Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04793620




Registration number
NCT04793620
Ethics application status
Date submitted
4/03/2021
Date registered
11/03/2021
Date last updated
1/11/2022

Titles & IDs
Public title
Pertussis Acellular Vaccine Adjuvanted With TQL1055
Scientific 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)
Secondary ID [1] 0 0
V1.1-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pertussis 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - TQL1055
Treatment: Other - Acellular pertussis vaccine

Experimental: TQL1055 - TQL1055 + acellular pertussis vaccine

Active comparator: Acellular pertussis vaccine - Acellular pertussis vaccine


Other interventions: TQL1055
Semisynthetic saponin adjuvant

Treatment: Other: Acellular pertussis vaccine
Acellular pertussis vaccine
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reactogenicity
Timepoint [1] 0 0
7 days
Secondary outcome [1] 0 0
Adverse Events
Timepoint [1] 0 0
365 days
Secondary outcome [2] 0 0
Incidence of abnormal laboratory test results
Timepoint [2] 0 0
28 days
Secondary outcome [3] 0 0
Immunogenicity
Timepoint [3] 0 0
28 days
Secondary outcome [4] 0 0
Immunogenicity
Timepoint [4] 0 0
365 days

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/02/2022
Sample size
Target
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Q-Pharm - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Adjuvance Technologies, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT04793620
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sean R Bennett, MD PhD
Address 0 0
Adjuvance Technologies, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04793620