Adverse effects associated with influenza vaccination in patients with COPD: a randomized controlled study. The immunogenicity of intradermal influenza vaccination in COPD patients. Comparison of outpatient visits and hospitalisations, in patients with chronic obstructive pulmonary disease, before and after influenza vaccination. Effects of annual influenza vaccination on winter mortality in elderly people with chronic pulmonary disease. Efficacy trial of live, cold-adapted and inactivated influenza virus vaccines in older adults with chronic obstructive pulmonary disease: a VA cooperative study. Prevalence of Influenza Vaccination in Chronic Obstructive Pulmonary Disease Patients and Impact on the Risk of Severe Exacerbations. Acute respiratory illness in patients with COPD and the effectiveness of influenza vaccination: a randomized controlled study. Economic evaluation of influenza vaccination in Thai chronic obstructive pulmonary disease patients. Occurrence and protective level of influenza infections using serology in patients with COPD in vaccination study. Influenza virus vaccination of patients with chronic lung disease. Immunity to influenza in older adults with chronic obstructive pulmonary disease.
OBJECTIVE The aim of this study was to assess the frequency and type of adverse reactions following influenza vaccination and its effects on lung function , dyspnoeic symptoms , exercise capacity , and clinical acute respiratory illness ( ARI ) in patients with COPD , and the relationship of these adverse effects to the degree of airflow obstruction . METHODOLOGY A stratified , r and omized , double-blind placebo-controlled study was conducted over an 18-month period at a single university hospital . In total , 125 patients with COPD were r and omized to the  vaccine  group ( 62 patients who received purified trivalent split-virus vaccine injections ) or the placebo group ( 63 patients ) . Local and systemic symptoms during the week following the injections were evaluated . Clinical ARI , lung function tests , dyspnoeic symptoms ( assessed using a visual analogue scale ) , and a 6-min walking test were evaluated before and at 1 week and 4 weeks following vaccination . RESULTS The frequency of local adverse reactions was 27 % in the vaccine group and 6 % in the placebo group ( P = 0.002 ) . There was no significant difference in systemic adverse reactions between the vaccine and placebo groups ( 76 % vs. 81 % ; P= 0.5 ) . No difference was observed in the incidence of ARI between the vaccine and placebo groups during the first week ( 6.4 % vs. 6.3 % ; P= 1 ) and the first 4 weeks ( 24.2 % vs. 31.7 % ; P= 0.5 ) following vaccination . There was no significant change in lung function , dyspnoeic symptoms , and exercise capacity of the patients in both groups , at 1 week and 4 weeks following vaccination , regardless of the severity of COPD . CONCLUSION Influenza vaccination is associated with minimal local adverse reactions in patients with COPD . Vaccination does not cause systemic adverse reactions , induce clinical exacerbations or adversely affect lung function , dyspnoeic symptoms and exercise capacity in patients with COPD , regardless of the severity of airflow obstruction We evaluated the immunogenicity of a reduced-dose intradermal trivalent , inactivated , split-virion seasonal influenza vaccine compared to that of a conventional intramuscular vaccination in chronic obstructive pulmonary disease ( COPD ) patients . One hundred and fifty-six COPD patients r and omly received either 0.2 ml ( 6 microg hemagglutinin ( HA ) per strain ) split into two-site intradermal ( ID ) injections or a single 0.5 ml ( 15 microg HA per strain ) intramuscular ( IM ) injection .  Geometric mean titers , seroconversion factors , seroconversion rates and seroprotection rates at 4 weeks post-vaccination in the ID group were less than those in the IM group . Only the seroconversion factor to influenza B in the ID group was statistically less than in the IM group ( 18.8 in the ID group , n=81 versus 37.3 in the IM group , n=75 , p=0.045 ) . Nevertheless , each strain of the ID vaccination met all the Committee for Proprietary Medicinal Products ( CPMP ) criteria . Seroprotection rates were above 60 % throughout the year in influenza A ( H3N2 ) , for at least 6 months in influenza A ( H1N1 ) and at least 4 weeks in influenza B in both ID and IM groups . The reduced-dose intradermal vaccination may be considered for use in COPD patients in a vaccine shortage situation OBJECTIVE To determine the effectiveness of influenza vaccination on acute respiratory illness ( ARI ) and on acute exacerbation of chronic obstructive pulmonary