Effect of an oral therapeutic HIV-1 vaccine on AIDS patients with CD4 count above 250 cells/mm3.

摘要

A simple delivery route, e.g. oral, would greatly facilitate the acceptance of an AIDS vaccine by a large target population. We developed a vaccine that took advantage of inherent properties of mucosal immunity in response to oral antigen challenge, namely the V-1 Immunitor vaccine (V1), which is a polyvalent oral Human immunodeficiency virus 1 (HIV-1) vaccine. The vaccine, currently manufactured in Thailand, contains pooled, inactivated viral antigens. In order to compare this vaccine with HIV-1 therapeutic vaccines reported earlier we analyzed retrospectively 13 HIV-1-positive patients that had the baseline CD4 T-cell counts greater than 250 cells/mm3 (range 270-605 cells/mm3). The patients self-administered one 850 mg vaccine tablet at breakfast and dinnertime for an average of 32 weeks (median 26 weeks). The treatment was well tolerated without any toxic effect. Twelve of thirteen patients (92%) and 9 of 13 patients (69%) experienced an elevation in CD4 and CD8 cells. The mean increase in absolute CD4 and CD8 cell counts across this group was 98 (22%; P = 0.02) and 324 (26%; P = 0.05) cells/mm3, respectively. Viral plasma load was measured by PCR in six patients. The observed viremia reduction was within 1 log unit. Subjective parameters, i.e., appetite, energy, and sense of well-being were reported by patients as being markedly improved, reflected in a mean body weight gain of 2.75 kg (P = 0.0008). Oral administration of HIV-1 immunogens provides compelling clinical response, especially when patients are treated earlier.