AIDS Treatment News Issue #228, August 4, 1995
A trial at Beth Israel Hospital in Boston is seeking 18
volunteers for a trial of a new kind of treatment vaccine.
Volunteers must have a CD4 (T-helper) count over 500, no
antiretroviral use for six months prior to entering the
study, no use of immunosuppressive agents, and must be
asymptomatic and generally in good health, and not become
pregnant during the trial.
The vaccine is a peptide (small part of a protein) found in
HIV, attached to a lipid (fat) "tail"; it is made entirely by
chemistry, not from live HIV. This vaccine has been tested in
a few HIV-negative volunteers; it appeared to be safe, and it
caused the body to produce HIV-specific CD8 CTLs (cytotoxic T
lymphocytes) -- cells which may specifically kill some HIV-
infected cells. It is hoped that this vaccine may delay
progression of HIV disease -- but this is a theoretical
possibility which has not yet been proven.
There are two parts of this study. In part I, six volunteers
will receive one injection of either low dose vaccine, high
dose vaccine, or placebo, and the study will last 32 weeks.
In part II, other volunteers will receive up to three
injections, and the study will last 36 weeks. In both parts,
there is at least a two-thirds chance of getting vaccine
instead of placebo. Everyone will have physical exams,
various lab tests, and HLA typing (the tissue typing used for
organ transplants); those in part II will also have viral
load tests and measurements of CTL responses. For part II,
some but not all of the volunteers will need to have certain
specific HLA types to qualify.
The vaccine is being developed by United Biomedicals, Inc.,
of New York. The principal investigator of the study is
Norman L. Letvin, M.D. The official title of the study is
"HIV Lipopeptide Immunotherapeutic in HIV-1 Seropositive
Human Subjects." Participants will receive a small payment,
$20 per visit plus $5 for parking.
For more information, contact Joan Callery, R.N., at 617/667-