A double-blind placebo-controlled study of the effect of influenza vaccination on airway responsiveness in asthma. Impact of influenza-like illness and effectiveness of influenza vaccination in oncohematological children who have completed cancer therapy Randomised placebo-controlled crossover trial on effect of inactivated influenza vaccine on pulmonary function in asthma Activation of virus replication after vaccination of HIV-1-infected individuals Efficacy of Influenza Vaccination in HIV-Infected Persons The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions. A prospective, comparative study of the immune response to inactivated influenza vaccine in pediatric liver transplant recipients and their healthy siblings. Effects of influenza vaccination in HIV-infected adults: a double-blind, placebo-controlled trial. Influenza Vaccination Is Efficacious and Safe in Renal Transplant Recipients Impact of influenza vaccine on response to vaccination with pneumococcal vaccine in HIV patients. Immunogenicity of trivalent influenza vaccine in children with acute lymphoblastic leukemia during maintenance therapy. Efficacy and Immunologic Responses to Influenza Vaccine in HIV-1-Infected Patients Serum antibody response to influenza vaccine in pulmonary patients receiving corticosteroids. Immune response to influenza vaccination in children and adults with asthma: effect of corticosteroid therapy.
Influenza A infection may cause severe exacerbations of asthma with increased airway responsiveness and airflow obstruction ( 1 ) . Annual vaccination against influenza is therefore recommended for patients with asthma by the Chief Medical Officer of the Department of Health . However , some patients report exacerbations of their asthma , apparently related to influenza vaccination , and there is reluctance to adhere to the recommended vaccination policy ( 2 ) . We therefore studied the effect of a current subunit vaccine on symptoms , medication use , spirometry and airway responsiveness in patients with stable asthma Abstract In order to evaluate the impact of influenza-like illness and the effectiveness of influenza vaccination  in children with oncohematological disease who have completed cancer therapy , 182 children with a diagnosis of oncohematological disease were divided into two subgroups on the basis of the length of time off therapy ( < 6 months or 6–24 months ) and r and omised 1:1 to receive influenza vaccination or not . The controls were 91 otherwise healthy children unvaccinated against influenza .  The results show that the clinical and socioeconomic impact of influenza-like illnesses and the effectiveness of influenza vaccination  in oncohematological children who have completed cancer therapy are related to the length of the off therapy period , and seem to be significantly greater in those who have been off therapy for less than 6 months in comparison with healthy controls . This suggests that the administration of influenza vaccination should be strongly recommended only among oncohematological children who have been off therapy for less than 6 months BACKGROUND Despite current recommendations , many people with asthma do not receive annual vaccination against influenza , partly because of concern that vaccine may trigger exacerbations . Colds can trigger exacerbations , which may be mistaken for vaccine-related adverse events . We undertook a double-blind placebo-controlled multicentre crossover study to assess the safety of influenza vaccine  in patients with asthma , with allowance for the occurrence of colds . METHODS We studied 262 patients , aged 18 - 75 years , who recorded daily peak expiratory flow ( PEF ) , respiratory symptoms , medication , medical consultations , and hospital admissions for 2 weeks before the first injection and until 2 weeks after the second injection . Order of injection ( vaccine and placebo ) was assigned r and omly . There was an interval of 2 weeks between injections . The main outcome measure was an exacerbation of asthma within 72 h of injection ( defined as a fall in PEF of > 20 % ) . FINDINGS Among 255 participants with paired data , 11 recorded a fall in PEF of more than 20 % after vaccine compared with three after placebo ( McNemar 's test p=0.06 ) ; a fall of more than 30 % was recorded by eight after vaccine compared with none after placebo ( binomial test p=0.008 ) . However , when participants with colds were excluded , there was no significant difference in the numbers with falls of more than 20 % between vaccine and placebo ( six vs three ; binomial test p=0.51 ) , although the difference for PEF decreases of more than 30 % approached significance ( five vs none ; binomial test , p=0.06 ) . This association was confined to first-time vaccinees . INTERPRETATION Our findings indicate that pulmonary-function abnormalities may occur as a complication of influenza