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The Science of HIV Vaccines an Introduction for Community Groups

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The Science of HIV Vaccines an Introduction for Community Groups The Science of HIV Vaccines An Introduction for Community Groups Second edition Acknowledgements The Science of HIV Vaccines: An Introduction for Community Groups, Second edition The development of this Science Primer would not have been possible without the support of organizations and individuals committed to ensuring that HIV vaccine research and development is enriched and improved through the active contribution of knowledgeable communities and organizations. ICASO wishes to thank Marlijn van Berne for developing the framework and first draft of the primer, Jane Rowley, Phumzile Yeni, Seth Greenberg, Chris Colliers and Emily Bass for their contribution, comments and input in the development of the first edition. ICASO also wishes to thank Alexandre Menezes and Simon Noble for the revisions made to the second edition of this primer (2009). This publication was made possible through the financial assistance of the International AIDS Vaccine Initiative (IAVI), the WHO – UNAIDS HIV Vaccine Initiative (WHO – UNAIDS HVI), and the Canadian International Development Agency (CIDA). Copies of this document’s original version are available in French and Spanish on the ICASO website at www.icaso.org. The revised, updated version, is available in English at www.icaso.org. Design: Tall Poppy Copyright © 2009 by the International Council of AIDS Service Organizations (ICASO) Information contained within this publication may be freely reproduced, published or otherwise used for non-profit purposes. ICASO should be cited as the source of the information. NOTE: The resources in this toolkit use the terms ‘HIV vaccine’ and ‘AIDS vaccine’ interchangeably, as both terms are widely accepted. Table of contents A Note about the 2008 edition Introduction The Immune System i. How the immune system functions ii. Organs of the immune system (Diagram) iii. Stages of an immune response The Effect of HIV on the Immune System i. Structure of HIV ii. How HIV virus invades and replicates What is an HIV Vaccine? i. Introduction 1 ii. Vaccine approaches The Science of HIV Vaccines i. Recombinant sub-unit vaccines ii. Recombinant vector vaccines iii. DNA vaccines iv. Combination vaccines v. Live attenuated vaccines vi. Whole-inactivated vaccines Conclusion I. Key challenges Additional Resources i. Glossary ii. Resources, websites and organizations A Note About the 2008 Edition The need for an HIV vaccine continues to be complex and complicated, yet is as urgent today, as ever. This document is part of a series of HIV vaccine primers for communities that have been developed over the past five years. This particular document was updated in 2008, to reflect some of the new advances, as well as recent setbacks in the search for an HIV vaccine. The document was updated and revised to ensure its usefulness as an accompanying resource to the Facilitators’ Guide that was developed by ICASO. Although the information contained in this document is current, the update does not fully explore all of the issues and new findings that have emerged in the vaccine research and development field over the past five years. However, we hope that the information included here will support action planning for community involvement in HIV vaccine advocacy, research and development. As the field of research into an HIV vaccine continues to evolve quickly, some of the information included in this document should be regularly re-visited and supplemented with updates that can be found through the websites listed as references in this document. Users of this Primer and the companion Facilitators’ Guide are encouraged to seek updated information related to the field of vaccines, including current and planned trials and key research that has been completed, such as the STEP and Phambili trials, which were interrupted in 2007, due to a lack of protective effect from the vaccine. 2 The Step and Phambili Trials In September 2007, the Data and Safety Monitoring Board (DSMB) for the STEP study of Merck’s AIDS vaccine candidate, known as MRK-Ad5, recommended halting immunizations. The unexpected announcement followed the DSMB’s planned interim analysis of the data from the first 1,500 volunteers in STEP, which showed that based on numbers of infections and viral load set points in vaccine and placebo recipients, there was no possibility of the vaccine showing efficacy. This is known as a finding of futility. Subsequent analyses of this data showed a trend towards increased numbers of infections in the vaccine arm as compared to the placebo arm of the trial. After the initial DSMB recommendation, additional The Science of HIV Vaccines analyses of the data from all 3,000 volunteers showed that the trend towards increased risk of HIV infection in vaccine recipients remained. This trend was only seen in vaccinated volunteers who had previously been exposed to the Ad5 cold virus, the type of adenovirus used (in disabled form) in the vaccine. An additional trial for the same