ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000830998

Ethics application status

Approved

Date submitted

21/05/2020

Date registered

21/08/2020

Date last updated

21/08/2020

Date data sharing statement initially provided

21/08/2020

Date results provided

21/08/2020

Type of registration

Retrospectively registered

Titles & IDs

Public title

Using influenza vaccination to understand and improve immune responses to vaccination in patients with chronic obstructive pulmonary disease (COPD) and healthy older people.

Scientific title

Immunogenicity of the influenza vaccination in patients with chronic obstructive pulmonary disease (COPD).

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

Trial acronym

IVC

Linked study record

Health condition

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

Chronic Obstructive Pulmonary Disease

Influenza viral disease

Condition category

Condition code

Respiratory

Chronic obstructive pulmonary disease

Infection

Other infectious diseases

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Open label, observational study of seasonal influenza vaccination in COPD patients and healthy age-matched control subjects.
COPD patients will be recruited over three (3) seasonal influenza vaccine years, with each year considered a separate cohort. Some patients will be repeat participants, however, they will be considered individual participants for separate years due to differences in age and physical parameters that occur in the course of one year. COPD patients will provide an initial single blood sample to be analysed of no more than 50ml, prior to receiving a single standard dose of inactivated and purified influenza vaccine in autumn of 2015, 2016, 2017. COPD patients will provide further single blood samples 24h post inoculation (p.i.) of no more 2.5ml, 7 and 28 days p.i. of no more than 40ml and 90 day p.i. of no more than 10ml.
COPD patients will be asked to attend three (3) mandatory study clinic visits, including administration of seasonal vaccine, with a additional 2 study clinic visits (days 7 and 90 p.i) being optional.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

Control group in observational study were healthy age-matched participants. All participants received the seasonal influenza vaccine as standard of care.
Healthy participants will be recruited over three (3) seasonal influenza vaccine years, with each year considered a separate cohort. Some participants will be repeat participants, however, they will be considered individual participants for separate years due to differences in age and physical parameters that occur in the course of one year. Healthy participants will provide an initial single blood sample to be analysed of no more than 50 ml, prior to receiving a single standard dose of inactivated and purified influenza vaccine in autumn of 2015, 2016, 2017. Healthy participants will provide further single blood samples 24 h post inoculation (p.i.) of no more 2.5 ml, 7 and 28 days p.i. of no more than 40 ml and 90 day p.i. of no more than 10 ml.
Healthy participants will be asked to attend three (3) mandatory study clinic visits, including administration of seasonal vaccine, with an additional 2 study clinic visits (days 7 and 90 p.i) being optional.

Control group

Active

Outcomes

Primary outcome [1]

Proportion of influenza vaccine recipients achieving antibody levels that connote protection against specific influenza vaccine antibody strains. Individual study participant serum antibody levels will be assessed via haemaglutination inhibition assay for specific influenza strains.

Timepoint [1]

Baseline, 24hrs, 7 days, 28 days and 90 days post initial influenza vaccine.

Secondary outcome [1]

Measure cellular phenotype, in particular dendritic, B-cell and T-cell populations, to identify differences between COPD and healthy participants in response to influenza vaccine.
Changes in immune cell numbers will be assessed by flow cytometry. To determine the quantity and isotype of B cells elicited, influenza-specific B cells were identified using recombinant HA (rHA) probes and assessed by flow cytometry

Timepoint [1]

Baseline, 24hrs, 7 days, 28 days and 90 days post initial Influenza Vaccine.

Secondary outcome [2]

Identification of deferentially expressed genes that differ between COPD and healthy participants in response to the influenza vaccine, via RNASeq.

Timepoint [2]

Baseline, and 24hrs post initial influenza vaccine.

Eligibility

Key inclusion criteria

Mild to very Severe COPD with a post bronchiodilater FEV1 less than 80% predicted FEV1 /FVC ratio less than 0.7. COPD patients will be stable with no COPD exacerbations or respiratory infections within the last 4 weeks.
Healthy controls no prior or current symptoms of lung disease, MRC dyspnoea scale less than 2 and normal spirometry. And normal spirometry with an FEV1 and FVC within normal range.

Minimum age

50 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Invasive malignancy within the last 2 years.
Renal impairment (eGFR less than 40ml/min).
Acute febrile illness with fever greater than 38.5 dC.
Hypersensitivity to egg protein.
Use of oral Prednisolone (or equivalent) greater than or equal to 10mg per day.
Use of other systemic immunosuppressive therapy.
Anaphylaxis following a previous dose of influenza vaccine.
Anaphylaxis following a vaccine component (including eggs).
History of Guilliane Barre within 6 weeks of a previous influenza vaccination

Cardiac disease, diabetes mellitus and superficial non- melanoma skin cancers WILL NOT be exclusion criteria provided these are stable and well controlled in the opinion of the investigator.

