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Adverse Reactions to HIV Vaccines: Medical, Ethical, and Legal Issues
Adverse Reactions to HIV Vaccines: Medical, Ethical, and Legal Issues September 1995 OTA-BP-H-163 GPO stock #052-003-01429-7 Recommended Citation: U.S. Congress, Office of Technology Assessment, Adverse Reactions to HIV Vaccines: Medical, Ethical, and Legal Issues, OTA-BP-H-163 (Washington, DC: U.S. Government Printing Office, September 1995). oreword IDS researchers are investigating new vaccines that would prevent infection with HIV and reduce the spread of AIDS. Some have argued that product liabil- ity concerns have discouraged investment in HIV vaccine research and devel- opment. The purpose of this OTA background paper is to describe the current state of development of HIV vaccines, and to discuss what is known about adverse reac- tions that may occur. The background paper provides an overview of ethical issues that arise in the conduct of HIV vaccine trials. The report also discusses alternatives to the current product liability system to encourage the development of HIV vaccines and to fairly compensate those who are harmed as a result of adverse reactions to the vaccine. This background paper was prepared in response to a request from the Subcommittee on Health of the House Ways and Means Committee. It is eleventh in OTA’s series of studies on HIV-related issues. The preceding papers in this series were: Do Insects Transmit AIDS? (9/87), AIDS and Health Insurance: An OTA Survey (2/88), How Effective is AIDS Education? (6/88), The Impact of AIDS on the Kaiser Permanente Medical Care Program (Northern California Region) (7/88), How Has Federal Research on AIDS/HIV Disease Contributed to Other Fields? (4/90), The Effectiveness of Drug Abuse Treatment: Implications for Controlling AIDS/HIV Infection (9/90), HIV in the Health Care Workplace (11/91), The CDC’s Case Definition of AIDS: Implications of the Proposed Revisions (8/92), Difficult-to-reuse Needles for the Prevention of HIV Infection Among Injecting Drug Abusers (10/92), and External Review of the Federal Centers for Disease Control and Prevention’s HIV Prevention Programs (9/94). -
Coversheet for Thesis in Sussex Research Online
A University of Sussex DPhil thesis Available online via Sussex Research Online: http://eprints.sussex.ac.uk/ This thesis is protected by copyright which belongs to the author. This thesis cannot be reproduced or quoted extensively from without first obtaining permission in writing from the Author The content must not be changed in any way or sold commercially in any format or medium without the formal permission of the Author When referring to this work, full bibliographic details including the author, title, awarding institution and date of the thesis must be given Please visit Sussex Research Online for more information and further details Knowledge Accumulation and Vaccine Innovation: Lessons from Polio and HIV/AIDS Ohid Yaqub Doctor of Philosophy University of Sussex Submitted in September 2008 ii I hereby declare that this thesis has not been submitted, either in the same or different form, to this or any other university for a degree. Ohid Yaqub iii To my parents and Corinne, Two worlds that should not be separate. iv ACKNOWLEDGEMENTS This thesis was funded by the Economic and Social Research Council and supervised by Paul Nightingale. Paul is a supervisor who is extremely generous with his time, ideas and encouragement; and who manages to make academia look extremely fun. His energy and enthusiasm were most important to me when I really thought the ship was sinking. I cannot thank him enough and feel privileged to have worked with him. My first opportunity to pursue some of the ideas in this thesis was under the supervision of Ed Steinmueller and Aldo Geuna. -
Republic of ARMENIA Country Profile
