Maddeppungeng Martira, Nurdin Asrawati, Nency Yetty Movieta, Sekartini Rini, Medise Bernie Endyarni, Soedjatmiko Soedjatmiko, Massi Muh Nasrum, Darma Sidrah, Darussalam Andi Husni Esa, Ramadhani Nur, Hidayah Najdah, Chalid Maisuri Tadjuddin, Ramadany Sri, Wahyuni Sitti, Djaharuddin Irawaty, Santoso Arif, Fikri Bahrul, Alimuddin Suriani, Pelupessy Ninny Meutia, Masadah Rina, Putri Azka Zhafira, Setyaningsih Lilis, Yani Finny Fitry, Anggrainy Fenty, Deza Putri Awaliyah, Maharani Nani, Mahati Endang, Hapsari Rebriarina, Farhanah Nur, Pramudo Setyo Gundi, Tri Anantyo Dimas
Department of Pediatrics, Dr. Wahidin Sudirohusodo Hospital, Makassar, Indonesia.
Department of Pediatrics, Faculty of Medicine, Universitas Hasanuddin, Makassar, Indonesia.
Hum Vaccin Immunother. 2024 Dec 31;20(1):2429231. doi: 10.1080/21645515.2024.2429231. Epub 2024 Dec 5.
Globally, dozens of COVID-19 vaccines are licensed under emergency or conditional authorization, but especially in low and middle-income countries, their availability varies. Indonesia decided to become independent and produce its own vaccines locally. This study investigated the safety and immunogenicity of a SARS-CoV-2 recombinant protein subunit vaccine adjuvanted with Alum + CpG 1018. This study involved 360 adults aged 18 years and above. It compared two vaccine dosages, a-12.5 µg and a 25-µg dose of receptor binding domain protein, to a placebo (1:1:1). A total of 40.6% of participants in this study experienced at least one adverse event (AE), with most being mild. There was no statistically significant difference in AEs between the groups. The microneutralization test showed the highest neutralizing antibody titer (IU/mL) in the 25 µg dose vaccine group at day 28 after the second dose (3,300 95%CI 2,215-4,914), although it was not statistically different from the 12.5 µg dose group (3,157 95%CI 2,135-4,669). Similarly, IgG antibody concentrations in the 25 µg dose vaccine group at day 28 were the highest compared to the 12.5 µg dose and placebo. According to protocol, only the formulation with the better antibody profile and comparable reactogenicity was further evaluated at months three and six. Thus, follow-up was only performed for the 25 µg dose vaccine, demonstrating antibody persistence at month six and had a favorable safety profile. These results position this SARS-CoV-2 recombinant protein subunit vaccine adjuvanted with Alum + CpG 1018 as a promising candidate to fight against COVID-19.
在全球范围内，数十种新冠疫苗已获得紧急或有条件授权许可，但尤其是在低收入和中等收入国家，这些疫苗的可及性各不相同。印度尼西亚决定实现自主，在当地生产自己的疫苗。本研究调查了一种佐以明矾+ CpG 1018的新冠重组蛋白亚单位疫苗的安全性和免疫原性。本研究纳入了360名18岁及以上的成年人。研究将两种疫苗剂量（12.5μg和25μg的受体结合域蛋白剂量）与一种安慰剂进行了比较（比例为1:1:1）。本研究中共有40.6%的参与者经历了至少一次不良事件（AE），大多数为轻度。各组之间的不良事件无统计学显著差异。微量中和试验显示，在第二剂接种后第28天，25μg剂量疫苗组的中和抗体滴度（IU/mL）最高（3300，95%置信区间2215 - 4914），尽管与12.5μg剂量组（3157，95%置信区间2135 - 4669）无统计学差异。同样，与12.5μg剂量组和安慰剂相比，25μg剂量疫苗组在第28天的IgG抗体浓度最高。根据方案，仅对抗体谱更好且反应原性相当的制剂在第3个月和第6个月进行了进一步评估。因此，仅对25μg剂量疫苗进行了随访，结果显示在第6个月抗体持续存在且安全性良好。这些结果表明，这种佐以明矾+ CpG 1018的新冠重组蛋白亚单位疫苗是对抗新冠的一个有前景的候选疫苗。
