Study design (if review, criteria of inclusion for studies)
randomised double-blind placebo controlled study over 3 years.
Participants
People with CF (n = 41) and family members (n = 89) attending the Vanderbilt CF clinic, Nashville, USA.
Interventions
An intranasal live attenuated cold adapted influenza A vaccine (A/Kawasaki/9/86 (H1N1), A/Los Angeles/2/87 (H3N2) plus IM standard monovalent influenza B vaccine versus egg allantoic fluid nose drops plus IM standard trivalent inactivated influenza A vaccine
Outcome measures
1. Number of hospital admissions (as rate per 100 patient years) 2. Adverse effects 3. Antibody levels
Main results
Local, respiratory, and systemic symptoms after vaccine were infrequent and did not differ between vaccine groups. CF patients did not differ from family members in immune response to either vaccine. Although antibody responses tended to be higher after triv vaccine, > or = 85% of subjects had mean hemagglutination inhibition antibody titers > or = 1:32 to influenza H1N1 and H3N2 after the first dose of either vaccine. Infection with influenza H3N2 viruses circulating during this study occurred with comparable low frequency in CF patients after ca (14 infections/100 subject-years of observation) or triv vaccine (10 infections/100 subject-years of observation).
Authors' conclusions
Influenza A ca vaccines appear to be safe, immunogenic alternatives to influenza A inactivated vaccines for CF patients and their families.