Pertussis Acellular Vaccine Adjuvanted With TQL1055 | NCT04793620

Studies
Pertussis Acellular Vaccine Adjuvanted With TQL1055

NCT04793620

Sponsor

Adjuvance Technologies, Inc.

Status

Terminated

Last Update Posted

Nov 1, 2022Actual

Enrollment

72Actual

Phase

Phase 1

Conditions

Pertussis

Interventions

TQL1055
Acellular pertussis vaccine

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

financial constraints

Expanded Access Info

Start Date

Apr 6, 2021Actual

Primary Completion Date

Aug 23, 2021Actual

Completion Date

Feb 14, 2022Actual

First Submitted Date

Mar 4, 2021

First Submission Date that Met QC Criteria

Mar 10, 2021

First Posted Date

Mar 11, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2022

Last Update Posted Date

Nov 1, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TQL1055	Experimental	TQL1055 + acellular pertussis vaccine	Other: TQL1055 Biological: Acellular pertussis vaccine
Acellular pertussis vaccine	Active Comparator	Acellular pertussis vaccine	Biological: Acellular pertussis vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TQL1055	Other	Semisynthetic saponin adjuvant	TQL1055
Acellular pertussis vaccine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sean R Bennett, MD PhD	Adjuvance Technologies, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Q-Pharm		Brisbane			Australia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014917	Whooping Cough

Ancestor Terms

ID	Term
D001885	Bordetella Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

Browse Leaves

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Browse Branches

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