The Potential Use of HIV Vaccines for the Treatment of HIV Infection: Scientific Summary of the State-of-the-Art

5. Immune Response Corporation Whole-Inactivated Virus (The "Salk vaccine"):
This product is an envelope-depleted whole-virus vaccine adjuvanted in
IFA. 22 patients with CDC stage 3 HIV infection have been followed for
approximately 4 years and no side effects have been noted. The
immunogenicity of the product has been followed by monitoring DTH
responses to vaccine skin test preparation. Individuals with strong DTH
responses appeared to progress more slowly than those with weaker DTH
responses as judged by clinical criteria. Follow up of these patients
continues.
The current company-sponsored study involves 60 persons. All are
asymptomatic with CD4+ T cells > 600/mm3, not taking AZT. Twelve
persons were given IFA and 48 received vaccine in IFA (50, 100, 200, 400
ug every 12 weeks). The product was shown to be safe. A rise in antip24 antibodies and an increase in the DTH response to the vaccine
preparation were observed. Western blotting has shown a broad increase
in anti-HIV antibodies. No effect on CD4 count or viral load data has
been reported. (S. Basta, Personal communication, 1992).
6. IDEC Corporation
A trial is underway using a monoclonal mouse antibody directed against
human anti-gpl20 (which itself has HIV neutralizing ability). The
immunoglobulin is adjuvanted with SAF (L121 pluronic block copolymer,
squalene, Tween 80, in phosphate-buffered saline) with or without
threonyl-MDP. The trial consists of 24 persons with CD4+ T cells >
600/mm3. 18 individuals received immunoglobulin with emulsion only and
6 received immunoglobulin plus emulsion plus threonyl-MDP. Preliminary
reports are that the product is safe. Other data is scheduled to be
presented in early 1993 (J. Merritt, personal communication, 1992).
7. Daniel Zagury & Colleagues
Zagury and co-workers conducted a unique therapeutic trial. Six
patients in Zaire (with baseline CD4 counts of 300, 320, 224, 570, 280 &
714) were vaccinated with fixed autologous CD8-enriched cells infected
with vaccinia expressing HIV gpl60, inactivated but immunogenic human
alpha interferon, formalin stabilized RNA-less HIV-1 virions and the
following selection of HIV-1 synthetic peptides: gpl20 419-439, gp41
569-599, gp41 735-753 & 837-857 and gag p7). The fixed cells (40 x 106)
were given by intravenous infusion one time at the start of the trial.
The alpha interferon, inactivated virions and selected HIV peptides were
given twice, at 9 and 10 months. No significant toxicity was reported
(based on clinical evaluation, full blood count and sedimentation rate).
After more than 1 year follow up, no opportunistic infections were
reported in the patients and Kaposi sarcoma present in one was
"stabilized" (with the addition of bleomycin therapy). DTH responses to
PPD and candida antigens were reported to have improved following the
therapy. Some CTL activity against p18 and gag peptide was
demonstrated in 3 of the patients. Tables of the CD4 counts of the
vaccinees showed that all patients had a count higher upon completion of

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