Sayad Babak, Vazirian Armin, Bozorgomid Arezoo, Sayad Nazanin, Janbakhsh Alireza, Afsharian Mandana, Mansouri Feizollah, Vaziri Siavash, Rezaeian Shahab, Gholizadeh Maryam
Infectious Diseases Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.
Clinical Research Development Center, Imam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran.
New Microbes New Infect. 2023 May 16;53:101141. doi: 10.1016/j.nmni.2023.101141. eCollection 2023 Jun.
Healthcare workers are at risk for HBV infection through percutaneous or mucosal contact with infected blood, body secretions, or blood products or via sharps injury. Hepatitis B vaccination, despite immunogenicity, may not induce a proper immune response in 5-10% of the general adult population. Increased immune response in healthcare providers that do not respond properly to conventional hepatitis B vaccination is an important health challenge. Therefore, the aim of the present study was to evaluate the effectiveness of hepatitis B vaccination plus oral levamisole as adjuvant in healthcare providers non-responsive to routine vaccination.
The healthcare workers that were non-responsive to previous hepatitis B vaccination were enrolled in a double-blind randomized placebo-controlled clinical trial. The participants were then randomized to two groups including hepatitis B vaccination (as a three-dose series on a 0, 1, and 2-month schedule in the deltoid muscle) plus levamisole (levamisole group) and hepatitis B vaccination plus placebo (placebo group) at a 1:1 ratio. The outcome measure was the HBs antibody titer one month after receiving each dose as well as the seroprotection ratio. The side effects were also evaluated in all participants.
In total, 22 subjects finished the trial (11 individual in per group). The median antibody titer one month after receiving the first and third doses increased more in the levamisole group compared to the placebo group but the difference was not significant (p = 0.34, p = 0.66, respectively).The seroprotection ratio after three doses was similarly high in both groups (90.9% in per group). Furthermore, the seroprotection ratio and median antibody titer had no significant correlation with age, sex, BMI, and history of smoking in intervention and control groups (p>0.05). No serious side effects were noted in both groups.
Re-vaccination can boost the immune response in healthcare professionals that were non-responsive to previous vaccination although the mean antibody titer was higher in the levamisole group.
医护人员存在通过经皮或黏膜接触感染血液、体液或血液制品，或因锐器伤而感染乙肝病毒（HBV）的风险。尽管乙肝疫苗具有免疫原性，但在5% - 10%的普通成年人群中可能无法诱导出适当的免疫反应。对常规乙肝疫苗无适当反应的医护人员中提高免疫反应是一项重要的健康挑战。因此，本研究的目的是评估乙肝疫苗接种加口服左旋咪唑作为佐剂对常规疫苗接种无反应的医护人员的有效性。
对之前乙肝疫苗接种无反应的医护人员纳入一项双盲随机安慰剂对照临床试验。然后将参与者按1:1的比例随机分为两组，一组为乙肝疫苗接种（在三角肌按0、1、2月的时间表进行三剂次接种）加左旋咪唑（左旋咪唑组），另一组为乙肝疫苗接种加安慰剂（安慰剂组）。观察指标为每次接种后1个月的乙肝表面抗体（HBs）滴度以及血清保护率。同时对所有参与者的副作用进行评估。
共有22名受试者完成试验（每组11名）。与安慰剂组相比，左旋咪唑组在接种第一剂和第三剂后1个月的抗体滴度中位数升高更多，但差异无统计学意义（分别为p = 0.34，p = 0.66）。两组三剂次接种后的血清保护率同样高（每组均为90.9%）。此外，干预组和对照组的血清保护率及抗体滴度中位数与年龄、性别、体重指数（BMI）和吸烟史均无显著相关性（p>0.05）。两组均未观察到严重副作用。
再次接种疫苗可增强对之前接种无反应医护人员的免疫反应，尽管左旋咪唑组的平均抗体滴度更高。