Anush PERIKHANYAN MPH Yerevan State Medical University Department of Public Health Republic of ARMENIA Country profile http://www.who.int/countries/arm/en/ 1 Armenia - a lower-middle income country 3-5% (officially)prevalence of HCV among the general population (2013). HCV in 3rd highest rate in CIS countries (Georgia 6.7% Armenia/CIS and Uzbekistan 6.5%) Hepatitis C in Armenia- 44% have HCV genotype 1 37% have genotype 3 19% have genotype 2 Maistat L., Golovin S., Deineka O. and T, Khan. Hepatitis C in Eastern Europe and Central Asiа: Civil Society Respone to the Epidemics; 2015. http://www.aidsalliance.org.ua/ru/news/pdf/28.10.2015/EECA%20HCV%20EN.pdf. Accessed November 9, 2015 injecting drug users imprisoned persons patients getting hemodialysis commercial sex workers patients with tuberculosis healthcare workers oncological patients healthy population 70% HCV among 60% different groups is: people who inject drugs; 50% people who use intranasal drugs; recipients of infected blood products or 40% invasive procedures in health-care facilities with inadequate infection control practices ; children born to mothers infected with HCV ; 30% people with sexual partners who are HCV- infected; 20% people with HIV infection; prisoners or previously incarcerated persons; 10% people who have had tattoos or piercings 0% 1 2 In 2015 effective N3691 order-A “Methodological guideline for epidemiological management of viral Management hepatitis B, C”. of Hepatitis C The epidemiological control of viral hepatitis C is done by the National Center for Disease Control of the in Armenia Republic of Armenia (NCDC), which provides methodological management of prevention and regular control activities of HCV. -
Qualitative Study to Explore the Knowledge and Attitude of Pregnant Women Regarding HIV/AIDS Testing in Kotayk Region and in Yerevan, Armenia
Qualitative study to explore the knowledge and attitude of pregnant women regarding HIV/AIDS testing in Kotayk region and in Yerevan, Armenia Utilizing Professional Publication Framework Henrik Khachatryan, MD, MPH candidate, American University of Armenia Primary Adviser: M. Thompson, MS, DrPH Secondary Adviser: K. White, RN, PhD, CNAA October 2005 Table of Contents INTRODUCTION ...........................................................................................................................................................1 Background Information and Literature review....................................................................................................1 Rationale for the Research and Research Questions.............................................................................................4 METHODS AND MATERIALS........................................................................................................................................5 Study design...........................................................................................................................................................5 Study population ....................................................................................................................................................5 Sampling and Study Setting...................................................................................................................................6 Data collection Instrument.....................................................................................................................................6 -
CURRICULUM VITAE Updated on Jan 24, 2020
T. Davtyan, Armenia CURRICULUM VITAE Updated on Jan 24, 2020 Surname Davtyan First name(s) Tigran Affiliation and official address Rhea Pharmaceutical Armenia LLC Armenia, 0084, Yerevan Gusan Sherami St., 2 Building (Malatia-Sebastia adm. district) Republic of Armenia Tel.: (+374-) 91 400994, 98-55-96-29 E-mail: [email protected] [email protected] Present Positions: Professor, Chief Scientist Rhea Pharmaceutical Armenia LLC Home address: Michurin str. 5, 23, 375041, Yerevan, Republic of Armenia. Tel: +374 10 55-96-29 Date and Place of birth: 1 December, 1966, Yerevan, Armenia Nationality: Armenian Citizenship: Republic of Armenia Passport ARM, AH0248176, 24 OCT 2006, 009 ID № 1112660259 Marital status: Married, has 2 children, 3 grandchild Education (degrees, dates, universities) 2016 Professor. Field: Biology 2003 Doctor of Biological Sciences (ScD). Field: Molecular Biology 1993 Candidate of Biological Sciences (Ph.D); Field :Genetics and Immunology 1989-1992 Ph.D. student, Laboratory of Genetic Mechanisms of Cell Malignization And Differentiation, Institute of Cytology, St. Petersburg, Russia. 1983-1988 Yerevan State Medical University, Faculty of Pharmacy Specialization (specify) Drug Design and quality control, HIV/AIDS and clinical immunology; Viral infections; immunity and stress resistance; Molecular mechanisms and Genetic regulation of innate immune response; Autoinflammation; 1 T. Davtyan, Armenia Career/Employment (employers, positions and dates) 2011- 2019 Director of Analytical Laboratory of Scientific Centre of Drug and Medical Thechnology Experttise JSC 1999 - 2011 Head of HIV-Clinical Trail Laboratory of the ARMENICUM Research Center, Yerevan, Rep. of Armenia. 1998 - 2006 Consultant on Science, Laboratory of Immunology, The Second Clinical Hospital of the Yerevan State Medical University, Rep. -
