A Randomized Controlled Trial Comparing Intradermal vs. Intramuscular Influenza Vaccine in Lung Transplant Recipients
2010
Background: Immunogenicity of standard infl uenza vaccine is suboptimal in
lung transplant recipients. Intradermal vaccine may elicit stronger responses due
to recruitment of local dendritic cells. We compared the immunogenicity of the
infl uenza vaccine administered intradermally (ID) to the standard intramuscular
(IM) vaccination.
Methods: In this investigator-blinded, two-center, prospective trial, lung transplant
patients were randomized to receive intradermal (6ug) or intramuscular (15ug)
2008/9 trivalent inactivated infl uenza vaccine. Immunogenicity was evaluated
using a standard hemagglutination inhibition assay (HIA). Response to the vaccine
was defi ned as a fourfold increase of the HIA levels for any of the 3 viral strains
in the vaccine. Geometric mean titers (GMT) and seroprotection rate (HIA ≥32)
were also analyzed. Patients were followed during 6 months for the development
of infl uenza or acute rejection.
Results: We randomized 84 patients to receive the ID (n=41) vs. IM (n=43) vaccine,
respectively. Baseline characteristics were similar between groups. Median time
from transplantation was 3.4 yrs (ID) vs. 3.3 yrs (IM) (p=0.84). Vaccine response
to at least one antigen was seen in 6/41 (14.6%) patients in the ID vs. 8/43 (18.6%)
in the IM group (p=0.77). In the ID group, GMTs (95% CI) after vaccination were
15.7 (11.1-22.3) for H1N1, 84.0 (52.0-135.7) for H3N2, and 14.5 (9.6-21.8) for B
strains vs. in the IM group 17.5 (11.8-25.9) for H1N1, 108.9 (77.5-153.2) for H3N2,
and 20.2 (12.8-31.9) for B (p=NS, all 3 strains). Seroprotection was 39% (H1N1),
82.9% (H3N2) and 29.3% (B strain) in the ID group vs. 27.9% (H1N1), 97.7%
(H3N2) and 58.1% (B strain) in the IM group. No factors associated with vaccine
response were identifi ed. Mild adverse events were seen in 44% of patients (ID)
vs. 34% (IM) (p=0.38). Two patients (4.8%) in the ID group developed infl uenza
infection compared to none in the IM group. Two patients in each group developed
biopsy-proven acute rejection during follow-up.
Conclusions: Immunogenicity of the 2008/09 infl uenza vaccine was poor in lung
transplant recipients. ID administration of the vaccine elicited similar immune
responses to standard IM vaccination. Novel strategies of vaccination are needed
to protect lung transplant recipients from infl uenza.
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