Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000822280
Ethics application status
Approved
Date submitted
4/05/2018
Date registered
14/05/2018
Date last updated
8/04/2021
Date data sharing statement initially provided
25/07/2019
Date results information initially provided
8/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Verifying the Immune Response to Pneumovax®23 Immunisation in Healthy Individuals
Scientific title
Verification of Pneumococcal IgG Antibody Responses to 23vPPV in Healthy Controls Using an Automated ELISA
Secondary ID [1] 292695 0
None
Universal Trial Number (UTN)
Trial acronym
PNAB Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vaccine Response 304449 0
Condition category
Condition code
Inflammatory and Immune System 303780 303780 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Immunisation with 23 valent pneumococcal polysaccharide vaccine (23vPPV) administered by community or hospital nurse. Single dose of 0.5ml intramuscularly into non-dominant deltoid.

Intervention with 23vPPV is to validate an automated ELISA measuring pre- and post-vaccination antibody levels to 23vPPV and not to assess efficacy of 23vPPV.
Intervention code [1] 298933 0
Treatment: Drugs
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303144 0
The primary objective of this study is to verify the current guideline for interpretation of pneumococcal IgG titres pre- and post- immunisation with 23vPPV using the TECAN EVO 2000 ELISA in healthy adults and children.
Timepoint [1] 303144 0
Timepoint 1 - immediately prior to vaccination (week 0)
Timepoint 2 - between 4-6 weeks following immunisation.
Secondary outcome [1] 338025 0
Feasibility of recruiting healthy participants for determination of pneumococcal IgG titres pre- and post- immunisation (recruitment rate & retention to completion of study).
Timepoint [1] 338025 0
6 months from beginning of recruitment.

Eligibility
Key inclusion criteria
Each adult must meet all of the following criteria to be enrolled in this study
- Is between the ages of 18 and 25 years at the time of enrolment
- Is capable of understanding the informed consent document and providing consent
- Is available to attend for the study follow up

Each child must meet all of the following criteria to be enrolled in this study:
- Is between the ages of 2 and 5 years at the time of enrolment
- Has received Prevenar13 as per the Australian National Immunisation Program Schedule at 2-, 4-, and 6-months of age
- Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant’s behalf
- Is available to attend for the study follow up
Minimum age
2 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants meeting any of the following criteria will be excluded from the study:
- Prior immunisation with 23vPPV
- Has a known hypersensitivity to any of the components of the 23vPPV vaccine
- Has a current fever or infection
- Is taking immunosuppressant medication, e.g. oral corticosteroids
- Has a prior diagnosis of invasive pneumococcal infection
- Has a pre-existing medical condition associated with increased risk of invasive pneumococcal disease (adapted from Immunisation Handbook)
* functional or anatomical asplenia
* immunocompromising conditions, including
** congenital or acquired immune deficiency
** haematological or other malignancies
** solid organ transplant
** haematopoietic stem cell transplant
** human immunodeficiency virus (HIV) infection
** chronic renal failure, or relapsing/persistent nephrotic syndrome
* proven or presumptive cerebrospinal fluid leak
* cochlear implants
* intracranial shunts
* chronic cardiac disease
* chronic lung disease
* chronic liver disease
* diabetes mellitus
* Down syndrome
* alcoholism
* preterm birth <28 weeks gestation
- Is currently pregnant, or considering pregnancy during the study period
- Is known to require a pneumococcal immunisation prior to the completion of the study follow up
- Inability or unwillingness of participant or legally acceptable representative to give written informed consent.

In addition, for adult participants, the following exclusion criteria apply:
- Prior immunisation with a pneumococcal conjugate vaccine

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2018
Actual
30/07/2018
Date of last participant enrolment
Anticipated
1/06/2020
Actual
15/11/2019
Date of last data collection
Anticipated
31/08/2020
Actual
5/10/2020
Sample size
Target
85
Accrual to date
Final
65
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10835 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 16969 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 297336 0
Charities/Societies/Foundations
Name [1] 297336 0
The Royal Children's Hospital Foundation
Country [1] 297336 0
Australia
Primary sponsor type
Hospital
Name
Royal Children's Hospital
Address
50 Flemington Road
Parkville VIC
Australia 3052
Country
Australia
Secondary sponsor category [1] 298682 0
None
Name [1] 298682 0
Address [1] 298682 0
Country [1] 298682 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298437 0
RCH Human Research Ethics Committee
Ethics committee address [1] 298437 0
Royal Children's Hospital
50 Flemington Road
Parkville
Victoria
Australia 3052
Ethics committee country [1] 298437 0
Australia
Date submitted for ethics approval [1] 298437 0
12/07/2017
Approval date [1] 298437 0
21/09/2017
Ethics approval number [1] 298437 0
37183

Summary
Brief summary
This research is about ensuring accurate diagnosis of children and adults in Victoria with poor immune systems (or “immune deficiency”). One method for assessing the way the immune system can fight infection is to see how well people respond to immunisations. People with immune deficiencies may respond poorly to immunisation; this information can help their doctors diagnose and treat their conditions. Recently the way the testing is performed has changed, and this study seeks to confirm the new test can be relied upon to accurately diagnose immune deficiency.

Pneumovax®23 is a key vaccine used to assess immune system function. It is a licenced vaccine that is given to people who are at risk of infection with the pneumococcal bacteria, and is recommended for all Australians over the age of 65 years. It is not routinely given to healthy people. The Royal Children’s Hospital does the testing for response to Pneumovax®23 for all patients from Victoria and many from across Australia. By giving the Pneumovax®23 to healthy people and testing their blood levels before and 4-6 weeks after immunisation, we will be able to tell if the new lab test is accurate.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77086 0
Dr Laine Hosking
Address 77086 0
Immunology Laboratory
Royal Children's Hospital
50 Flemington Road
Parkville
Victoria
Australia 3052
Country 77086 0
Australia
Phone 77086 0
+613 9345 5725
Fax 77086 0
Email 77086 0
[email protected]
Contact person for public queries
Name 77087 0
Dr Laine Hosking
Address 77087 0
Immunology Laboratory
Royal Children's Hospital
50 Flemington Road
Parkville
Victoria
Australia 3052
Country 77087 0
Australia
Phone 77087 0
+613 9345 5725
Fax 77087 0
Email 77087 0
[email protected]
Contact person for scientific queries
Name 77088 0
Dr Laine Hosking
Address 77088 0
Immunology Laboratory
Royal Children's Hospital
50 Flemington Road
Parkville
Victoria
Australia 3052
Country 77088 0
Australia
Phone 77088 0
+613 9345 5725
Fax 77088 0
Email 77088 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbasePneumococcal IgG Antibody Responses to 23vPPV in Healthy Controls Using an Automated ELISA.2022https://dx.doi.org/10.1007/s10875-022-01230-8
N.B. These documents automatically identified may not have been verified by the study sponsor.