Abstract | BACKGROUND: OBJECTIVE: METHODS: This was a substudy of a larger multicenter, randomized, double-masked, placebo-controlled, crossover study investigating the safety of trivalent influenza vaccine in patients with asthma. At baseline, 294 subjects were randomized 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:
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Authors | Nicola A Hanania, Marianna Sockrider, Mario Castro, Janet T Holbrook, James Tonascia, Robert Wise, Robert L Atmar, American Lung Association Asthma Clinical Research Centers |
Journal | The Journal of allergy and clinical immunology
(J Allergy Clin Immunol)
Vol. 113
Issue 4
Pg. 717-24
(Apr 2004)
ISSN: 0091-6749 [Print] United States |
PMID | 15100679
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Adrenal Cortex Hormones
- Antigens, Viral
- Influenza Vaccines
- Placebos
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Topics |
- Adolescent
- Adrenal Cortex Hormones
(therapeutic use)
- Adult
- Antibody Formation
(drug effects)
- Antigens, Viral
(immunology)
- Asthma
(drug therapy, immunology)
- Cross-Over Studies
- Double-Blind Method
- Female
- Humans
- Influenza Vaccines
(immunology, therapeutic use)
- Influenza, Human
(prevention & control)
- Male
- Middle Aged
- Placebos
- Vaccination
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