Follow-up of HIV Infected Patients Who Received a Therapeutic Anti-Tat Vaccination
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KeywordsPlacebo Infectious Disease Cancer Research High Serum Structure Treatment
Basic and epidemiological documentation as well as non human primate experimentation prompted us to develop anti Tat therapeutic vaccine based on Tat toxoid, a non toxic but immunogenic HIV-1 Tat derivative. Phase I trial conducted at the Hemophiliac Bonomi Center of Milan (Pr. Gringeri) in 1997–1998 and Phase I/II trial organized by Aventis Pasteur showed that the Tat toxoid immunogen adjuvanted with either Seppic oil (ISA51), DcChol or Alum was safe and immunogenic on patients under HAART or not. A structured treatment interruption study (STI) monitored according to EU guidelines was conducted at Brussels (Pr. Clumeck) on the 31 vaccinees who received either a DcChol adjuvanted Tat Toxoid (n = 12), a DcChol placebo (n = 8) or non adjuvanted Tat Toxoid (n = 11). Anti-Tat Ab responders (n = 9) exhibiting both high serum Ab titers (>10 pg/ml) and a serum anti-Tat neutralizing capacity at the end of the vaccine trial remained significantly HAART-free. By contrast in patients in whom HAART has been prescribed during STI, serum collected prior to treatment did not exercise anti-Tat neutralizing capacity.