vaccination . However , the risk of pulmonary complications is very small and outweighed by the benefits of vaccination Little is known about the factors that govern the level of  HIV-1 replication in infected individuals . Recent studies ( using potent antiviral drugs ) of the kinetics of HIV-1 replication in vivo have demonstrated that steady-state levels of viremia are sustained by continuous rounds of de novo infection and the associated rapid turnover of CD4 + T lymphocytes . However , no information is available concerning the biologic variables that determine the size of the pool of T cells that are susceptible to virus infection or the amount of virus produced from infected cells . Furthermore , it is not known whether all CD4 + T lymphocytes are equally susceptible to HIV-1 infection at a given time or whether the infection is focused on cells of a particular state of activation or antigenic specificity . Although HIV-1 replication in culture is known to be greatly facilitated by T cell activation , the ability of specific antigenic stimulation to augment HIV-1 replication in vivo has not been studied . We sought to determine whether vaccination of HIV-1-infected adults leads to activation of virus replication and the targeting of vaccine antigen- responsive T cells for virus infection and destruction . Should T cell activation result ing from exposure to environmental antigens prove to be an important determinant of the steady-state levels of HIV-1 replication in vivo and lead to the preferential loss of specific population s of CD4 + T lymphocytes , it would have significant implication s for our underst and ing of and therapeutic strategies for HIV-1 disease . To begin to address these issues , HIV-1-infected individuals and uninfected controls were studied by measurement of immune responses to influenza antigens and quantitation of virion- associated plasma HIV-1 RNA levels at baseline and at intervals after immunization with the trivalent influenza vaccine . Influenza vaccination result ed in readily demonstrable but transient increases in plasma HIV-1 RNA levels , indicative of activation of viral replication , in HIV-1-infected individuals with preserved ability to immunologically respond to vaccine antigens . Activation of HIV-1 replication by vaccination was more often seen and of greater magnitude in individuals who displayed a T cell proliferative response to vaccine antigens at baseline and in those who mounted a significant serologic response after vaccination . The fold increase in viremia , as well as the rates of increase of HIV-1 in plasma after vaccination and rates of viral decline after peak viremia , were higher in individuals with higher CD4 + T cell counts . ( ABSTRACT TRUNCATED AT 400 WORDS Influenza vaccination is recommended for patients with HIV-1 infection ( 1 ) , but no studies have measured its efficacy in this population . Patients infected with HIV-1 , especially those with low CD4 + cell counts , often have minimal antibody responses to influenza vaccine ( 2 , 3 ) , leading some research ers to conclude that vaccination is not cost-effective ( 4 ) . In addition , vaccination has been associated with transient increases in HIV replication ( 5 - 8 ) and small decreases in percentage of CD4 cells ( 8) ; both of these findings are of undetermined clinical relevance . To better estimate the potential benefit of routine influenza vaccination in persons infected with HIV , we conducted a r and omized , controlled trial of influenza vaccine in a sample of HIV-1-infected patients during one influenza season . Methods Study Design The study site , a hospital-based clinic affiliated with the U.S. military , provides care to 400 to 500 patients infected with HIV-1 . Posters invited patients who visited the clinic from October to December 1995 to refer themselves for enrollment . All HIV-infected patients who had not yet received their annual influenza vaccine were eligible to participate . All patients gave informed consent , and the hospital 's institutional review board approved the study . Blood was drawn for measurement of CD4 + cell counts , influenza antibody titers , and plasma quantitative HIV-1 RNA level . Using a r and om computer-generated sequence , which was kept sealed until the end of the study , pharmacy staff prepared syringes that were filled with saline or with influenza vaccine purchased by the hospital for clinical use ( whole virion containing 15 g each of A/Johannesburg/33/94 [ H3N2 ] , A/Texas/36/91 [ H1N1 ] , and B/Harbin/07/94 [ Pasteur Mrieux Connaught , Lyon , France ] . Clinic staff could not distinguish vaccine from placebo . At 1 and 3 months after vaccination , patients returned for follow-up measurement of CD4 + cell count and HIV-1 RNA level and for serologic examination for influenza . Patients returned for viral cultures only if respiratory symptoms