Pertussis Acellular Vaccine Adjuvanted With TQL1055

Phase 1

Terminated

• Conditions: Pertussis
• Interventions: Other: TQL1055; Biological: Acellular pertussis vaccine

• Registration Number: NCT04793620
• Lead Sponsor: Adjuvance Technologies, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2021-03-04
• Study First Submitted QC: 2021-03-10
• Study First Posted: 2021-03-11
• Study Start: 2021-04-06
• Primary Completion: 2021-08-23
• Study Completion: 2022-02-14
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• 18 to 50 years of age
• General good health
• BMI between 17 and 35 kg/m2
• Not of childbearing potential OR using adequate contraception

Key

Exclusion Criteria

• Pregnant or lactating
• Prior medical condition that could adversely affect subject safety
• Clinically significant abnormal laboratory parameter
• Current acute febrile illness
• Contraindication to intramuscular injection
• Contraindication to pertussis vaccination
• Received pertussis vaccine within 3 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
TQL1055	Acellular pertussis vaccine	TQL1055 + acellular pertussis vaccine
TQL1055	TQL1055	TQL1055 + acellular pertussis vaccine
Acellular pertussis vaccine	Acellular pertussis vaccine	Acellular pertussis vaccine

Primary Outcome Measures

Name	Time	Method
Reactogenicity	7 days	Solicited local and systemic adverse events

Secondary Outcome Measures

Name	Time	Method
Incidence of abnormal laboratory test results	28 days	Incidence of abnormal laboratory test results
Immunogenicity	365 days	Anti-Pertussis Toxin antibodies
Adverse Events	365 days	Adverse Events/Serious Adverse Events

Trial Locations

Locations (1)

Q-Pharm; 🇦🇺 Brisbane, Australia