economic policy & africa

economic policy & africa - HIV Vaccine All vaccine...

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HIV Vaccine All vaccine slides created by Kent Weinholdt, Director Center for AIDS Research (CFAR), Duke
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Ideal Attributes of an Efficacious AIDS Vaccine Safe Stable Inexpensive to produce and distribute worldwide Single dose Elicit robust humoral and cellular reactivities both systemically and mucosally Confer broad protection against genetically diverse viruses Long-lasting mucosal and systemic immunologic memory
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Induction of persistent Induction of persistent broadly cross-reactive broadly cross-reactive antibodies. antibodies. Induction of broadly Induction of broadly cross-reactive cross-reactive polyfunctional polyfunctional cytotoxic T lymphocytes. cytotoxic T lymphocytes. Induction of mucosal immunity. Induction of mucosal immunity. Perhaps not sterilizing immunity but capacity to lower initial Perhaps not sterilizing immunity but capacity to lower initial viral burdens to prevent disease progression and viral burdens to prevent disease progression and transmission. transmission. HIV Vaccine?
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Vaccine Introduced Virus Identified Vaccine Type Rabies Yellow Fever Influenza Polio Virus Measles Mumps Rubella Japanese Encephalitis Adenovirus Hepatitis B Varicella HIV 1885 1936 1938 1955 1963 1967 1969 1974 1980 1981 1983 1881 1 1900 1933 1907 1911 1934 1962 1935 1953 1971 1952 1983 Live Attenuated Virus Live Attenuated Virus Inactivated Virus 1 Live Attenuated, Inactivated Live Attenuated Virus Live Attenuated Virus Live Attenuated Virus Inactivated Virus Live Attenuated Virus Subunit/particle Live Attenuated Virus From Virus to Vaccine From Virus to Vaccine 1 Contemporary vaccines are envelope subunits. Hepatitis A 1995 1973 Inactivated Virus Variola 1000AD/1798 ? Live Attenuated Virus Rotavirus 1998 1973 Live Attenuated Virus - -
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Critical Steps in Vaccine Development Critical Steps in Vaccine Development 1. Determine ‘correlates of immune protection’ in animal models. (Pre-clinical studies) 2. Demonstrate parallel responses in Phase I clinical trials (Small numbers of low risk volunteers). 3. Demonstrate similar responses in Phase II clinical trials (Larger numbers, including ‘high risk’ volunteers). 4. Demonstrate efficacy in Phase III clinical trials. 5. Identify surrogate markers of protection to evaluate subsequent vaccine candidates.
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Design of Clinical Vaccine Trials Design of Clinical Vaccine Trials Trial (size) Phase I (10-100 volunteers) Phase II (100-500 volunteers) Phase III (>10,000 volunteers) Objective Safety, toxicity, (immunogenicity) Safety, immunogenicity Efficacy
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Antibodies
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85 62 49 26 8 7 Viral "Set Point" as a Predictor of Disease Time % of patients with AIDS at 5 years 6 5 4 3
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Possible Correlates of Immune Protection Possible Correlates of Immune Protection Against HIV-1 Infection Against HIV-1 Infection Neutralizing Antibodies
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economic policy & africa - HIV Vaccine All vaccine...

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