Novel Oral Polio Vaccines for Polio

No longer recruiting at 3 trial locations

Overseen By Rahsan Erdem, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: PATH

Must not be taking: Immunosuppressants, Immune-modifying drugs

Disqualifiers: Immunodeficiency, Gastrointestinal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

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. ^{1 2 3 4 5}

Why 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. ^{1 2 6 7 8}

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

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

• Abstinence from penile-vaginal intercourse

• Combined estrogen and progesterone oral contraceptives

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study vaccine, with two doses given 28 days apart for some groups

8 weeks

Multiple visits for vaccination and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse event monitoring and fecal shedding analysis

Up to 169 days

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?

Group I: Group1: nOPV1 (IPV History) Experimental Treatment 1 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 Treatment 1 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 Treatment 1 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 Treatment 1 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 Control 1 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 Control 1 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 Control 1 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 Control 1 Intervention

Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.

Who Is Running the Clinical Trial?

PATH

Lead Sponsor

Trials

182

Recruited

629,000+

Viroclinics Biosciences B.V.

Industry Sponsor

Trials

2

Recruited

290+

Viroclinics Biosciences B.V.

Collaborator

Trials

2

Recruited

290+

Bill and Melinda Gates Foundation

Collaborator

Trials

428

Recruited

23,060,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

The Emmes Company, LLC

Industry Sponsor

Trials

149

Recruited

1,052,000+

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

1. cdc.gov cdc.gov/vaccines/vpd/polio/hcp/effectiveness-duration-protection.html

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-trial

Novel 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- ...

3. thelancet.com thelancet.com/journals/laninf/article/PIIS1473-3099(25)00285-3/fulltext

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 ...

4. polioeradication.org polioeradication.org/about-polio/the-vaccines/opv/

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 ...

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK526039/

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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04529538

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; ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40818478/

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, ...

8. who.int who.int/groups/global-advisory-committee-on-vaccine-safety/topics/poliovirus-vaccines

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 ...