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Trial registered on ANZCTR


Registration number
ACTRN12613001244796
Ethics application status
Approved
Date submitted
8/11/2013
Date registered
13/11/2013
Date last updated
22/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Long term follow up of the immunogenicity of 7-valent pneumococcal conjugate vaccine (PCV7) in vulnerable elderly populations at high risk for invasive pneumococcal disease
Scientific title
Long term follow up of the immunogenicity of 7-valent pneumococcal conjugate vaccine (PCV-7) vs 23-valent pneumococcal polysaccharide vaccine (23vPPV) PPV in vulnerable elderly populations at high risk for invasive pneumococcal disease
Secondary ID [1] 253059 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Long term follow up PCV vs PPV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long term Immunity to Pneumococcal Vaccines 258624 0
Long term immunity to pcv7 and ppv13 290428 0
Condition category
Condition code
Infection 258768 258768 0 0
Other infectious diseases
Inflammatory and Immune System 290871 290871 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
5-10
Target follow-up type
Years
Description of intervention(s) / exposure
a long term follow up study of subjects five and ten years after the 12 month follow up period of a completed trial of pneumococcal vaccines in frail elderly people ( registration ID: ACTRN12607000387426), to determine persistence or waning of immunity in surviving subjects for 23PPV and PCV7.
Intervention code [1] 288244 0
Not applicable
Comparator / control treatment
subjects who received pneumococcal polysaccharide vaccination (PPV) vs subject who received pneumococcal conjugate vaccine (PCV-7).
Control group
Active

Outcomes
Primary outcome [1] 290845 0
Determine trends in total functional antibody levels following 23PPV or PCV7 in a vulnerable elderly population by serum assay analysis
Timepoint [1] 290845 0
Five years and ten years after the final follow-up in the previously completed trial
Primary outcome [2] 290846 0
Determine trends in total functional antibody levels following 23PPV or PCV7 in a vulnerable elderly population by serum assay analysis
Timepoint [2] 290846 0
five years and ten years after the final follow-up in the previously completed trial.
Secondary outcome [1] 305426 0
changes over time in the frailty index
Timepoint [1] 305426 0
5 years and 10 years after the final follow-up in the previously completed trial
Secondary outcome [2] 305427 0
Readmission rates after the final follow-up
Timepoint [2] 305427 0
6 months and 5 years after the final follow-up in the previously completed trial

Eligibility
Key inclusion criteria
Surviving subjects from the community who have previously participated in a completed trial of pneumococcal vaccines in frail elderly people when they were admitted to Westmead hospital between 2005-2007( Trial registration number ACTRN12607000387426)
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not being able or refuse to provide a blood sample

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
We will use appropriate corrections to reduce the probability required to accept statistical significance. Geometric means of the antibody concentrations (GMC) of ELISA (micro-gram/millilitre) and geometric mean titers (GMT) of OPA (titer-1) at each of the five visits and geometric mean fold rise (GMR) between visits will be calculated within each treatment group for each of the 7 pneumococcal serotypes (4,6B, 9V, 14, 18C, 19F and 23F), and 95% confidence intervals will be constructed by back transformation of the confidence intervals for the mean of the log transformed assay results computed using the Student t distribution. Comparisons of geometric mean antibody concentrations and titers measured by ELISA and OPA, respectively, between the immunization groups were performed by unpaired 2-tailed t-test for parametric analyses and Wilcoxon rank sum test for non-parametric analyses. Based on changes of GMC of ELISA and GMT of OPA at five time points (visits), the rate of wanning immunity can be calculated.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 7548 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 288234 0
Self funded/Unfunded
Name [1] 288234 0
Address [1] 288234 0
Country [1] 288234 0
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmead. National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases
Address
The Children's Hospital at Westmead
Cnr Hawkesbury Rd & Hainsworth St, Westmead
Post: Locked Bag 4001, Westmead NSW 2145, Australia
Country
Australia
Secondary sponsor category [1] 286971 0
None
Name [1] 286971 0
Address [1] 286971 0
Country [1] 286971 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290139 0
Western Sydney Local health Network
Ethics committee address [1] 290139 0
Westmead Hospital
Darcy St Westmead NSW 2145
Ethics committee country [1] 290139 0
Australia
Date submitted for ethics approval [1] 290139 0
09/02/2011
Approval date [1] 290139 0
14/03/2011
Ethics approval number [1] 290139 0
2010/12/4/4.17 (3257)

