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Safety and immunogenicity of Towne cytomegalovirus vaccine with or without adjuvant recombinant interleukin-12

机译：有或没有佐剂重组白介素12的Towne巨细胞病毒疫苗的安全性和免疫原性

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The Towne, human cytomegalovirus (CMV) vaccine is safe and immunogenic but has not prevented infection at doses tested to date. We administered 3000pfu Towne CMV vaccine, with or without adjuvant recombinant interleukin-12 (rhIL-12), to CMV-seronegative healthy volunteers and then measured CMV gB-specific IgG titers and CMV-specific CD4+ and CD8+ T cell proliferation and IFNgamma expression after stimulation with whole viral lysate and immunodominant peptide CMV antigens. Adjuvant rhIL-12 at doses up to 2mug were well-tolerated and associated with (1) dose-related increases in peak anti-CMV gB IgG titers (though not in sustained titers), (2) dose-related increases in the weak CMV viral lysate-specific CD4+ T cell proliferation responses induced by vaccine alone after 360 days of follow-up, and (3) decreases in the very robust CMV IE-specific peak CD4+ T cell and Day 360 CD8+ T cell proliferation responses induced by the vaccine alone. Also, qualitative CD8+ T cell IFNgamma responses to stimulation with the immunodominant CMV antigen, pp65, tended to occur more frequently in vaccinees who received 0.5-2.0mug rhIL-12 compared to lower dose or no rhIL-12. Thus, adjuvant IL-12 may be a promising strategy for improving antibody and T cell immune responses to a CMV vaccine.
机译：Towne人巨细胞病毒（CMV）疫苗是安全且具有免疫原性的疫苗，但迄今已测试的剂量并未预防感染。我们给CMV血清阴性的健康志愿者注射了3000pfu Towne CMV疫苗，有或没有佐剂重组白介素12（rhIL-12），然后测量CMV gB特异性IgG滴度，CMV特异性CD4 +和CD8 + T细胞增殖以及IFNγ表达。全病毒裂解液和免疫优势肽CMV抗原刺激。剂量高达2mug的佐剂rhIL-12具有良好的耐受性，并且与（1）抗CMV gB IgG峰值滴度的剂量相关性增加（尽管不是持续滴度），（2）弱CMV中的剂量相关性增加相关在360天的随访后，仅由疫苗诱导的病毒裂解物特异性CD4 + T细胞增殖反应，（3）疫苗诱导的非常强大的CMV IE特异性CD4 + T细胞高峰和360天CD8 + T细胞增殖反应降低单独。同样，与免疫剂量较低或不使用rhIL-12相比，接受0.5-2.0杯rhIL-12的疫苗中，定性CD8 + T细胞IFNγ对免疫优势CMV抗原pp65刺激的反应往往更频繁发生。因此，佐剂IL-12可能是改善针对CMV疫苗的抗体和T细胞免疫应答的有前途的策略。

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