Novel Oral Polio Vaccines for Polio
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new oral polio vaccines to determine their safety and ability to trigger an effective immune response. It tests two vaccines, Novel Oral Polio Vaccine Type 1 (nOPV1) and Novel Oral Polio Vaccine Type 3 (nOPV3), against polio types 1 and 3, comparing them to existing vaccines. The trial seeks healthy adults who have been fully vaccinated against polio, either by injection or oral form. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive these new vaccines.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on long-acting immune-modifying drugs or chronic immunosuppressants, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study showed that the new oral polio vaccines, nOPV1 and nOPV3, had promising safety results. Most reported side effects were mild, and serious side effects were rare and evenly distributed among participants.
This research indicates that both nOPV1 and nOPV3 are generally well-tolerated in adults previously vaccinated against polio, meaning participants experienced few negative effects from the vaccine.
Overall, the evidence suggests that these new vaccines have a good safety profile, making them a potentially safe option for those considering joining a clinical trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these novel oral polio vaccines (nOPV1 and nOPV3) because they are designed to improve safety and effectiveness over traditional oral polio vaccines (OPV). Unlike current OPVs, which can, in rare cases, revert to a form that might cause outbreaks, these new vaccines are engineered to reduce that risk significantly. Additionally, they aim to provide robust immunity against polio with potentially fewer doses. This makes them a promising option in the global effort to eradicate polio, especially in areas where the disease remains a threat.
What evidence suggests that this trial's treatments could be effective for polio?
Research shows that the new oral polio vaccines, nOPV1 and nOPV3, tested in this trial, are promising in terms of effectiveness. Participants will receive either nOPV1 or nOPV3, depending on their assigned group. Studies found that 28 days after the first dose, 100% of participants developed antibodies against the virus, similar to the 86% to 100% effectiveness seen with standard oral polio vaccines. Historically, oral polio vaccines have reduced global polio cases by over 99% since 1988. This evidence suggests that the new vaccines could continue to effectively fight polio.12678
Who Is on the Research Team?
Jessica Crothers, MD
Principal Investigator
University of Vermont
Arlene Sena, MD
Principal Investigator
University of North Carolina
Peter Wright, MD
Principal Investigator
Dartmouth-Hitchcock Medical Center
Mohamed Al-Ibrahim, MB CHB, FACP
Principal Investigator
Pharmaron CPC, Inc.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the study vaccine, with two doses given 28 days apart for some groups
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse event monitoring and fecal shedding analysis
What Are the Treatments Tested in This Trial?
Interventions
- Novel Oral Polio Vaccine Type 1 (nOPV1)
- Novel Oral Polio Vaccine Type 3 (nOPV3)
- Sabin Monovalent Oral Polio Vaccine Type 1 (mOPV1)
- Sabin Monovalent Oral Polio Vaccine Type 3 (mOPV3)
How Is the Trial Designed?
8
Treatment groups
Experimental Treatment
Active Control
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.
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.
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
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.
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of mOPV1 containing 10\^6.0 CCID50 on Day 1.
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.
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.
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
Find a Clinic Near You
Who Is Running the Clinical Trial?
PATH
Lead Sponsor
Viroclinics Biosciences B.V.
Industry Sponsor
Viroclinics Biosciences B.V.
Collaborator
Bill and Melinda Gates Foundation
Collaborator
Centers for Disease Control and Prevention
Collaborator
The Emmes Company, LLC
Industry Sponsor
Peter Ronco
The Emmes Company, LLC
Chief Executive Officer since 2023
BSc from Nottingham University
Dr. Joe Sliman
The Emmes Company, LLC
Chief Medical Officer since 2020
MD from Uniformed Services University of the Health Sciences, MPH from Johns Hopkins University, BSc in Molecular and Cell Biology from Pennsylvania State University
Citations
Polio Vaccine Effectiveness and Duration of Protection
Two doses of inactivated polio vaccine (IPV) are 90% effective or more against paralytic polio; three doses are 99% to 100% effective.
2.
cidrap.umn.edu
cidrap.umn.edu/polio/novel-live-type-1-and-3-oral-polio-vaccines-show-good-safety-immune-response-phase-1-trialNovel live type 1 and 3 oral polio vaccines show good ...
Homotypic seroprotection was 100% 28 days after the first dose, similar to that of nOPV (86% to 100%) and mPOV (86% to 93%). Fecal viral- ...
Safety and immunogenicity of novel live attenuated type 1 ...
This study is the first-in-human trial of novel type 1 and type 3 oral poliovirus vaccines (nOPV1 and nOPV3, respectively). It includes safety ...
Oral polio vaccine - GPEI
The use of OPV has helped reduce global polio cases by over 99% since 1988, and it remains a vital tool in the effort to end polio everywhere. Advantages. OPVs ...
Polio Vaccine - StatPearls - NCBI Bookshelf
Oral Polio Vaccine Like IPV, the OPV is generally very well-tolerated. However, the vaccine causes 2 rare but severe events—vaccine-associated ...
Study of Novel Types 1 and 3 Oral Poliomyelitis Vaccines
The purpose of this study is to assess the safety (primary objective), the ability to trigger the production of antibodies (immunogenicity; ...
Safety and immunogenicity of novel live attenuated type 1 ...
Safety and immunogenicity of novel live attenuated type 1 and type 3 oral poliomyelitis vaccines in healthy adults in the USA: a first-in-human, ...
Poliovirus vaccines
Clinical trial data has confirmed the safety of nOPV2, and the non-inferior immunogenicity compared with monovalent oral polio vaccine type 2 (mOPV2).3, 4 nOPV2 ...
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