Paper # 805LB 
Low Rate of Immunoresponse to the Novel Split Virion, Inactivated, Adjuvanted Pandemic H1N1 Influenza Vaccine in HIV-1-infected Patients
Markus Bickel*, I Wieters, N von Hentig, P Khaykin, G Nisius, A Haberl, C Stephan, H Doerr, H R Brodt, and R Allwinn
Goethe Univ Hosp, Frankfurt, Germany
Background: The objective of this study was to determine seroconversion
after a single dose of the novel split virion, inactivated, adjuvanted pandemic
H1N1 influenza vaccine (A/California/7/2009) in HIV-1 infected patients (ClinicalTrials.gov Identifier:
NCT01017172). Response rates in the general population are reported to be 79%
to 100% across all ages.
Methods:
Adult HIV-1 infected individuals scheduled for H1N1 vaccination where included.
Serum samples where taken before and 21 days after vaccination. Antibody titers
were determined by H1N1 hemagglutination inhibition
assay (HAI), clinical and HIV related data were extracted from the charts.
Seroconversion was defined by an HAI titer ≥1:40 and
a minimum 4-fold increase in antibody titer post vaccination.
Results: To
present, 160 patients (125 males/35 females) have received a single
vaccination. Before vaccination 23
patients (14.4%) had a HAI titer ≥1:40. At a median
of 22 days post vaccination, 110 (69%) patients had
seroconverted. Seroconverters were younger (45.1 vs
48.8 years; P =0.04), had a higher CD4 cell
count (532 vs 475 cells/µL; P =0.03) and had more often received a previous H5N1 vaccination in 2009 (25
vs 8 %; P =0.009) when compared to non-responders. No other
significant differences were found comparing the 2 groups (prevaccination HAI
titer ≥1:40, AIDS, HAART,
HIV RNA PCR <50 copies/mL, CD4 nadir, CD4 and CD8 percentage, sex, BMI,
chronic hepatitis B or C).
Conclusions:
Response rates to a split virion, inactivated,
adjuvanted pandemic H1N1 influenza vaccine of HIV
infected patients are lower as reported for the general population. Further
studies are needed to investigate whether a second dose will increase response
rates.
|
|
responder
|
non-responder
|
all patients
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p-value
|
|
n (%)
|
110 (69)
|
50 (31)
|
160 (100)
|
|
|
age (years, SD)
|
45.1 (10.0)
|
48.8 (11.3)
|
46.2 (10.5)
|
0.044
|
|
previous AIDS n (%)
|
27 (25)
|
13 (27)
|
40 (25)
|
0.815
|
|
duration of HIV infection (years, SD)
|
10.1 (7.5)
|
10.6 (6.8)
|
10.2 (7.3)
|
0.545
|
|
CD4 cell count (cells/µl, SD)
|
532 (227)
|
475 (281)
|
514 (246)
|
0.034
|
|
CD4 nadir (cells/µl,
SD)
|
162 (131)
|
157 (143)
|
160 (134)
|
0.701
|
|
HAART n (%)
|
100 (92)
|
43 (86)
|
143 (90)
|
0.276
|
|
HIV RNA PCR <50 c/ml n (%)
|
80 (73)
|
31 (62)
|
111 (70)
|
0.150
|
|
H5N1 vaccination in 2009 n (%)
|
27 (25)
|
4 (8)
|
31 (9)
|
0.009
|
|
seasonal influenza vaccination in 2009 n (%)
|
12 (11)
|
6 (12)
|
18 (11)
|
0.840
|
|
geometric mean HAI titer
before vaccination (95 % CI)
|
8.5 (7.1, 10.1)
|
9.6 (6.6, 14.0)
|
8.82 (7.5, 10.4)
|
0.719
|
|
geometric mean HAI titer
after vaccination (95 % CI)
|
205.9 (169.0, 250.1)
|
16.9 (11.6, 24.8)
|
94.3 (73.1,121.7)
|
<0.0001
|
|