disease ( AE COPD ) during a 2-year study conducted prior to and after influenza vaccination in patients with chronic obstructive pulmonary disease ( COPD ) . MATERIAL S AND METHODS Eighty-seven male patients with COPD were stratified on the basis of their forced expiratory volume in 1 s ( FEV(1 ) ) as having mild , moderate and severe COPD . These patients were evaluated for a total duration of 2 years ; 1 year prior to vaccination and for a period of 1 year following influenza vaccination . The vaccine ( split virion , inactivated ) composed of A/New Caledonia/20/99 ( H1N1 ) ; A/California/7/2004(H3N2 ) and B/Shanghai/361/2002 strains all with 15 mug of haemagglutinin in each 0.5 ml dose . MEASUREMENTS The number of episodes and severity of ARI and AE COPD , classified as outpatient treatment , hospitalisation and requirement of mechanical ventilation , for a period of 1 year before and 1 year after influenza vaccination were recorded . RESULTS The incidence of ARI and AE COPD was 28.6 per 100 person-years prior to vaccination and 9.7 per 100 person-years postvaccination [ relative risk ( RR ) 0.33 ; p = 0.005 ) . Among the exacerbations because of natural infections prior to vaccination the incidences were 16.12 , 42.1 and 33.14 per 100 person-years in the patients with mild , moderate and severe COPD respectively . These were significantly lower following vaccination with the incidences being 6.5 , 18.5 and 8.42 per 100 person-years in the same subgroup of patients . Vaccine effectiveness in patients with mild COPD was 60 % RR , 0.4 ( p = 0.26 ) ; in patients with moderate COPD was 60 % RR , 0.4 ( p = 0.56 ) ; and in patients with severe COPD was 75 % RR , 0.25 ( p = 0.02 ) . The total number of outpatient visits and hospitalisations before vaccination was eight and 14 , respectively for a duration of 1 year in the total 87 patients with COPD being studied which decreased significantly to four outpatient visits and four hospitalisations postvaccination ( p = 0.02 ) . The overall effectiveness of influenza vaccination  was 67 % . CONCLUSIONS Influenza vaccination is highly effective in the prevention of ARI . Maximum protection was found to be in patients with severe COPD . Influenza vaccination in patients is associated with fewer outpatient visits and fewer hospitalisations BACKGROUND Although there is a general agreement for the recommendation of the influenza vaccine to persons with chronic obstructive pulmonary disease ( COPD ) , the magnitude of clinical effectiveness and benefit from the annual vaccination is controversial . We assessed the effects of annual influenza vaccination on winter mortality in older adults with COPD . METHODS This prospect i ve cohort study included 1298 Spanish community-dwelling individuals aged 65 years or older with a diagnosis of COPD followed from 1 January 2002 to 30 April 2005 . The primary outcome was all-cause death during influenza periods ( January-April ) . Multivariable Cox proportional hazard models adjusted by age , sex and comorbidity were used to evaluate vaccine effectiveness . RESULTS Influenza vaccination was associated with a non-statistically significant 16 % reduction in winter mortality among vaccinated COPD patients [ unadjusted hazard ratio ( HR ) : 0.84 ; 95 % confidence interval ( CI ) : 0.60 - 1.17 ] . Multivariable analysis showed that there was an insignificant trend towards a reduced mortality in the vaccinated group considering overall influenza periods 2002 - 2005 ( adjusted HR : 0.76 ; 95 % CI : 0.52 - 1.06 ; p=0.098 ) . We estimated that , in the total COPD population , one death was prevented for every 187 annual vaccinations ( 95 % CI : 62 to infinity ) . CONCLUSIONS Our data suggest benefit from the influenza vaccination and support an annual vaccination strategy for elderly COPD patients We assessed whether trivalent live , cold-adapted influenza virus ( CAIV-T ) vaccine provides added protection when co-administered with trivalent inactivated influenza virus vaccine ( TVV ) in patients with chronic obstructive pulmonary disease ( COPD ) . Subjects ( N=2215 ) were r and omly assigned to receive either TVV intramuscularly ( IM ) and CAIV-T intranasally ( TC ) , or TVV and placebo ( TP ) . The vaccines were well-tolerated . Efficacy of TC compared to TP was not statistically significant and was 0.16 for any influenza virus strain ( 95 % confidence limit ( CL ) : -0.22 , 0.43 ) , 0.26 for A ( H3N2 ) virus ( 95 % CL : -0.17 , 0.53 ) , and -0.05 for type B virus ( 95 % CL : -1.13 , 0.48 ) . However , there was a possible advantage for TC over TP in reducing respiratory consequences of an influenza season measured by pulmonary function and symptoms at end of study OBJECTIVE To determine the prevalence of influenza vaccination in chronic obstructive pulmonary disease ( COPD ) patients , and the effectiveness of the procedure . METHODS Retrospective population -based cohort study . On 31 December 2011 , influenza vaccination history was retrieved from 899 patients with confirmed COPD selected by simple r and om sampling from all COPD patients in Cantabria ( northern Spain ) .  