developed . At the conclusion of the study , all patients were interviewed about respiratory illness ( broadly defined as any rhinitis , pharyngitis , or cough ) experienced during the study period . Laboratory Assays Sample s for T-cell subset analysis were processed according to st and ard methods . The variation of percentage of CD4 cells on replicate testing was 1 % . Plasma sample s for measurement of HIV-1 RNA level were drawn in acid citrate-dextrose tubes , separated at 2000 rpm for 15 minutes , and stored at 70 C. Serum sample s were stored similarly . Quantitative HIV RNA reverse transcriptase polymerase chain reaction assays ( Amplicor Monitor , Roche , Nutley , New Jersey ) were done in batches by Quest Diagnostics at Nichols Institute , San Juan Capistrano , California ; all specimens from individual patients were tested simultaneously . The lower limits of quantification were 400 RNA copies per mL of plasma , and the intra-assay coefficient of variation of 32.3 % to 45.3 % . Serum sample s taken before and 1 month after vaccination were tested for antibody responses to each of the three individual vaccine components by microtiter hemagglutination inhibition ; egg-grown virus antigens starting at a dilution of 1:4 were used ( 9 ) . Sample s below this threshold were assigned a value of 1:2 . Serum sample s obtained 1 month and 3 months after vaccination were tested against the A/Johannesburg/33/94 and A/Nanchang/33/95 ( H3N2 ) virus strains ; the latter is antigenically similar to the A/Wuhan/95-like viruses that were circulating in the United States in 1995 and 1996 . All of the patients who responded to A/Johannesburg/94 ( those who demonstrated a fourfold or greater increase in titer ) also responded to A/Nanchang/95 . Because both A/Johannesburg-like and A/Wuhan-like viruses circulated in the study sample , an antibody response to A/Nanchang/95 occurring between 1 and 3 months after vaccination was defined as evidence of influenza A infection . Viral cultures were performed by using st and ard laboratory methods . Statistical Analysis Statistical analysis was done by using Statview 4.5 software ( Abacus Concepts , Inc. , Berkeley , California ) . Changes in antibody titer , plasma HIV-1 RNA level , and CD4 + cell count were analyzed by using the unpaired t-test to compare vaccine and placebo recipients . Illness rates were compared by using the chi-square test . The percentage of protective efficacy of vaccination was calculated as 1 ( risk ratio comparing vaccine and placebo recipients ) 100 . Results Characteristics of the Study Group A total of 102 patients enrolled in the study . Fifty-five patients were r and omly assigned to receive vaccine , and 47 patients were r and omly assigned to receive placebo .  Table 1 summarizes the participants ' characteristics . Because the study was conducted in fall 1995 , antiretroviral regimens were limited to single or double reverse transcriptase inhibitor combinations . No patients were taking protease inhibitors .  All patients had received at least one previous influenza vaccination .  Table 1 . Baseline Characteristics of the Study Sample Serologic Response to Vaccination Prevaccination and postvaccination paired serum sample s from 49 vaccine recipients and 43 placebo recipients were tested against the three vaccine constituents ( Table 2 ) . Although the aggregate responses to vaccination were statistically significant , only 12 % , 29 % , and 36 % of vaccine recipients had a fourfold or greater response to the A/H1N1 , A/H3N2 , and B components , respectively . Table 2 . Antibody Response to Influenza Vaccination  Protective Efficacy of Influenza Vaccination Peak influenza activity in San Diego County in 1995 and 1996 occurred from mid-January through early February and was predominately caused by the A/Johannesburg ( H3N2 ) virus strain ; some A/Wuhan ( H3N2 ) virus was also present ( San Diego Public Health Department . Personal communication ) . Sixteen of 55 vaccine recipients ( 29 % ) , compared with 23 of 47 placebo recipients ( 49 % ) , reported symptoms of respiratory illness during the fall and winter of 1995 and 1996 ( P=0.04 ) . No patients were hospitalized or treated for pneumonia during the study period . Twenty of 39 patients ( 12 placebo recipients and 8 vaccine recipients ) who reported respiratory illness returned to the clinic for viral respiratory culture . Influenza A ( H3N2 ) virus was isolated from 3 patients , and influenza B virus was isolated from 2 patients , all of whom received placebo . Serum sample s taken 1 and 3 months after vaccination were available for 86 patients ( 43 vaccine recipients and 43 placebo recipients ) . One vaccine recipient and 10 placebo recipients had serologic evidence of influenza A infection ( P=0.004 ) . During the 1995 - 1996 influenza season , 13 of 47 placebo recipients had laboratory-documented