[Memorandum to Samuel Broder from Jay Berzofsky, Gene M. Shearer and Robert C. Gallo]

1DI PATAILNT 01 lLAL.TH & It.1i7 AN S1.IZ\1C1 F. *c i:'.c' c.
I a d Z" o./ 8
I ate: *i j1.ntaa, 1S69 Roo(3' G / ).
FroIn: IChi, Molecular lmmuiog'&n&'tics and Vaccine '. <h ection, Nlettlolism
Branch, I)CI), NC
Chi('f, (ellular lUUIm1unologv of mOdiflkit! St!! t (-t Iction, In1nanalojy
Branch, DCBlD, NC
Chief, Laboratory of Tumor Cell 1ioloui 11(1 NCI
Subject: Request '0ir approval o fi i 1 terinaitio 121 c( 'I Ia ll oratI Ik:; it Ih Pr. 1waniel Zaury for
i I*iro testini; of peripheral blood from Iuiutan v *I ueers previousl
immunized against AIDS
We have made an agreement with Dr. Daniel Zagurv, Universit( de Pierre et
Marie Curie, Paris, France, to (1o testing of cells and serim $i l17ro from the peripheral
blood of normal human volunteers whom Dr. Zagury has immunized with a
recombinant vaccinia virus expressing the gene for the gpl60 envelope protein of the
Human Immunodeficiency Virus (HIV), type HTLV11113. Some of these were also..
boosted with purified recombinant envelope proteins or fragments. We have been
assured that the volunteers, consisting of Dr. Zagury himself and 14 or 15 individuals
from Kinshasa, Zaire, have all signed appropriate informed consent documents, and
the studies in Zaire were done with the explicit approval of the government of Zaire.
However, our part in these studies is merely to test peripheral blood from these
volunteer donors who have already been immunized. None of the NiH collaborators
has any responsibility for the immunizations (which have already' been written up
separately by Dr. Zagury) or any other in Mzio manipulatiln of human subjects in these
studies. It is important for us to be able to test the peripheral blood of these volunteer
donors, which Dr. Zagury has so kindly made available to us, for antibodies and T-cell
responses specific for the AIDS virus and proteins and peptides therefrom, in order to
further the work at NIH on the development of a vaccine for AIDS. We therefore
request permission from you and the Institute Clinical Nesearch Subpanel to carry out
these studies in vitro as outlined. Thank you for your consideration.
Jay A. Berzofsky, M.D., Ph. D.
Gene M. Shearer, Ph.!).

Robert C. Gallo, M. D.
5571095.0346.043