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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]

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

Long term immunity to pcv7 and ppv13

Condition category

Condition code

Infection

Other infectious diseases

Inflammatory and Immune System

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]

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]

Determine trends in total functional antibody levels following 23PPV or PCV7 in a vulnerable elderly population by serum assay analysis

Timepoint [1]

Five years and ten years after the final follow-up in the previously completed trial

Primary outcome [2]

Determine trends in total functional antibody levels following 23PPV or PCV7 in a vulnerable elderly population by serum assay analysis

Timepoint [2]

five years and ten years after the final follow-up in the previously completed trial.

Secondary outcome [1]

changes over time in the frailty index

Timepoint [1]

5 years and 10 years after the final follow-up in the previously completed trial

Secondary outcome [2]

Readmission rates after the final follow-up

Timepoint [2]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/03/2012

Actual

14/03/2012

Date of last participant enrolment

Anticipated

16/10/2012

Actual

16/10/2012

Date of last data collection

Anticipated

Actual

Sample size

Target

136

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2145 - Westmead

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Sydney Local health Network

Ethics committee address [1]

Westmead Hospital
Darcy St Westmead NSW 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/02/2011

Approval date [1]

14/03/2011

Ethics approval number [1]

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

Prof Raina MacIntyre

Address

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

Australia

Phone

+61 2 9385 3811

Fax

[email protected]

Contact person for public queries

Name

Iman Ridda

Address

School of Public Health, Tropical Medicine & Rehabilitation Sciences
James Cook University
1 James Cook Drive
Townsville QLD 4811

Country

Australia

Phone

61747815094

Fax

[email protected]

Contact person for scientific queries

Name

Raina MacIntyre

Address

Country

Australia

Phone

+61 2 9385 3811

Fax

[email protected]

No information has been provided regarding IPD availability

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

No additional documents have been identified.

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