柳叶刀:宝宝再也不用害怕打针了,“无痛疫苗贴片”让你跟针头Say Bye
2017/06/29
据英国BBC报道,一种“无痛疫苗贴片”已经在人体通过了Ⅰ期临床试验(安全性测试),结果发表在最新一期的医学杂志《柳叶刀》(The Lancet)上。研究者表示:贴片上有100个毛发细的可以穿透皮肤表面的微针,可以用来接种流感疫苗,就像注射了普通流感疫苗一样有效。

贴片的直径仅数厘米,中心嵌有细小的、毛发状的针

前阵子,由华人科学家顾臻教授团队开发的“智能胰岛素贴片”获得了580万美元的投资,引发了糖尿病患者对无需针头注射胰岛素的美好期冀。

这不,除了“智能胰岛素贴片”,科学家还开发了“无痛疫苗贴片”。这意味着,今后亿万儿童在接种疫苗时将不再畏惧打针,而可以通过这种新型的无痛贴片将疫苗输入皮肤中。

针头,再见!

据英国BBC报道,这种“无痛疫苗贴片”已经在人体通过了Ⅰ期临床试验(安全性测试),结果发表在最新一期的医学杂志《柳叶刀》(The Lancet)上。研究者表示:贴片上有100个毛发细的可以穿透皮肤表面的微针,可以用来接种流感疫苗,就像注射了普通流感疫苗一样有效。

与标准流感疫苗不同,它不需要被保存在冰箱里,这意味着药店可以很容易地将其储存在货架上供人们购买。因此,这种无痛的、一次性的疫苗贴片有望降低人们对针头注射的需求。

大多数志愿者表示:相比于打针,他们更倾向于这种无痛贴片

参与这项研究的科研人员来自美国埃默里大学和乔治亚理工学院,他们皆受到了美国国立卫生研究院(NIH)的资助。在首席研究员Prof Mark Prausnitz教授看来,这种疫苗与普通疫苗在预防效果上没有差别,但是它不会让接种者感到疼痛:普通疫苗是通过肌内注射,这款智能疫苗是通过皮肤表层进入人体。目前,已经有一家公司希望获取这项技术的授权。

在临床试验过程中,科研人员对100名志愿者中的一部分人进行普通疫苗注射,另一部分人采用贴片(在手腕上贴上20min)。结果大多数人反映使用贴片是无痛的,但有些人有轻微的副作用——皮肤部位的红肿、瘙痒和触痛,不过这些症状过几天就好了。

易于使用

来自埃默里大学的Nadine Rouphael博士表示,虽然这款“无痛疫苗贴片”获得FDA的批准进行广泛使用还需要经过几年的进一步临床试验,但“无痛贴片”是未来的疫苗接种趋势。在不久的将来,我们可以在家里、工作场所进行免疫接种,可以去药店购买疫苗,也可以通过网络进行购买,这是一种“颠覆”的预防免疫方式。

此外,一方面这种贴片在使用过后由于药效消失可以随意扔在垃圾桶里,不需要当做医疗废弃物来处理;另一方面它可以在不制冷的环境中安全储存长达一年,这在发展中国家是非常有用的。

伦敦卫生医学院、传染病专家John Edmunds表示,尽管英国已经为那些不喜欢针头的小孩引入了一种鼻腔喷雾流感疫苗,但是这项研究开启了一种更好地疫苗接种方式。

参考资料:

Painless flu jab patch for people scared of injections

The safety, immunogenicity, and acceptability of inactivated influenza vaccine delivered by microneedle patch (TIV-MNP 2015): a randomised, partly blinded, placebo-controlled, phase 1 trial

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  • The safety, immunogenicity, and acceptability of inactivated influenza vaccine delivered by microneedle patch (TIV-MNP 2015): a randomised, partly blinded, placebo-controlled, phase 1 trial

    Background Microneedle patches provide an alternative to conventional needle-and-syringe immunisation, and potentially offer improved immunogenicity, simplicity, cost-effectiveness, acceptability, and safety. We describe safety, immunogenicity, and acceptability of the first-in-man study on single, dissolvable microneedle patch vaccination against influenza. Methods The TIV-MNP 2015 study was a randomised, partly blinded, placebo-controlled, phase 1, clinical trial at Emory University that enrolled non-pregnant, immunocompetent adults from Atlanta, GA, USA, who were aged 18–49 years, naive to the 2014–15 influenza vaccine, and did not have any significant dermatological disorders. Participants were randomly assigned (1:1:1:1) to four groups and received a single dose of inactivated influenza vaccine (fluvirin: 18 μg of haemagglutinin per H1N1 vaccine strain, 17 μg of haemagglutinin per H3N2 vaccine strain, and 15 μg of haemagglutinin per B vaccine strain) (1) by microneedle patch or (2) by intramuscular injection, or received (3) placebo by microneedle patch, all administered by an unmasked health-care worker; or received a single dose of (4) inactivated influenza vaccine by microneedle patch self-administered by study participants. A research pharmacist prepared the randomisation code using a computer-generated randomisation schedule with a block size of 4. Because of the nature of the study, participants were not masked to the type of vaccination method (ie, microneedle patch vs intramuscular injection). Primary safety outcome measures are the incidence of study product-related serious adverse events within 180 days, grade 3 solicited or unsolicited adverse events within 28 days, and solicited injection site and systemic reactogenicity on the day of study product administration through 7 days after administration, and secondary safety outcomes are new-onset chronic illnesses within 180 days and unsolicited adverse events within 28 days, all analysed by intention to treat. Secondary immunogenicity outcomes are antibody titres at day 28 and percentages of seroconversion and seroprotection, all determined by haemagglutination inhibition antibody assay. The trial is completed and registered with ClinicalTrials.gov, number NCT02438423. Findings Between June 23, 2015, and Sept 25, 2015, 100 participants were enrolled and randomly assigned to a group. There were no treatment-related serious adverse events, no treatment-related unsolicited grade 3 or higher adverse events, and no new-onset chronic illnesses. Among vaccinated groups (vaccine via health-care worker administered microneedle patch or intramuscular injection, or self-administered microneedle patch), overall incidence of solicited adverse events (n=89 vs n=73 vs n=73) and unsolicited adverse events (n=18 vs n=12 vs n=14) were similar. Reactogenicity was mild, transient, and most commonly reported as tenderness (15 [60%] of 25 participants [95% CI 39–79]) and pain (11 [44%] of 25 [24–65]) after intramuscular injection; and as tenderness (33 [66%] of 50 [51–79]), erythema (20 [40%] of 50 [26–55]), and pruritus (41 [82%] of 50 [69–91]) after vaccination by microneedle patch application. The geometric mean titres were similar at day 28 between the microneedle patch administered by a health-care worker versus the intramuscular route for the H1N1 strain (1197 [95% CI 855–1675] vs 997 [703–1415]; p=0·5), the H3N2 strain (287 [192–430] vs 223 [160–312]; p=0·4), and the B strain (126 [86–184] vs 94 [73–122]; p=0·06). Similar geometric mean titres were reported in participants who self-administered the microneedle patch (all p>0·05). The seroconversion percentages were significantly higher at day 28 after microneedle patch vaccination compared with placebo (all p<0·0001) and were similar to intramuscular injection (all p>0·01). Interpretation Use of dissolvable microneedle patches for influenza vaccination was well tolerated and generated robust antibody responses.

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