Severe exacerbations ( hospitalization due to COPD exacerbation ) and overall mortality during 2012 were treated as dependent variables . Odds ratios ( OR ) were estimated by logistic regression , adjusting for age , sex , smoking status , severity of COPD , and frequency of exacerbations during the previous year . Prevented fraction among the exposed ( PFe-adjusted ) was determined as a measure of impact . RESULTS Overall prevalence of influenza vaccination  was 62.7 % , but this rate fell in patients classified as more severe according to FEV1 ( 52.0 % ) . Influenza vaccination showed a statistically significant protective effect against severe exacerbations in the following year : Ora : 0.54 ( 95%CI : 0.35 - 0.84 ) ; FPe-adjusted : 0.46 ( 95%CI : 0.16 - 0.65 ) . A non-significant protective effect for overall mortality was observed : Ora : 0.76 ( 95%CI : 0.41 - 1.40 ) . When stratified according to COPD severity ( FEV1 ) , the protective effect against risk of hospitalization was higher in more severe COPD patients : Ora : 0.23 ( 95%CI : 0.11 - 0.48 ) ; FPe-adjusted : 0.77 ( 95%CI : 0.52 - 0.89 ) . CONCLUSIONS We found that influenza vaccination has a protective effect and reduces the risk of hospitalization due to exacerbations in the following year . Despite the evidence for protection , prevalence of vaccination was not optimal , especially in more severe COPD patients STUDY OBJECTIVES To determine the effectiveness of influenza vaccination on influenza-related acute respiratory illness ( ARI ) and overall ARI in patients with COPD , and its relationship to the degree of airflow obstruction . DESIGN Stratified , r and omized , double-blind , placebo-controlled trial . SETTING From June 1997 to November 1998 at a single university hospital . PATIENTS AND INTERVENTIONS One hundred twenty-five patients with COPD were stratified based on their FEV(1 ) as having mild , moderate , and severe COPD . Within each group , they were r and omized to the vaccine group ( 62 patients who received purified , trivalent , split-virus vaccine ) or the placebo group ( 63 patients ) . MEASUREMENTS The number of episodes and severity of total ARI , classified as outpatient treatment , hospitalization , and requirement of mechanical ventilation ; and the number of episodes and severity of influenza-related ARI . RESULTS The incidence of influenza-related ARI was 28.1 per 100 person-years and 6.8 per 100 person-years in the placebo group and vaccine group , respectively ( relative risk [ RR ] , 0.24 [ p = 0.005 ] ; vaccine effectiveness , 76 % ) . The incidences were 28.2 , 23.8 , and 31.2 per 100 person-years in the patients with mild , moderate , and severe COPD , respectively , in the placebo group , and 4.5 , 13.2 , and 4.6 per 100 person-years in the patients with mild , moderate , and severe COPD , respectively , in the vaccine group ( RR , 0.16 [ p = 0.06 ] ; vaccine effectiveness , 84 % ; RR , 0.55 [ p = 0.5 ] ; vaccine effectiveness , 45 % ; and RR , 0.15 [ p = 0.04 ] ; vaccine effectiveness , 85 % , in the patients with mild , moderate , and severe COPD , respectively ) . Bivariate analysis revealed that the effectiveness of influenza vaccination  was not modified by the severity of COPD , comorbid diseases , age , gender , or current smoking status . There was no difference in the incidence or severity of total ARI between the placebo group and the vaccine group . CONCLUSIONS Influenza vaccination is highly effective in the prevention of influenza-related ARI regardless of the severity of COPD . Influenza vaccination does not prevent other ARIs unrelated to influenza . The effectiveness of influenza vaccination in the prevention of overall ARI in patients with COPD will depend on how much the proportion of influenza-related ARI contributes to the incidence of total ARI . Influenza vaccination should be recommended to all patients with COPD UNLABELLED To determine the cost-effectiveness and cost-benefit of influenza vaccination in chronic obstructive pulmonary disease ( COPD ) patients the authors conducted a stratified r and omized , double-blind , placebo-controlled trial from June 1997 to November 1998 at a university hospital in Thail and . A total of 125 COPD patients were stratified based