NCT04793620

Pertussis Acellular Vaccine Adjuvanted With TQL1055

A Phase 1, Randomized, Double Blind, Active-Controlled Dose-Escalation Study to Assess the Safety and Immunogenicity of Pertussis Acellular Vaccine Adjuvanted With TQL1055 (PAVA)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Adjuvance Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1 study to evaluate the safety and immunogenicity of the semisynthetic saponin adjuvant TQL1055 administered in combination with an acellular pertussis vaccine.

Detailed description

The recent increase in the incidence of pertussis has prompted the need for improvements to current acellular pertussis vaccines. Use of novel adjuvants is one approach to such improvement. TQL1055 is a rationally designed, semisynthetic analog of the licensed Quillaja saponin (QS)-21. It has been designed to maintain adjuvant activity with improved tolerability and greater ease of manufacture. This is a Phase 1, randomized, double blind, active-controlled sequential-group study, designed to evaluate the safety, tolerability, and immunogenicity of the combination of TQL1055 and acellular pertussis vaccine. The dose of TQL1055 will increase by group.

Conditions

• Pertussis

Interventions

Type	Name	Description
OTHER	TQL1055	Semisynthetic saponin adjuvant
BIOLOGICAL	Acellular pertussis vaccine	Acellular pertussis vaccine

Timeline

• Start date: 2021-04-06
• Primary completion: 2021-08-23
• Completion: 2022-02-14
• First posted: 2021-03-11
• Last updated: 2022-11-01

Locations

1 site across 1 country: Australia