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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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57
Awards & highlights

Summary

This trial is testing two new oral polio vaccines in healthy adults who have already been vaccinated against polio. The goal is to see if these new vaccines are safe and effective. The vaccines work by helping the body recognize and fight off poliovirus types 1 and 3. The new oral polio vaccines being tested are part of ongoing efforts to improve polio immunization, building on decades of experience with oral poliovirus vaccines and recent developments in bivalent and monovalent OPVs.

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

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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
174 Previous Clinical Trials
615,767 Total Patients Enrolled
Bill and Melinda Gates FoundationOTHER
409 Previous Clinical Trials
22,923,706 Total Patients Enrolled
~46 spots leftby Sep 2025
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