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Inactivated Polio Vaccine

fIPV + dmLT Vaccine Combo for Polio

Phase 1
Waitlist Available
Led By Jessica W Crothers, MD
Research Sponsored by University of Vermont
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18 to 45 years old
History of receipt of childhood polio vaccine series consisting of at least 3 doses of Inactivated Polio Vaccine (IPV). No history of receipt of OPV.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights

Study Summary

This trial is studying a new vaccine combination to see if it can help control viral shedding.

Who is the study for?
Healthy adults aged 18-45 who have received the IPV childhood polio vaccine series and not OPV, with good general health and no history of severe allergies to IPV or OPV components. Women must not be pregnant, breastfeeding, or unwilling to use contraception. Participants cannot have a recent history of certain medications or vaccines, drug abuse, travel outside the US during the study period, contact with immunosuppressed individuals or infants under six months.Check my eligibility
What is being tested?
This phase 1 trial is testing if adding dmLT (a mucosal adjuvant) to intradermal fIPV can control fecal viral shedding better than fIPV alone in healthy adults. It's a randomized double-blind controlled trial where participants also receive an oral polio vaccine challenge to test mucosal immunity.See study design
What are the potential side effects?
Potential side effects may include local reactions at injection sites such as redness and swelling, mild fever, fatigue, headache and gastrointestinal symptoms like nausea or diarrhea due to immune response stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 45 years old.
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I received at least 3 doses of the polio vaccine as a child, but never the oral version.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
mucosal immunity to poliovirus
Secondary outcome measures
Safety and local reactogenicity: systemic and local injection site adverse reactions (ARs)
Safety: serious adverse events
Systemic Immunogenicity: poliovirus-specific serum neutralizing antibody responses

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: fIPV-dmLTExperimental Treatment2 Interventions
Intradermal administration of fIPV with the addition of 0.47ug dmLT
Group II: fIPVActive Control2 Interventions
Intradermal administration of fIPV alone.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of VermontLead Sponsor
266 Previous Clinical Trials
3,743,672 Total Patients Enrolled
World Health OrganizationOTHER
233 Previous Clinical Trials
1,566,254 Total Patients Enrolled
Jessica W Crothers, MDPrincipal InvestigatorUVM Vaccine Testing Center

Media Library

Intradermal Fractional Dose IPV (fIPV) (Inactivated Polio Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05327426 — Phase 1
Polio Research Study Groups: fIPV, fIPV-dmLT
Polio Clinical Trial 2023: Intradermal Fractional Dose IPV (fIPV) Highlights & Side Effects. Trial Name: NCT05327426 — Phase 1
Intradermal Fractional Dose IPV (fIPV) (Inactivated Polio Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05327426 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies in this clinical trial for participants?

"According to the information provided on clinicaltrials.gov, this medical investigation is searching for participants at present; it was initially posted in April of 2022 and has been updated most recently in September of that same year."

Answered by AI

Does this research project restrict participation to those 85 years of age or younger?

"Consistent with the prerequisites for this trial, individuals must be between 18 and 45 years of age to qualify."

Answered by AI

To what extent can Monovalent oral poliomyelitis vaccine (mOPV), Sabin strain be hazardous?

"Our team at Power assessed the safety of Monovalent oral poliomyelitis vaccine (mOPV), Sabin strain as a 1 due to it being in its initial phase and only having limited data regarding efficacy and safety."

Answered by AI

What is the aggregate figure of individuals participating in this experiment?

"Affirmative. Clinicaltrials.gov records show that this clinical trial is actively enrolling participants, with an initial postdate of April 1st 2022 and a recent update on September 2nd 2022. The overall aim is to recruit 40 individuals from one medical centre."

Answered by AI

Would I meet the criteria to join this clinical investigation?

"For this trial, 40 individuals aged 18 to 45 and affected by poliomyelitis are being admitted. Prior to joining the study, applicants must provide a signed informed consent form as well as evidence of completing an Inactivated Polio Vaccine (IPV) series consisting of at least 3 doses with no history of receipt of OPV. Additionally, they must have neutralizing antibody titers > 1:8 for polio type 1 and demonstrate good general health through medical history review, physical exam and basic laboratory screening."

Answered by AI

Who else is applying?

What state do they live in?
Vermont
What site did they apply to?
University of Vermont Vaccine Testing Center at the Larner College of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Im a trail coordinator and I know how important research is. I would like be apart of reach out aide of my work.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Intradermal Fractional Dose IPV (fIPV) in Combination With dmLT
Jessica Crothers 2022. "Intradermal Fractional Dose IPV (fIPV) in Combination With dmLT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05327426.
All > Polio
~6 spots leftby Apr 2025
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