastrointestinal (GI) tract. Immunity in the GI tract is called mucosal immunity. The downsides of using OPV are that it can be shed into the environment in people's feces after vaccination where it can infect people who are not vaccinated, and it can cause paralysis in 2-4 of every one million children vaccinated with OPV. The United States (U.S.) stopped giving any OPV to people for vaccinations in the 1990's. Since then, a polio vaccine called inactivated polio vaccine (IPV) is given as an injection for routine childhood immunizations in the U.S. You cannot get polio infection from IPV and it will not be shed into the environment. In 2016, the WHO started a plan to help other countries gradually get rid of OPV. The downside of using IPV by itself is that, unlike OPV, it doesn't give enough mucosal immunity to protect people living in places where there is still polio. There are also supply shortages of IPV, which is a problem if there are outbreaks of polio. For the supply of IPV to help more people, it is safe and effective to use a tiny dose of IPV injected under the top layer of skin (intradermal or ID injection) rather than getting the full dose in the muscle. This is called a fractional dose of IPV, or fIPV. To help stop using OPV globally, a better fIPV vaccine is needed. fIPV vaccine needs a substance to help stimulate a mucosal immune response. dmLT is a substance that has been shown to stimulate a mucosal immune response. It has been shown to be safe and effective in both huma
Interventions
- BIOLOGICAL dmLT
- BIOLOGICAL fIPV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2019-03-19 |
| Est. Completion | 2020-06-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03922061
The ClinicalTrials.gov registry entry for NCT03922061 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Vermont, which has 162 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which dmLT is the first listed.
NCT03922061 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03922061 about?
NCT03922061 is a clinical study titled "Evaluation of Safety, Reactogenicity and Immunogenicity of Fractional-dose Inactivated Polio Vaccine (fIPV) Given Intradermally With Double Mutant Enterotoxigenic Escherichia Coli Heat Labile Toxin (dmLT) Adjuvant". Polio is a serious disease that can cause paralysis and death. It is caused by a virus and can be prevented by vaccine. The World Health Organization's (WHO) Global Polio Eradication Initiative is trying to get rid of all polio disease around the world. Researchers want to help by testing a new vacc...
What is the current status of trial NCT03922061?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2019-03-19. Estimated completion is 2020-06-04.
What interventions are being tested in trial NCT03922061?
The interventions under investigation include: dmLT (BIOLOGICAL), fIPV (BIOLOGICAL).
Who is sponsoring clinical trial NCT03922061?
This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.
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