[Memorandum to Vida Beaven from Maryann Roper]

DEPARTMENTOF HEALTH & HUMAN SERVICES National Institutes of Health
National Cancer Institute
Memorandum.tFebruary 5, 1988
Date
From Acting Deputy Director, NCI
Subject NIH/NCI COLLABORATION IN TE ZAGURY AIDS VACCINE TRIAL
Dr. Vida Beaven
To Special Assistant to the Director, NIH
Attached is a copy of the letter from Drs. Gallo, Berzofsky and
Shearer that went to our IRB, on January 25, requesting permission
to test blood samples from Zagury's vaccinated subjects. My
understanding is that the IRB did not grant this permission, but
requested more information about the trial.
As I related to you in our earlier conversation, Dr. Gallo's
recollection of the events leading up to the vaccine trial are:. Dr. Zagury received material from Dr. Moss with the
understanding (not in writing) that this material
____ was not to be used in human subjects. Dr. Zagury used this material in animal experiments. Dr. Zagury requested more material from Dr. Moss and
- O this request was not granted
(0
Dr. Zagury then made his own material and used this
- ') to vaccinate human subjects
-o
- O. The material that was used in the vaccine trial was
- O made in France and proper permits for its use in humans
had been obtained from the French government and
military and from the Zairian government and military
(Dr. Gallo says that he has seen these permissions).Dr. Gallo has tested one sample --Dr. Zagury' s own blood.Dr. Zagury and his technician spent some time at the FCRF
to learn the screening and culture techniques
The major issue seems to be the source of the actual vaccine
material. If Dr. Moss's material was used for injection into human

subjects, then my understanding is that NIH would be concerned
about further collaboration in a project that proceeded without
proper assurances for the safety of human subjects. This might
also have impact on the NCI request to test subjects' blood