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

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
National Institutes of Health
Bethesda, Maryland 20892
Building:/0
Date: 4 January, 1988 Room 4 C /.
(301) 496- eaE- 1
To: Dr. Samuel Broder, Associate Director, Clinical Oncology Program, DCT, NCI
FroM: Chief, Molecular Immunogenetics and Vaccine Research Section, Metabolism
Branch, DCBD, NCI
Chief, Cellular Immunology of Modified Self Antigens Section, Immunology
Branch, DCBD, NCI
Chief, Laboratory of Tumor Cell Biology, DCE, NCI
Subject: Request for approval of international collaboration with Dr. Daniel Zagury for
in vitro testing of peripheral blood from human volunteers previously
immunized against AIDS
We have made an agreement with Dr. Daniel Zagury, Universit6 de Pierre et
Marie Curie, Paris, France, to do testing of cells and serum in vitro 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 HTLV IIIB. 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 vivo manipulation 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 Research 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.D.
5571095.0346.037...
Robert C. Gallo, M. D.