GeoVax Labs,
Inc. an Atlanta based biotechnology company, announced
today excellent safety and
immunogenicity data from its full-dose HIV/AIDS
vaccine human trial which
began in September 2006.
This full-dose
trial is the second in a series of four Phase 1 human
trials designed to test
the safety and immunogenicity of the GeoVax
HIV/AIDS vaccines. Involving
36 participants of which 30 received vaccine
and 6 received placebo,
this trial protocol included vaccination with two
full-doses of GeoVax's DNA
vaccine to prime the immune response followed by
two full- doses of GeoVax's
MVA vaccine to boost the immune response.
GeoVax's DNA and MVA vaccines
express over 50% of the AIDS virus (HIV-1)
protein components in order
to stimulate a broad anti-HIV immune response.
The vaccines cannot cause
AIDS because they do not include complete virus.
A Phase 1 human trial, started
in April 2006, evaluated the delivery of
only 1/10th of the full
dosage and utilized the same vaccine regimen
evaluated in the full dose
trial.
From data
collected from the 26 participants who completed the trial,
the following positive conclusions
were observed:
-- GeoVax
HIV/AIDS vaccines, both DNA and MVA, continue to demonstrate
that they are quite safe
and immunogenic following the delivery of the four
full-doses (two of each
vaccine) used in the trial's protocol
-- The
full-dose regimen of GeoVax vaccines continues to be well
tolerated without any type
of reaction, mild or systemic, in the majority
of participants
-- CD4
T-cell and CD8 T-cell responses are very evident both in the
1/10th dose and full-dose
vaccine recipients
-- Antibody
responses to the envelope glycoprotein (Env) increased
following the fourth vaccination,
and were present in 88% of the full-dose
participants
-- Delivery
of the fourth vaccination increased the frequency and
magnitude of the CD8 T-cell
and Antibody responses
Two additional
Phase 1 human trials testing different vaccine regimens
started in June 2007 and
are currently in process. Planning of a large
Phase 2 trial is underway
and tentatively scheduled for a mid-2008 start.
"These
results extend the earlier positive results for both our full
and 1/10th dose groups to
a larger number of volunteers," says Dr. Harriet
Robinson, GeoVax Chief Scientific
Advisor. "They are extremely encouraging
and provide a strong foundation
for proceeding with phase 2 human testing."
The human
trials, testing GeoVax's HIV/AIDS vaccines, are conducted by
the HIV Vaccine Trials Network
(HVTN) based in Seattle, Washington. The
HVTN, funded and supported
by the National Institutes of Health (NIH), is
the largest worldwide clinical
trials program dedicated to the development
and testing of HIV/AIDS
vaccines. Preclinical work enabling the development
of the clinical evaluation
of GeoVax's DNA and MVA vaccines was funded by
the National Institute of
Allergy and Infectious Diseases of the US
National Institute of Health.
The NIH recently provided additional support
to GeoVax's vaccine development
program in the form of a $15 million IPCAVD
grant awarded in October
2007.
About
GeoVax Labs, Inc. (http://www.geovax.com)
GeoVax
Labs, Inc. is a biotechnology company, established to develop,
manufacture, license and
commercialize human vaccines for diseases caused
by HIV-1 (Human Immunodeficiency
Virus) and other infectious agents.
GeoVax's vaccine technology
is protected by 20 filed patent applications
and issued patents.
GeoVax
HIV/AIDS vaccines are designed to prevent development of
Acquired Immunodeficiency
Disease (AIDS), caused by the virus known as
HIV-1, by vaccinating individuals
prior to infection with the AIDS virus.
In addition, GeoVax AIDS
vaccines may be effective as therapeutics
(treatment of people infected
with AIDS virus). Studies evaluating these
vaccines in already HIV/AIDS
infected individuals are being planned.
GeoVax
DNA and Recombinant MVA HIV/AIDS vaccines:
-- Use
DNA vaccines to "prime" immune responses and MVA vaccines to
"boost" immune responses
against the AIDS virus
-- Vaccinate
against more than 50% of AIDS virus components and cannot
cause AIDS
-- Protected
22 of 23 (96%) non-human primates against the development
of AIDS for over 3 1/2 years
-- Are
manufactured & tested under GMP/GLP - EMEA (EU) and FDA
guidelines
-- Satisfactorily
completed earlier DNA HIV/AIDS vaccine Phase 1 human
trial
-- Are currently
being tested in 4 Human Trials. Two started in 2006,
two in summer 2007
-- Have been
demonstrated safe to date in human trials
-- Are demonstrating
positive immune responses against HIV in the
majority of vaccine recipients
-- Are in planning
stage for a larger Phase 2 human trial in 2008
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