Warrington R, Ismail S
NACI Herpes Zoster Working Group Chair, Edmonton, AB.
Department of Internal Medicine, Adult Allergy & Clinical Immunology, University of Manitoba, Winnipeg, MB.
Can Commun Dis Rep. 2018 Sep 6;44(9):220-225. doi: 10.14745/ccdr.v44i09a06.
Steep increases in herpes zoster (HZ) incidence, hospitalization due to HZ and the risk of post-herpetic neuralgia as a complication of HZ occur in people over 50 years of age. Two HZ vaccines are currently authorized for use in those 50 years of age and older in Canada: a live attenuated zoster vaccine (LZV) authorized in 2008; and a recombinant subunit vaccine (RZV) authorized in October 2017.
To review current evidence and develop guidance on whether the previously authorized LZV (Zostavax) and/or the recently authorized RZV (Shingrix) vaccine should be offered to Canadians 50 years of age and older: 1) at a population-level, in publicly funded immunization programs; and 2) at an individual-level, to individuals wishing to prevent HZ, or by clinicians wishing to advise individual patients about preventing HZ.
The National Advisory Committee on Immunization (NACI) Herpes Zoster Working Group developed a predefined search strategy to identify all eligible studies, assessed their quality, and summarized and analyzed the findings. A Cost Utility Analysis of LZV and RZV was also conducted from a health care system perspective. Recommendations were proposed according to NACI's evidence-based process. The strength of these recommendations was defined, and the Grade of evidence supporting them was identified. In light of the evidence, the recommendations were then considered and approved by NACI.
Five recommendations were developed for public health and individual-level decision-making. 1) RZV to populations/individuals >50 years of age without contraindications (Strong NACI Recommendation, Grade A evidence). 2) RZV to populations/individuals >50 years of age without contraindications who have previously been vaccinated with LZV (Strong NACI Recommendation, Grade A evidence). Re-immunization with two doses of RZV may be considered one year after LZV (Discretionary NACI Recommendation, Grade I evidence). 3) RZV to populations/individuals >50 years of age without contraindications who have had a previous episode of HZ (Strong NACI Recommendation, Grade B evidence). Immunization with two doses of RZV may be considered one year after the HZ episode (Discretionary NACI Recommendation, Grade I evidence). 4) LZV for immunocompetent populations/individuals >50 years of age without contraindications when RZV is contraindicated, unavailable or inaccessible (Discretionary NACI Recommendation, Grade A evidence). 5) RZV (not LZV) in immunocompromised adults >50 years of age on a case-by-case basis (Discretionary NACI Recommendation, Grade I evidence).
Both vaccines have been shown to be safe and immunogenic and to reduce the incidence of HZ and post-herpetic neuralgia. Vaccine efficacy of LZV against HZ decreases with age at, and time since vaccination. The vaccine efficacy of RZV remains higher and appears to decline more slowly than vaccine efficacy of LZV across all age groups. Both vaccines are cost-effective in those 50 years of age and older compared with no vaccination, especially in those 65-79 years of age. RZV is more cost-effective than LZV.
50岁以上人群中,带状疱疹(HZ)发病率、因HZ住院率以及作为HZ并发症的带状疱疹后神经痛风险急剧上升。加拿大目前有两种HZ疫苗被批准用于50岁及以上人群:2008年批准的减毒活带状疱疹疫苗(LZV);以及2017年10月批准的重组亚单位疫苗(RZV)。
审查现有证据,并就是否应向50岁及以上的加拿大人提供先前批准的LZV(Zostavax)和/或最近批准的RZV(Shingrix)疫苗制定指导意见:1)在人群层面,在公共资助的免疫计划中;2)在个体层面,向希望预防HZ的个人,或向希望就预防HZ向个体患者提供建议的临床医生。
国家免疫咨询委员会(NACI)带状疱疹工作组制定了预定义的搜索策略,以识别所有符合条件的研究,评估其质量,并总结和分析研究结果。还从医疗保健系统的角度对LZV和RZV进行了成本效用分析。根据NACI基于证据的流程提出了建议。定义了这些建议的强度,并确定了支持它们的证据等级。根据证据,这些建议随后由NACI进行审议和批准。
针对公共卫生和个体层面的决策制定了五项建议。1) 向无禁忌证的50岁以上人群/个体接种RZV(NACI强烈建议,A级证据)。2) 向无禁忌证且先前已接种LZV的50岁以上人群/个体接种RZV(NACI强烈建议)。接种两剂RZV可在接种LZV一年后考虑(NACI酌情建议,I级证据)。3) 向无禁忌证且先前有HZ发作史的50岁以上人群/个体接种RZV(NACI强烈建议,B级证据)。接种两剂RZV可在HZ发作一年后考虑(NACI酌情建议,I级证据)。4) 当RZV禁忌、无法获得或无法接种时,向无禁忌证的50岁以上免疫功能正常人群/个体接种LZV(NACI酌情建议,A级证据)。5) 对于50岁以上的免疫功能低下成年人,根据具体情况接种RZV(而非LZV)(NACI酌情建议,I级证据)。
两种疫苗均已证明安全且具有免疫原性,并可降低HZ和带状疱疹后神经痛的发病率。LZV对HZ的疫苗效力随年龄和接种后的时间而降低。在所有年龄组中,RZV的疫苗效力仍然较高,且似乎比LZV的疫苗效力下降得更慢。与未接种疫苗相比,两种疫苗在50岁及以上人群中均具有成本效益,尤其是在65-79岁人群中。RZV比LZV更具成本效益。