Phase I trial of a melanoma vaccine expressing the p97 antigen (Meeting abstract). NLM AIDSLINE Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.

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Phase I trial of a melanoma vaccine expressing the p97 antigen (Meeting abstract).

Proc Annu Meet Am Soc Clin Oncol; 12:A1346 1993. Unique Identifier : AIDSLINE ICDB/94695745
Goodman G; Hellstrom I; Hu SL; Hanson M; Klemola-Phillips R; Nicaise C; Hellstrom KE; Bristol-Myers Squibb Pharmaceutical Research Inst., Seattle, WA

Abstract: A melanoma tumor immunogen (v-p97NY), consisting of a recombinant vaccinia virus was tested in a dose-escalating Phase I trial. 24 patients (pts) with melanoma, or at high risk for recurrence, were given a single intradermal injection. Doses started at 2 x 10(4) pfu and were escalated 10-fold/dose to a max of 2 x 10(7) pfu. Pts were monitored for clinical evidence of viral replication and toxicity. Serum was assayed for antibody responses and lymphocytes for proliferative responses to p97 and vaccinia. No toxicity was seen except for pruritus and erythema at the site of injection. Three pts receiving 2 x 10(7) pfu developed a small pustular lesion at the site of injection. No pts developed antibody titers against p97. Vaccinia-neutralizing antibody titers increased by a factor of 4 or more in 7/14 pts who received the highest dose. No pt developed a lymphocyte proliferative response to p97. This immunogen induced no measurable immunological response to p97 antigen, only a minor increase in immunity to vaccinia and had no clinical effect. The low response is in contrast to results obtained for a recombinant vaccinia virus expressing HIV antigens, where the response rate was 100% (Cooney et al, Lancet 337:567, 1991). This contrast may underscore important differences between viral constructs or inoculation regimens. In addition, in vitro assays may underestimate the effects of recombinant vaccinia virus priming in vivo, which are only evident after boosting with soluble antigens. Whether such effects occurred in pts in this study will require further investigation.
Keywords: Antigens, Neoplasm/*IMMUNOLOGY Human HIV Antigens/IMMUNOLOGY Immunotherapy, Active/*ADVERSE EFFECTS Melanoma/*IMMUNOLOGY/*THERAPY Vaccines/*TOXICITY Vaccines, Synthetic/TOXICITY/THERAPEUTIC USE Vaccinia Virus/IMMUNOLOGY ABSTRACT CLINICAL TRIAL CLINICAL TRIAL, PHASE IKWDantigens,neoplasm/KWDimmunologyhumanhivantigens/immunologyimmunotherapy,active/KWDadverseeffectsmelanoma/KWDimmunology/KWDtherapyvaccines/KWDtoxicityvaccines,synthetic/toxicity/therapeuticusevacciniavirus/immunologyabstractclinicaltrialclinicaltrial,phasei
940228
M9420820

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