严重急性呼吸综合征冠状病毒2（SARS-CoV-2）蛋白亚单位重组疫苗（IndoVac）作为印度尼西亚成年人新冠病毒病加强针的免疫原性和安全性
Immunogenicity and Safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (IndoVac) as a Booster Dose against COVID-19 in Indonesian Adults.
作者信息
Rusmil Kusnandi, Fadlyana Eddy, Girsang Rodman Tarigan, Adrizain Riyadi, Reza Rahmadi Andri, Suryadinata Hendarsyah, Dwi Putra Muhammad Gilang, Fulendry Frizka Primadewi, Nashsyah Dinda Tiaraningrum, Utami Rona Kania, Zahra Mardiah Behesti, Trisna Windiani I Gusti Ayu, Sugitha Adnyana I Gusti Agung Ngurah, Sukma Pratiwi Murti Ni Luh, Agus Somia I Ketut, Utama I Made Susila, Soetjiningsih Soetjiningsih, Mutiara Ulfa Luthfiani Nurkamila, Puspita Mita
机构信息
Department of Child Health, Faculty of Medicine, Universitas Padjadjaran/Hasan Sadikin Hospital, Bandung 40161, Indonesia.
Department of Internal Medicine, Faculty of Medicine, Universitas Padjadjaran/Hasan Sadikin Hospital, Bandung 40161, Indonesia.
出版信息
Vaccines (Basel). 2024 May 14;12(5):540. doi: 10.3390/vaccines12050540.
According to the WHO target product profile for COVID-19 vaccines, the vaccine in development should be indicated for active immunisation in all populations. Therefore, PT Bio Farma developed a candidate vaccine in a subunit protein recombinant platform to help overcome the issue. This trial was an observer-blind, randomised, prospective intervention study. This study targeted individuals who had received complete primary doses of the authorised/approved COVID-19 vaccine. The groups were divided into the primary inactivated vaccine (CoronaVac) group, the primary viral vector vaccine (ChAdOx1) group, and the primary mRNA vaccine (BNT162b2) group that received the recombinant protein (IndoVac). The groups were compared with the control and primary mRNA vaccine (BNT162b2). The participants enrolled in the study were from two primary care centres in Bandung City and three primary care centres in Denpasar City. A total of 696 participants were enrolled from 1 September to 31 October 2022. The demographic characteristics of the all-vaccine group showed a uniform distribution. The results showed that, compared with the control, the investigational product had inferior effectiveness 14 days after the booster dose was administered. However, 28 days after the booster dose, the investigational product exhibited non-inferior effectiveness compared with the primary groups that received CoronaVac (GMR 0.76 (0.57-0.99)) and ChAdOx1 (GMR 0.72 (0.56-59.93)), but the BNT162b2 group (GMR 0.61 (0.39-0.94)) was inferior to the control. At 12 months follow-up after the booster dose, three serious adverse events (SAEs) were reported in three participants, with causality not correlated with the investigated products. Neither AEs of special interest nor severe COVID-19 cases were reported throughout the follow-up period; thus, the IndoVac vaccine as a booster was immunogenic and safe. Until the 6-month follow-up after the booster dose, the IndoVac vaccine was well tolerated and all reported AEs resolved. This vaccine is registered and can be included in the immunisation programme.
根据世界卫生组织（WHO）针对新冠疫苗的目标产品概况，正在研发的疫苗应适用于所有人群的主动免疫。因此，印尼国营制药公司（PT Bio Farma）在亚单位蛋白重组平台上研发了一种候选疫苗，以帮助解决这一问题。该试验是一项观察者盲法、随机、前瞻性干预研究。本研究的对象是已接种完授权/批准的新冠疫苗基础剂量的个体。这些组被分为基础灭活疫苗（科兴疫苗）组、基础病毒载体疫苗（ChAdOx1）组和基础mRNA疫苗（BNT162b2）组，这三组都接种了重组蛋白（印尼疫苗）。将这些组与对照组和基础mRNA疫苗（BNT162b2）组进行比较。参与该研究的受试者来自万隆市的两个初级保健中心和登巴萨市的三个初级保健中心。2022年9月1日至10月31日期间，共有696名受试者入组。所有疫苗组的人口统计学特征显示分布均匀。结果表明，与对照组相比，在接种加强剂量14天后，研究产品的有效性较差。然而，在接种加强剂量28天后，与接种科兴疫苗（GMR 0.76（0.57 - 0.99））和ChAdOx1（GMR 0.72（0.56 - 59.93））的基础组相比，研究产品显示出非劣效性有效性，但BNT162b2组（GMR 0.61（0.39 - 0.94））比对照组差。在接种加强剂量后的12个月随访中，三名受试者报告了三起严重不良事件（SAE），其因果关系与研究产品无关。在整个随访期间，既未报告特别关注的不良事件，也未报告重症新冠病例；因此，作为加强针的印尼疫苗具有免疫原性且安全。直到接种加强剂量后的6个月随访时，印尼疫苗耐受性良好，所有报告的不良事件均已缓解。该疫苗已注册，可纳入免疫规划。
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