@aides.watson.ibm.com@squid.cs.ucla.edu, , (09/19/90)
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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.
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Dan Greening 12 Foster Court NY (914) 784-7861
dgreen@cs.ucla.edu Croton-on-Hudson, NY 10520 CA (213) 825-2266