on their FEV1 as mild COPD ( FEV1 > or = 70 % predicted ) , moderate COPD ( FEV1 50 - 69 % predicted ) and severe COPD ( FEV1 < 50 % predicted ) and in each severity stratum they were r and omized to the vaccine group ( received intramuscular injection with purified trivalent split-virus vaccine containing A/Texas/36/91 ( H1N1 ) , A/Nanchang 1933/95 ( H3N2 ) and B/Harbin 107/94 ) or the placebo group ( received intramuscular injection with vit B1 ) . Number of episodes of acute respiratory illness ( ARI ) related to influenza ( clinical ARI + a serum hemagglutination inhibition antibody titre of 38 or greater and a four fold titre increase in convalescent serum compared to acute serum ) as well as severity of each ARI ( outpatient treatment , hospitalization or required mechanical ventilation ) and costs of treatment ( direct medical costs comprised real drug costs from the hospital dispensary in outpatient cases and real charges in hospitalization cases ) were collected and analyzed for the cost-effectiveness and cost-benefit of influenza vaccination . The incidence of influenza-related ARI in the study year was 27 per cent in the placebo group and 6.4 per cent in the vaccine group ( relative risk [ RR ] 0.24 , vaccine effectiveness 76 % ) . The incidence was 27.3 per cent , 23.5 per cent and 29.2 per cent in mild , moderate and severe COPD respectively in the placebo group and 4.3 per cent , 12.5 per cent , and 4.3 per cent in the mild , moderate and severe COPD respectively in the vaccine group ( RR 0.16 , 0.53 and 0.15 ; vaccine effectiveness 84 % , 47 % , and 85 % respectively ) . The incremental cost-effectiveness ratios demonstrated that for every 100 patients with mild COPD whom the authors decided to vaccinate , the cost would be 24,840 baht more and would prevent 18.2 out patients , 4.8 hospitalizations and 0 patient from mechanical ventilation due to ARI related to influenza . Likewise , the authors would have prevented 5.1 out patients , 5.9 hospitalizations , 5.9 mechanical ventilation and 20.8 out patients , 3.9 hospitalizations , 8.3 mechanical ventilation for every 100 moderate COPD and every 100 severe COPD patients vaccinated respectively . More than 90 per cent of the costs of treatment of influenza-related ARI were costs of hospitalization and for patients with moderate and severe airflow obstruction , more than 90 per cent of these costs were attributed to the costs of treating the patients who required mechanical ventilation . Predicted cost savings for every 100 mild COPD , 100 moderate COPD and 100 severe COPD patients vaccinated were 125,629 baht , 538,184.3 baht , and 680,647.1 baht respectively . IN CONCLUSION Influenza vaccination  is highly effective in the prevention of acute respiratory illness related to influenza virus infection in COPD , regardless of severity of airflow obstruction . Vaccination is more cost-effective in preventing mechanical ventilation episodes and more cost-benefit in patients with more severe airflow obstruction . Influenza vaccination should be recommended to all patients with COPD with the higher priority provided to patients with more severe airflow obstruction OBJECTIVE To investigate the prevalence , occurrence and protective level of influenza infections using serology in patients with chronic obstructive pulmonary disease ( COPD ) during a one-year influenza vaccination study . MATERIAL AND METHOD A total of 123 patients with COPD were enrolled during the period of 1997 to 1998 . There were 61 patients in the vaccine group and 62 patients in the placebo group with a mean age + /- SD of 67.6 + /- 8.0 and 69.1 + /- 7.5 , respectively . The vaccine was composed of influenza A/Texas/36/91 ( H1N1 ) , A/Nanchang/933/95 ( H3N2 ) and B/Harbin/07/94 strains .  Antibodies to influenza viruses were detected by hemagglutination inhibition ( HI ) test using antigens of vaccine strains . RESULTS The incidence of influenza proven by serological examination was 22/123 ( 17.9 % ) cases . Among 17/62 ( 27.4 % ) influenza cases in the placebo group representing natural infections , 3 ( 17.6 % ) were diagnosed as A ( H1N1 ) , 8 ( 47.1 % ) as A ( H3N2 ) , 3 ( 17.6 % ) as type A , 1 ( 5.9 % ) as type B and 2 ( 11.8 % ) as untypeable viruses . The 8.2 % of influenza cases found in the vaccine group was significantly lower than 27.4 % of that in the placebo group ( Chi-square test , p = 0.01 ) . The protection rate of influenza vaccination was 71 % . Among 23 acute blood sample s from 22 influenza cases , the titers ranged from < 10 to 20 corresponding to its type/subtype . In the vaccine group , 5 influenza cases occurred at 7 , 7 , 10 , 11 and 11 months after vaccination . The