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Vaccine Adjuvant in Immunocompromised Patients

Immune senescence, a normal aging process, has been related to a gradual decline in thymus function and thymic hormone production. The lack of thymic hormones may contribute to the decline in immune function, particularly the T-cell component. (112-114) In the elderly, quantitative and qualitative analysis of a specific antibody response after vaccination has been shown to be compromised when compared with response in young subjects. (115,116)

Decreased antibody response to T-cell dependent antigens may be one factor that accounts for insufficient efficacy of certain vaccination programs (eg, influenza). Diminished antibody responses have also been reported in patients with end-stage renal disease. The evidence for impairment of cellmediated immunity in hemodialysis patients has been attributed to incompetence in T-cell–mediated immune responses. (117-121) Several studies have reported poor antibody response after hepatitis B vaccination in hemodialysis patients. (122-124)

Since Zadaxin can enhance T-cell-dependent specific antibody production, the addition of Zadaxin to vaccination programs for immunocompromised individuals should be effective. In vaccinated elderly individuals, in vitro influenza antibody synthesis was augmented with the addition of Zadaxin. (115) Enhancement of specific antibody responses to tetanus toxoid and sheep red blood cells also was observed by the in vivo administration of Zadaxin to older mice or mice immunosuppressed with cocaine. (125,126) These experimental data support that Zadaxin, when appropriately administered with a vaccine, can enhance immune function and enhance an antibody response in individuals with a compromised immune system.

Six clinical studies have been completed that evaluated the efficacy of Zadaxin as an adjuvant for influenza and hepatitis B antiviral vaccines in subjects immunocompromised due to age or hemodialysis. When compared with vaccine plus placebo, administration of Zadaxin in conjunction with vaccine increased and sustained the specific antibody response, increased protection against illness, and overcame previous lack of specific antibody response and age-associated decline in specific antibody response. The studies also show that Zadaxin is safe for administration to immunocompromised subjects, and no serious adverse effects were observed in any of the studies.

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