Study design

Purpose

Screening

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Based on pilot data, a sample size of 36 COPD patients and 36 control subjects in each age strata (56-64 years, 65-74 years, and over 75 years) has a power of 90% to detect a difference between patients and controls in post-vaccination antibody titre at a significance level of 0.05. Thus a total of 108 COPD and 108 Control subjects will need to complete the study. On the assumption that 20% of participants will fail to attend one or more of the scheduled blood collections, we estimate that 135 COPD patients and 135 control subjects will need to be recruited.

Recruitment

Recruitment status

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Lack of funding/staff/facilities
Participant recruitment difficulties

Date of first participant enrolment

Anticipated

Actual

13/04/2015

Date of last participant enrolment

Anticipated

Actual

8/06/2017

Date of last data collection

Anticipated

Actual

30/08/2017

Sample size

Target

216

Accrual to date

Final

171

Recruitment in Australia

Recruitment state(s)

QLD,VIC

Recruitment hospital [1]

Princess Alexandra Hospital - Woolloongabba

Recruitment hospital [2]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [3]

Mater Adult Hospital - South Brisbane

Recruitment postcode(s) [1]

4102 - Woolloongabba

Recruitment postcode(s) [2]

3050 - Parkville

Recruitment postcode(s) [3]

4101 - South Brisbane

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

16 Marcus Clarke street
Canberra, ACT, 2601

Country [1]

Australia

Primary sponsor type

Hospital

Name

Princess Alexandra Hospital

Address

199 Ipswitch Rd
Woolloongabba, QLD, 4102

Country

Australia

Secondary sponsor category [1]

University

Name [1]

The University of Queensland

Address [1]

Brisbane, St Lucia, QLD, 4072

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South Health Human Research Ethics Committee

Ethics committee address [1]

Metro South Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/12/2009

Approval date [1]

25/03/2010

Ethics approval number [1]

HREC/09/QPAH/297

Ethics committee name [2]

UQ Human Ethics, Research Management Office

Ethics committee address [2]

Research Management Office, 
UQ Research and Innovation,
The University of Queensland, Brisbane Queensland 4072

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

05/02/2015

Approval date [2]

13/02/2015

Ethics approval number [2]

2011000502

Summary

Brief summary

Influenza infection is a frequent and important problem in chronic obstructive pulmonary disease (COPD). Influenza can have severe consequences in these patients, leading to acute exacerbations of COPD, pneumonia and respiratory failure. COPD patients are thus recognised as a group at particular risk of influenza, and current guidelines recommend yearly influenza vaccination. These recommendations are largely based on expert opinion and observational studies, with very few randomised controlled trials having been conducted in COPD. It has been suggested that people with COPD may have an aberrant immune response to influenza viruses, and as such, they may be less able to effectively mount an immune response to influenza vaccination. This study will examine influenza vaccination in people with COPD, and healthy age-matched controls, focussing on the factors that predict an effective antibody response to the vaccine (seroprotection), especially aspects of dendritic cell and T-cell function. 
We will conduct an open-label observational study of seasonal influenza vaccine in 108 COPD patients and 108 healthy, age-matched control subjects. Subjects will receive a single dose of inactivated and purified split influenza vaccine in the autumn of 2015, 2016 and 2017. Primary outcomes of this study will be the proportion of vaccine recipients who achieve seroprotection or seroconversion.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof John W Upham

Address

The University of Queensland Diamantina Institute
Translational Research Institute
37 Kent Street
Woolloongabba, QLD 4102

Country

Australia

Phone

+617 3443 8024

Fax

j.upham@uq.edu.au

Contact person for public queries

Name

John W Upham

Address

The University of Queensland Diamantina Institute
Translational Research Institute
37 Kent Street
Woolloongabba, QLD 4102

Country

Australia

Phone

+617 3443 8024

Fax

j.upham@uq.edu.au

Contact person for scientific queries

Name

John W Upham

Address

The University of Queensland Diamantina Institute
Translational Research Institute
37 Kent Street
Woolloongabba, QLD 4102

Country

Australia

Phone

+617 3443 8024

Fax

j.upham@uq.edu.au

Data sharing statement

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

No/undecided IPD sharing reason/comment

Data for individual patients will not be available publicly due to ethical restrictions. Combined data for the trial will be publicly available.

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	Vaccine strain affects seroconversion after influenza vaccination in COPD patients and healthy older people.	2022	https://dx.doi.org/10.1038/s41541-021-00422-4

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