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Virus Therapy
Study of Novel Types 1 and 3 Oral Poliomyelitis Vaccines
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 days 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Polio
- Polio Vaccines
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Serious Adverse Events (SAEs)
Number of Participants With Solicited Adverse Events (AEs) 7 Days After First Dose of Study Vaccine
Number of Participants With Solicited Adverse Events 7 Days After Second Dose of Study Vaccine
+1 moreSecondary study objectives
Amount of Type 1 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Amount of Type 3 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Area Under the Curve From Vaccination to 28 Days After Vaccination (AUC₀-₂₈) of Vaccine Virus Shed in Stool in Participants With an IPV Vaccination History
+11 moreSide effects data
From 2023 Phase 1 trial • 226 Patients • NCT0452953826%
Fatigue
23%
Headache
23%
Nausea
14%
Abdominal pain
14%
Diarrhoea
6%
Myalgia
6%
Arthralgia
3%
Chills
3%
Productive cough
3%
Sinusitis
3%
Constipation
3%
Bacterial vaginosis
3%
Vomiting
3%
Nasal congestion
3%
COVID-19
3%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 7: nOPV3 (OPV History)
Group 5: nOPV3 (IPV History)
Group 8: mOPV3 (OPV History)
Group 3: nOPV1 (OPV History)
Group 6: mOPV3 (IPV History)
Group1: nOPV1 (IPV History)
Group 2: mOPV1 (IPV History)
Group 4: mOPV1 (OPV History)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Active Control
Group I: Group1: nOPV1 (IPV History)Experimental Treatment1 Intervention
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of novel OPV type 1 (nOPV1) containing 10\^6.5 cell culture infectious dose 50% (CCID50) on Day 1.
Group II: Group 7: nOPV3 (OPV History)Experimental Treatment1 Intervention
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were 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
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
Group IV: Group 3: nOPV1 (OPV History)Experimental Treatment1 Intervention
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were 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
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of mOPV1 containing 10\^6.0 CCID50 on Day 1.
Group VI: Group 8: mOPV3 (OPV History)Active Control1 Intervention
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were 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
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
Group VIII: Group 6: mOPV3 (IPV History)Active Control1 Intervention
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Novel Oral Polio Vaccine Type 3 (nOPV3)
2021
Completed Phase 1
~230
Novel Oral Polio Vaccine Type 1 (nOPV1)
2021
Completed Phase 1
~230
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
176 Previous Clinical Trials
626,819 Total Patients Enrolled
Bill and Melinda Gates FoundationOTHER
416 Previous Clinical Trials
22,956,819 Total Patients Enrolled
Centers for Disease Control and PreventionFED
892 Previous Clinical Trials
22,000,668 Total Patients Enrolled
The Emmes Company, LLCIndustry Sponsor
147 Previous Clinical Trials
1,051,912 Total Patients Enrolled
Elizabeth R Colgate, PhDPrincipal InvestigatorUniversity of Vermont
Jessica Crothers, MDPrincipal InvestigatorUniversity of Vermont
Arlene Sena, MDPrincipal InvestigatorUniversity of North Carolina
Peter Wright, MDPrincipal InvestigatorDartmouth-Hitchcock Medical Center
1 Previous Clinical Trials
28 Total Patients Enrolled
Mohamed Al-Ibrahim, MB CHB, FACPPrincipal InvestigatorPharmaron CPC, Inc.