Summary
Brief summary
Streptococcus pneumoniae is the commonest cause of pneumonia in the community, and a major cause of illness and death in the elderly. A free pneumococcal polysaccharide vaccination (PPV) program was introduced, in Australia, in 2005. However, responses to PPV in the elderly are often poor. A more immunogenic pneumococcal conjugate vaccine (PCV-7) is available for children under 2 but is not licensed for adults. We completed a study that compared the immunogenicity of PCV-7 and PPV in the hospitalised elderly who are at highest risk for pneumococcal disease. Elderly patients admitted to hospital that had not previously received PPV, were recruited and randomised to receive PCV-7 or PPV; those who received PCV-7 received PPV six months later. Results showed no significant differences in response after one dose of each vaccine; severely frail patients have less vigorous response to either vaccine. Final follow up was done at 12 months.
To our knowledge there are no data on long term immunogenicity studies beyond 12 months comparing PCV and PPV responses in the elderly.

The proposed study is a longer term follow up study of subjects five and ten years after the 12 month follow up period of a completed trial of pneumococcal vaccines in frail elderly people, to determine persistence or waning of immunity in surviving subjects as well as measuring influenza vaccine antibody. It is impractical to measure efficacy in such a group in a clinical trial, due to the low incidence of pneumococcal disease, so proxy measures of efficacy using immunologic surrogates are necessary.
The surviving study subjects from the above mentioned study will be contacted and interviewed, a blood sample will be collected from them at their current residence to determine persistence or waning of immunity in surviving subjects as well as measuring influenza vaccine antibody.

We seek permission to access hospital medical records to be able to determine rates of readmission and other clinical outcomes of older people and ascertain predictors of readmission. Access to the death register will enable us to determine death date and cause and ensure that no attempts are made to contact deceased participants.

Following ethics approval, we will check hospital records to identify any further deaths in the trial cohort. For those patients still thought to be alive, we will then contact their last known GP, and check on vital status and medical presentations not resulting in hospitalisation and vaccinations received. If the GP believes the patient is still alive, we will write to them giving them notice that we wish to contact them to ask them to consider being included in a new long-term follow-up cohort study. In this initial letter we will enclose the patient and Responsible Person information leaflets with the consent form and a pre-paid envelope for them to consent or decline further involvement.

There is limited available long-term follow-up data on antibody levels in older persons who have been vaccinated with conjugate pneumococcal vaccines.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes
Nil

Contacts
Principal investigator
Name 31896 0
Prof Raina MacIntyre
Address 31896 0
Head of School
School of Public Health and Community Medicine
UNSW Australia, The University of New South Wales
Sydney, NSW, 2052
and
Senior Principal Research Fellow
National Centre for Immunisation Research and
Surveillance of Vaccine Preventable Diseases
Country 31896 0
Australia
Phone 31896 0
+61 2 9385 3811
Fax 31896 0
Email 31896 0
r.macintyre@unsw.edu.au
Contact person for public queries
Name 15143 0
Dr Iman Ridda
Address 15143 0
School of Public Health, Tropical Medicine & Rehabilitation Sciences
James Cook University
1 James Cook Drive
Townsville QLD 4811
Country 15143 0
Australia
Phone 15143 0
61747815094
Fax 15143 0
Email 15143 0
iman.ridda@jcu.edu.au
Contact person for scientific queries
Name 6071 0
Prof Raina MacIntyre
Address 6071 0
Head of School
School of Public Health and Community Medicine
UNSW Australia, The University of New South Wales
Sydney, NSW, 2052
and
Senior Principal Research Fellow
National Centre for Immunisation Research and
Surveillance of Vaccine Preventable Diseases
Country 6071 0
Australia
Phone 6071 0
+61 2 9385 3811
Fax 6071 0
Email 6071 0
r.macintyre@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary