HVTN 505 Study HIV Vaccine Candidate Not Effective

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1 Subscribe Unsubscribe HVTN 505 Study HIV Vaccine Candidate Not Effective The National Institute of Allergy and Infectious Diseases (NIAID) and the HIV Vaccine Trials Network have announced there will be no further vaccinations of participants in the HVTN 505 study because the vaccine did not show efficacy. This means it did not work to prevent HIV infection nor reduce the amount of virus (viral load) in the blood among people in the study who became infected with HIV. Like every study that tests whether or not an experimental drug or vaccine will work, this study has been closely monitored by a group of experts called a Data Safety Monitoring Board (DSMB). This group of experts regularly reviews study information to make sure that the study remains safe for participants and is on track to answer its main research questions. The DSMB can see who is getting the vaccines and who is getting the placebo. At their regularly scheduled meeting on April 22, 2013, the HVTN 505 DSMB looked at the data from the study and compared the results in people who got the vaccine to results in people who got the placebo. The results showed that the vaccine did not prevent HIV infection. The vaccine also did not reduce the viral load in those who became infected with HIV. NIAID and the study leadership agreed with the DSMB s recommendation to stop vaccinations and moved quickly to implement this recommendation and provide participants with the information. Calendar of Upcoming Events and Awareness Days HIV Vaccine Awareness Day (HVAD) May 18 HVAD is an annual observance to recognize and thank the thousands of volunteers, community members, health professionals, and scientists who are working together to find a safe and effective HIV vaccine. It is also a day to educate our communities about the importance of preventive HIV vaccine research. HVAD is led by the National Institutes of Health s National Institute of Allergy and Infectious Diseases. Get more information. National Asian and Pacific Islander (API) HIV/AIDS Awareness Day May 19 First observed in 2005, National Asian and Pacific Islander HIV/AIDS Awareness Day is a day to break the silence about HIV/AIDS in Asian and Pacific Islander communities and encourage individuals to get tested for HIV. This year's theme is "Saving face can't make you safe. Talk about HIV for me, for you, for everyone." The Banyan Tree Project plans and implements this observance

2 The HVTN 505 study enrolled 2,504 volunteers (men who have sex with men and transgender people who have sex with men) at 21 sites in 19 U.S. cities. The data examined by the DSMB was gathered from 1,250 volunteers who received the investigational vaccine regimen and 1,244 volunteers who received the placebo. In the primary analysis (which was based on those participants enrolled long enough to have received all vaccinations) 27 HIV infections occurred among the vaccine recipients, and 21 HIV infections occurred among the placebo recipients. The number of HIV infections in the investigational vaccine group compared to those in the placebo group was not statistically significant. (Read the NIH Statement for more detailed information) Participants are being contacted by each research site to ensure they have the most up-to-date information. The HVTN would like to follow all participants for the planned five years to maximize the ability to explain what is now known, to continue to monitor participants safety, and to provide ongoing HIV testing and risk reduction counseling. Each participant will have an opportunity to learn if they received vaccine or placebo. Information learned from this follow-up will inform future efforts to develop a preventive HIV vaccine. The lack of efficacy of the vaccine regimen in HVTN 505 is a setback to all who are dedicated to the mission of finding a safe and effective HIV vaccine. However, it is only through clinical research that we will ultimately achieve this goal. The trial participants continue to be our heroes. They and the dedicated staff at the research sites must now find ways to renew their commitment in the light of this news. Together with NIAID, the HVTN and all the research site staff we will all continue to work toward our goal of finding an effective HIV vaccine. with support from the CDC. Articles of Interest AIDS Vaccine Moves One Step Closer to Realization as Scientists Find Antibody 'Roadmap' Go to article How Vaccines Have Changed Our World In One Graphic Go to article Resources Understanding the Clinical Research Process and Principles of Clinical Research HANC, Community Partners, and BTG Bridge are pleased to announce that the Spanish translation of the Understanding the Clinical Research Process and Principles of Clinical Research and The Role of a CAB and Principles of Community Involvement, Participants Guide and Power Point CAB training materials for crossnetwork use, are now available on the HANC website. NIH Statement on HVTN 505 NIH Questions and Answers on HVTN 505 April is National Minority Health Month This month-long observance is a time to raise awareness about health disparities affecting racial and ethnic minorities

3 groups in the United States. It is also a call to action to health professionals, local and national agencies, media, public officials and community leaders to focus their efforts on helping to reduce the lack of parity so that so that some populations are not so disproportionately affected by certain diseases such as HIV/AIDS. Despite significant milestones reached in biomedical HIV prevention research and today s availability of treatment and care, health disparities continue to manifest among minority groups as differences in rates of disease, health outcomes and access to healthcare. For example, racial and ethnic minorities accounted for almost 71% of the newly diagnosed cases of HIV infection in 2010 and 84% of children born with HIV infection belong to minority groups. These gaps must be closed. African-Americans represent approximately 13% of the U.S. population, yet the latest estimates show that they account for almost half (46%) of all HIV infections cases diagnosed in African-American men are 9.5 times more likely to die of AIDS than non-hispanic White men. African-American women are also impacted by this disease and are almost 20 times more likely to die from HIV/AIDS, as compared to non- Hispanic White women. According to the most recent data, AIDS is the third leading cause of death among African- American women and men between 35 and 44 years of age. Hispanics/Latinos living in the U.S. also continue to be disproportionately impacted by the HIV/AIDS epidemic. Despite representing just 16.7% of the population, Hispanics accounted for an estimated 20% of AIDS cases in Hispanics are almost three times more likely to be diagnosed with AIDS than Whites. Hispanic males were also 2.5 times more likely to die of AIDS than their non-hispanic White counterparts. Hispanic women were 3.8 times more likely to die from AIDS. Though the numbers are small, Native Indians are also disproportionately affected, and are 1.6 times as likely to have AIDS as Whites. For Asians and Pacific Islanders, HIV/AIDS is the ninth leading cause of death in men aged 25 to 34. As we continue to push forward toward an AIDS-free generation, the inclusion of racial and ethnic groups remains a fundamental priority for biomedical HIV prevention research, with studies that seek to acknowledge and address the cultural

4 sensitivities, needs, and epidemiological trends of people from all walks of life. Please visit our YouTube channel to view members of our communities sharing their experiences with biomedical HIV prevention research and their personal efforts to end AIDS. Other Network Updates THE HIV PREVENTION TRIALS NETWORK (HPTN) HPTN is sponsoring a special supplement to Journal of Acquired Immune Deficiency Syndromes (JAIDS) to be published in conjunction with the IAS 2013 Conference. The supplement titled, State of the ART HIV Prevention, will feature 22 manuscripts devoted to diverse aspects of HIV prevention with a critical analysis of science breakthroughs, promises and challenges. The supplement will be available online atwww.jaids.org and as of June 25, The supplement is funded by NIAID and Office of Global AIDS Coordinator. For more information, visit THE MICROBICIDE TRIALS NETWORK (MTN) MTN is partnering with BTGB to host Rectal Microbicides for HIV Prevention: A Transgender Update and Consultation on Sunday, May 19, 2013 in San Francisco, CA. The invitationonly consultation is a forum to engage transgender communities in biomedical HIV prevention research, discuss the rectal microbicides research landscape, and encourage greater involvement of transgender communities in rectal microbicide research moving forward. There will also be opportunities for in-depth discussions about various aspects of these efforts and strategies, and for attendees to provide input on continued efforts to build partnerships between communities and researchers. For more information, visit

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