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.

中文翻译：

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流感疫苗（Fluvax）对癌症患者的治疗效果：一项前瞻性单臂开放标签研究。

目的

流感病毒感染在具有免疫抑制的医学合并症患者中具有显着的发病率和死亡率。在接受化疗的患者中，季节性流感疫苗的功效尚未得到很好的研究。我们评估了季节性流感疫苗在非血液系统恶性肿瘤患者积极治疗（化学疗法和靶向疗法）中的疗效。

方法

这项前瞻性单臂开放标签研究针对2011年和2012年流感季节招募的53名非血液学癌症患者进行了研究。参与者在接种之前或之中接种一剂2011/2012三价疫苗，其中含有A / California / 7/2009（H1N1），A / Perth / 16/2009（H3N2）和B / Brisbane / 60/2008（Fluvax）菌株治疗周期。在基线第3、6和24周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周后SCR晚期。

• 24周时持续血清保护滴度（SPR）的比率。

血清转化定义为疫苗接种后HIA滴度≥4倍，血清保护定义为HIA≥1:40。

结果

3周时，H1N1，H3N2和B / Bris菌株的SCR分别为35％，30％和22.5％。6周或24周没有新的SC晚期病例。

3周时对H1N1，H3N2和B / Bris的SPR分别为72.5％，65％和40％。H1N1，H3N2和B / Bris在24周时的SPR分别为40％，52.5％和17.5％。

结论

接受各种实体瘤治疗的患者可获得与普通人群相同的血清保护率。接种疫苗后24周，血清保护性HIA滴度没有持续。