Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000233527
Ethics application status
Approved
Date submitted
31/01/2024
Date registered
11/03/2024
Date last updated
11/03/2024
Date data sharing statement initially provided
11/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Extension study of DV2-TDAP-01 to assess immuno of Tdap-1018 to pertussis antigens.
Scientific title
Extension Study of DV2-TDAP-01 to Assess Immunogenicity to Pertussis Antigens Three Years Following Study Injection with Tdap-1018 3000 mcg or Boostrix
Secondary ID [1] 311322 0
DV2-TDAP-101
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12620001177943. This is a follow up study

Health condition
Health condition(s) or problem(s) studied:
Pertussis 332572 0
Diptheria 332573 0
Tetanus 332574 0
Condition category
Condition code
Respiratory 329270 329270 0 0
Other respiratory disorders / diseases
Infection 329271 329271 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a non- interventional clinical study. This is an extension study to assess immunogenicity of Tdap-1018 3000 mcg (Tdap with 3000 mcg of 1018) and Boostrix approximately 3 years after study injection in Study DV2-TDAP-01. Participants will be invited to return approximately 3 years after the DV2-TDAP-01 study injection for a follow up blood draw. Participants received Tdap-1018 3000 mcg in ACTRN12620001177943 and participants must have been a part of ACTRN12620001177943 in order to be included in this study.

Participants will also be asked for consent to collect data from medical records and for a blood sample.

Up to 57 adult participants who received Tdap-1018 3000 mcg or Boostrix in Dynavax study DV2-TDAP-01 will be enrolled and the total duration of individual participation in this study is only one day.
Intervention code [1] 327776 0
Diagnosis / Prognosis
Comparator / control treatment
Participants who received intramuscular Boostrix as part of study registered under ACTRN12620001177943: containing 5 Lf of tetanus toxoid, 2.5 Lf of diphtheria toxoid, 8 mcg of inactivated PT, 8 mcg of FHA, and 2.5 mcg of PRN adsorbed on 0.3 mg of aluminum hydroxide hydrate and 0.2 mg of aluminium phosphate.
Control group
Active

Outcomes
Primary outcome [1] 337102 0
To assess immunogenicity to pertussis antigens 3 years after receipt of a booster vaccination with Tdap-1018 3000 mcg or Boostrix
Timepoint [1] 337102 0
Blood samples will be collected at a single timepoint, Day 1, the only visit day (approximately 3 years after administration of Tdap-1018 3000 mcg or Boostrix in ACTRN12620001177943).
Primary outcome [2] 337440 0
To assess immunogenicity to pertussis antigens 3 years after receipt of a booster vaccination with Tdap-1018 3000 mcg or Boostrix
Timepoint [2] 337440 0
Blood samples will be collected at a single timepoint, Day 1, the only visit day (approximately 3 years after administration of Tdap-1018 3000 mcg or Boostrix in ACTRN12620001177943).
Primary outcome [3] 337441 0
To assess immunogenicity to pertussis antigens 3 years after receipt of a booster vaccination with Tdap-1018 3000 mcg or Boostrix
Timepoint [3] 337441 0
Blood samples will be collected at a single timepoint, Day 1, the only visit day (approximately 3 years after administration of Tdap-1018 3000 mcg or Boostrix in ACTRN12620001177943).
Secondary outcome [1] 431868 0
To assess immunogenicity to pertussis antigens 3 years after receipt of a booster vaccination with Tdap-1018 3000 mcg or Boostrix
Timepoint [1] 431868 0
Blood samples will be collected at a single timepoint, Day 1, the only visit day (approximately 3 years after administration of Tdap-1018 3000 mcg or Boostrix in ACTRN12620001177943).

Eligibility
Key inclusion criteria
A participant must meet the following criteria to be eligible for enrollment and participation in
the study:
1) Willing to participate; informed consent provided for the study
2) Male or female, 18 to 22 years of age at time of receipt of Tdap-1018 3000 mcg or Boostrix
injection in Dynavax study DV2-TDAP-01
3) Able to comprehend and follow all required study procedures
4) All participants must have been a part of ACTRN12620001177943 in order to be included in this study.
Minimum age
18 Years
Maximum age
26 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
A participant with any 1 of the following criteria is not eligible for enrollment in the study:
1) Vaccinated against pertussis following receipt of the DV2-TDAP-01 injection and prior to date of study visit in DV2-TDAP-101
2) Any other finding that the Investigator considers will make the subject unsuitable for the study

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/02/2024
Date of last participant enrolment
Anticipated
3/04/2025
Actual
Date of last data collection
Anticipated
3/04/2025
Actual
Sample size
Target
57
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 315574 0
Commercial sector/Industry
Name [1] 315574 0
Dynavax Technologies Corporation
Country [1] 315574 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Dynavax Technologies Corporation
Address
2100 Powell Street, Suite 720, Emeryville, CA 94608, USA
Country
United States of America
Secondary sponsor category [1] 317669 0
Commercial sector/Industry
Name [1] 317669 0
Novotech (Australia) Pty Ltd.
Address [1] 317669 0
Level 19, 66 Goulburn Street, Sydney, NSW, 2000
Country [1] 317669 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314472 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 314472 0
123 Glen Osmond Road, Eastwood, SA, 5063,
Ethics committee country [1] 314472 0
Australia
Date submitted for ethics approval [1] 314472 0
22/11/2023
Approval date [1] 314472 0
22/12/2023
Ethics approval number [1] 314472 0

Summary
Brief summary
This is a non interventional extension study to assess immunogenicity of Tdap-1018 3000 mcg and Boostrix approximately 3 years after study injection in Study DV2-TDAP-01. Adult individuals who participated in Dynavax-sponsored study DV2-TDAP-01 and received either Tdap-1018 3000 mcg or Boostrix will be invited to return 3 years (± 60 days) after the DV2-TDAP-01 study injection for a follow-up blood draw.
This is an extension study to ACTRN12620001177943.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131702 0
Dr Fiona Napier Flood
Address 131702 0
Paratus Clinical Research Western Sydney, Level 2, Suite 201, 116 Main Street, Blacktown, NSW, 2148
Country 131702 0
Australia
Phone 131702 0
+61 417 487 363
Fax 131702 0
Email 131702 0
fiona.napier@paratusclinical.com
Contact person for public queries
Name 131703 0
Dr Ouzama Henry
Address 131703 0
Dynavax Technologies Corporation, 2100 Powell Street Suite 720 Emeryville, CA 94608, USA
Country 131703 0
United States of America
Phone 131703 0
+1 617 686 4796
Fax 131703 0
Email 131703 0
ohenry@dynavax.com
Contact person for scientific queries
Name 131704 0
Dr Ouzama Henry
Address 131704 0
Dynavax Technologies Corporation, 2100 Powell Street Suite 720 Emeryville, CA 94608, USA
Country 131704 0
United States of America
Phone 131704 0
+1 617 686 4796
Fax 131704 0
Email 131704 0
ohenry@dynavax.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.