Fadlyana Eddy, Rusmil Kusnandi, Dwi Putra Muhammad Gilang, Fulendry Frizka Primadewi, Somantri Nitta Kurniati, Putri Alvira Dwilestarie, Sari Rini Mulia, Puspita Mita, Dewi Gianita Puspita
Clinical Research Unit, Growth and Development-Social Pediatrics Division, Department of Child Health, Faculty of Medicine, Universitas Padjadjaran, Hasan Sadikin Hospital, Bandung 40161, Indonesia.
Garuda Primary Health Care Centres, Bandung City Health Service, Bandung 40161, Indonesia.
Vaccines (Basel). 2024 Aug 22;12(8):938. doi: 10.3390/vaccines12080938.
Adolescents are vulnerable to Coronavirus disease 2019 (COVID-19) infections; thus, their antibodies should be maintained above the protective value. This study aimed to evaluate the immune response and safety to the SARS-CoV-2 protein subunit recombinant vaccine (IndoVac) as a heterologous booster dose against COVID-19 in Indonesian adolescents. This open-label prospective intervention study enrolled 150 clinically healthy adolescents aged 12-17 years who had received complete primary doses of the CoronaVac vaccine from Garuda Primary Care Centres in Bandung City. The result of immunogenicity was presented with a 95% confidence interval (CI) and analyzed with -tests from 14 days and 3, 6, and 12 months. The neutralizing antibody geometric mean titers (GMTs) (IU/mL) at baseline and 14 days after booster dose were 303.26 and 2661.2, respectively. The geometric mean fold rises (GMFR) at 3, 6, and 12 months after booster dose were 6.67 (5.217-8.536), 3.87 (3.068-4.886), and 2.87 (2.232-3.685), respectively. Both the neutralizing antibody and IgG antibody were markedly higher in the adolescents than in the adults at every timepoint. The incidence rate of adverse effects (AEs) until 28 days after booster dose was 82.7%, with a higher number of local events reported. Most reported solicited AEs were local pain followed by myalgia with mild intensity. Unsolicited AEs varied with each of the incidence rates < 10%, mostly with mild intensity. Adverse events of special interest (AESI) were not observed. At the 12-month follow-up after the booster dose, four serious adverse events (SAEs) not related to investigational products and research procedures were noted. This study showed that IndoVac has a favorable immunogenicity and safety profile as a booster in adolescents and that the antibody titer decreases over time.
青少年易感染2019冠状病毒病（COVID-19）；因此，他们的抗体应维持在保护值以上。本研究旨在评估SARS-CoV-2蛋白亚单位重组疫苗（IndoVac）作为异源加强剂量对印度尼西亚青少年COVID-19的免疫反应和安全性。这项开放标签的前瞻性干预研究招募了150名年龄在12至17岁之间、临床健康的青少年，他们从万隆市的鹰航初级保健中心接受了完整的科兴疫苗（CoronaVac）初免剂量。免疫原性结果以95%置信区间（CI）呈现，并在14天以及3、6和12个月时进行t检验分析。加强剂量前基线和14天后的中和抗体几何平均滴度（GMTs）（IU/mL）分别为303.26和2661.2。加强剂量后3、6和12个月时的几何平均倍数增长（GMFR）分别为6.67（5.217 - 8.536）、3.87（3.068 - 4.886）和2.87（2.232 - 3.685）。在每个时间点，青少年的中和抗体和IgG抗体均明显高于成年人。加强剂量后直至28天的不良反应（AE）发生率为82.7%（报告的局部事件较多）。大多数报告预期的AE为局部疼痛，其次是轻度肌痛。非预期AE的发生率各不相同，均<10%，大多为轻度。未观察到特别关注的不良事件（AESI）。在加强剂量后的12个月随访中，记录到4起与研究产品和研究程序无关的严重不良事件（SAE）。本研究表明，IndoVac作为青少年的加强疫苗具有良好的免疫原性和安全性，且抗体滴度会随时间下降。
