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Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study

BACKGROUND: 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. METHODS: This was an observer-blind, randomised, phase 2/3...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9833646/
https://www.ncbi.nlm.nih.gov/pubmed/36647543
http://dx.doi.org/10.1016/j.lansea.2022.100139
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author 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
author_facet 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
author_sort Kulkarni, Prasad S.
collection PubMed
description BACKGROUND: 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. METHODS: 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. Trial registration: CTRI/2021/02/031554. FINDINGS: 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. INTERPRETATION: SII-NVX-CoV2373 induced a non-inferior immune response compared to NVX-CoV2373 and has acceptable safety profile. FUNDING: SIIPL, 10.13039/501100001411Indian Council of Medical Research, 10.13039/100014101Novavax.
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spelling pubmed-98336462023-01-12 Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study 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 Lancet Reg Health Southeast Asia Articles BACKGROUND: 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. METHODS: 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. Trial registration: CTRI/2021/02/031554. FINDINGS: 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. INTERPRETATION: SII-NVX-CoV2373 induced a non-inferior immune response compared to NVX-CoV2373 and has acceptable safety profile. FUNDING: SIIPL, 10.13039/501100001411Indian Council of Medical Research, 10.13039/100014101Novavax. Elsevier 2023-01-11 /pmc/articles/PMC9833646/ /pubmed/36647543 http://dx.doi.org/10.1016/j.lansea.2022.100139 Text en © 2022 The Author(s) https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Articles
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
Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study
title Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study
title_full Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study
title_fullStr Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study
title_full_unstemmed Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study
title_short Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study
title_sort safety and immunogenicity of sii-nvx-cov2373 (covid-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study
topic Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9833646/
https://www.ncbi.nlm.nih.gov/pubmed/36647543
http://dx.doi.org/10.1016/j.lansea.2022.100139
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