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Cablegate: Landmark Thai/U.S. Study: Hiv Vaccine Effective

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UNCLAS SECTION 01 OF 05 BANGKOK 002437

C O R R E C T C O P Y - REMOVE REPEATED PARAS

SIPDIS

DEPT FOR OES/IHB and O/GAC
SECDEF PASS WALTER REED
OES PASS NIH

E.O. 12958: N/A
TAGS: TBIO KHIV EAID PREL TH
SUBJECT: Landmark Thai/U.S. study: HIV Vaccine Effective

REF: BANGKOK 611

BANGKOK 00002437 001.6 OF 005

1. SUMMARY: A groundbreaking, six-year, joint Thai/U.S. HIV vaccine
study found 31 percent efficacy in preventing HIV infection. The
study was the first ever to show that a vaccine can prevent HIV
infection, and the over 16,000 Thai volunteers made this the largest
HIV vaccine trial ever conducted. The Thai Minister of Public
Health and the Ambassador led a press conference on September 24 to
locally brief the media on the results. The trial, a "prime-boost"
investigation, used two vaccines, one of which was provided by a
U.S. firm. The U.S. Army Medical Component - Armed Forces Research
Institute of Medical Sciences (AFRIMS) helped the Royal Thai
Ministry of Public Health conduct the study. While more studies
need to be done, the safe and modestly effective results bring us a
step closer to an HIV vaccine. Thai/U.S. medical cooperation
continues to break ground in the global battle to fight infectious
disease. END SUMMARY.
2. COMMENT: An effective vaccine to prevent HIV infection is our
best hope for ending the AIDS pandemic. This study and its results
demonstrate the commitment by the Royal Thai Government, Mission
Bangkok, the U.S. Army, and USG medical agencies to develop a
globally effective HIV vaccine. Thailand has shown that it can
successfully complete a large scale and complex medical trial. With
USG partnership, Thailand is developing into a model as well as a
mentor for other nations and their public health systems. END
COMMENT.

THE STUDY, THE RESULTS: HIV VACCINE THAT WORKS
--------------------------------------------- -
3. In Thailand, the Phase III Human Immunodeficiency Virus (HIV)
vaccine trial (known as RV144), the largest HIV vaccine trial every
conducted, has been an international collaborative effort involving
more than 16,000 Thai volunteers and hundreds of scientists and
clinicians from Thailand, Europe and the United States. The trial
began in 2003 and ended this year in June; the data was then
analyzed by an independent firm. The results show that the vaccine
regimen studied was safe and 31.2 percent effective in preventing
HIV infection. This is the first time that an HIV vaccine candidate
has reduced the risk of HIV infection in humans.

AMBASSADOR AND HEALTH MINISTER ANNOUNCE RESULTS
--------------------------------------------- --
4. The Minister of Public Health, Witthaya Kaewparadai and the
Ambassador led a press conference on September 24 to locally brief
the media on the results. Their remarks were broadcast live on
Thailand's public television. Press questions focused on safety for
the volunteers and when the vaccine could be licensed in Thailand.
Questions also highlighted the AFRIMs/MoPH parallel investigation
(RV152) for those who became HIV positive during the study. After
the press conference, MoPH conducted a live video conference with
the volunteers in the two study provinces to answer questions from
the volunteer and community representatives. (NOTE: The U.S. Army
plans to hold a press conference on September 24 in the United
States to announce results of the HIV vaccine study there. End
Note.)

GLOBAL IMPLICATIONS
-------------------
5. The study's finding has important implications for the design of
future HIV vaccines and how they are tested. Although the modest
level of efficacy may not have immediate public health impact,
ultimately the decision to deploy a vaccine must be made by public
health officials and national authorities. Future studies will
build on this trial to test this vaccine regimen and others. The
collaborative efforts in this trial can also serve as a model of how

BANGKOK 00002437 002.6 OF 005


STUDY DETAILS
-------------
6. The study, begun in 2003 and ended in June 2009, was designed to
test two vaccines' ability to prevent HIV infection, as well as
reduce the amount of HIV in the blood of those who became infected
after they enrolled in the study. The "prime-boost" combination of
vaccines ALVAC HIV and AIDSVAX B/E lowered the rate of HIV infection
by 31.2 percent compared with a placebo. The prime boost vaccine
strategy combined two vaccines based on strains (subtypes) of HIV
that circulate in Thailand. The 31.2 percent efficacy rate was
derived from the fact that 74 of 8,198 placebo recipients became
infected with HIV as compared with 51 of 8,197 participants who
received the vaccine regimen. This level of effectiveness in
preventing HIV infection was found to be statistically significant
with a 95 percent confidence interval greater than zero. The
vaccine regimen had no effect on the amount of virus in the blood of
volunteers who became HIV-infected during the study.

AMERICAN VACCINE
----------------
7. The first or "prime" vaccine, known as ALVAC HIV, was developed
by Sanofi Pasteur, a French firm. The "boost" vaccine, AIDSVAX B/E,
was originally developed by VaxGen and is now licensed to Global
Solutions for Infectious Diseases (GSID, a not-for-profit
institution based in the United States).

