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GUIDELINES FOR VACCINE TRIALS

GUIDELINES FOR VACCINE TRIALS

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Published by: adieyal on Mar 10, 2011
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02/02/2013

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DRAFTGUIDELINES FOR HIV VACCINETRIALS IN HUMAN PARTICIPANTS
SADC
April 2004
 
HIV/AIDS VACCINES TRIAL GUIDELINES
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HIV/AIDS VACCINES TRIAL GUIDELINES
TABLE OF CONTENTS
1.1 Why guidelines are necessary1.2 Principals underlying the HIV vaccines guidelines2 BACKGROUND TO HIV VACCINES2.1 Overview of HIV Vaccines2.2 HIV vaccines categories2.2.1 Inactivated vaccines2.2.2 Recombinant protein vaccines2.2.3 Recombinant DNA vaccines2.2.4 Recombinant Viral vector vaccines2.2.5 Recombinant bacterial vector vaccines2.2.6 Life attenuated HIV virus vaccines3 REQUIRED CONTENTS FOR HIV VACCINES TRAILS PROPOSALS3.1 Clinical trials guidelines3.2 Manufacturing and GMP3.3 Primary and secondary objectives3.4 Study design3.5 Laboratory testing and specimen handling and storage3.6 Statistics section with explanation3.7 GCP Monitoring of the trial3.8 Ethics monitoring of the trial3.9 Timetable3.10 Ethical approval4 PHASE I HIV VACCINE TRIAL GUIDELINES4.1 Introduction4.2 Definition of Phase I clinical studies4.3 Requirements for Trial materials4.4 Stability4.5 Safety of Vaccine Material5 PRECLINICAL DATA5.1 Preliminary Potency5.2 Immunogenicity5.3 In vitro and toxicology data6 TRIAL CONDUCT6.1 Trial design6.2 Safety monitoring6.3 Detection of Adverse Events6.4 Assessment of Adverse events6.5 Trial Monitoring6.6 Management and Prevention of Serious Adverse Events6.7 Communication of Serious Adverse Events6.8 Trial monitoring7 THE ETHICAL CONDUCT OF HIV VACCINE TRIALS7.1 Introduction7.2 General7.3 Conduct of the research7.4 Members of the research team and trial sites7.5 Study population7.6 Community participation7.7 Informed consent7.8 Benefits7.9 Risk reduction of HIV infection during study period
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