None listed
Conditions
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.
Interventions
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.
Sponsors
Royal Children's Hospital
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
2 Years to 25 Years
Healthy volunteers
Yes
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
Outcome results
None listed