PHASE-I SAFETY AND ANTIGENICITY OF TA-GW - A RECOMBINANT HPV6 L2E7 VACCINE FOR THE TREATMENT OF GENITAL WARTS

A phase I double-blind, randomized, placebo-controlled study was carri ed out in healthy subjects to assess the safety and immunogenicity of TA-GW, a recombinant HPV6 L2E7 fusion protein vaccine for the treatmen t of genital warts. Forty-two healthy male volunteers were randomised to receive three intramuscular injections of either 0, 3, 30 or 300 mu g of recombinant L2E7 adsorbed onto Alhydrogel(R). Two vaccination sc hedules were compared: weeks 0, 1 and 3 (accelerated schedule) and wee ks 0, 4 and 8 (classical schedule). Subjects were monitored for advers e events throughout. immunogenicity was assessed by measuring L2E7 spe cific in vitro T cell proliferative responses, production of IFN gamma and IL-5 and serum antibodies. Dose-dependent and long-lived T and B cell immune responses were elicited by TA-GW with both vaccination sch edules. In conclusion: TA-GW is both safe, well-tolerated and immunoge nic. The results allow the selection of the 300-mu g vaccine formulati on and accelerated vaccination schedule for phase II trials in patient s with genital warts. (C) 1998 Elsevier Science Ltd. All rights reserv ed.