Vaccine
Adjuvant in Immunocompromised Patients
Cornell Medical Center (Ithaca, New York)
and University of Wisconsin trials
Cornell Medical Center (Ithaca, New York) and University of
Wisconsin trials. The immunoenhancing effect of Zadaxin for
influenza vaccination was examined by Gravenstein et al at the
University of Wisconsin and Cornell Medical Center. (127)
| Patients and
protocol: |
| • |
9 elderly subjects (age
range 65 to 99 years) |
| • |
Subjects nonresponsive
to influenza vaccination 1 year earlier |
| • |
Initial administration
of influenza vaccine |
| • |
Subsequent biweekly Zadaxin (0.9 mg/m2)
injections for 5 weeks |
| Results: |
| • |
67% (6/9) of Zadaxin subjects
responded with high levels of anti-influenza antibodies |
| • |
10% typical response rate to revaccination
in elderly subjects |
 |
Figure 15.
Clinical response to influenza vaccination. There
was a lower incidence of influenza in subjects who received
8 doses of Zadaxin compared with placebo (6/100 [5.5%]
vs 21/110 [19%];
P = 0.002). (129) |
This trial was followed by a double-blind, randomized,placebo-controlled
study at the Wisconsin Veterans’ administration Medical
Center, Madison, conducted by the same group of researchers.
(128)
| Patients and
protocol: |
| • |
90 male veterans > 64
years of age |
| • |
Mean age 77.3 years |
| • |
Age range 65 to 99 years |
| • |
45 subjects randomized
to Zadaxin 0.9 mg/m2 SC BIW for 4 weeks following vaccination
IM with trivalent influenza vaccine |
| • |
45 subjects randomized
to placebo injections SC BIW for 4 weeks following vaccination
IM with trivalent influenza vaccine |
| • |
Groups were similar with
respect to age, underlying disease, and medications |
| • |
Effective immunization
defined as fourfold or greater rise in antibody titer
over 3 to 6 weeks as measured by ELISA |
| Results: |
| • |
69% (31/45) of Zadaxin
subjects effectively immunized |
| • |
52% (21/40) of placebo
subjects effectively immunized |
| • |
P = 0.023 |
| • |
Differences were greater
in subjects older than 77 years |
| • |
Relationship between antibody
levels and age (P < 0.039) |
| • |
Antibody levels declining
with age in placebo subjects |
| • |
Antibody levels remaining
stable with age in Zadaxin-treated subjects |
| • |
Antibody levels in Zadaxin-treated
older subjects comparable to levels in younger subjects |
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