influenza A infection ( by culture or serologic examination ) compared with only 1 of 55 vaccine recipients ( P<0.001 ) ( calculated protective efficacy , 93 % [ CI , 69 % to 100 % ] ) . The one vaccinated patient who had serologic evidence of influenza infection had advanced HIV infection with a CD4 + count of 36 cells/mm3 at baseline . Although our study included too few patients with CD4 + cell counts less than 200 cells/mm3 to make firm conclusions , only one of five vaccine recipients ( 20 % ) reported respiratory symptoms during the study period compared with four of eight placebo recipients ( 50 % ) ( P>0.2 ) . The one vaccinated patient with serologic evidence of infection did not report symptoms of respiratory illness during the study period . Ten placebo recipients and no vaccine recipients had symptomatic laboratory-confirmed influenza A ( protective efficacy , 100 % [ CI , 73 % to 100 % ] ) . Effect of Vaccination and Influenza on Plasma HIV-1 RNA Level and CD4 Cell Count No significant differences were seen in changes in the percentage of CD4 cells or plasma HIV-1 RNA levels between the vaccine and placebo groups or between patients with and those without documented influenza infection . At 1 month , the plasma HIV RNA level increased 0.03 log ( CI , 0.12 log to 0.18 log ) in vaccinated patients , a value that is well within the anticipated variability ( 0.3 to 0.5 log ) of the plasma HIV RNA level ( 10 ) . Twenty-six percent of the study patients ( 14 vaccine recipients and 13 placebo recipients ) changed their antiretroviral regimens during the study period . Discussion Our results indicate that influenza vaccine is highly effective in HIV-infected patients . Calculated protective efficacy was 100 % for symptomatic influenza A , and the lower bound of the CI around this estimate was 73 % . This protection is comparable to the 70 % efficacy described in immunocompetent adults ( 1 ) . Although patients with AIDS were underrepresented , the subset of such patients showed nonstatistically significant decreases in respiratory illness that were nearly identical to those of the group as a whole . Our use of serodiagnosis may have missed influenza infections in vaccinated patients who did not have follow-up titers or had antibody titers that were already high before the influenza season . However , the protective efficacy , as measured by serodiagnosis , was supported by a similar decrease in culture-positive illness and significant reductions in respiratory symptoms . Although excellent protection was seen against H3N2 influenza , which was circulating in 1995 and 1996 , an inherent limitation of study ing influenza is that other vaccine components may not be as efficacious against future epidemic influenza strains . Although our study is the first to examine the efficacy of influenza vaccine in persons infected with HIV-1 , many studies have measured the immunogenicity of influenza vaccine in this population ( 2 , 3 , 7 , 11 - 16 ) . Reported response rates range from 0 % to 85 % . The wide variation reflects host factors , such as stage of illness , and variable antigenicity of different vaccine strains . Although the patients in our sample were relatively healthy , OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity BACKGROUND Annual influenza vaccination is routinely recommended for pediatric solid organ transplant recipients . However , there are limited data defining the immune response to the inactivated vaccine in this population . METHODS This prospect i ve study compared the humoral and cell-mediated immune responses to the trivalent subvirion influenza vaccine in pediatric liver transplant recipients with those in their healthy siblings . All subjects received inactivated influenza vaccine .  Hemagglutination inhibition and interferon-gamma ( IFN-gamma ) enzyme-linked immunosorbent spot assays for New Caledonia and Shanghai strains were performed at baseline , after each vaccine dose , and 3 months after the series . Seroconversion was defined as a 4-fold increase in antibody titers ; seroprotection was defined as an antibody titer > or = 1:40 . An increase in the number of T cells secreting IFN-gamma was considered to be a positive enzyme-linked immunosorbent spot response . RESULTS After 1 dose of vaccine , transplant recipients achieved rates of antibody seroprotection and seroconversion that were similar to those achieved by their healthy siblings . However , for both influenza strains , IFN-gamma responses by enzyme-linked immunosorbent spot were significantly attenuated in transplant recipients after 2 doses of vaccine . No cases of influenza or vaccine-related serious adverse events were documented in the study . CONCLUSIONS The diminished cell-mediated immune response to influenza vaccination that was observed in pediatric liver transplant recipients suggests that the current vaccine