Browsing by Author "Deborah Birx"

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    Country Level Diversity of the HIV-1 Pandemic between 1990 and 2015
    (2021-01-01) Joris Hemelaar; Shanghavie Loganathan; Ramyiadarsini Elangovan; Jason Yun; Leslie Dickson-Tetteh; Shona Kirtley; Alash’le G. Abimiku; Simon Agwale; Chris Archibald; Boaz Avidor; María Gabriela Barbás; Francoise Barre-Sinoussi; Banson Barugahare; El Hadj Belabbes; Silvia Bertagnolio; Deborah Birx; Aleksei F. Bobkov; James Brandful; Helba Bredell; Catherine A. Brennan; James Brooks; Marie Bruckova; Luigi Buonaguro; Franco Buonaguro; Stefano Buttò; Anne Buvé; Mary Campbell; Jean Carr; Alex Carrera; Manuel Gómez Carrillo; Connie Celum; Beth Chaplin; Macarthur Charles; Dimitrios Chatzidimitriou; Zhiwei Chen; Katsumi Chijiwa; David Cooper; Philip Cunningham; Anoumou Dagnra; Cillian F. de Gascun; Julia Del Amo; Elena Delgado; Ursula Dietrich; Dominic Dwyer; Dennis Ellenberger; Barbara Ensoli; Max Essex; Hervé Fleury; Peter N. Fonjungo; Vincent Foulongne; Deepak A. Gadkari; Feng Gao; Federico García; Roger Garsia; Guy Michel Gershy-Damet; Judith R. Glynn; Ruth Goodall; Zehava Grossman; Monick Lindenmeyer Guimarães; Beatrice Hahn; Raph L. Hamers; Osamah Hamouda; Ray Handema; Xiang He; Joshua Herbeck; David D. Ho; Africa Holguin; Mina Hosseinipour; Gillian Hunt; Masahiko Ito; Mohamed Ali Bel Hadj Kacem; Erin Kahle; Pontiano Kaleebu; Marcia Kalish; Adeeba Kamarulzaman; Chun Kang; Phyllis Kanki; Edward Karamov; Jean Claude Karasi; Kayitesi Kayitenkore; Tony Kelleher; Dwip Kitayaporn; Leondios G. Kostrikis; Claudia Kucherer; Claudia Lara; Thomas Leitner; Kirsi Liitsola; Jai Lingappa; Marek Linka; Ivette Lorenzana de Rivera; Vladimir Lukashov; Shlomo Maayan; Luzia Mayr; Francine McCutchan; Nicolas Meda; Elisabeth Menu; Fred Mhalu; Doreen Mloka; John L. Mokili; Brigitte Montes; Groupe d’étude Haïtien sur le Sarcome de Kaposi et les Infections Opportunistes; National Center for AIDS/STD Control and Prevention; Amsterdam Institute for Global Health and Development; Chinese Academy of Medical Sciences & Peking Union Medical College; Duke University Medical Center; Université de Bordeaux; Muhimbili University of Health and Allied Sciences; Universidad Nacional Autónoma de Honduras; University of Lome; Georg-Speyer-Haus; Centre MURAZ; Uganda Virus Research Institute; Uganda Ministry of Health; D.I. Ivanovsky Institute of Virology; N. F. Gamaleya Institute of Epidemiology and Microbiology, Ministry of Health of the Russian Federation; Institut Pasteur - Alger; Université de Tunis El Manar, Hôpital Charles Nicolle; Harvard T.H. Chan School of Public Health; Centre Hospitalier Universitaire de Montpellier; National Institute for Communicable Diseases; London School of Hygiene & Tropical Medicine; Vanderbilt University Medical Center; Universiti Malaya; Prins Leopold Instituut voor Tropische Geneeskunde; University of Washington School of Medicine; Universidad de Granada; Agence de la santé publique du Canada; The University of Edinburgh; Organisation Mondiale de la Santé; Rockefeller University; The Kirby Institute; Fundacao Oswaldo Cruz; St. Vincent's Hospital Sydney; The University of North Carolina at Chapel Hill; NYU Grossman School of Medicine; University College London; Kyushu University Hospital; Centers for Disease Control and Prevention; Hospital Ramon y Cajal; Karolinska Universitetssjukhuset; Royal Prince Alfred Hospital; University of Ghana; Istituto Nazionale Tumori IRCCS - Fondazione G Pascale, Napoli; Robert Koch Institut; Aristotle University of Thessaloniki; University of Maryland, Baltimore (UMB); HJF; Seoul National University; National Institute of Public Health Prague; Istituto Superiore Di Sanita; University of Yamanashi; Tel Aviv Sourasky Medical Center; University of Pennsylvania; Los Alamos National Laboratory; University College Dublin; Westmead Hospital; University of Oxford Medical Sciences Division; Universiteit van Amsterdam; Emory University School of Medicine; National AIDS Research Institute India; Israel Ministry of Health; Institut Pasteur, Paris; Abbott Laboratories; Instituto de Salud Carlos III; Universidad de Buenos Aires; University of Cape Town; Hadassah University Medical Centre; Office of the Global AIDS Coordinator; Gede Foundation; National Institute for Health; National Reference Laboratory; Ministerio de Salud; HIV/AIDS Collaboration
