甲型肝炎和水痘疫苗在南非暴露于HIV但未感染及未暴露于HIV儿童中的短期免疫原性和安全性

Short-term immunogenicity and safety of hepatitis-A and varicella vaccines in HIV-exposed uninfected and HIV-unexposed South African children.

作者信息

Mutsaerts Eleonora A M L, Nunes Marta C, Bhikha Sutika, Ikulinda Benit T, Jose Lisa, Koen Anthonet, Moultrie Andrew, Grobbee Diederick E, Klipstein-Grobusch Kerstin, Weinberg Adriana, Madhi Shabir A

机构信息

Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.

出版信息

Vaccine. 2020 May 8;38(22):3862-3868. doi: 10.1016/j.vaccine.2020.03.045. Epub 2020 Apr 16.

DOI:10.1016/j.vaccine.2020.03.045

PMID:32307279

Abstract

BACKGROUND

HIV-exposed uninfected (HEU) children have increased risk of infectious morbidity during early childhood. We evaluated the short-term immunogenicity and safety of single dose inactivated hepatitis-A virus (HAV) vaccine and live attenuated varicella zoster virus (VZV) vaccine in South African children.

METHODS

195 HIV-unexposed and 64 HEU children received either one dose of HAV or VZV vaccine at 18 months of age. Blood samples were tested for hepatitis-A or VZV antibodies before and one month after vaccination by chemiluminescent microparticle immunoassay and enzyme-linked immunosorbent assay, respectively. All children were evaluated for solicited adverse events (AEs).

RESULTS

One-month post-vaccination, a similar percentage of HIV-unexposed (91.8%) and HEU (82.9%) children were seropositive for hepatitis-A (p = 0.144). VZV antibody geometric mean fold-rise was also similar in HIV-unexposed (5.6; 95%CI: 4.6-6.7) and HEU children (5.1; 95%CI: 3.7-7.2); however, only 44% HIV-unexposed and HEU seroconverted (titers > 50 mIU/ml). AEs occurred with similar frequency and severity between groups, except for more systemic AEs after VZV vaccination in HEU than HIV-unexposed children.

CONCLUSIONS

Single dose HAV and VZV vaccine was similarly immunogenic in HIV-unexposed and HEU children. We did not identify differences in short-term humoral immunity after administration of either a live attenuated or inactivated vaccine. Seroconversion rates after a single dose of VZV vaccine were, however, lower compared to reports from previous studies (85-89%).

CLINICAL TRIALS REGISTRATION

NCT03330171.

摘要

背景

暴露于HIV但未感染（HEU）的儿童在幼儿期感染性疾病发病风险增加。我们评估了单剂量甲型肝炎病毒（HAV）灭活疫苗和水痘带状疱疹病毒（VZV）减毒活疫苗在南非儿童中的短期免疫原性和安全性。

方法

195名未暴露于HIV的儿童和64名HEU儿童在18个月龄时接种了一剂HAV或VZV疫苗。分别在接种前和接种后1个月通过化学发光微粒免疫分析和酶联免疫吸附测定检测血样中的甲型肝炎或VZV抗体。对所有儿童进行了预期不良事件（AE）评估。

结果

接种疫苗1个月后，未暴露于HIV的儿童（91.8%）和HEU儿童（82.9%）中甲型肝炎血清阳性的比例相似（p = 0.144）。未暴露于HIV的儿童（5.6；95%CI：4.6 - 6.7）和HEU儿童（5.1；95%CI：3.7 - 7.2）中VZV抗体几何平均倍数升高也相似；然而，未暴露于HIV的儿童和HEU儿童中只有44%发生血清转化（滴度>50 mIU/ml）。两组间AE的发生频率和严重程度相似，但HEU儿童接种VZV疫苗后发生的全身性AE比未暴露于HIV的儿童更多。