Abstract

Safety of VSSP as immunopotentiator in cuban HIV/AIDS patients treated with antiretroviral

A. Trujillo¹, D. Abreu², R. Diaz¹, A. Rittoles¹, M.C. Godinez¹, R. Molina¹, Y. Borrero¹, Y. Bebelagua³, D. Garrido¹, T. Rojas¹, A. Urbino¹, T. Serrano¹, D. Cofat¹, O. Calderon¹, F. Nuñez¹, M. Leal¹, A. Gonzalez¹, M. Trueba², A. Carr³, R. Perez⁴, L.E. Fernandez³, J. Perez⁵

¹Tropical Medicine Institute Pedro Kouri (IPK), Clinical, Havana, Cuba, ²Tropical Medicine Institute Pedro Kouri (IPK), Pharmacy, Havana, Cuba, ³Center of Molecular Immunology, Vaccine, Havana, Cuba, ⁴Center of Molecular Immunology, Research Director, Havana, Cuba, ⁵Tropical Medicine Institute Pedro Kouri (IPK), Clinical Director, Havana, Cuba

Background: VSSP (very small sized proteoliposomes) is a new approach to enhance immune restoration and control HIV replication. Properties of VSSP as immunopotentiator have been reported. VSSP is a potent adjuvant for dendritic cells activation and Th1 differentiation. VSSP was obtained trough the incorporation of NAcGM3 (a strong immunosuppressive ganglioside) into the outer membrane protein complex of Neisseria meningitides (Nm). On the other hand, certain experimental evidences support the view that NAcGM3 and CXCR4 are components of a functional multi-molecular complex critical for HIV-1 entry.

Methods: 39 patients treated with intramuscular injections of VSSP, emulsified with Montanide ISA 51, were enrolled in a Phase I clinical trial. Two groups were conformed; patients in the first group initiated anti-retroviral therapy (lamivudine + stavudine + nevirapine) 3-6 months before starting VSSP treatment while in patients from the second group the Retroviral therapy and VSSP were concomitantly administered. The first five doses were injected every two weeks (induction phase) and the other six doses, monthly. Primary outcome was the clinical tolerance.

Results: After 12 weeks of treatment viral loads (VL) in 75 % of patients in the second group were not detectable (ND) (less than 500 copies/mL), while the same was just for 50 % of patients belonging to the first group. More than 45% of patients generated antibodies against the NAcGM3 ganglioside and main toxicities were: pain in the injection site, fever and cephalea, disappearing spontaneously or by antipyretic treatment. The frequency of events (classified according to WHO) was similar in both groups. All treated patients remained alive and/or free of new AIDS-defining events for a year.

Conclusions: Our findings support the safety of VSSP + antiretroviral treatment in HIV/AIDS patients

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