Content deleted Content added
Abrilando232 (talk | contribs) →External links: -template |
Rescuing 1 sources and tagging 0 as dead.) #IABot (v2.0.9.5) (Noxoug1 - 20085 |
||
| (22 intermediate revisions by 17 users not shown) | |||
Line 42:
}}
{{COVID-19 pandemic sidebar}}
'''SCB-2019''' is a [[protein subunit]] [[COVID-19 vaccine]]
SCB-2019 is being funded by [[Coalition for Epidemic Preparedness Innovations|CEPI]] as part of [[COVAX]]<ref name=":3">{{Cite web | vauthors = Rogers J | date = July 2021 |title=From lab to potential jab: Clover's COVID-19 vaccine story |url= https://cepi.net/news_cepi/from-lab-to-potential-jab-clovers-covid-19-vaccine-story/ |access-date=2021-07-08 |website=CEPI |language=en-US}}</ref> and has received advanced purchase orders from [[GAVI]] for 400 million doses == Medical uses ==
The vaccine was administered in 2 doses in 4 weeks.<ref>{{cite journal | vauthors = Richmond PC, Hatchuel L, Pacciarini F, Hu B, Smolenov I, Li P, Liang P, Han HH, Liang J, Clemens R | display-authors = 6 | title = Persistence of the Immune Responses and Cross-Neutralizing Activity With Variants of Concern Following 2 Doses of Adjuvanted SCB-2019 Coronavirus Disease 2019 Vaccine | journal = The Journal of Infectious Diseases | volume = 224 | issue = 10 | pages = 1699–1706 | date = November 2021 | pmid = 34480575 | pmc = 8499965 | doi = 10.1093/infdis/jiab447 | doi-access = free }}</ref>
=== Efficacy ===
In September 2021, SCB-2019 announced Phase III results showing 67.2% efficacy against all cases of COVID-19 of any degree of severity, 83.7% efficacy against moderate-to-severe disease, and 100% against hospitalisation and severe cases.<ref name=":6" /><ref name=":7" /> Additionally, the vaccine was 79% effective against all cases of [[Delta variant|Delta]]. Of the 207 cases found during the trials, 52 were from the vaccinated group and 155 from the placebo group.<ref name=":6" /> These Phase II/III results have been published in the Lancet. <ref>{{cite journal | vauthors = Bravo L, Smolenov I, Han HH, Li P, Hosain R, Rockhold F, Clemens SA, Roa C, Borja-Tabora C, Quinsaat A, Lopez P, López-Medina E, Brochado L, Hernández EA, Reynales H, Medina T, Velasquez H, Toloza LB, Rodriguez EJ, de Salazar DI, Rodríguez CA, Sprinz E, Cerbino-Neto J, Luz KG, Schwarzbold AV, Paiva MS, Carlos J, Montellano ME, de Los Reyes MR, Yu CY, Alberto ER, Panaligan MM, Salvani-Bautista M, Buntinx E, Hites M, Martinot JB, Bhorat QE, Badat A, Baccarini C, Hu B, Jurgens J, Engelbrecht J, Ambrosino D, Richmond P, Siber G, Liang J, Clemens R | display-authors = 6 | title = Efficacy of the adjuvanted subunit protein COVID-19 vaccine, SCB-2019: a phase 2 and 3 multicentre, double-blind, randomised, placebo-controlled trial | journal = Lancet | volume = 399 | issue = 10323 | pages = 461–472 | date = January 2022 | pmid = 35065705 | pmc = 8776284 | doi = 10.1016/S0140-6736(22)00055-1 }}</ref>
Clover expects to submit its Phase III results for approval by the [[World Health Organization]], [[European Medicines Agency]], and [[National Medical Products Administration|China's NMPA]] in the fourth quarter of 2021.<ref name=":7" />
==== Efficacy against variants ====
In Phase III trials, SCB-2019 showed efficacy of 81.7% for moderate-to-severe cases of COVID-19 caused by [[Delta variant|Delta]], 91.8% for [[SARS-CoV-2 Gamma variant|Gamma]], and 58.6% for [[SARS-CoV-2 Mu variant|Mu]].<ref name=":6" /><ref name=":7" /> 56 Delta cases, 37 Mu cases, and 13 Gamma cases were recorded during the trials.<ref name=":6" />
== Pharmacology ==
SCB-2019 has a trimeric form of the SARS-CoV-2 spike protein (S-Trimer) combined with one of two different [[Immunologic adjuvant|adjuvants]] AS03 ([[GlaxoSmithKline]]) or CpG/Alum (Dynavax).<ref name="Hotez">{{cite journal | vauthors = Hotez PJ, Bottazzi ME | title = Whole Inactivated Virus and Protein-Based COVID-19 Vaccines | journal = Annual Review of Medicine | volume = 73 | issue = 1 | pages = 55–64 | date = January 2022 | pmid = 34637324 | doi = 10.1146/annurev-med-042420-113212 | s2cid = 238747462 | doi-access = free }}</ref><ref name=":1" /> The vaccine displays the spike protein in its natural three-part form, leading to a potentially better immune response.<ref name=":3" /> The vaccine
