Beran Jiří, Xie Fang, Zent Olaf
Vaccination and Travel Medicine Centre, Poliklinika, Hradec Králové, Czech Republic.
Novartis Vaccines, Emeryville, CA, USA.
Vaccine. 2014 Jul 23;32(34):4275-80. doi: 10.1016/j.vaccine.2014.06.028. Epub 2014 Jun 17.
Long-term vaccination programs are recommended for individuals living in regions endemic for tick-borne encephalitis (TBE). Current recommendations suggest a first booster vaccine be administered 3 years after a conventional regimen or 12-18 months after a rapid regimen. However, the research supporting subsequent booster intervals is limited. The aim of this study was thus to evaluate the long-term persistence of TBE antibodies in adults and adolescents after a first booster dose with Encepur(®). A total of 323 subjects aged 15 years and over, who had received one of four different primary TBE vaccination series in a parent study, participated in this follow-up Phase IV trial. Immunogenicity and safety were assessed for up to five years after a first booster dose, which was administered three years after completion of the primary series. One subset of subjects was excluded from the booster vaccination since they had already received their booster prior to enrollment. For comparison, immune responses were still recorded for these subjects on Day 0 and on an annual basis until Year 5, but safety information was not collected. Following a booster vaccination, high antibody titers were recorded in all groups throughout the study. Neutralization test (NT) titers of ≥ 10 were noted in at least 94% of subjects at every time point post-booster (on Day 21 and through Years 1-5). These results demonstrated that a first booster vaccination following any primary immunization schedule results in high and long-lasting (>5 years) immune responses. These data lend support to the current belief that subsequent TBE booster intervals could be extended from the current recommendation. NCT00387634.
建议对居住在蜱传脑炎(TBE)流行地区的个人实施长期疫苗接种计划。目前的建议是,在常规接种方案后3年或快速接种方案后12 - 18个月接种第一剂加强疫苗。然而,支持后续加强免疫间隔时间的研究有限。因此,本研究的目的是评估成人和青少年在接种第一剂Encepur(®)加强疫苗后TBE抗体的长期持久性。共有323名15岁及以上的受试者参与了这项IV期随访试验,他们在一项前期研究中接受了四种不同的TBE初级疫苗接种系列之一。在完成初级系列接种3年后接种第一剂加强疫苗,之后对免疫原性和安全性进行长达5年的评估。一组受试者被排除在加强疫苗接种之外,因为他们在入组前已经接种了加强疫苗。为作比较,仍记录了这些受试者在第0天及直至第5年每年的免疫反应,但未收集安全性信息。加强疫苗接种后,在整个研究过程中所有组均记录到高抗体滴度。在加强接种后的每个时间点(第21天以及第1 - 5年),至少94%的受试者中和试验(NT)滴度≥10。这些结果表明,按照任何初级免疫接种方案接种第一剂加强疫苗都会产生高且持久(>5年)的免疫反应。这些数据支持了目前的观点,即后续TBE加强免疫间隔时间可以从当前建议时间延长。NCT00387634。