A DeMaria, L Kunches, K Mayer, C Cohen, P Epstein, B Werner, J Day, J DeCristofaro, S Landers, Y Tang, W Coady
{"title":"晚期HIV感染成人对重组人免疫缺陷病毒1型(HIV-1) gpl60疫苗的免疫应答马萨诸塞州gp160工作组。","authors":"A DeMaria, L Kunches, K Mayer, C Cohen, P Epstein, B Werner, J Day, J DeCristofaro, S Landers, Y Tang, W Coady","doi":"","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To assess immunogenicity of recombinant human immunodeficiency virus type 1 (HIV-1) envelope vaccine (rgp160) in late HIV infection.</p><p><strong>Study design/methods: </strong>HIV-infected volunteers (n = 142), with CD4+ T lymphocyte counts of <400/mm3, were enrolled in a dose-comparison, open-label trial with stratification by CD4+ cell count, randomization to a primary series at two dose levels, and a sub-group receiving interferon-gamma (IFN-gamma) as an adjuvant. Subjects received booster doses of vaccine over a follow-up period of 18-28 months.</p><p><strong>Results: </strong>At 6 and 12 months, 36% and 38% of participants, respectively, had new or augmented antibody titers (> or =4-fold increase) against one or more gpl60 epitopes (C1, V3, C41, 448C). Delayed-type hypersensitivity (DTH) to intradermal gpl60, initially not present in any participant, developed after immunization in 41%, with higher prevalence in participants receiving the lower dose of vaccine. Both antibody and skin test responses occurred in 20-25% of vaccine recipients. Virtually all antibody and skin test responses occurred in participants with initial CD4+ cell counts of >100 cells/mm3. IFN-gamma had no significant effect on immune response. Immunization was well tolerated. Trends in CD4+ cell count, clinical events, and laboratory findings correlated with baseline CD4+ T lymphocyte count stratum and not with immunization regimen. Opportunistic conditions occurred at expected rates. Viral load trends (p24 antigen in all participants and viral RNA by reverse transcription-polymerase chain reaction in a subset of 26 participants) did not correlate with immunization regimen.</p><p><strong>Conclusion: </strong>Immunization of patients with advanced HIV infection with rgpl60 resulted in new and augmented humoral and DTH responses, without unexpected significant adverse events or evident clinical benefits attributable to immunization.</p>","PeriodicalId":80032,"journal":{"name":"Journal of human virology","volume":"3 4","pages":"182-92"},"PeriodicalIF":0.0000,"publicationDate":"2000-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Immune responses to a recombinant human immunodeficiency virus type 1 (HIV-1) gpl60 vaccine among adults with advanced HIV infection. Massachusetts gp160 Working Group.\",\"authors\":\"A DeMaria, L Kunches, K Mayer, C Cohen, P Epstein, B Werner, J Day, J DeCristofaro, S Landers, Y Tang, W Coady\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To assess immunogenicity of recombinant human immunodeficiency virus type 1 (HIV-1) envelope vaccine (rgp160) in late HIV infection.</p><p><strong>Study design/methods: </strong>HIV-infected volunteers (n = 142), with CD4+ T lymphocyte counts of <400/mm3, were enrolled in a dose-comparison, open-label trial with stratification by CD4+ cell count, randomization to a primary series at two dose levels, and a sub-group receiving interferon-gamma (IFN-gamma) as an adjuvant. Subjects received booster doses of vaccine over a follow-up period of 18-28 months.</p><p><strong>Results: </strong>At 6 and 12 months, 36% and 38% of participants, respectively, had new or augmented antibody titers (> or =4-fold increase) against one or more gpl60 epitopes (C1, V3, C41, 448C). Delayed-type hypersensitivity (DTH) to intradermal gpl60, initially not present in any participant, developed after immunization in 41%, with higher prevalence in participants receiving the lower dose of vaccine. Both antibody and skin test responses occurred in 20-25% of vaccine recipients. Virtually all antibody and skin test responses occurred in participants with initial CD4+ cell counts of >100 cells/mm3. IFN-gamma had no significant effect on immune response. Immunization was well tolerated. Trends in CD4+ cell count, clinical events, and laboratory findings correlated with baseline CD4+ T lymphocyte count stratum and not with immunization regimen. Opportunistic conditions occurred at expected rates. Viral load trends (p24 antigen in all participants and viral RNA by reverse transcription-polymerase chain reaction in a subset of 26 participants) did not correlate with immunization regimen.</p><p><strong>Conclusion: </strong>Immunization of patients with advanced HIV infection with rgpl60 resulted in new and augmented humoral and DTH responses, without unexpected significant adverse events or evident clinical benefits attributable to immunization.</p>\",\"PeriodicalId\":80032,\"journal\":{\"name\":\"Journal of human virology\",\"volume\":\"3 4\",\"pages\":\"182-92\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2000-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of human virology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of human virology","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Immune responses to a recombinant human immunodeficiency virus type 1 (HIV-1) gpl60 vaccine among adults with advanced HIV infection. Massachusetts gp160 Working Group.
Objective: To assess immunogenicity of recombinant human immunodeficiency virus type 1 (HIV-1) envelope vaccine (rgp160) in late HIV infection.
Study design/methods: HIV-infected volunteers (n = 142), with CD4+ T lymphocyte counts of <400/mm3, were enrolled in a dose-comparison, open-label trial with stratification by CD4+ cell count, randomization to a primary series at two dose levels, and a sub-group receiving interferon-gamma (IFN-gamma) as an adjuvant. Subjects received booster doses of vaccine over a follow-up period of 18-28 months.
Results: At 6 and 12 months, 36% and 38% of participants, respectively, had new or augmented antibody titers (> or =4-fold increase) against one or more gpl60 epitopes (C1, V3, C41, 448C). Delayed-type hypersensitivity (DTH) to intradermal gpl60, initially not present in any participant, developed after immunization in 41%, with higher prevalence in participants receiving the lower dose of vaccine. Both antibody and skin test responses occurred in 20-25% of vaccine recipients. Virtually all antibody and skin test responses occurred in participants with initial CD4+ cell counts of >100 cells/mm3. IFN-gamma had no significant effect on immune response. Immunization was well tolerated. Trends in CD4+ cell count, clinical events, and laboratory findings correlated with baseline CD4+ T lymphocyte count stratum and not with immunization regimen. Opportunistic conditions occurred at expected rates. Viral load trends (p24 antigen in all participants and viral RNA by reverse transcription-polymerase chain reaction in a subset of 26 participants) did not correlate with immunization regimen.
Conclusion: Immunization of patients with advanced HIV infection with rgpl60 resulted in new and augmented humoral and DTH responses, without unexpected significant adverse events or evident clinical benefits attributable to immunization.
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