THE PARTNERS
------------
8. The Royal Thai Ministry of Public Health (MoPH) conducted the
study. The U.S. Army Surgeon General was the study sponsor, with the
U.S. Military HIV Research Program (MHRP) providing overall project
leadership. The U.S. Army Medical Component - Armed Forces Research
Institute of Medical Sciences (AFRIMS) helped execute the trial in
Thailand on behalf of the sponsor. MHRP, centered at the Walter
Reed Army Institute of Research, is an international HIV vaccine
research program that integrates HIV/AIDS prevention, care and

BANGKOK 00002437 003.6 OF 005


THE VOLUNTEERS
--------------
9. There were over 60,000 Thais who showed interest in volunteering
for this study. The trial enrolled over 16,000 Thai volunteers who
were men and women, aged 18-30, who were not HIV positive at the
time the study began. The group was designed as a cross section of
varying risk categories of the communities in Thailand's Rayong and
Chon Buri provinces. Half received a placebo vaccine, the other
half the vaccine regimen. All were regularly tested and counseled
on how to prevent HIV infection. Volunteers who acquired HIV were
given access to medical care, including antiretroviral therapy based
on MoPH guidelines.

NEXT STEPS
----------
10. The focus of the U.S. and other sponsors and collaborators,
including the Thai MoPH, is now to pursue further development of the
vaccine regimen. Trial partners, along with outside experts, are
already working to determine next steps. The vaccines in this study
are based on HIV strains in Thailand; therefore, additional studies
would be needed for other HIV subtypes and risk groups. Other
studies would also likely investigate which immune responses are
associated with vaccine protection.

THAI- U.S. COOPERATION
----------------------
11. This successful vaccine trial is another example of the
long-standing, productive collaboration between U.S. and Thai
military and civilian scientists to conduct basic and applied
research on infectious diseases of global health and military
importance. Through such collaboration and other efforts, Mission
Bangkok remains on the cutting edge of HIV/AIDS activities. In line
with S/GAC Ambassador Goosby's new PEPFAR vision, the CDC and USAID

BANGKOK 00002437 004.6 OF 005


12. Mission Bangkok's collaboration has led to other HIV/AIDS
achievements, such as CDC work in the field of prevention of
HIV/AIDS transmission from mothers to children. CDC's Global AIDS
Program has provided key technical assistance to build MoPH capacity
to respond to the HIV/AIDS epidemic, and recently developed new
technical support programs in Laos and Papua New Guinea, working in
close partnership with AFRIMS, USAID's Regional Development Mission
Asia (RDMA) and WHO to complement existing USAID HIV programs.
RDMA's work with civil society partners in Thailand has a force
multiplying effect, providing the models for government partnering
with civil society HIV responses for prevention and treatment in
Laos, Burma, China and Papua New Guinea. USAID/RDMA supports key
treatment facilities such as the Mercy Center, visited by President
Bush in 2008, that provide education and home-based care to AIDS
victims in low-income communities. CDC's Division of HIV/AIDS
Prevention (DHAP) also has a long history of collaborative HIV/AIDS
research with Thai partners such as the Bangkok Metropolitan
Authority (BMA), Mahidol University, and VaxGen Inc. to conduct the
first phase III HIV vaccine trial in Asia. DHAP is currently working
with BMA and MOPH to conduct an HIV Pre-exposure Prophylaxis Study
using the antiretroviral drug, Tenofovir; results are expected in
2010 and could have important global implications for HIV prevention
in high risk populations.

LEVERAGING WITH THAILAND TO ASSIST OTHER NATIONS
--------------------------------------------- --
13. HIV/AIDS is only one of the Mission's top health-related
priorities. With over one-fifth of Mission Bangkok's staff of
roughly 2000 working on health issues, the Embassy hosts one of the
USG's largest efforts to fight the world's other most dangerous
diseases: malaria, TB, dengue fever and avian/pandemic influenza.
USAID, HHS/CDC, USDA/APHIS and AFRIMS collaborate with each other,
Thailand and other Asian nations. USG collaboration from Thailand

BANGKOK 00002437 005.6 OF 005


AFRIMS - Key USG Partner
------------------------
14. AFRIMS is a special foreign activity of the Walter Reed Army
Institute of Research and of the U.S. Army Medical Research and
Materiel Command. Over 50 years ago the U.S. Army identified the
Royal Thai Army Medical Department (RTAMD) as the ideal medical
collaborator in the region, and Thailand the ideal site for its
research. AFRIMS works in militarily-relevant infectious disease
research, with activities that include: conducting disease
surveillance and evaluating and testing new drugs, vaccines, and
diagnostic procedures. AFRIMS now has approximately 470 American
and Thai employees and contractors. Beyond HIV/AIDS and its
in-house research on diseases of military importance to U.S.
servicemen and women, AFRIMS conducts collaborative research with
Thai and international partners on malaria, dengue, Japanese
encephalitis, scrub typhus and other rickettsioses, diarrheal and
respiratory diseases. Partner nations include Cambodia, Bhutan,
Nepal, Philippines and Vietnam. AFRIMS assists RTAMD with health
surveillance in several Thai border regions and for the UN
peacekeeping forces that Thailand provides.

FURTHER INFORMATION
-------------------
15. For additional information on Mission Bangkok's health-related
activities, POC is Hal Howard, Regional Environment Science
Technology and Health (ESTH) officer, howardhh@state.gov. Websites
include www.hivresearch.org for the RV144 trial; for AFRIMS, see
http://www.afrims.org/ or http://www.afrims.go.th/.

JOHN

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