Manufacturer : The Immune Response Corporation San Diego, CA, USA

PRODUCT DESCRIPTION:

REMUNE^® is derived from Zairian HIV-1 strain HZ-321, composed of gp 120-depleted HIV-1 propagated in HUT-78 cells and inactivated in beta-propiolactone and irradiation. The inactivated material is emulsified with mineral oil (Incomplete Freund's Adjuvant) at 1:1 ratio. Each 1 ml dose (at least 100μg or 10 units) has viral protein and p24.

POTENTIAL BENEFITS OF THIS TECHNOLOGY:

Administration of inactivated virus may stimulate humoral and cellular immune responses, which may slow the replication of HIV-1 through increased immunologic control over infected cells or other as yet undetermined mechanisms. The use of inactivated virus could theoretically stimulate broader immune responses that are capable of suppressing more diverse strains of HIV than vaccines based on sub-units of the virus.

PAST USA TRIAL RESULTS:

These previous clinical studies of REMUNE^® have demonstrated distinct benefits in both immunologic and virologic parameters in HIV-1 infected individuals undergoing treatment. Subjects undergoing treatment with REMUNE^® showed improvements in percentage of CD4 cells, HIV-1 DNA in PBMCs, and weight. An augmentation of cellular immune responses has also been demonstrated, as measured by lymphocyte proliferation to HIV-1 and p24 antigens, as well as greater DTH reactivity to HIV-1 antigen. HIV-1 DTH reactivity in immunized subjects has also been shown to correlate with a more favorable clinical course. Previous studies also indicate that REMUNE^® can safely be given in combination with antiviral drugs.