Study of Novel Types 1 and 3 Oral Poliomyelitis Vaccines

Summary

The purpose of this study is to assess the safety (primary objective), the ability to trigger the production of antibodies (immunogenicity; a secondary objective) and presence of vaccine virus in the stool (fecal shedding; a secondary objective) of two novel oral polio vaccines (nOPV), novel oral poliomyelitis vaccine type 1 (nOPV1) and novel oral poliomyelitis vaccine type 3 (nOPV3), as compared to Sabin strain monovalent oral poliomyelitis vaccine (mOPV) controls, in healthy adults.

Conditions

• Poliomyelitis

Interventions

BIOLOGICAL

Novel Oral Polio Vaccine Type 1 (nOPV1)

Each 0.1 mL (2 drops) dose of vaccine contains approximately 10\^6.5 CCID50.

BIOLOGICAL

Novel Oral Polio Vaccine Type 3 (nOPV3)

Each 0.1 mL (2 drops) dose of vaccine contains approximately 10\^6.5 CCID50.

BIOLOGICAL

Sabin Monovalent Oral Polio Vaccine Type 1 (mOPV1)

The Sabin mOPV1 control vaccine contains ≥ 10\^6.0 CCID50 per 0.1 mL (2 drops) dose.

BIOLOGICAL

Sabin Monovalent Oral Polio Vaccine Type 3 (mOPV3)

the Sabin mOPV3 control vaccine contains ≥ 10\^5.8 CCID50 per 0.1 mL (2 drops) dose.

Sponsors & Collaborators

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Centers for Disease Control and Prevention

  collaborator FED

• Viroclinics Biosciences B.V.

  collaborator INDUSTRY

• The Emmes Company, LLC

  collaborator INDUSTRY

• PATH

  lead OTHER

Principal Investigators

• Jessica Crothers, MD · University of Vermont

• Arlene Sena, MD · University of North Carolina

• Peter Wright, MD · Dartmouth-Hitchcock Medical Center

• Mohamed Al-Ibrahim, MB CHB, FACP · Pharmaron CPC, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-03-26

Primary Completion

2023-02-17

Completion

2023-02-17

FDA Drug

Yes

Countries

• United States

Study Locations