da Cunha Rosa Luana Rocha, Brandão Leyla Gabriela Verner Amaral, Moura Winny Éveny Alves, Campos Lays Rosa, Pessoni Grécia Carolina, de Oliveira Roque E Lima Juliana, de Moraes José Cássio, Dos Santos Carneiro Megmar Aparecida, Teles Sheila Araújo, Caetano Karlla Antonieta Amorim
Faculty of Nursing, Federal University of Goias, Goiânia 74605-080, GO, Brazil.
Municipal Health Secretariat, Goiânia 74884-900, GO, Brazil.
Vaccines (Basel). 2023 Mar 5;11(3):597. doi: 10.3390/vaccines11030597.
Universal immunization against hepatitis B has contributed to reducing incidence of the disease, but older individuals remain susceptible to acquiring the hepatitis B virus worldwide. Thus, this study aimed to investigate the epidemiology of HBV infection in individuals aged 50 years and over in central Brazil and to evaluate the immunogenicity of the monovalent vaccine against hepatitis B in this age group using two vaccine regimens.
Initially, a cross-sectional and analytical study was carried out to investigate the epidemiology of hepatitis B. Then, individuals without proof of vaccination for hepatitis B were recruited for a phase IV randomized and controlled clinical trial using two vaccine regimens: Intervention Regimen (IR) (three doses of 40 μg at months 0, 1 and 6) vs. Comparison Regimen (CR) (three doses of 20 μg at months 0, 1 and 6).
The overall prevalence of exposure to HBV was 16.6% (95% CI: 14.0%-9.5%). In the clinical trial, statistical differences in protective titers were observed ( = 0.007; IR 96% vs. CR 86%) and the geometric mean of anti-HBs titers was higher in individuals who received the IR (518.2 mIU/mL vs. 260.2 mIU/mL). In addition, the proportion of high responders was higher among those who received the IR (65.3%).
reinforced doses should be used in individuals aged 50 years or older to overcome the lower efficacy of the vaccine against hepatitis B.
全球乙肝普遍免疫接种有助于降低该疾病的发病率,但在全球范围内,老年人仍易感染乙肝病毒。因此,本研究旨在调查巴西中部50岁及以上人群中乙肝病毒感染的流行病学情况,并使用两种疫苗接种方案评估该年龄组单价乙肝疫苗的免疫原性。
首先,开展了一项横断面分析研究以调查乙肝的流行病学情况。然后,招募未接种乙肝疫苗的个体进行IV期随机对照临床试验,使用两种疫苗接种方案:干预方案(IR)(在第0、1和6个月各接种三剂40μg)与对照方案(CR)(在第0、1和6个月各接种三剂20μg)。
乙肝病毒暴露的总体患病率为16.6%(95%可信区间:14.0%-9.5%)。在临床试验中,观察到了保护性抗体滴度的统计学差异(P=0.007;IR为96%,CR为86%),接受IR方案的个体中抗-HBs抗体滴度的几何平均值更高(518.2mIU/mL对260.2mIU/mL)。此外,接受IR方案的个体中高应答者的比例更高(65.3%)。
对于50岁及以上的个体,应使用加强剂量以克服乙肝疫苗较低的效力。