Gabutti G, Guido M, Durando P, De Donno A, Quattrocchi M, Bacilieri S, Ansaldi F, Cataldini S, Chiriacò P G, De Simone M, Minniti S, Sticchi L, Gasparini R
Laboratory of Hygiene, Department of Biological and Environmental Sciences and Technologies, Faculty of Sciences, University of Lecce, Lecce, Italy.
J Int Med Res. 2005 Jul-Aug;33(4):406-16. doi: 10.1177/147323000503300406.
In this study of influenza vaccination, 37 human immunodeficiency virus (HIV)-1-seropositive patients were randomized to receive either a vaccine with a conventional subunit or one adjuvanted with MF59. Blood samples were collected at the time of vaccination, and then 30 and 180 days later, to evaluate immunogenicity, CD4+ T-lymphocyte count and HIV-1 RNA levels. Seroconversion rates against the three viral strains included in the vaccine ranged between 44% and 72% and 53% and 68% for the adjuvanted vaccine and the subunit vaccine, respectively. Other criteria of the European Medicines Evaluation Agency were also met. Vaccination was not associated with serious adverse events. Local and systemic effects were mild and of short duration. CD4+ T-lymphocyte counts and viraemia levels were not negatively affected by vaccination. These results confirmed the safety and immunogenicity of these currently available vaccines in HIV-1-seropositive patients, thus supporting the recommendation for influenza immunization in this high-risk category.
在这项流感疫苗接种研究中,37名人类免疫缺陷病毒(HIV)-1血清阳性患者被随机分为两组,分别接种传统亚单位疫苗或添加MF59佐剂的疫苗。在接种疫苗时、接种后30天和180天采集血样,以评估免疫原性、CD4+ T淋巴细胞计数和HIV-1 RNA水平。佐剂疫苗和亚单位疫苗针对疫苗中包含的三种病毒株的血清转化率分别在44%至72%和53%至68%之间。欧洲药品评估局的其他标准也得到了满足。疫苗接种未出现严重不良事件。局部和全身反应轻微且持续时间短。CD4+ T淋巴细胞计数和病毒血症水平未受到疫苗接种的负面影响。这些结果证实了这些现有疫苗在HIV-1血清阳性患者中的安全性和免疫原性,从而支持对这一高危人群进行流感免疫接种的建议。