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Viewing cable 09BANGKOK2437, Landmark Thai/U.S. study: HIV Vaccine Effective

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Reference ID Created Released Classification Origin
09BANGKOK2437 2009-09-24 10:52 2011-08-25 00:00 UNCLASSIFIED Embassy Bangkok
VZCZCXRO5220
OO RUEHCHI RUEHDT RUEHHM RUEHNH
DE RUEHBK #2437/01 2671052
ZNR UUUUU ZZH
O 241052Z SEP 09 ZDS
FM AMEMBASSY BANGKOK
TO RUEHC/SECSTATE WASHDC IMMEDIATE 8379
INFO RUEHCHI/AMCONSUL CHIANG MAI 7033
RUEHUJA/AMEMBASSY ABUJA 0057
RUEHAB/AMEMBASSY ABIDJAN 0048
RUEHDS/AMEMBASSY ADDIS ABABA 0516
RUEHBJ/AMEMBASSY BEIJING 7498
RUEHDR/AMEMBASSY DAR ES SALAAM 0333
RUEHOR/AMEMBASSY GABORONE 0209
RUEHSB/AMEMBASSY HARARE 0028
RUEHKM/AMEMBASSY KAMPALA 0062
RUEHLGB/AMEMBASSY KIGALI 0005
RUEHLG/AMEMBASSY LILONGWE 0095
RUEHLS/AMEMBASSY LUSAKA 0026
RUEHTO/AMEMBASSY MAPUTO 0083
RUEHNR/AMEMBASSY NAIROBI 0324
RUEHNE/AMEMBASSY NEW DELHI 5792
RUEHTO/AMEMBASSY MAPUTO 0084
RUEHPF/AMEMBASSY PHNOM PENH 2941
RUEHPU/AMEMBASSY PORT AU PRINCE 0065
RUEHSA/AMEMBASSY PRETORIA 1354
RUEHWD/AMEMBASSY WINDHOEK 0015
RUCNASE/ASEAN MEMBER COLLECTIVE
RUEHPH/CDC ATLANTA GA
RUEAUSA/DEPT OF HHS WASHINGTON DC
RUEKJCS/SECDEF WASHINGTON DC
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