NCT04793620

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
26 days until next milestone

Study Start

First participant enrolled

April 6, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2022

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

5 months

First QC Date

March 4, 2021

Last Update Submit

October 28, 2022

Conditions

Pertussis

Keywords

vaccineadjuvant

Outcome Measures

Primary Outcomes (1)

  • Reactogenicity

    Solicited local and systemic adverse events

    7 days

Secondary Outcomes (4)

  • Adverse Events

    365 days

  • Incidence of abnormal laboratory test results

    28 days

  • Immunogenicity

    28 days

  • Immunogenicity

    365 days

Study Arms (2)

TQL1055

EXPERIMENTAL

TQL1055 + acellular pertussis vaccine

Other: TQL1055Biological: Acellular pertussis vaccine

Acellular pertussis vaccine

ACTIVE COMPARATOR

Acellular pertussis vaccine

Biological: Acellular pertussis vaccine

Interventions

TQL1055OTHER

Semisynthetic saponin adjuvant

TQL1055
Acellular pertussis vaccineBIOLOGICAL

Acellular pertussis vaccine

Acellular pertussis vaccineTQL1055

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to 50 years of age
  • General good health
  • BMI between 17 and 35 kg/m2
  • Not of childbearing potential OR using adequate contraception

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Q-Pharm

Brisbane, Australia

Location

MeSH Terms

Conditions

Whooping Cough

Condition Hierarchy (Ancestors)

Bordetella InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • Sean R Bennett, MD PhD

    Adjuvance Technologies, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Sequential-group dose-escalation study.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 11, 2021

Study Start

April 6, 2021

Primary Completion

August 23, 2021

Study Completion

February 14, 2022

Last Updated

November 1, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)