    The global diversity of HIV forms a major challenge to the development of an HIV vaccine, as well as diagnostic, drug resistance, and viral load assays, which are essential to reaching the UNAIDS 90:90:90 targets. We sought to determine country level HIV-1 diversity globally between 1990 and 2015. We assembled a global HIV-1 molecular epidemiology database through a systematic literature search and a global survey. We searched PubMed, EMBASE (Ovid), CINAHL (Ebscohost), and Global Health (Ovid) for HIV-1 subtyping studies published from 1 January 1990 to 31 December 2015. We collected additional unpublished data through a global survey of experts. Prevalence studies with original HIV-1 subtyping data collected between 1990 and 2015 were included. This resulted in a database with 383,519 subtyped HIV-1 samples from 116 countries over four time periods (1990 to 1999, 2000 to 2004, 2005 to 2009, and 2010 to 2015). We analyzed country-specific numbers of distinct HIV-1 subtypes, circulating recombinant forms (CRFs), and unique recombinant forms (URFs) in each time period. We also analyzed country-specific proportions of infections due to HIV-1 recombinants, CRFs, and URFs and calculated the Shannon diversity index for each country. Finally, we analyzed global temporal trends in each of these measures of HIV-1 diversity. We found extremely wide variation in complexity of country level HIV diversity around the world. Central African countries such as Chad, Democratic Republic of the Congo, Angola, and Republic of the Congo have the most diverse HIV epidemics. The number of distinct HIV-1 subtypes and recombinants was greatest in Western Europe (Spain and France) and North America (United States) (up to 39 distinct HIV-1 variants in Spain). The proportion of HIV-1 infections due to recombinants was highest in Southeast Asia (>95% of infections in Viet Nam, Cambodia, and Thailand), China, and West and Central Africa, mainly due to high proportions of CRF01_AE and CRF02_AG. Other CRFs played major roles (>75% of HIV-1 infections) in Estonia (CRF06_cpx), Iran (CRF35_AD), and Algeria (CRF06_cpx). The highest proportions of URFs (>30%) were found in Myanmar, Republic of the Congo, and Argentina. Global temporal analysis showed consistent increases over time in country level numbers of distinct HIV-1 variants and proportions of CRFs and URFs, leading to increases in country level HIV-1 diversity. Our study provides epidemiological evidence that the HIV pandemic is diversifying at country level and highlights the increasing challenge to prevention and treatment efforts. HIV-1 molecular epidemiological surveillance needs to be continued and improved. IMPORTANCE This is the first study to analyze global country level HIV-1 diversity from 1990 to 2015. We found extremely wide variation in complexity of country level HIV diversity around the world. Central African countries have the most diverse HIV epidemics. The number of distinct HIV-1 subtypes and recombinants was greatest in Western Europe and North America. The proportion of HIV-1 infections due to recombinants was highest in South-East Asia, China, and West and Central Africa. The highest proportions of URFs were found in Myanmar, Republic of the Congo, and Argentina. Our study provides epidemiological evidence that the HIV pandemic is diversifying at country level and highlights the increasing challenge to HIV vaccine development and diagnostic, drug resistance, and viral load assays.
