Trialling a double-dose of influenza vaccine to examine the efficacy of the influenza vaccination in patients with chronic obstructive pulmonary disease (COPD)
Efficacy of a prime-boost, double-dose immunisation of the seasonal influenza vaccination in COPD patients.
Princess Alexandra Hospital
43 participants
Apr 9, 2018
Interventional
Conditions
Summary
It has been suggested that people with chronic obstructive pulmonary disease (COPD) 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. As little is known about the efficacy of influenza vaccine in COPD, this pilot study will examine the effect of two sequential doses of the seasonal influenza vaccination in those with COPD, and whether this higher vaccine dose is able to augment the immune response in COPD patients. Outcomes will focus on antibody response and the factors that predict an effective antibody response to the vaccine.
Eligibility
Inclusion Criteria3
- Mild to very Severe COPD with a post bronchiodilater FEV1 less than 80%.
- Predicted FEV1/FVC ratio less than 0.8.
- COPD patients will be stable with no COPD exacerbations or respiratory infections within the 4 weeks prior to participating in the study.
Exclusion Criteria10
- Invasive malignancy within the last 2 years.
- Renal impairment (eGFR less than 40 ml/min).
- Acute febrile illness with fever greater than 38.5 degrees Celsius.
- Hypersensitivity to egg protein.
- Use of oral Prednisolone or equivalent. greater than or equal to 10 mg 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
- Non-stable cardiac disease, non-stable diabetes mellitus, and some skin cancers as assessed by the principal investigator,
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Open label, interventional study of two sequential doses of seasonal influenza vaccination in COPD patients. Initial recruitment of COPD patients via telephone contact will occur onward from January 2018, in readiness for receiving the 2018 seasonal influenza vaccine upon its availability. Study information will then be sent to potential participants via mail prior to their first study clinic visit. COPD patients will provide an initial single blood sample to be analysed of no more than 40 ml, prior to receiving a single, standard-dose (15 ug/strain) of inactivated and purified seasonal influenza vaccine, administered intra-muscularly in the deltoid by a clinical nurse. COPD patients will return 28 days post initial inoculation (p.i.), to provide a second single blood sample of no more 40 ml, prior to receiving a second single, standard-dose (15 ug/strain) of inactivated and purified seasonal influenza vaccine. COPD patients will then attend two further clinic visits to provide blood samples of no more than 40 ml at 56 days, and no more than 10 ml at 84 days post initial vaccine. In 2018, COPD patients will be asked to attend four (4) mandatory study clinic visits, including administration of two sequential, standard, seasonal vaccines delivered 28 days apart. The duration of the first study clinic visit will be approximately two hours in which to complete study screening paperwork, signed consent forms, perform initial lung capacity testing, including a 15 minute period to assess patient reaction to vaccine. Duration of remaining study clinic visits will be approximately 45min, in which to take blood samples and assess patient health, and includes a 15 minute period to assess patient reaction to vaccine on the second visit. Participants will be telephoned to remind them of upcoming clinic visits and research nurses will maintain an attendance log to monitor participant clinic visits for follow up blood collections.
Locations(2)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12620000954921