Randomized, double-blind comparative trial of subunit and virosomal influenza vaccines for immunocompromised patients.
BACKGROUND
To our knowledge, no study to date has compared the effects of a subunit influenza vaccine with those of a virosomal influenza vaccine on immunocompromised patients.


METHODS
A prospective, double-blind, randomized study was conducted to compare the immunogenicity and reactogenicity of subunit and virosomal influenza vaccines for adult patients who had an immunosuppressive disease or who were immunocompromised as a result of treatment.


RESULTS
There were 304 patients enrolled in our study: 131 with human immunodeficiency virus (HIV) infection, 47 with a chronic rheumatologic disease, 74 who underwent a renal transplant, 47 who received long-term hemodialysis, and 5 who had some other nephrologic disease. There were 151 patients who received the subunit vaccine and 153 patients who received the virosomal vaccine. A slightly higher percentage of patients from the subunit vaccine group were protected against all 3 influenza vaccine strains after being vaccinated, compared with patients from the virosomal vaccine group (41% vs. 30% of patients; P = .03). Among HIV-infected patients, the level of HIV RNA, but not the CD4 cell count, was an independent predictor of vaccine response. Among renal transplant patients, treatment with mycophenolate significantly reduced the immune response to vaccination. The 2 vaccines were comparable with regard to the frequency and severity of local and systemic reactions within 7 days after vaccination. Disease-specific scores for the activity of rheumatologic diseases did not indicate flare-ups 4-6 weeks after vaccination.


CONCLUSIONS
For immunosuppressed patients, the subunit vaccine was slightly more immunogenic than the virosomal vaccine. The 2 vaccines were comparable with regard to reactogenicity. Vaccine response decreased with increasing degree of immune suppression. Among HIV-infected patients, the viral load, rather than the CD4 cell count, predicted the protective immune response to the vaccine.


BACKGROUND
NCT00783380 .
Department of Infectious Diseases, Bern University Hospital and University of Bern, Bern, Switzerland. john-marc.evison@insel.ch
John
J
Evison
Stefan
S
Farese
Michael
M
Seitz
Dominik E
DE
Uehlinger
Hansjakob
H
Furrer
Kathrin
K
Mühlemann
D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016867:Immunocompromised Host; D007252:Influenza Vaccines / Q000009:adverse effects / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D022223:Vaccines, Subunit / Q000009:adverse effects / Q000276:immunology; D022721:Vaccines, Virosome / Q000009:adverse effects / Q000276:immunology
D007252:Influenza Vaccines; D022223:Vaccines, Subunit; D022721:Vaccines, Virosome