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    Enhanced sensitivity of detection of cytotoxic T lymphocyte responses to HIV type 1 proteins using an extended in vitro stimulation period for measuring effector function in volunteers enrolled in an ALVAC-HIV phase I/II prime boost vaccine trial in Thailand
    (2004-06-01) Wannee Kantakamalakul; Mark De Souza; Chitraporn Karnasuta; Arthur Brown; Sanjay Gurunathan; Deborah Birx; Prasert Thongcharoen; The Taveg; Mahidol University; Armed Forces Research Institute of Medical Sciences, Thailand; Aventis; U.S. Military HIV Research Program; Thailand AIDS Vacc. Evaluation Group
    A phase I/II prime-boost vaccine trial in HIV-1-seronegative adults was conducted in Thailand using ALVAC-HIV (vCP1521) as a prime, boosting with either oligomeric gp160 TH023/LAI or Chiron HIV Thai subtype E (CM235) plus U.S. subtype B (SF2) gp120. Cytotoxic T lymphocyte (CTL) assays were conducted at one of the vaccine trial sites (Siriraj Hospital) at a single time point following the completion of immunization demonstrated that 8 of 50 (16%) vaccine recipients showed HIV-specific CTL by standard chromium release assay (CRA) after in vitro stimulation (IVS) for 2 weeks. Five additional vaccinees (13/50 = 26%) showed CTL responses after IVS for up to 4 weeks. Moreover, one volunteer with a positive CTL response to a single HIV antigen at Day 14 demonstrated a response to an additional HIV-1 antigen(s) after the longer IVS period. CTL activity was CD8+ restricted. Despite extension of the IVS up to 4 weeks, no CTL responses were detected in placebo recipients. These results imply that extension of the IVS period may increase the sensitivity of the CRA when measuring HIV-specific CTL in ALVAC-HIV prime-boost recipients without compromising specificity.
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    Executive summary and recommendations from the WHO/UNAIDS/IAVI expert group consultation on 'Phase IIB-TOC trials as a novel strategy for evaluation of preventive HIV vaccines', 31 January-2 February 2006, IAVI, New York, USA
    (2007-02-01) Jim Ackland; Susan Allen; Daniel Barth-Jones; Deborah Birx; Elwyn Chomba; Gavin Churchyard; Ann Duerr; Shuigao Jin; Margaret Johnston; Patricia E. Fast; Alan Fix; Mary Foulkes; Dean Follmann; Raymond Hutubessy; Siobhan Malone; Ronald Gray; Abhay Indrayan; Jonathan Levin; Bonnie J. Mathieson; Timothy D. Mastro; John McNeil; Saladin Osmanov; Punnee Pitisuttithum; Barry Peters; Etienne Karita; Michael N. Robertson; R. Ramakrishnan; Helen Rees; Wasima Rida; Yuhua Ruan; Eric Sandström; Claudia Schmidt; Peter Smith; Steven Self; Georges Thiry; Judith Wasserheit; Frances Priddy; Ibou Thior; Mitchell Warren; David Cooper; Pontiano Kaleebu; Ruth Macklin; Godfrey Tangwa; Global BioSolutions; Rollins School of Public Health; Wayne State University School of Medicine; Centers for Disease Control and Prevention; Zambia-UAB HIV Research Project; Ernest Oppenheimer Hospital; Scientific Support Unit; Chinese Center for Disease Control and Prevention; National Institute of Allergy and Infectious Diseases; International AIDS Vaccine Initiative; Food and Drug Administration; Organisation Mondiale de la Sante; Bill and Melinda Gates Foundation; Johns Hopkins Bloomberg School of Public Health; University College of Medical Sciences; South African Medical Research Council; OAR HIV/AIDS Vaccine Coordinating Committee; National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention; Mahidol University; Guy's and St Thomas' NHS Foundation Trust; Projet San Francisco Rwanda; Merck & Co., Inc.; National Institute of Epidemiology; University of Witwatersrand; Statistics Collaborative; Karolinska University Hospital; London School of Hygiene & Tropical Medicine; Statistical Center for HIV/AIDS Research and Prevention; IAVI; HIV Vaccine Trials Network; Emory University; Botswana Harvard AIDS Institute Partnership; AIDS Vaccine Advocacy Coalition; Kirby Institute; Uganda Virus Research Institute; Albert Einstein College of Medicine of Yeshiva University; Universite de Yaounde I
