Pertussis Acellular Vaccine Adjuvanted With TQL1055

Pertussis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04793620
• Other study ID #: V1.1-101
• Status: Terminated
• Phase: Phase 1
• Start date: April 6, 2021
• Est. completion date: February 14, 2022

Study information

• Verified date: October 2022
• Source: Adjuvance Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: February 14, 2022
• Est. primary completion date: August 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Key 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

Related Conditions & MeSH terms

• Pertussis
• Whooping Cough

Intervention

Other:
• TQL1055
Semisynthetic saponin adjuvant

Biological:
• Acellular pertussis vaccine
Acellular pertussis vaccine

Locations

Country	Name	City	State
Australia	Q-Pharm	Brisbane

Sponsors (1)

Lead Sponsor	Collaborator
Adjuvance Technologies, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reactogenicity	Solicited local and systemic adverse events	7 days
Secondary	Adverse Events	Adverse Events/Serious Adverse Events	365 days
Secondary	Incidence of abnormal laboratory test results	Incidence of abnormal laboratory test results	28 days
Secondary	Immunogenicity	Anti-Pertussis Toxin antibodies	28 days
Secondary	Immunogenicity	Anti-Pertussis Toxin antibodies	365 days