strategy may not provide optimal protection . Because of concerns regarding potential emergence of more virulent influenza strains , further studies are warranted to determine if IFN-gamma responses are predictive of efficacy and to identify the optimal vaccination strategy to protect population s with a high risk of infection Annual influenza vaccine is recommended for persons with HIV infection . Recent reports indicate that immunizations may increase HIV replication in infected individuals . Forty-seven HIV-infected patients were r and omized to influenza vaccine or saline placebo using a double blind study design . One month after vaccination , plasma HIV-1 RNA increased in the vaccinated but not placebo group ( p = 0.029 ) . At 3 months , CD4 % dropped an average of 1.6 points in the vaccinated group compared to an increase of 0.1 points in the placebo group ( p = 0.039 ) . Patients on stable antiretroviral regimens had CD4 % drop an average of 2.3 points in the vaccinated group at 3 months versus 0.1 points in the placebo group ( p = 0.015 ) . It is concluded that HIV-infected patients are at risk for increased HIV replication and decreases in CD4 % following influenza vaccination . Since influenza has not been associated with significant morbidity in this population , further study of routine influenza vaccination for HIV-infected patients is warranted Whether  influenza vaccination in solid‐organ transplant recipients is efficacious remains a controversial issue . Furthermore , theoretical concerns have been raised regarding the safety of vaccination as it might trigger rejection of the allograft . The present prospect i ve trial is aim ed at investigating the antibody response and safety of influenza vaccination  in renal transplant recipients ( RTR ) The clinical effectiveness of 23-valent pneumococcal vaccine in human immunodeficiency virus (HIV)-infected patients is controversial , because of the low immunological response in these subjects . We studied the clinical response of  pneumococcal vaccine  and the relative impact of influenza vaccine  by administering both pneumococcal and influenza vaccine in a group of 150 HIV patients belonging to all CDC categories . In the group of 90 HIV-infected patients vaccinated against both pneumonia and influenza virus , there was a low incidence of mild influenza ( 13.3 % ) and no case of pneumococcal pneumonia . On the contrary , among 60 nonvaccinated HIV patients , 61.6 % underwent mild to severe influenza and two developed pneumococcal pneumonia .  23-valent pneumococcal vaccine ( PV ) seems to be clinical ly effective in preventing pneumonia in HIV-infected patients , and even more if strengthened by influenza vaccine PURPOSE The aim of this study was to assess the immune response of children with acute lymphoblastic leukemia ( ALL ) to influenza vaccine and to compare it with healthy controls . PROCEDURE Thirty-two children aged 1 - 18 years with ALL on maintenance therapy and 30 healthy sibling controls were enrolled in the study . All children were vaccinated with trivalent inactivated influenza vaccine .  Hemagglutinin-inhibition ( HI ) antibody titers were determined in sera of both patient and control groups just before and 4 weeks after vaccination . The ability of each group to mount a protective ( > or = 40 ) and /or fourfold titer was measured . RESULTS The protective response for virus subunits among patients and healthy controls were 43.4 % versus 88 % for H1N1 ( P = 0.04 ) , 63.3 % versus 80 % for H3N2 antigens ( P = 0.06 ) , and 26 % versus 73 % for B antigen ( P = 0.001 ) . Responses for H1N1 and B subunits were significantly lower in patients than controls . In the patient group , the significant response to each virus was demonstrated in the analysis of pre- and post-vaccination geometric mean titer ( GMT ) ( P = 0.001 ) . The percentage of patients and controls with fourfold increase in HI titers were 56.2 % versus 80 % for H1N1 ( P = 0.04 ) , 40.6 % versus 53.3 % for H3N2 ( P = 0.31 ) , and 59.4 % versus 83.3 % for B ( P = 0.038 ) . Immune responses for H1N1 and B subunits were significantly lower in patients than controls . CONCLUSIONS Influenza vaccine is tolerated well in ALL patients with acceptable but limited immune response compared to healthy controls . These findings support the recommendation for annual influenza vaccination in children with ALL Influenza vaccine is recommended for HIV-1-infected patients . The present prospect i ve study was conducted to evaluate the clinical efficacy and immunologic responses to the vaccine . From November 1 to December 27 , 2002 , 262 HIV-1-infected patients received a trivalent influenza subunit vaccine  , whereas 66 did not . Influenza illness occurred in 16 vaccinated and 14 nonvaccinated patients ( incidence = 6.1 % [ 95 % confidence interval ( CI ) : 4%-10 % ] in vaccinated vs. 21.2 % [ CI : 