Africa's First Large-Scale HIV Vaccine Study Launches

The launch of the first large-scale
study to evaluate a candidate HIV vaccine on the African continent was
announced today by study collaborators in the United States and South
Africa. The trial will involve up to 3,000 participants at five sites
throughout South Africa and is expected to continue for four years.


The sites are part of the HIV Vaccine Trials Network (HVTN), which is
headquartered at Fred Hutchinson Cancer Research Center in Seattle and
supported through a cooperative agreement with the National Institute of
Allergy and Infectious Diseases of the National Institutes of Health. The
trial sites also receive funding from the South African AIDS Vaccine
Initiative.



"This trial will answer several major scientific issues that face all
of us in the field of HIV-vaccine development," said Lawrence Corey, M.D.,
principal investigator of the HVTN and a member of the Hutchinson Center's
Clinical Research Division. "It will determine the usefulness of vaccines
that induce high immune response to the parts of the virus that are similar
between different strains of HIV-1."



The study is known as a phase IIb or "test of concept" efficacy trial
because it enables researchers to determine whether the test vaccine
prevents HIV infection, results in lower HIV levels in those who become
infected after vaccination or both. In addition, investigators for the
South Africa vaccine trial will determine if this vaccine, which is based
on clade B HIV, has the potential to protect against the clade C virus, the
subtype prevalent in South Africa. Phase IIb trials cannot be used to
support licensure of a vaccine, however, the data from this study will
guide whether this type of vaccine approach offers promise to interrupt the
continued spread of HIV.



Additionally, the South African study is likely to provide important
new data on how the test vaccine might work in a predominantly heterosexual
HIV epidemic, how well the vaccine works in women, and whether the vaccine
works in populations with pre-existing immunity to the viral vector used in
the vaccine, according to Corey, who is also head of the Infectious
Diseases Program and Virology Division at the University of Washington
School of Medicine.



"South Africa is an excellent location for this trial due to the high
levels of infection coupled with the good clinical infrastructure,
including internationally recognized immunology laboratories, a
well-established national vaccine initiative and experience in running
clinical trials," said James Kublin, M.D., M.P.H., one of study's lead
investigators, along with Glenda Gray, MBBCH, FCPaeds (SA), of the
Perinatal HIV Research Unit, University of the Witwatersrand, based at the
Chris Hani Baragwanath Hospital in Soweto. "Community involvement and
education initiatives in South Africa are robust and mature, and they are
essential for running trials involving thousands of volunteers," said
Kublin, who is a staff physician in the Hutchinson Center's Clinical
Research Division and a clinical associate professor of health services at
the University of Washington School of Public Health and Community
Medicine.
















The test vaccine, known as the MRKAd5 HIV-1 trivalent vaccine, is
manufactured by Merck & Co., Inc. and already has been studied for several
years in phase I and II trials involving thousands of volunteers in the
Americas, Africa and Australia to evaluate safety and immune responses. In
those previous trials this vaccine was found to be safe and to stimulate
cellular immune responses against HIV in more than half of volunteers.



Merck Research Laboratories developed the test vaccine that is based on
an adenovirus -- a common cold virus that has been modified so that it
cannot cause a cold in humans or be passed from person to person. The
adenovirus is the carrier or vector which transports copies of three HIV
genes called gag, pol and nef. The vaccine is made in the laboratory and
does not contain live HIV. The test vaccine therefore cannot cause
infection.



The hope is that these HIV genes will produce a cellular immune
response to HIV and cause the body to make killer cells that are programmed
to recognize and destroy cells that are infected with HIV. The studies
already completed with this vaccine suggest that it is generally well
tolerated and that the response of the immune system or immunogenicity is
high.



In South Africa, the vaccine trial is called "Phambili," which means
"moving forward" in the Xhosa language. Volunteers will be healthy HIV
negative males and females, aged 18 to 35 years, who are sexually active
and not pregnant.



The trial design will compare the test vaccine to a placebo (a harmless
substance) and, to eliminate bias, neither volunteers nor researchers will
know who receives the vaccine and who receives the placebo. The trial will
last about four years. The trial has been approved by the South African
Medicines Control Council and the South African Department of Agriculture,
and has been reviewed by the US Food and Drug Administration. Approval has
also been given or is pending by institutional ethics and bio-safety
committees at all the trial sites. In addition, there will be an
independent Data and Safety Monitoring Board, a group of independent
experts, not affiliated with Merck and Co. Inc, the HVTN, or the clinical
trial investigators, who will carefully monitor the safety of the trial
participants.



A cornerstone of this vaccine trial is a commitment to the highest
level of preventive care for all participants. To meet this commitment, all
participants will receive extensive, state-of-the-art risk-reduction
counseling on a regular basis throughout the study, and high-quality male
and female condoms will be provided to participants. Participants also will
be provided access to treatment for any sexually transmitted infection
acquired during the study. Recent research has shown that men who are
circumcised are less likely to become HIV infected when they have sexual
relations with women. As a result, access to medical circumcision also will
be provided to male participants who choose to undergo the procedure.



At Fred Hutchinson Cancer Research Center, our interdisciplinary teams
of world-renowned scientists and humanitarians work together to prevent,
diagnose and treat cancer, HIV/AIDS and other diseases. Our researchers,
including three Nobel laureates, bring a relentless pursuit and passion for
health, knowledge and hope to their work and to the world. For more
information, please visit fhcrc.



The HIV Vaccine Trials Network is an international collaboration of
scientists and institutions whose goal is to accelerate the search for an
HIV vaccine by sharing trial results and facilitating parallel, concurrent
testing. The HVTN is a unique hybrid that combines the depth and diversity
of the academic community and the flexibility of a commercial drug company.
Working with industry and government, the HVTN seeks to expedite and
coordinate the trial process, advancing vaccine candidates and building a
body of knowledge around HIV vaccine trials. The HVTN is funded and
supported by the NIAID of the NIH, an agency of the U.S. Department of
Health and Human Services (DHHS). The HVTN comprises more than 25 research
institutions worldwide, coordinated from its headquarters at the Fred
Hutchinson Cancer Research Center in Seattle.


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