Study of Novel Types 1 and 3 Oral Poliomyelitis Vaccines

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

226 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug 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)?

The effectiveness of similar vaccines, like the Novel Oral Polio Vaccine Type 2 (nOPV2), has been demonstrated in controlling outbreaks of vaccine-derived poliovirus in countries like Nigeria, Tajikistan, and Liberia, suggesting that these vaccines can effectively boost immunity and control polio outbreaks. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

The novel oral polio vaccines, including nOPV2, have been tested in various trials and are considered to have similar tolerability to existing vaccines, with no major safety concerns reported in the studies. ^{1 2 6 7 8}

How is the novel oral polio vaccine different from other polio vaccines?

The novel oral polio vaccines nOPV1 and nOPV3 are designed to be more genetically stable than previous vaccines, reducing the risk of causing new outbreaks of vaccine-derived poliovirus. This makes them unique compared to traditional oral polio vaccines, which have a higher risk of genetic changes that can lead to outbreaks. ^{1 2 3 9 10}

Research Team

Mohamed Al-Ibrahim, MB CHB, FACP

Principal Investigator

Pharmaron CPC, Inc.

Arlene Sena, MD

Principal Investigator

University of North Carolina

Peter Wright, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Jessica Crothers, MD

Principal Investigator

University of Vermont

Eligibility Criteria

Inclusion Criteria

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

• Abstinence from penile-vaginal intercourse

Timeline

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

Treatment Details

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)

Participant Groups

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

References

1. United States pubmed.ncbi.nlm.nih.gov

Immunogenicity of novel oral poliovirus vaccine type 2 administered concomitantly with bivalent oral poliovirus vaccine: an open-label, non-inferiority, randomised, controlled trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of novel oral polio vaccine type 2 SIA impact in a large outbreak of circulating vaccine-derived poliovirus in Nigeria. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Protective efficacy of a monovalent oral type 1 poliovirus vaccine: a case-control study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Assessment of serological responses following vaccination campaigns with type 2 novel oral polio vaccine: a population-based study in Tajikistan in 2021. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Poliovirus antibodies following two rounds of campaigns with a type 2 novel oral poliovirus vaccine in Liberia: a clustered, population-based seroprevalence survey. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Intestinal Antibody Responses to 2 Novel Live Attenuated Type 2 Oral Poliovirus Vaccines in Healthy Adults in Belgium. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Evaluation of the safety, immunogenicity, and faecal shedding of novel oral polio vaccine type 2 in healthy newborn infants in Bangladesh: a randomised, controlled, phase 2 clinical trial. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Exploring public perceptions of vaccine-derived poliovirus and a novel oral polio vaccine in the Democratic Republic of the Congo, Kenya, and Nigeria. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Immunogenicity of bivalent types 1 and 3 oral poliovirus vaccine: a randomised, double-blind, controlled trial. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Immunogenicity of three doses of bivalent, trivalent, or type 1 monovalent oral poliovirus vaccines with a 2 week interval between doses in Bangladesh: an open-label, non-inferiority, randomised, controlled trial. [2023]