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Clinical Trials (Mauro Schechter)

Clinical Trials (Mauro Schechter)

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Published by: National Press Foundation on Apr 08, 2011
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08/18/2014

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Projeto Praça Onze
Universidade Federal do Rio de Janeiro
Clinical Trials at AIDS Vaccine µ09
Scientific Journalists Training ProgramGlobal HIV Vaccine EnterpriseParis, October 19, 2009
Mauro Schechter 
Principal Investigator, Projeto Praça OnzeProfessor of Infectious DiseasesUniversidade Federal do Rio de Janeiro
 
Development of HIV vaccines
Laboratory and animal protectionexperiments20±50 HIV-negative volunteers (lower risk);safety and immunogenicity 
II II III III IV IV 
100s of HIV-negative volunteers (lower and higher risk); safety, immunogenicity; doses, routes of administration, different populations1000s of HIV-negative volunteers (higher risk);efficacy Effectiveness; operational research
Pre-clinical phaseClinicalPhases**
*
Randomized clinical trials
 
Randomised Controlled Trials (RCTs)
‡
Experimental, (usually) longitudinal, prospective
‡
andomised
±
ensures that treatment groups aresimilar at start of trial; any differences are due tochance only
‡
C
ontrolled
±
control group allows to conclude thatoutcome is due to the test vaccine rather than someother factor
‡
C
omparison is usually between a new regimen orintervention and an existing standard of care orplacebo

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