A Review on Prevention and Treatment of Aids
Pharmacy & Pharmacology International Journal Review Article Open Access A Review on prevention and treatment of aids Abstract Volume 5 Issue 1 - 2017 Human immunodeficiency virus (HIV) is a retrovirus which causes acquired immune Chinmaya keshari sahoo,1 Nalini kanta deficiency syndrome (AIDS) a condition where CD4+ cell count falls below 200 cells/ Sahoo,2 Surepalli Ram Mohan Rao,3 Muvvala µl and immune system begins to fail in humans leading to life threatening infections. 4 Many factors are associated with the sexual transmission of HIV causing AIDS. HIV Sudhakar 1 is transmitted by three main routes sexual contact, exposure to infected body fluids or Department of Pharmaceutics, Osmania University College of Technology, India tissues and from mother to child during pregnancy, delivery or breast feeding (vertical 2Department of Pharmaceutical Analysis and Quality assurance, transmission). Hence the efforts for prevention and control of HIV have to rely largely MNR College of Pharmacy, India on sexually transmitted disease (STD) control measures and AIDS. In the developing 3Mekelle University, Ethiopia countries both prevalence and incidence of AIDS are very high. The impact of AIDS 4Department of pharmaceutics, Malla Reddy College of on women’s health adversely affected by various reasons such as more susceptibility Pharmacy, India than men, asymptomatic nature of infection etc. The management of AIDS can be controlled by antiretroviral therapy, opportunistic infections and alternative medicine. Correspondence: Chinmaya keshari sahoo, Department of In present study is an update on origins of HIV, stages of HIV infection, transmission, Pharmaceutics, Osmania University College of Technology, India, diagnosis, prevention and management of AIDS. Email [email protected] Keywords: aids, HIV cd4+, vertical transmission, antiretroviral therapy Received: November 18, 2016 | Published: February 08, 2017 Abbreviations: HIV, human immunodeficiency virus; AIDS, bodily fluids such as saliva and tears do not transmit HIV. -
Lessons from Viral Superinfections for HIV-1 Vaccine Design Stephanie Jost* Ragon Institute of MGH, MIT and Harvard, USA
C S & lini ID ca A l f R o e l s Journal of a e n a r r Jost, J AIDS Clinic Res 2013, S3 c u h o J DOI: 10.4172/2155-6113.S3-005 ISSN: 2155-6113 AIDS & Clinical Research Review Article Open Access Lessons from Viral Superinfections for HIV-1 Vaccine Design Stephanie Jost* Ragon Institute of MGH, MIT and Harvard, USA Abstract Superinfection refers to a second viral infection in the context of a pre-existing adaptive immune response to prior infection with a viral strain that has not been cleared, the two viruses being genetically distinct yet belonging to the same genus. As such, this phenomenon provides unique settings to gain insights into the immune correlates of protection against HIV-1. The focus of this review is to discuss the current knowledge about immune responses to HIV-1 and to other viruses that are associated with partial or complete immunity to superinfection, or lack thereof, and how that could be applied to future HIV-1 vaccine strategies. Keywords: HIV-1; Superinfection; Vaccine; Co-infection; Viral HIV-1 Rapid Evolution and Diversity: A Challenge for infection; Recombination Vaccine Design Introduction The extremely rapid evolution of the virus probably largely contributed to the failure or limited success of HIV-1 vaccines evaluated The human immunodeficiency virus type 1 (HIV-1) affects 34 to date [5]. HIV-1’s extensive genetic diversity was first brought to light million adults and children worldwide, and the ongoing spread of the around 1983, when full-length sequences of the virus became available, epidemic resulted in about 2.5 million new infections and 1.7 million and has since then expanded [6]. -
Hypervariable Region 3 Residues of HIV Type 1 Gp120 Involved in CCR5 Coreceptor Utilization: Therapeutic and Prophylactic Implications
