[Memo to CBCTN Committee Members from Ellen Cooper]

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MIEMORANDU M
To: CBCVIN Steeriig Comnmittee Members
prom; Ellen Cooper
Date; July 16, 1993
Subject: DOD Therapeutic Varclne t'rial
I met with Deborah 9irx ycsterday to discuss t~e current status of development of the mti
product large trial of therapeutic vaccines, The following is a summnary of the hlghiights of ha
meeting; however, nothingi yet written in stone, so please do not disseminate any of t~
iniforimatioii outside your lmnwdiate otff.
1) DOD, with DDr. B~rx to lead role, will conduct a large randomized, placebo controle
thensputic t~cine study to begin as soon as possible. Tony Fauci And the NIH suppr
this arangement.
2) The budget for the study is 520 million, per the relevant congressional authoriza P r:cptn h r aetclc c im wl oti uev ia e e t io n.
clinicl monitoring and data miar ement needs, which will be overseen by WyeAes, u~ n hy ret g e m n ih Mc o3 n~ st ucaei t h.
supply of their vacine to donate to the studye Other omand scolsderzg
participation include Immune Response Corporation (Salk vacine) Immuno. AG,te
3kc;ineCompany, anti Qenentch.
31 tudy desigznI bscl ythe leage.simple trial coltranidotireblinded, paebo

the endpoint Mill be earliest, so this aspect of the design and powering will require rmn
dbicsson, I believe,
5571095.0447.039