NCT04529538

Study of Novel Types 1 and 3 Oral Poliomyelitis Vaccines

A First-in-human, Phase 1, Randomized, Observer-blind, Controlled Study to Assess the Safety and Immunogenicity of Novel Live Attenuated Type 1 and Type 3 Oral Poliomyelitis Vaccines in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

This multicenter trial is the first-in-human assessment of two novel oral polio vaccines for poliovirus type 1 and type 3. It will be a 4-cohort, 8-arm, randomized, observer-blind, controlled trial, with Sabin monovalent vaccines serving as the control for each type: Cohort 1: Healthy adults with an exclusive inactivated poliovirus vaccine (IPV) prior vaccination history will be randomized in a 1:1 ratio and allocated to receive nOPV1 (Group 1) or mOPV1 (Group 2). Cohort 2: Healthy adults with an OPV-containing prior vaccination history will be randomized in a 2:1 ratio and allocated to receive two doses of nOPV1 (Group 3) or mOPV1 (Group 4), respectively; Cohort 3: Healthy adults with an exclusive IPV prior vaccination history will be randomized in a 1:1 ratio and allocated to receive nOPV3 (Group 5) or mOPV3 (Group 6); Cohort 4: Healthy adults with an OPV-containing prior vaccination history will be randomized in a 2:1 ratio to study groups 3 and 4 and allocated to receive two doses of nOPV3 (Group 7) or mOPV3 (Group 8), respectively.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-26
• Primary completion: 2023-02-17
• Completion: 2023-02-17
• First posted: 2020-08-27
• Last updated: 2024-11-20
• Results posted: 2024-09-25

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study