Landmark Thai/U.S. study: HIV Vaccine Effective

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