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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Other interventions - Acellular pertussis vaccine

Experimental: TQL1055 - TQL1055 + acellular pertussis vaccine

Active Comparator: Acellular pertussis vaccine - Acellular pertussis vaccine


Other interventions: TQL1055
Semisynthetic saponin adjuvant

Other interventions: Acellular pertussis vaccine
Acellular pertussis vaccine
Intervention code [1] 0 0
Other interventions
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
Terminated
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/ct2/show/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/ct2/show/NCT04793620