Kulkarni Prasad S, Kadam Abhijit, Godbole Sheela, Bhatt Varsha, Raut Abhishek, Kohli Sunil, Tripathi Santanu, Kulkarni Praveen, Ludam Rakhi, Prabhu Madhav, Bavdekar Ashish, Gogtay Nithya J, Meshram Sushant, Kadhiravan Tamilarasu, Kar Sonali, Narayana D H Ashwath, Samuel Clarence, Kulkarni Govind, Gaidhane Abhay, Sathyapalan Dipu, Raut Sidram, Hadda Vijay, Bhalla Hira Lal, Bhamare Chetanraj, Dharmadhikari Abhijeet, Plested Joyce S, Cloney-Clarke Shane, Zhu Mingzhu, Pryor Melinda, Hamilton Stephanie, Thakar Madhuri, Shete Ashwini, Gautam Manish, Gupta Nivedita, Panda Samiran, Shaligram Umesh, Poonawalla Cyrus S, Bhargava Balram, Gunale Bhagwat, Kapse Dhananjay
Serum Institute of India Pvt Ltd, Pune, India.
Indian Council of Medical Research-National AIDS Research Institute, Pune, India.
Lancet Reg Health Southeast Asia. 2023 Mar;10:100139. doi: 10.1016/j.lansea.2022.100139. Epub 2023 Jan 11.
NVX-CoV2373, a Covid-19 vaccine was developed in the USA with ∼90% efficacy. The same vaccine is manufactured in India after technology transfer (called as SII-NVX-CoV2373), was evaluated in this phase 2/3 immuno-bridging study.
This was an observer-blind, randomised, phase 2/3 study in 1600 adults. In phase 2, 200 participants were randomized 3:1 to SII-NVX-CoV2373 or placebo. In phase 3, 1400 participants were randomized 3:1 to SII-NVX-CoV2373 or NVX-CoV2373 (940 safety cohort and 460 immunogenicity cohort). Two doses of study products (SII-NVX-CoV2373, NVX-CoV2373 or placebo) were given 3 weeks apart. Primary objectives were to demonstrate non-inferiority of SII-NVX-CoV2373 to NVX-CoV2373 in terms of geometric mean ELISA units (GMEU) ratio of anti-S IgG antibodies 14 days after the second dose (day 36) and to determine the incidence of causally related serious adverse events (SAEs) through 180 days after the first dose. Anti-S IgG response was assessed using an Enzyme-Linked Immunosorbent Assay (ELISA) and neutralizing antibodies (nAb) were assessed by a microneutralization assay using wild type SARS CoV-2 in participants from the immunogenicity cohort at baseline, day 22, day 36 and day 180. Cell mediated immune (CMI) response was assessed in a subset of 28 participants from immunogenicity cohort by ELISpot assay at baseline, day 36 and day 180. The total follow-up was for 6 months. CTRI/2021/02/031554.
Total 1596 participants (200 in Phase 2 and 1396 in Phase 3) received the first dose. SII-NVX-CoV2373 was found non-inferior to NVX-CoV2373 (anti-S IgG antibodies GMEU ratio 0.91; 95% CI: 0.79, 1.06). At day 36, there was more than 58-fold rise in anti-S IgG and nAb titers compared to baseline in both the groups. On day 180 visit, these antibody titers declined to levels slightly lower than those after the first dose (13-22 fold-rise above baseline). Incidence of unsolicited and solicited AEs was similar between the SII-NVX-CoV2373 and NVX-CoV2373 groups. No adverse event of special interest (AESI) was reported. No causally related SAE was reported.
SII-NVX-CoV2373 induced a non-inferior immune response compared to NVX-CoV2373 and has acceptable safety profile.
SIIPL, Indian Council of Medical Research, Novavax.
NVX-CoV2373是一种在美国研发的新冠疫苗，有效率约为90%。该疫苗经技术转让后在印度生产（称为SII-NVX-CoV2373），在这项2/3期免疫桥接研究中进行了评估。
这是一项针对1600名成年人的观察者盲法、随机、2/3期研究。在2期，200名参与者按3:1随机分配至SII-NVX-CoV2373组或安慰剂组。在3期，1400名参与者按3:1随机分配至SII-NVX-CoV2373组或NVX-CoV2373组（940名安全性队列和460名免疫原性队列）。研究产品（SII-NVX-CoV2373、NVX-CoV2373或安慰剂）分两剂，间隔3周给药。主要目标是在第二剂接种后14天（第36天）证明SII-NVX-CoV2373在抗S IgG抗体几何平均酶联免疫吸附测定单位（GMEU）比值方面不劣于NVX-CoV2373，并确定首剂接种后180天内因果相关严重不良事件（SAE）的发生率。使用酶联免疫吸附测定（ELISA）评估抗S IgG反应，在基线、第22天、第36天和第180天，通过使用野生型SARS-CoV-2的微量中和试验评估免疫原性队列参与者的中和抗体（nAb）。在免疫原性队列的28名参与者亚组中，通过ELISpot试验在基线、第36天和第180天评估细胞介导免疫（CMI）反应。总随访期为6个月。CTRI/2021/02/031554。
共有1596名参与者（2期200名，3期1396名）接种了首剂。发现SII-NVX-CoV2373不劣于NVX-CoV2373（抗S IgG抗体GMEU比值为0.91；95%置信区间：0.79，1.06）。在第36天，两组的抗S IgG和nAb滴度相比基线均升高了58倍以上。在第180天随访时，这些抗体滴度降至略低于首剂后的水平（比基线升高13 - 22倍）。SII-NVX-CoV2373组和NVX-CoV2373组之间自发和诱发不良事件的发生率相似。未报告特殊关注不良事件（AESI）。未报告因果相关SAE。
与NVX-CoV2373相比，SII-NVX-CoV2373诱导的免疫反应不劣且具有可接受的安全性。
SIIPL、印度医学研究理事会、诺瓦瓦克斯公司。
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