Pertussis Acellular Vaccine Adjuvanted With TQL1055

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Pertussis

Intervention / Treatment
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* Other: TQL1055
* Biological: Acellular pertussis vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Sequential-group dose-escalation study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TQL1055<br>TQL1055 + acellular pertussis vaccine | Other: TQL1055<br>* Semisynthetic saponin adjuvant<br>Biological: Acellular pertussis vaccine<br>* Acellular pertussis vaccine<br>|
| Active Comparator: Acellular pertussis vaccine<br>Acellular pertussis vaccine | Biological: Acellular pertussis vaccine<br>* Acellular pertussis vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reactogenicity | Solicited local and systemic adverse events | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Adverse Events/Serious Adverse Events | 365 days | 
| Incidence of abnormal laboratory test results | Incidence of abnormal laboratory test results | 28 days | 
| Immunogenicity | Anti-Pertussis Toxin antibodies | 28 days | 
| Immunogenicity | Anti-Pertussis Toxin antibodies | 365 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccine, adjuvant