    This report summarizes the discussions and recommendations from a consultation held in New York City, USA (31 January-2 February 2006) organized by the joint World Health Organization-United Nations Programme on HIV/AIDS HIV Vaccine Initiative and the International AIDS Vaccine Initiative. The consultation discussed issues related to the design and implementation of phase IIB 'test of concept' trials (phase IIB-TOC), also referred to as 'proof of concept' trials, in evaluating candidate HIV vaccines and their implications for future approval and licensure. The results of a single phase IIB-TOC trial would not be expected to provide sufficient evidence of safety or efficacy required for licensure. In many instances, phase IIB-TOC trials may be undertaken relatively early in development, before manufacturing processes and capacity are developed sufficiently to distribute the vaccine on a large scale. However, experts at this meeting considered the pressure that could arise, particularly in regions hardest hit by AIDS, if a phase IIB-TOC trial showed high levels of efficacy. The group largely agreed that full-scale phase III trials would still be necessary to demonstrate that the vaccine candidate was safe and effective, but emphasized that governments and organizations conducting trials should consider these issues in advance. The recommendations from this meeting should be helpful for all organizations involved in HIV vaccine trials, in particular for the national regulatory authorities in assessing the utility of phase IIB-TOC trials in the overall HIV vaccine research and development process. © 2007 Lippincott Williams & Wilkins, Inc.
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    Safety and immunogenicity of an HIV subtype B and E prime-boost vaccine combination in HIV-negative Thai adults
    (2004-08-15) Sorachai Nitayaphan; Punnee Pitisuttithum; Chitraporn Karnasuta; Chirapa Eamsila; Mark De Souza; Patricia Morgan; Victoria Polonis; Michael Benenson; Tom VanCott; Silvia Ratto-Kim; Jerome Kim; Darawan Thapinta; Robin Garner; Valai Bussaratid; Pricha Singharaj; Raphaelle El Habib; Sanjay Gurunathan; William Heyward; Deborah Birx; John McNeil; Arthur E. Brown; Mahidol University; Chiang Mai University; Walter Reed Army Institute of Research; Sanofi Pasteur SA; VaxGen, Inc.; Armed Forces Research Institute of Medical Sciences, Thailand; Leahi Hospital; Tripler Regional Med Center; National Institute of Allergy and Infectious Diseases
    ALVAC-HIV (vCP1521) and AIDSVAX B/E were evaluated in a phase 1/2 trial of human immunodeficiency virus (HIV)-negative Thai adults. Of 133 volunteers enrolled, 122 completed the trial. There were no serious vaccine-related adverse events, nor were there intercurrent HIV infections. Lymphoproliferative responses to glycoprotein 120 E were induced in 63% of the volunteers, and HIV-specific CD8 cytotoxic T lymphocyte responses were induced in 24%. Antibody responses increased in frequency and magnitude in association with the dose level of AIDSVAX B/E. Binding and neutralizing antibodies to the MN strain were induced in 100% and 98%, respectively, of the volunteers receiving 600 μg of AIDSVAX B/E, and such antibodies to E strains were induced in 96% and 71%, respectively, of these volunteers. This vaccine combination was well tolerated and was immunogenic, meeting milestones for advancement to phase 3 evaluation.