vaccine candidate in South Africa, called the Phambili trial, was also halted. These results have been the subject of much discussion, with significant implications for the vaccine development pipeline and ethical and safety considerations around future vaccine trials. It is important to note that MRK-Ad5 (nor any other HIV vaccine candidate being developed) did not and cannot cause HIV infection itself. While the results of the trials were surprising and disappointing, the trials themselves were not considered a failure. Volunteers from both the STEP and Phambili trials continue to be followed, and the knowledge derived from the trial results continues to contribute to our understanding of HIV, the immune system and what would be considered a successful vaccine. These issues should be updated and considered in any educational activities focusing on HIV vaccines. Introduction to The Science of HIV Vaccines “An AIDS vaccine is possible, overcoming the challenges will take a sustained, focused effort. Developing an AIDS vaccine to save lives and economies will be one of the world’s greatest achievements. Not to do so would be one of its greatest failures.” IAVI website, www.iavi.org In a world where almost 7,500 people are newly infected every single day, finding an effective method to prevent HIV infection is the best long-term hope for controlling a pandemic that continues to destroy lives, families, and communities. In rising to the challenge, researchers worldwide have expanded their research efforts, communities have become more involved in understanding clinical research, and great achievements have been made in understanding the human immunodeficiency virus (HIV). This science primer provides a basic introduction to ‘The Science of HIV Vaccines,’ a field of research that scientists hope will provide a significant measure of protection against HIV infection and disease. Although by no means a comprehensive review, the primer aims to provide the reader with a clearer understanding of the science behind the search for an HIV vaccine, starting with an introduction to the immune system. This is the basis for understanding vaccine science. Vaccines work through different components of the immune system. Some of these immune cells are also the primary targets of HIV. By learning how the body usually responds to illness— and the ways that HIV is able to disrupt that response—we can shed light on the challenges involved in finding a vaccine against HIV. 3 The language used in this primer has been adapted to help non-scientists grasp the The Science of HIV Vaccines ABCs of HIV vaccines in layman’s terms. This document is part of a series of primers developed by the International Council of AIDS Service Organizations. Community groups who would like more detailed information on HIV vaccine development, should consult the list of resources at the end of this document. The Immune System i. How the Immune System Functions The immune response to an invader—whether virus, bacteria, or other—can be thought of in terms of a microscopic war that takes place inside the body. Using this metaphor, we can characterize the immune system as an army or defense force that defends a country from external threats and invasions. Just as the soldiers of an army defend their country from attack and invasion, the components of the immune system respond to attacks on the human body. The body’s immune system comprises of a complex system of white blood cells and proteins that work together to respond to, and limit, the damage or illness caused by invading organisms. The white blood cells (which are formed in the bone marrow) form three different ‘regiments’, namely phagocytes (including macrophages and dendritic cells), and two types of lymphocytes, T cells and B cells. Phagocytes form part of the nonspecific defense mechanism of the body, called innate immunity. T and B cells form part of the specific defense mechanism, called adaptive immunity. The components of the immune system can be divided into two arms: humoral and cell-mediated immunity. Humoral refers to antibody-producing B cells (see below for more details.) Cell-mediated immunity refers to T cells, most importantly CD8+ and CD4+ T cells. These terms are important in vaccine science since different vaccines induce relatively different responses from the two arms of the immune system. Antibodies effectively stop virus particles (or other invaders) that have not yet entered 4 cells and are an important first line of defense. But once a virus has infected a cell, cell-mediated immune responses become crucial. While each of these ‘regiments’ has its own mission and defense strategy, they all have the same objective: to identify and destroy all invasive microorganisms that might be harmful to the body, and to create an immunological ‘memory’ of these invaders so that the forces can mount a swift, effective response if they return. There are different stages in each immune response that the body makes: Stage 1: The battle begins The Science of HIV Vaccines Stage 2: The forces multiply Stage 3: The attack and victory Stage 4: The cessation of hostility ii.
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