Purpose: To evaluate the safety and efficacy of an orally available, therapeutic HIV vaccine (V-1 Immunitor) in patients who were not treated with antiviral drugs.
Method: All entrants who had been tested at least once at entry and at postimmunization were considered for analysis. Main endpoints were vaccine safety and differential effects on CD4 and CD8 cell counts, plasma HIV RNA levels, and body weight change. Forty patients, 21 females (52%) and 19 males (48%), aged 22-65 years (mean/median age, 35/32 years) with a mean 225/mm3 CD4 cells at baseline were retrospectively analyzed. Patients self-administered two 850-mg pills containing inactivated HIV-1 antigens b.i.d. for 27 weeks (median, 24 weeks).
Results: The treatment was well tolerated without significant adverse effects. The mean body weight gain was 2.2 kg (p =.0004). The mean increase in absolute CD4 and CD8 cells was 51 (18%; p =.0088) and 172 (16%; p =.0199) cells/mm3. Viral load was measured by polymerase chain reaction (PCR) in 8 individuals; although overall decrease did not reach standard cut-off statistical significance (Friedman p =.0588), the trend in reduction of viremia attributable to vaccine administration was highly significant (Spearman correlation test: r = 0.96, p =.0005).
Conclusion: Mucosal delivery of HIV antigens provides compelling results and deserves further evaluation in placebo-controlled clinical trials.