Proc. Natl. Acad. Sci. USA Vol. 96, pp. 4558–4562, April 1999 Medical Sciences Hypervariable region 3 residues of HIV type 1 gp120 involved in CCR5 coreceptor utilization: Therapeutic and prophylactic implications WEI-KUNG WANG,TIM DUDEK,MAX ESSEX, AND TUN-HOU LEE* Department of Immunology and Infectious Diseases, Harvard School of Public Health, 651 Huntington Avenue, Boston, MA 02115 Communicated by Elkan R. Blout, Harvard Medical School, Cambridge, MA, February 17, 1999 (received for review November 2, 1998) ABSTRACT Crystallographic characterization of a ter- The coreceptor binding step of the HIV-1 life cycle is a nary complex containing a monomeric gp120 core, parts of potential target for therapeutic and prophylactic interventions. CD4, and a mAb, revealed a region that bridges the inner and To design intervention strategies targeting this critical step of outer domains of gp120. In a related genetic study, several HIV-1 entry requires knowing how V3 works in concert with residues conserved among primate lentiviruses were found to those residues in the bridging sheet to interact with CCR5, the play important roles in CC-chemokine receptor 5 (CCR5) chemokine coreceptor most often used by the so-called R5 coreceptor utilization, and all but one were mapped to the viruses of human and nonhuman primate lentiviruses (15, 16). bridging domain. To reconcile this finding with previous To that end, it is essential to provide a full account of V3 reports that the hypervariable region 3 (V3) of gp120 plays an residues involved in CCR5 utilization. In this study, we iden- important role in chemokine coreceptor utilization, elucidat- tified several V3 residues, both highly conserved and variable ing the roles of various V3 residues in this critical part of the ones, that were shown to play a role in CCR5 utilization. -
Sexually Transmitted Diseases Treatment Guidelines, 2015
Morbidity and Mortality Weekly Report Recommendations and Reports / Vol. 64 / No. 3 June 5, 2015 Sexually Transmitted Diseases Treatment Guidelines, 2015 U.S. Department of Health and Human Services Centers for Disease Control and Prevention Recommendations and Reports CONTENTS CONTENTS (Continued) Introduction ............................................................................................................1 Gonococcal Infections ...................................................................................... 60 Methods ....................................................................................................................1 Diseases Characterized by Vaginal Discharge .......................................... 69 Clinical Prevention Guidance ............................................................................2 Bacterial Vaginosis .......................................................................................... 69 Special Populations ..............................................................................................9 Trichomoniasis ................................................................................................. 72 Emerging Issues .................................................................................................. 17 Vulvovaginal Candidiasis ............................................................................. 75 Hepatitis C ......................................................................................................... 17 Pelvic Inflammatory -
Developing a Vaccine Against HIV Infection
Developing a vaccine against HIV infection KEY POINTS Researchers have been working on an HIV vaccine since the 1980s, but progress towards an effective vaccine has been much slower than anticipated. Finding at least a partially effective vaccine remains of critical importance for the HIV response. The biggest reduction in new infections would be achieved by a combination of PrEP, universal antiretroviral treatment for people already living with HIV, and a vaccine.1 An HIV vaccine is a more realistic prospect today than a decade ago and an optimistic forecast of HIV vaccine availability is that one might be available by 2030. Explore this page to find out more about the need for a vaccine against HIV, challenges in vaccine development, progress in developing a vaccine and achieving an effective vaccine for HIV. What is an HIV vaccine? Today, an effective vaccine against HIV does not exist. A vaccine