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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
72
Semisynthetic saponin adjuvant
Acellular pertussis vaccine
Q-Pharm
Brisbane, Australia
Reactogenicity
Solicited local and systemic adverse events
Time frame: 7 days
Adverse Events
Adverse Events/Serious Adverse Events
Time frame: 365 days
Incidence of abnormal laboratory test results
Incidence of abnormal laboratory test results
Time frame: 28 days
Immunogenicity
Anti-Pertussis Toxin antibodies
Time frame: 28 days
Immunogenicity
Anti-Pertussis Toxin antibodies
Time frame: 365 days
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