13%-35 % ] in nonvaccinated persons , P < 0.001 ; relative risk = 0.29 [ CI : 0.14 - 0.55 ] ) . Influenza vaccine provided clinical ly effective protection against influenza illness in HIV-1-infected patients . In baseline antibody-negative patients , anti-H1 and anti-H3 antibody responses to the vaccination were significant in those patients with a CD4 count > 200 cells/μL compared with those with a CD4 count < 200 cells/μL ( P < 0.05 ) . In contrast , in baseline antibody-positive patients , good antibody responses were observed irrespective of CD4 counts , like the healthy controls . Based on these results , annual vaccination is recommended . Specific CD4 responses correlated with HIV-1 viral load ( VL ) , especially in patients treated with highly active antiretroviral therapy ( HAART ) compared with those without HAART ( P < 0.01 ) , although the clinical efficacy did not correlate with HIV-1 VL . HAART may enhance the immunologic efficacy of influenza vaccine OBJECTIVE Despite the recommendation that patients with chronic lung diseases -- many of whom receive corticosteroids -- receive annual influenza vaccination , it is not known whether corticosteroids influence antibody response to influenza vaccine in this population . The purpose of this study was to assess whether patients with pulmonary conditions receiving long-term corticosteroid therapy develop an adequate antibody response . DESIGN We prospect ively studied 39 consecutive c and i date s for influenza vaccination , 25 of whom were receiving corticosteroids for underlying lung diseases . Patients with immunosuppression besides corticosteroids were excluded . Serum sample s were obtained prior to and 1 month after vaccination with inactivated trivalent influenza vaccine and assayed for antibodies to the three strains using a hemagglutination inhibition assay . No patients had any intercurrent illness compatible with influenza during the study period and patients receiving  corticosteroids continued treatment with them during this time . RESULTS A fourfold rise in antibody titer at 1 month to at least one component was seen in 21 of 25 ( 84 % ) of corticosteroid-treated patients , which was similar to patients not receiving corticosteroids ( 11/14 , 79 % ) . There was no corticosteroid-antibody , dose-response relationship . CONCLUSIONS Patients with pulmonary conditions receiving corticosteroids can generate an adequate antibody response to killed influenza virus vaccine . Long-term therapy with corticosteroids should not preclude influenza vaccination in patients with chronic pulmonary diseases who are deemed vaccine c and i date BACKGROUND Annual influenza vaccination is currently recommended as a preventative measure for all patients with asthma . However , the effect of maintenance corticosteroid therapy on the immune response to influenza vaccine has received limited evaluation . OBJECTIVE In this study , we evaluated the effect of corticosteroid therapy on the immune response to influenza vaccine in children and adults with asthma . METHODS This was a sub study of a larger multicenter , r and omized , double-masked , placebo-controlled , crossover study investigating the safety of trivalent influenza vaccine in patients with asthma . At baseline , 294 subjects were r and omized to receive either placebo first ( n=139 ) or inactivated trivalent split-virus influenza vaccine first ( n=155 ) . Study subjects were categorized into 2 groups : subjects in group 1 ( n=148 ) were receiving medium-dose or high-dose inhaled corticosteroids ( ICSs ) or oral corticosteroids , whereas subjects in group 2 ( n=146 ) were not receiving corticosteroids or were receiving low-dose ICSs .  Serum hemagglutination inhibition antibody titers for the vaccine antigens were measured before and 4 weeks after the administration of placebo or vaccine . RESULTS Serologic responses to each influenza vaccine antigen were significantly higher in vaccine than in placebo recipients and were similar among influenza vaccine recipients in groups 1 and 2 for the following endpoints : rise in antibody titer , percent of participants who developed a serological response , and percent of subjects who developed a serum hemagglutination inhibition antibody titer > or = 1:32 . Post hoc subgroup analyses demonstrated an attenuated response to influenza B antigen in subjects receiving high-dose ICS compared with subjects who were steroid-naïve ( P<.05 ) . CONCLUSION The immune response to the A antigens of the inactivated influenza vaccine in subjects with asthma is not adversely affected by ICS therapy . High-dose ICS therapy may diminish the response to the B antigen of the vaccine , an observation that needs further investigation
Many national guidelines recommend annual influenza vaccination of immunocompromised patients , although the decision to vaccinate is usually at clinical discretion .