Date: Tue, 21 Jun 1994 10:37:53 -0400 (EDT)
From: "ANNE WILSON, CDC NAC" <CLEARINGHOUS@delphi.com>

N I A I D   N E W S
***********************************************
NATIONAL INSTITUTES OF HEALTH
National Institute of Allergy and Infectious Diseases
June 17, 1994
 
 
            NIAID Advisors Recommend Continuing But Not 
              Expanding at This Time Ongoing Trials of 
                     Two Candidate HIV Vaccines
 
 
      On June 17, 1994, the National Institute of Allergy and
Infectious Diseases (NIAID) held a joint meeting in Bethesda, Md., of
the NIAID AIDS Research Advisory Committee (ARAC) and the
NIAID AIDS Subcommittee of the National Advisory Allergy and
Infectious Diseases Council.  At the meeting, NIAID solicited a
recommendation from the group about whether or not to expand at this
time the NIAID's U.S.-based clinical trials of the two gp120 subunit
HIV candidate vaccines furthest along in development.  Ashley T.
Haase, M.D., ARAC chairperson and head of the Department of
Microbiology at the University of Minnesota Medical School in
Minneapolis, chaired the meeting.    
 
      After a full day of discussion and deliberation, these advisors 
recommended that the Institute continue, but not expand, the current 
vaccine trials of the two gp120 candidates in question and continue the 
development of other candidates currently under study.  The committee 
members also recommended NIAID proceed with expanded clinical trial 
evaluation when a vaccine of a different design and/or when other 
compelling data from current or other studies are available.  In 
recognition of the difference in the dynamics of the epidemic throughout 
the world, the majority of the advisers also agreed that at the present 
time this recommendation applies only to studies of these two products 
in the United States. 
 
      The discussion and subsequent recommendation to NIAID
Director, Anthony S. Fauci, M.D., is part of NIAID's ongoing
decision-making process about when to begin its first efficacy trial of
preventive HIV vaccines.  Because of the clear, overwhelming
consensus of the advisors, Dr. Fauci adopted the recommendation.
 
      The two vaccines are based on genetically engineered forms of
the major HIV surface protein, gp120, from closely related but distinct
HIV-1 strains representative of most infections in North America and
Europe.  The Biocine Company (Emeryville, Calif., a joint venture of
Chiron and CIBA-Geigy) makes its vaccine from the SF-2 strain. 
Genentech, Inc., (South San Francisco) bases its vaccine on the MN
strain.  At this time, these HIV vaccines are the only ones in an
NIAID-sponsored Phase II clinical trial.  NIAID began the trial in
December 1992.
 
      NIAID will evaluate data from new and ongoing HIV vaccine
studies before it identifies a suitable candidate vaccine to propose for
expanded trials. The Institute estimates that one to three years are
needed to get such data.  NIAID is committed to the development of
a vaccine to prevent HIV infection and disease.  This means continuing
the Institute's comprehensive basic and applied program of preclinical
and clinical work on candidates and concepts currently in earlier stages
of development.  Additional community preparedness work will also
be carried out.  The clinical trials conducted through NIAID's vaccine
clinical trial networks are part of a broader prevention effort that
includes non-vaccine prevention research.
 
      NIAID, a component of the National Institutes of Health (NIH),
supports research on AIDS, tuberculosis and other infectious diseases
as well as allergies and immunology.  NIH is an agency of the U.S.
Public Health Service, U.S. Department of Health and Human Services.
 
Prepared by:
Office of Communications
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Bethesda, MD 20892
 
Public Health Service
U.S. Department of Health and Human Services