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Virus Therapy

Novel Oral Polio Vaccine Type 1 (nOPV1) for Polio

Phase 1
Waitlist Available
Led By Elizabeth R Colgate, PhD
Research Sponsored by PATH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males or females, from 18 to 45 years of age (inclusive) at the time of enrollment
Healthy, as defined by the absence of any clinically significant medical conditions, either acute or chronic, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator Willing and able to provide written informed consent prior to performance of any study-specific procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57
Awards & highlights

Study Summary

This trial is testing the safety of two new oral polio vaccines. The main goal is to see if they are safe for humans. A secondary goal is to see if the vaccines cause immunogenicity (an immune response) and if the virus sheds in the feces.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Serious Adverse Events (SAEs)
Number of Participants with Solicited Adverse Events (AEs) 7 Days after Each Dose of Study Vaccine
Number of Participants with Unsolicited Adverse Events (AEs) up to 28 days Post Vaccination
Secondary outcome measures
Amount of Vaccine Virus in each Stool Sample Positive for Virus in Participants with IPV Vaccination History
Area Under the Curve (AUC) of Vaccine Virus Shed in Stool in Participants with an IPV Vaccination History
Geometric Mean Titer Ratio of Anti-polio Serum Neutralizing Antibody Titer for Poliomyelitis Type 1 among Participants with a Vaccine History of IPV
+18 more

Trial Design

8Treatment groups
Experimental Treatment
Active Control
Group I: Group1: nOPV1 (IPV History)Experimental Treatment1 Intervention
15-20 healthy adults fully vaccinated against polio exclusively by IPV will be administered 1 vaccination of novel OPV type 1 (nOPV1) containing 10^6.5 CCID50/dose.
Group II: Group 7: nOPV3 (OPV History)Experimental Treatment1 Intervention
30-50 healthy adults fully vaccinated against polio by OPV will be administered 2 vaccinations of nOPV3 in a dose of 10^6.5 CCID50/dose, given 28 days apart.
Group III: Group 5: nOPV3 (IPV History)Experimental Treatment1 Intervention
15-20 healthy adults fully vaccinated against polio exclusively by IPV will be administered 1 vaccination of nOPV3 containing 10^6.5 CCID50/dose.
Group IV: Group 3: nOPV1 (OPV History)Experimental Treatment1 Intervention
30-50 healthy adults fully vaccinated against polio by OPV will be administered 2 vaccinations of nOPV1 containing 10^6.5 CCID50/dose, given 28 days apart.
Group V: Group 2: mOPV1 (IPV History)Active Control1 Intervention
15-20 healthy adults fully vaccinated against polio exclusively by IPV will be administered 1 vaccination of mOPV1 containing 10^6.0 CCID50/dose.
Group VI: Group 8: mOPV3 (OPV History)Active Control1 Intervention
15-25 healthy adults fully vaccinated against polio by OPV will be administered 2 vaccinations of mOPV3 containing ≥ 10^5.8 CCID50/dose, given 28 days apart.
Group VII: Group 4: mOPV1 (OPV History)Active Control1 Intervention
15-25 healthy adults fully vaccinated against polio by OPV will be administered 2 doses of mOPV1containing ≥ 10^6.0 CCID50/dose, given 28 days apart
Group VIII: Group 6: mOPV3 (IPV History)Active Control1 Intervention
15-20 healthy adults fully vaccination against polio by exclusively IPV will be administered 1 vaccination of mOPV3 containing ≥ 10^5.8 CCID50/dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Novel Oral Polio Vaccine Type 3 (nOPV3)
2021
Completed Phase 1
~210
Novel Oral Polio Vaccine Type 1 (nOPV1)
2021
Completed Phase 1
~210

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Viroclinics Biosciences B.V.UNKNOWN
1 Previous Clinical Trials
60 Total Patients Enrolled
PATHLead Sponsor
171 Previous Clinical Trials
606,080 Total Patients Enrolled
Bill and Melinda Gates FoundationOTHER
407 Previous Clinical Trials
22,923,883 Total Patients Enrolled

Frequently Asked Questions

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

Is this clinical trial a pioneering endeavor in its field?

"Currently, 3 nOPV1 trials are taking place in 11 cities over 4 countries. The earliest of these studies began in 2020 and was sponsored by NeuroActiva, Inc., involving 3600 participants. Subsequently, 22 other related clinical investigations have been carried out since then."

Answered by AI

Are geriatric individuals excluded from this investigation?

"The requirements for this medical trial dictate that individuals enrolling must be within the 18-45 age range. Additionally, there are 7 trials specifically focusing on underage patients and 2 studies dedicated to those 65 years of age or above."

Answered by AI

Are there any past trials that have featured Novel Oral Polio Vaccine Type 1 (nOPV1)?

"The Coronavirus Research Institute- Testing Site was the initial site of exploration for Novel Oral Polio Vaccine Type 1 (nOPV1) in 2020. There have been 22 finished studies since then and 3 active ones, mainly based out of Lebanon, New hampshire."

Answered by AI

What risk factors should be taken into consideration when administering nOPV1?

"Our team at Power has assigned Novel Oral Polio Vaccine Type 1 (nOPV1) a score of 1 on the safety scale, owing to its status as an early-phase trial with limited evidence supporting efficacy and security."

Answered by AI

Is enrollment still open for this research endeavor?

"This clinical trial is no longer admitting applicants, having last been amended on August 24th 2022. Prospective participants who are interested in trials for poliomyelitis or Novel Oral Polio Vaccine Type 1 (nOPV1) should note that there are currently 9 and 3 studies respectively recruiting patients."

Answered by AI

Who is qualified to join this research program?

"This study is searching for 205 individuals aged 18 to 45 with poliomyelitis. It is mandatory that these participants be male or female, abide by any hormonal injections prescribed, and practice abstinence from sexual intercourse."

Answered by AI

What is the enrollment size of this investigation?

"This research initiative is no longer recruiting participants. It was published on March 26th 2021 and last updated August 24th 2022. Those seeking other medical studies can look into the 9 trials related to poliomyelitis or 3 studies pertaining to Novel Oral Polio Vaccine Type 1 (nOPV1) that are still actively searching for subjects."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Novel Types 1 and 3 Oral Poliomyelitis Vaccines
2021. "Study of Novel Types 1 and 3 Oral Poliomyelitis Vaccines". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04529538.
~51 spots leftby Apr 2025
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