HI antibodies to influenza A ( H1N1 ) , A ( H3N2 ) and B viruses at titers of > or = 10 vs > or = 40 were 50.4 % vs 21.9 % , 54.5 % vs 28.5 % and 17.9 % vs 4.1 % , respectively . CONCLUSION The findings indicated that from 1997 to 1998 , the occurrence of influenza as natural infection was 27.4 % . Influenza A ( H3N2 ) was more frequently prevalent than A ( H1N1 ) and B viruses . The influenza vaccination in COPD patients was effective . The protective HI antibody titers were > or = 40 . The patients without protective HI antibody to A ( H1N1 ) , A ( H3N2 ) and B viruses were 78.1 % , 71.5 % and 95.9 % , respectively . Such patients were considered to be at high-risk for influenza and recommended to have vaccination STUDY OBJECTIVES To evaluate the safety of , and mucosal and systemic immune responses induced by two influenza virus vaccine regimens in subjects with COPD . DESIGN Single-center , blinded , r and omized , prospect i ve clinical trial evaluating two vaccine regimens . SETTING Outpatient clinics of St. Louis Department of Veterans Affairs Medical Center . PARTICIPANTS Volunteers ( age range , 42 to 88 years ) had preexisting COPD with severe obstruction to airflow on average , were male , and were not receiving immunosuppressive medication . INTERVENTIONS Twenty-nine volunteers were r and omly assigned to receive either bivalent live attenuated influenza A virus vaccine ( CAV ) or saline solution placebo intranasally . All subjects also received an i.m . injection of trivalent inactivated influenza virus vaccine ( TVV ) simultaneously . MEASUREMENTS AND RESULTS Clinical status and pulmonary function measured by spirometry did not change significantly after vaccination . Using hemagglutinins ( H1 and H3 HA ) which more closely resembled those in CAV , mean levels of anti-HA immunoglobulin A ( IgA ) antibodies in nasal washings increased significantly after vaccination with CAV and TVV compared to prevaccination , but they did not increase significantly after TVV and intranasal placebo .  Mean levels of influenza A virus-stimulated interleukin-2 and -4 produced by peripheral blood mononuclear cells in vitro increased significantly after administration of the combination vaccine regimen and to a lesser extent after TVV and intranasal placebo compared to respective prevaccination levels . The timing of the cytokine response appeared different following CAV and TVV compared to TVV and intranasal placebo . CONCLUSIONS Intranasally administered CAV was safe when given with i.m . administered TVV and there may be an immunologic advantage to administration of the combination vaccine regimen compared to TVV with intranasal placebo BACKGROUND Chronically ill older adults constitute a population vulnerable for complications associated with influenza . Study of their immunity to influenza virus may help design better strategies to stimulate protective immune responses . METHODS Immunogenicity of influenza vaccines and immune protection from natural influenza were assessed in older adults with chronic obstructive pulmonary disease as part of a vaccine efficacy trial . Subjects received either trivalent inactivated influenza virus vaccine ( TVV ) intramuscularly and trivalent live cold-adapted influenza virus vaccine ( CAIV-T ; n=1107 ) intranasally ( inl ) or TVV and placebo inl ( P ; n=1108 ) . RESULTS In the subsets of study subjects assessed , serum hemagglutination inhibition ( HAI ) and nasal-wash antihemagglutinin ( HA ) immunoglobulin ( Ig ) A and IgG antibody levels and anti-influenza virus CD8(+ ) cytotoxic T lymphocyte activity increased after immunization . Mean postimmunization nasal-wash IgA antibody levels to influenza A H3/HA and B HA were statistically higher in the TVV+CAIV-T group ( n=957 ) than in the TVV+P group ( n=951 ) . Postimmunization serum HAI and nasal-wash IgA antibodies to influenza A/H3N2 and B viruses were associated with a reduced relative risk for natural influenza infection . CONCLUSIONS TVV+CAIV-T appeared more immunogenic than TVV+P , but the observed difference may be clinical ly unimportant . Anti-influenza serum and nasal-wash antibodies were associated with immune protection
Background Influenza is a frequent cause of exacerbations of chronic obstructive pulmonary disease ( COPD ) .
Exacerbations are associated with worsening of the airflow obstruction , hospitalisation , reduced quality of life , disease progression , death , and ultimately , substantial healthcare-related costs .
Despite longst and ing recommendations to vaccinate vulnerable high-risk groups against seasonal influenza , including patients with COPD , vaccination rates remain sub-optimal in this population .