Verifying the Immune Response to Pneumovax®23 Immunisation in Healthy Individuals

Not Applicable

Completed

• Conditions: Vaccine Response; Inflammatory and Immune System - Normal development and function of the immune system

• Registration Number: ACTRN12618000822280
• Lead Sponsor: Royal Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-14
• Study Completion: 2020-10-05
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 65

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 - immediately prior to vaccination (week 0)<br>Timepoint 2 - between 4-6 weeks following immunisation. ]

Secondary Outcome Measures

Name	Time	Method
Feasibility of recruiting healthy participants for determination of pneumococcal IgG titres pre- and post- immunisation (recruitment rate & retention to completion of study).[6 months from beginning of recruitment.]