Absence of Clinical, Virological, and Immunological Signs of Progression in HIV-1-Infected Patients Receiving Active Anti-Interferon-α Immunization: A 30-Month Follow-Up Report

Publisher Website
Google Scholar
Abstract
Twenty-seven HIV-1-infected patients, 16 at early stage of disease and without concomitant antiretroviral therapy and 11 at more advanced stage of disease receiving antiretroviral therapy, have been followed since their enrollment, November 1992 and July 1993, respectively, in phase I/II studies to evaluate safety and immunogenicity of an anti-interferon-α (IFN-α) vaccine, aimed at modulating the impaired cytokine network in AIDS patients by counteracting IFN-α overproduction. We compared clinical, virological, and immunological markers of disease progression, including circulating IFN-α levels in a 24- to 30-month follow-up period with those of 62 patients fulfilling the same enrollment criteria and comparable for sex, risk factor, and age, regularly followed at our center. Anti-IFN-α immunization consisted of four-six intramuscular injections 1 month apart of a water-in-oil emulsion of 500 μg formalin-inactivated recombinant IFN-α-2b (iIFN-α) followed by intramuscular injections of 250 μg iIFN-α adsorbed onto calcium phosphate every 3 months. Neither clinical deterioration nor a CD4+ cell count decrease from pretreatment values was observed in IFN-α-immunized patients in the follow-up period, whereas clinical and immunological disease progressions were observed among open-comparison patients. Furthermore, statistical analysis showed a strong association between occurrence of clinical manifestations and high circulating IFN-α titers, while nonprogression of IFN-α-immunized patients was associated with decreased levels of circulating IFN-α.