Document 2814
 DOCN  M94A2814
 TI    Therapeutic gp160 vaccine (VaxSyn) in adults with CD4 counts < 400/mm3.
       Massachusetts DPH gp160 Working Group.
 DT    9412
 AU    DeMaria A; Coady W; Cohen C; Epstein P; Kunches L; Mayer K; Werner B;
       Mass. Department of Public Health, Jamaica Plain 02130.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):219 (abstract no. PB0307). Unique
       Identifier : AIDSLINE ICA10/94369761
 AB    To evaluate the safety and immunogenicity of recombinant gp160 vaccine
       (VaxSyn, MicroGeneSys) in more advanced HIV disease, 140 patients with
       CD4 counts < 400/mm3 are being evaluated in 4 treatment groups. Patients
       with 200-400 CD4 count (n = 90) are randomized to 7 monthly VaxSyn
       injections of either: A) 160 mcg, B) 160 mcg with interferon gamma [5
       mil u sc], or C) 640 mcg; all patients with CD4 count < 200 (n = 50)
       receive 640 mcg. Enrollment to date (n = 118) includes 32% women, 37%
       people of color, mean age 39 yrs, 24% with AIDS-defining OI, 18%
       asymptomatic, 33% not on antiretrovirals at entry. VaxSyn has been well
       tolerated, with complaints limited to injection site soreness (38%),
       mild fever (12%), myalgia (10%), fatigue (8%). To date, 10% of subjects
       have completed the 6-month primary vaccine series after which epitopal
       antibody enhancement and skin test response to rgp160 and controls will
       be determined. Non-responders after 7 doses may be dose-escalated or
       given interferon gamma with VaxSyn doses; responders will receive
       boosters bimonthly and be followed for 15 months. To date, there is no
       evidence of increased viral activity (from base-dissociated p24 Ag
       trends). Complete 6 month immunogenicity data and clinical follow-up
       will be presented.
 DE    Adult  AIDS Vaccines/*THERAPEUTIC USE  Biological Response Modifiers
       Comparative Study  Female  Gene Products, env/IMMUNOLOGY/*THERAPEUTIC
       USE  Human  HIV Infections/BLOOD/*THERAPY  *Immunotherapy, Active
       Interferon Type II/THERAPEUTIC USE  Leukocyte Count  Male  Protein
       Precursors/IMMUNOLOGY/*THERAPEUTIC USE  Recombinant
       Proteins/IMMUNOLOGY/THERAPEUTIC USE  T4 Lymphocytes  Vaccines,
       Synthetic/THERAPEUTIC USE  CLINICAL TRIAL  MEETING ABSTRACT  RANDOMIZED
       CONTROLLED TRIAL

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).