Biological E Limited, 18/1&3, Azamabad, Hyderabad 500 020, Telangana, India.
Biological E Limited, 18/1&3, Azamabad, Hyderabad 500 020, Telangana, India.
Vaccine. 2022 Nov 22;40(49):7130-7140. doi: 10.1016/j.vaccine.2022.10.045. Epub 2022 Oct 31.
After establishing safety and immunogenicity of Biological-E's CORBEVAX™ vaccine in adult population (18-80 years) in Phase 1-3 studies, vaccine is further tested in children and adolescents in this study.
This is a phase-2/3 prospective, randomised, double-blind, placebo-controlled study evaluating safety, reactogenicity, tolerability and immunogenicity of CORBEVAX™ vaccine in children and adolescents of either gender between <18 to ≥12 years of age in Phase-2 and <18 to ≥5 years of age in Phase-Phase-2/Phase-3 with placebo as a control. This study has two age sub-groups; subgroup-1 with subjects <18 to ≥12 years of age and subgroup-2 with subjects <12 to ≥5 years of age. In both sub groups, eligible subjects (SARS-CoV-2 RT-PCR negative and seronegative at baseline) were randomized to receive either CORBEVAX™ vaccine or Placebo in 3:1 ratio.
The safety profile of CORBEVAX™ vaccine in both pediatric cohorts was comparable to the placebo-control group. Majority of reported adverse events (AEs) were mild in nature. No severe or serious-AEs, medically attended AEs (MAAEs) or AEs of special interest (AESI) were reported during the study period and all reported AEs resolved without any sequelae. In both pediatric age groups, CORBEVAX™ vaccinated subjects showed significant improvement in humoral immune-responses in terms of anti-RBD-IgG concentrations, anti-RBD-IgG1 titers, neutralizing-antibody (nAb)-titers against Ancestral-Wuhan and Delta-strains. Significantly high interferon-gamma immune- response (cellular) was elicited by CORBEVAX™ vaccinated subjects with minimal effect on IL-4 cytokine secretion.
The safety profile of CORBEVAX™ vaccine in <18 to ≥5 years' children and adolescents was found to be safe and tolerable. Significant increase in anti-RBD-IgG and nAb-titers and IFN-gamma immune-responses were observed post-vaccination in both pediatric age sub-groups. The nAb titers observed in both the pediatric age cohorts were non-inferior to the adult cohort (BECT069 study) in terms of ratio of the GMT's of both the cohorts. This study shows that CORBEVAX™ vaccine is highly immunogenic and can be safely administered to pediatric population as young as 5 years old. The study was prospectively registered with clinical trial registry of India- CTRI/2021/10/037066.
在 1 期至 3 期研究中，生物制药公司的 CORBEVAX™疫苗在成年人群（18-80 岁）中已确立安全性和免疫原性，在此研究中进一步在儿童和青少年中进行疫苗测试。
这是一项 2/3 期、前瞻性、随机、双盲、安慰剂对照研究，评估 CORBEVAX™疫苗在 2 期年龄组<18 至≥12 岁和 3 期年龄组<18 至≥5 岁的儿童和青少年中的安全性、反应原性、耐受性和免疫原性，以安慰剂作为对照。本研究有两个年龄亚组；亚组 1 为<18 至≥12 岁的受试者，亚组 2 为<12 至≥5 岁的受试者。在两个亚组中，合格的受试者（SARS-CoV-2 RT-PCR 阴性且基线时血清学阴性）按 3:1 的比例随机接受 CORBEVAX™疫苗或安慰剂。
CORBEVAX™疫苗在两个儿科队列中的安全性与安慰剂对照组相当。大多数报告的不良事件（AE）性质为轻度。研究期间未报告严重或严重 AEs、需要医疗处理的 AEs（MAAEs）或特殊关注的 AEs（AESI），所有报告的 AEs 均已解决，无任何后遗症。在两个儿科年龄组中，CORBEVAX™接种的受试者在体液免疫反应方面均显示出显著改善，表现在抗 RBD-IgG 浓度、抗 RBD-IgG1 滴度、针对原始武汉和 Delta 株的中和抗体（nAb）滴度方面。CORBEVAX™接种的受试者引起了高水平的干扰素-γ免疫反应（细胞），而对白细胞介素-4 细胞因子的分泌影响最小。
CORBEVAX™疫苗在<18 至≥5 岁儿童和青少年中的安全性和耐受性良好。在两个儿科年龄亚组中，接种疫苗后均可观察到抗 RBD-IgG 和 nAb 滴度以及 IFN-γ 免疫反应显著增加。在这两个儿科年龄队列中观察到的 nAb 滴度与成人队列（BECT069 研究）相比，在两组 GMT 的比值方面非劣效。这项研究表明，CORBEVAX™疫苗具有高度免疫原性，可安全地用于 5 岁以下的儿童人群。该研究已在印度临床试验注册中心（CTRI）前瞻性注册，注册号为 CTRI/2021/10/037066。
