@aides.watson.ibm.com@squid.cs.ucla.edu, , (09/19/90)
Received from a reader who wishes to remain anonymous (thank you): ----------------------------------------------------------------- The following is one abstract presented to the VI AIDS conference in San Francisco, CA during June 1990 by MicroGeneSys, Inc of West Haven, CT. The results described here are very encouraging. Phase I Trial Evaluating Recombinant GP160 as a Candidate AIDS Vaccine OBJECTIVE: To evaluate the safety and immunogenicity of recombinant gp160 in a dose-escalation study. METHODS: Recombinant gp160, produced in a baculovirus vector, was administered to groups of 15 men at the following doses: 10, 20, 40, 80, 160, 320, 640 and 1280 ug. Ten volunteers in each group received a booster at 1-month, and for the groups receiving 160 ug and higher, 6 in each group received a second booster at 6-months. Safety monitoring including CBC, blood chemistries, and immune function, including CD4 counts. Immunogenicity was evaluated by recombinant (r) and licensed (l) ELISA and Western blot (WB) assays as well as blastogenic responses to recombinant gp160. RESULTS: No significant toxicity attributable to the vaccine was seen. Following the 1-month booster, antibody responses were detected in the 640 (5/10) and 1280 ug (7/10) groups by WB and r- ELISA but not l-ELISA. Most volunteers developed a detectable antibody response following the 6-month booster: 20/21 in the 160 to 1280 ug groups had antibody responses detected by WB and 7/21 by l-ELISA. Strong bands to gp160, gp120 and gp41 were seen by WB and responses have persisted for at least 6-months in most volunteers. R-ELISA titers up to 1:25,000 have developed to date. Blastogenic responses to recombinant gp160 were seen at 80 ug or higher. CONCLUSIONS: Recombinant gp160 is safe at doses that can achieve both antibody and blastogenic responses to HIV. Further evalua- tions of sera, including determination of neutralizing activity and antibody-dependent cellular cytotoxicity, are being performed to determine the role of vaccine-induced immune responses in protecting against HIV infection. -- Dan Greening 12 Foster Court NY (914) 784-7861 dgreen@cs.ucla.edu Croton-on-Hudson, NY 10520 CA (213) 825-2266