流感疫苗（Fluvax）在治疗中癌症患者中的疗效：一项前瞻性单臂、开放标签研究。

Efficacy of influenza vaccine (Fluvax) in cancer patients on treatment: a prospective single arm, open-label study.

机构信息

Department of Medical Oncology, Flinders Medical Centre, Bedford Park, Adelaide, 5042, Australia.

Flinders Centre for Innovation in Cancer, Flinders University, Bedford Park, Adelaide, 5042, Australia.

出版信息

Support Care Cancer. 2020 Nov;28(11):5411-5417. doi: 10.1007/s00520-020-05384-2. Epub 2020 Mar 7.

DOI:10.1007/s00520-020-05384-2

PMID:32144585

Abstract

PURPOSE

Influenza virus infection has significant morbidity and mortality in patients with medical co-morbidities who are also immunosuppressed. The efficacy of the seasonal influenza vaccine has not been well studied in patients receiving chemotherapy. We assessed the efficacy of seasonal influenza vaccine in patients with non-haematological malignancy on active treatment (chemotherapy and targeted therapy).

METHODS

A prospective single arm, open label study with 53 patients with non-haematological cancers recruited during the 2011 and 2012 influenza seasons. Participants had one dose of 2011/2012 trivalent vaccine containing strains A/California/7/2009(H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 (Fluvax) prior to or in-between treatment cycles. Haemagglutination inhibition antibody (HIA) titres in serum were measured at baseline 3, 6 and 24 weeks. Primary endpoint: seroconversion rate (SCR) at 3 weeks. Secondary endpoints: late SCR at 6 weeks. rate of sustained sero-protection titres (SPR) at 24 weeks. Seroconversion was defined as postvaccination ≥ 4-fold increase in HIA titre and sero-protection defined as a HIA ≥ 1:40.

RESULTS

The SCR at 3 weeks were 35%, 30% and 22.5% to the H1N1, H3N2 and B/Bris strains, respectively. There were no new cases of late SC at 6 weeks or 24 weeks. The SPR at 3 weeks were 72.5%, 65% and 40%, respectively, to H1N1, H3N2 and B/Bris. The SPR at 24 weeks to H1N1, H3N2 and B/Bris were 40%, 52.5% and 17.5%, respectively.

CONCLUSIONS

Patients on various solid tumour treatments achieve sero-protection rate congruent with the general population. The sero-protection HIA titres were not sustained at 24 weeks postvaccination.

摘要

目的

流感病毒感染在合并医学合并症且免疫抑制的患者中具有显著的发病率和死亡率。在接受化疗的患者中，季节性流感疫苗的疗效尚未得到很好的研究。我们评估了在接受非血液恶性肿瘤治疗（化疗和靶向治疗）的患者中使用季节性流感疫苗的效果。

方法

一项前瞻性、单臂、开放标签研究，纳入了 2011 年和 2012 年流感季节期间招募的 53 名非血液恶性肿瘤患者。参与者在治疗周期之前或期间接受了一剂 2011/2012 年三价疫苗，其中包含 A/California/7/2009(H1N1)、A/Perth/16/2009(H3N2)和 B/Brisbane/60/2008(Fluvax)株。在基线、3、6 和 24 周时测量血清中的血凝抑制抗体（HIA）滴度。主要终点：3 周时的血清转化率（SCR）。次要终点：6 周时的晚期 SCR。24 周时持续血清保护滴度（SPR）的发生率。血清转化率定义为接种疫苗后 HIA 滴度增加≥4 倍，血清保护定义为 HIA≥1:40。

结果

3 周时，H1N1、H3N2 和 B/Bris 株的 SCR 分别为 35%、30%和 22.5%。在 6 周或 24 周时，没有新的晚期 SCR 病例。3 周时，H1N1、H3N2 和 B/Bris 的 SPR 分别为 72.5%、65%和 40%。24 周时，H1N1、H3N2 和 B/Bris 的 SPR 分别为 40%、52.5%和 17.5%。