Randomised placebo-controlled crossover trial on effect of inactivated influenza vaccine on pulmonary function in asthma

• Published in: The Lancet (British edition) Vol. 351; no. 9099; pp. 326 - 331
• Main Authors: Nicholson, Karl G, Nguyen-Van-Tam, Jonathan S, Ahmed, Ala'eldin H, Wiselka, Martin J, Leese, Jane, Ayres, Jon, Campbell, James H, Ebden, Philip, Eiser, Noemi M, Hutchcroft, Bruce J, Pearson, James CG, Willey, Richard F, Wolstenholme, Roger J, Woodhead, Mark A
• Format: Journal Article
• Language: English
• Published: London Elsevier Ltd 31.01.1998; Lancet; Elsevier Limited
• Subjects: Adult; Aged; Asthma; Asthma - etiology; Biological and medical sciences; Clinical trials; Cross-Over Studies; Double-Blind Method; Epidemiology. Vaccinations; Female; General aspects; Humans; Infectious diseases; Influenza; Influenza Vaccines - adverse effects; Injection; Lung - physiopathology; Lungs; Male; Medical sciences; Middle Aged; Respiratory function; Risk Assessment; Spirometry; Vaccines; Human; Respiratory disease; Multicenter study; Vaccination; Controlled therapeutic trial; Asthma; Infection; Prevention; Safety factor; Randomization; Viral disease; Influenza; Double blind study; Obstructive pulmonary disease; Public health
• ISSN: 0140-6736; 1474-547X
• DOI: 10.1016/S0140-6736(97)07468-0

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. 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 randomly. 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%). 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. 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.