that can prevent infection would teach the immune system to respond to HIV by making antibodies that can bind to the virus and stop it from infecting cells, or by promoting other immune responses that kill the virus. No vaccine is 100% effective, and this is likely to be the same for HIV. Some people who receive a vaccine will not respond strongly enough to the vaccine and will not be protected, as in the case of the seasonal flu vaccine. But finding at least a partially effective vaccine remains of critical importance for the HIV response, as all successful disease elimination strategies have included a vaccine among their arsenal. The need for a vaccine against HIV UNAIDS estimates that 1.8 million people became infected with HIV in 2017, 36.9 million people were living with HIV and 21.7 million were receiving antiretroviral therapy. -
LIST of REGISTRED DRUGS in ARMENIA (Up to 31.12.2017)
LIST OF REGISTRED DRUGS IN ARMENIA (Up to 31.12.2017) International nonproprietary Registration Term of Legal status for N Trade name name (generic) or Drug form Dose and packaging Manufacturer Country ATC1 code License holder number registration supply active ingredients name Lek Pharmaceuticals pefloxacin Lek Pharmaceuticals 400mg, 10.03.2015 d.d., Verovskova Str. 1 Abaktal (pefloxacin tablets film-coated d.d., Verovskova Str. Slovenia J01MA03 14308 PoM2 in blister (10/1x10/) 10.03.2020 57, 1526 Ljubljana, mesylate dihydrate) 57, 1526 Ljubljana Slovenia Lilly France S.A.S., Eli Lilly Regional 100IU/ml, Zone Industrielle, 2 17.03.2017 Operations GmbH., 2 Abasaglar insulin glargine solution for injection France A10AE04 16535 PoM 3ml cartridges (5) rue du Colonel Lilly, 17.03.2022 Koelblgasse 8-10, 67640 Fegersheim 1030, Vienna, Austria Help S.A ,10 ambroxol Help S.A. Pedini, Valaoritou str., GR 6mg/ml, 09.03.2016 3 Abrobion (ambroxol syrup Ioanninon, Ioannina, Greece R05CB06 15404 OTC3 144 52, 125ml glass bottle 09.03.2021 hydrochloride) 45500 Metamorphosis, Attika, Greece Salutas Pharma GmbH, Otto-von- Guericke-Alle-1, 100mg/5ml, 39179 Barleben-batch Sandoz 30g powder in 75ml glass powder for oral releaser, Allphamed Pharmaceuticals d.d., bottle and measuring 20.10.2015 4 ACC acetylcysteine solution with orange Pharbil Arzneimittel Germany R05CB01 14947 OTC Verovskova Str. 57, spoon 5ml, 60g powder in 20.10.2020 flavour GmbH Hildebrandstr. 1000 Ljubljana, 150ml glass bottle and 12, 37081 Gottingen, Slovenia measuring spoon 5ml Germany-bulk manufacturer, packager 1 Salutas Pharma GmbH, Otto-von- Guericke-Alle-1, 39179 Barleben - Sandoz batch releaser Pharmaceuticals d.d., 100mg, 21.11.2014 5 ACC 100 acetylcysteine tablets effervescent (Hermes Pharma Germany R05CB01 13967 OTC Verovskova Str. -
Status of HIV Vaccine Research & Development
Status of HIV Vaccine Research & Development Wayne C. Koff, Ph.D. Chief Scientific Officer, IAVI Global Vaccine Immunization Research Forum Bethesda, Maryland March 4, 2014 HIV continues to devastate…. 35.3 million people living with HIV worldwide 2.3 million new infections in 2012 ; 2012 2008 6,300 new HIV infections daily 33 million 35.3 million 36 million AIDS-related deaths to date 2005 32 million Women bear the brunt of the epidemic, representing almost 60% of HIV-infected adults in Africa and half of adults worldwide 2000 28.5 million Since the beginning >70,000,000 HIV Infections 1995 18.5 million 1990 7.5 million people living with HIV Remarkable scale up of treatment; however, doesn’t solve problem. Lifetime treatment required and for every (1) person put on treatment, (2) are newly infected. THE WORLD NEEDS AN HIV VACCINE Source: Joint United Nations Programme on HIV/AIDS Public Health Impact: A Vaccine Is Needed to “Get Close to Zero” Cumulative infections avoided 2011-50 22.5M 16.0M New HIV Infections HIV New 7.4M * An illustrative vaccine with an assumed efficacy of 60%, not representative of any specific candidate in development. Coverage reaches 70% in generalized HIV/AIDS epidemics, 60% in concentrated epidemics. Potential impact of an AIDS vaccine as part of the UNAIDS Enhanced Investment Framework, IFE Modeling project – UNAIDS, Futures Institute, IAVI, AVAC [funded by USAID] 3 AIDS vaccine development: Scientific Challenges 1. HIV variability 2. Lack of an ideal animal model 3. Natural immunity fails to clear HIV 4. HIV is a retrovirus- integrates into the host genome- short window of opportunity to control 5.