The vaccine is stable for at least six months under normal refrigeration conditions and at least one month at 40 degrees Celsius.<ref name=":7" />
▲SCB-2019 has a trimeric form of the SARS-CoV-2 spike protein (S-Trimer) combined with two different [[Immunologic adjuvant|adjuvants]] AS03 ([[GlaxoSmithKline]]) or CpG/Alum (Dynavax).<ref name=":1" /> The vaccine displays the spike protein in its natural three-part form, leading to a potentially better immune response.<ref name=":3" /> The vaccine employs similar technology to other protein subunit COVID-19 vaccines including [[Novavax COVID-19 vaccine|Novavax]], [[Abdala (vaccine)|Abdala]], and [[ZF2001]].<ref>{{Cite news| vauthors = Zimmer C, Corum J, Wee SL |title=Coronavirus Vaccine Tracker|language=en-US|work=The New York Times|url=https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html|access-date=2021-07-08|issn=0362-4331}}</ref>
== Manufacturing ==
Line 55 ⟶ 70:
In February 2021, Clover decided to proceed with the adjuvant from Dynavax for its Phase II/III trials over GlaxoSmithKline after evaluating manufacturing considerations.<ref name=":5">{{Cite news| vauthors = Liu R |date=2021-02-01|title=Clover ends COVID-19 vaccine partnership with GSK|language=en|work=Reuters|url=https://www.reuters.com/article/health-coronavirus-clover-gsk-idUSL1N2K70R6|access-date=2021-07-08}}</ref> Separately, CEPI provided $99 million funding to Dynavax to produce its adjuvant for various COVID-19 vaccines.<ref name=":5" />
Vaccine production is expected to begin in 2021.<ref name=":7" />
=== Orders ===
Line 62 ⟶ 79:
=== Phase I & II trials ===
In June 2020, Phase I trial were launched to assess safety, reactogenicity, and immunogenicity at multiple dose levels with 151 participants in [[Perth]], Australia using 2 separate adjuvants, AS03 and CpG/Alum.<ref>{{ClinicalTrialsGov|NCT04405908|SCB-2019 as COVID-19 Vaccine}}</ref><ref name="clover-cta">{{cite web|date=20 June 2020|title=Clover Biopharmaceuticals starts Phase I Covid-19 vaccine trial|url=https://www.clinicaltrialsarena.com/news/clover-vaccine-covid-19-trial/|url-status=live|archive-url=https://web.archive.org/web/20201011084945/https://www.clinicaltrialsarena.com/news/clover-vaccine-covid-19-trial//|archive-date=11 October 2020|access-date=25 June 2020|publisher=Clinical Trials Arena}}</ref><ref name=":0" /> In results published in ''[[The Lancet
In August 2021, a Phase II trial will launch to assess immunogenicity and safety with 800 participants in China.<ref>{{ClinicalTrialsGov|NCT04954131|Immunogenicity and Safety Study of Adjuvanted SARS-CoV-2 (SCB-2019) Vaccine in Adults in China}}</ref>
=== Phase II/III trials ===
In March 2021, a larger combined-Phase II/III trial was launched to evaluate efficacy, immunogenicity, reactogenicity, and safety of the CpG/Alum adjuvated SCB-2019 vaccine.<ref>{{ClinicalTrialsGov|NCT04672395|A Controlled Phase 2/3 Study of Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Vaccine (SCB-2019) for the Prevention of COVID-19 (SCB-2019)}}</ref><ref name=":0" /> In July 2021, enrollment in the Phase II/III trials was completed with 45% of the 29,000 participants in Asia, 45% in Latin America and the rest in Europe and Africa
=== Efficacy against variants ===
In September 2021, results published in ''[[The Journal of Infectious Diseases]]'' showed SCB-2019 induced antibodies responses up to 184 days in the Phase I trial. Additionally, the vaccine produced neutralizing antibodies against three of the most common variants of concern; [[Alpha variant|Alpha]], [[SARS-CoV-2 Beta variant|Beta]], and [[SARS-CoV-2 Gamma variant|Gamma]].<ref>{{
In
== References ==
Line 84 ⟶ 101:
{{Portal bar | Medicine | Viruses | COVID-19}}
[[Category:Clinical trials related to COVID-19]]
[[Category:Chinese COVID-19 vaccines]]
[[Category:Science and technology in China]]
[[Category:Protein subunit vaccines]]
| |||