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Pertussis Acellular Vaccine Adjuvanted With TQL1055

Primary Purpose

Pertussis

Status
Terminated
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
TQL1055
Acellular pertussis vaccine
Sponsored by
Adjuvance Technologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pertussis focused on measuring vaccine, adjuvant

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Q-Pharm

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TQL1055

Acellular pertussis vaccine

Arm Description

TQL1055 + acellular pertussis vaccine

Acellular pertussis vaccine

Outcomes

Primary Outcome Measures

Reactogenicity
Solicited local and systemic adverse events

Secondary Outcome Measures

Adverse Events
Adverse Events/Serious Adverse Events
Incidence of abnormal laboratory test results
Incidence of abnormal laboratory test results
Immunogenicity
Anti-Pertussis Toxin antibodies
Immunogenicity
Anti-Pertussis Toxin antibodies

Full Information

First Posted
March 4, 2021
Last Updated
October 28, 2022
Sponsor
Adjuvance Technologies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04793620
Brief Title
Pertussis Acellular Vaccine Adjuvanted With TQL1055
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
financial constraints
Study Start Date
April 6, 2021 (Actual)
Primary Completion Date
August 23, 2021 (Actual)
Study Completion Date
February 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adjuvance Technologies, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pertussis
Keywords
vaccine, adjuvant

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Sequential-group dose-escalation study.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TQL1055
Arm Type
Experimental
Arm Description
TQL1055 + acellular pertussis vaccine
Arm Title
Acellular pertussis vaccine
Arm Type
Active Comparator
Arm Description
Acellular pertussis vaccine
Intervention Type
Other
Intervention Name(s)
TQL1055
Intervention Description
Semisynthetic saponin adjuvant
Intervention Type
Biological
Intervention Name(s)
Acellular pertussis vaccine
Intervention Description
Acellular pertussis vaccine
Primary Outcome Measure Information:
Title
Reactogenicity
Description
Solicited local and systemic adverse events
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Adverse Events/Serious Adverse Events
Time Frame
365 days
Title
Incidence of abnormal laboratory test results
Description
Incidence of abnormal laboratory test results
Time Frame
28 days
Title
Immunogenicity
Description
Anti-Pertussis Toxin antibodies
Time Frame
28 days
Title
Immunogenicity
Description
Anti-Pertussis Toxin antibodies
Time Frame
365 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean R Bennett, MD PhD
Organizational Affiliation
Adjuvance Technologies, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Q-Pharm
City
Brisbane
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pertussis Acellular Vaccine Adjuvanted With TQL1055

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