ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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

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]

None

Universal Trial Number (UTN)

Trial acronym

PNAB Study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Vaccine Response

Condition category

Condition code

Inflammatory and Immune System

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]

Treatment: Drugs

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Timepoint 1 - immediately prior to vaccination (week 0)
Timepoint 2 - between 4-6 weeks following immunisation.

Secondary outcome [1]

Feasibility of recruiting healthy participants for determination of pneumococcal IgG titres pre- and post- immunisation (recruitment rate & retention to completion of study).

Timepoint [1]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Royal Childrens Hospital - Parkville

Recruitment postcode(s) [1]

3052 - Parkville

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

The Royal Children's Hospital Foundation

Address [1]

48 Flemington Road
Parkville
VIC
Australia 3052

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Children's Hospital

Address

50 Flemington Road
Parkville VIC
Australia 3052

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

RCH Human Research Ethics Committee

Ethics committee address [1]

Royal Children's Hospital
50 Flemington Road
Parkville 
Victoria
Australia 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/07/2017

Approval date [1]

21/09/2017

Ethics approval number [1]

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

Dr Laine Hosking

Address

Immunology Laboratory
Royal Children's Hospital
50 Flemington Road
Parkville
Victoria
Australia 3052

Country

Australia

Phone

+613 9345 5725

Fax

laine.hosking@rch.org.au

Contact person for public queries

Name

Laine Hosking

Address

Immunology Laboratory
Royal Children's Hospital
50 Flemington Road
Parkville
Victoria
Australia 3052

Country

Australia

Phone

+613 9345 5725

Fax

laine.hosking@rch.org.au

Contact person for scientific queries

Name

Laine Hosking

Address

Immunology Laboratory
Royal Children's Hospital
50 Flemington Road
Parkville
Victoria
Australia 3052

Country

Australia

Phone

+613 9345 5725

Fax

laine.hosking@rch.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Pneumococcal IgG Antibody Responses to 23vPPV in Healthy Controls Using an Automated ELISA.	2022	https://dx.doi.org/10.1007/s10875-022-01230-8

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically