Koen Anthonet, Madhi Shabir, Lyabis Olga, Vidor Emmanuel, Cowper Beverley, Marais Thinus, Patel Dhaval, Vigne Claire
Medical Research Council: Vaccines and Infectious Diseases Analytical Research Unit, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa.
Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa.
Hum Vaccin Immunother. 2021 Jun 3;17(6):1770-1778. doi: 10.1080/21645515.2020.1839289. Epub 2020 Dec 16.
Human immunodeficiency virus (HIV)-exposed infants may be at increased risk of vaccine-preventable disease. This study was conducted as a post-licensure commitment in this population to evaluate the primary series, antibody persistence, and booster response to a licensed fully liquid hexavalent vaccine containing diphtheria (D), tetanus (T), acellular pertussis (aP), inactivated poliovirus (IPV), hepatitis B (HB), and type b antigens (PRPT). This was a Phase III, open-label, randomized study conducted at a single center in the Republic of South Africa. The DTaP-IPV-HB-PRPT vaccine was administered to HIV-exposed infected (Group A: N = 14) and HIV-exposed uninfected (Group B: N = 50) infants as a 6, 10, 14 week primary series with a toddler booster at 15-18 months of age. Immunogenicity of each antigen was measured using validated assays and vaccine reactogenicity was recorded using diary cards. The low number of HIV-exposed infected participants, due to widespread pre- and peri-natal retroviral treatment, meant that between-group comparisons should be treated with caution. In each group, primary series and booster immune seroprotection rates were strong, and pre-booster antibody persistence was good, although anti-HBs ≥10 mIU/mL in Group A was 78.6% post-primary series, 58.3% pre-booster, and 75.0% post-booster. There were no safety concerns. In conclusion, primary series and booster vaccination of the DTaP-IPV-HB-PRP~T vaccine were immunogenic and safe in HIV-exposed infected and uninfected infants. These results were comparable to historical data in healthy infants and toddlers.
暴露于人类免疫缺陷病毒（HIV）的婴儿罹患疫苗可预防疾病的风险可能会增加。本研究作为针对这一人群的上市后承诺开展，旨在评估一种含白喉（D）、破伤风（T）、无细胞百日咳（aP）、灭活脊髓灰质炎病毒（IPV）、乙型肝炎（HB）和b型抗原（PRP-T）的已获许可的全液体制剂六价疫苗的基础免疫程序、抗体持久性及加强免疫反应。这是一项在南非共和国一个中心进行的III期开放标签随机研究。DTaP-IPV-HB-PRP-T疫苗作为基础免疫程序在6、10、14周龄时接种于暴露于HIV的感染婴儿（A组：N = 14）和暴露于HIV的未感染婴儿（B组：N = 50），并在15 - 18月龄时进行幼儿加强免疫。使用经过验证的检测方法测量每种抗原的免疫原性，并使用日记卡记录疫苗的反应原性。由于广泛的产前和围产期抗逆转录病毒治疗，暴露于HIV的感染参与者数量较少，这意味着组间比较应谨慎对待。在每组中，基础免疫程序和加强免疫的免疫血清保护率都很高，加强免疫前抗体持久性良好，尽管A组中抗-HBs≥10 mIU/mL在基础免疫程序后为78.6%，加强免疫前为58.3%，加强免疫后为75.0%。未发现安全问题。总之，DTaP-IPV-HB-PRP-T疫苗的基础免疫程序和加强免疫在暴露于HIV的感染和未感染婴儿中具有免疫原性且安全。这些结果与健康婴幼儿的历史数据相当。
