Delving into the Latest Updates on Recombinant novel coronavirus 2-valent (Alpha + Beta variants) S trimeric protein vaccine with Synapse

Overview

Basic Info

Drug Type

Recombinant protein, Prophylactic vaccine

Synonyms

Bivalent recombinant trimeric Sprotein vaccine Sinocelltech

+ [2]

Target

SARS-CoV-2 S protein

Mechanism

SARS-CoV-2 S protein inhibitors(Coronavirus spike glycoprotein inhibitors)

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

COVID-19

Inactive Indication-

Originator Organization

Sinocelltech Group Ltd.

Active Organization

Sinocelltech Group Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (04 Dec 2022),

COVID-19

RegulationEmergency Use Authorization (CN)

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A Randomized, Double-blind, and Positive-controlled Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C (A Bivalent SARS-CoV-2 Trimeric Spike Protein Vaccine) and SCTV01E (A COVID-19 Alpha/Beta/Delta/Omicron Variants S-Trimer Vaccine) in Population Aged ≥18 Years Previously Vaccinated With Either Inactivated or mRNA COVID-19 Vaccine or Previously Diagnosed With COVID-19

The study is a randomized, double-blind, and positive-controlled Phase III booster study. It will evaluate the immunogenicity and safety of one dose of SCTV01C or SCTV01E as booster compared with either one dose of Sinopharm inactivated COVID-19 vaccine (Cohort 1) or one dose of Comirnaty (Cohort 2).

Start Date30 May 2022

Sponsor / Collaborator

Sinocelltech Group Ltd.

NCT05239975 / WithdrawnPhase 2

A Randomized, Double-blind Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C (A Bivalent SARS-CoV-2 Trimeric Spike Protein Vaccine) in Population Aged ≥12 Years and Previously Vaccinated With Inactivated COVID-19 Vaccine

The objective of this study is to evaluate the immunogenicity and safety of SCTV01C in participants aged ≥12 years and previously fully immunized with inactivated COVID-19 vaccine.

Start Date25 Apr 2022

Sponsor / Collaborator

Sinocelltech Group Ltd.

NCT05239806 / Unknown statusPhase 2

A Randomized, Double-blind Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C (A Bivalent SARS-CoV-2 Trimeric Spike Protein Vaccine) and SCTV01E (A COVID-19 Alpha/Beta/Delta/Omicron Variants S-Trimer Vaccine) in Population Aged ≥12 Years Previously Fully Vaccinated With Inactivated COVID-19 Vaccine

The objective of study is to evaluate the immunogenicity and safety of SCTV01C or SCTV01E as booster compared with Sinopharm inactivated COVID-19 vaccine as booster. The study will also evaluate the immunogenicity and safety of 2-dose vaccinations.

Start Date01 Apr 2022

Sponsor / Collaborator

Sinocelltech Group Ltd.

100 Clinical Results associated with Recombinant novel coronavirus 2-valent (Alpha + Beta variants) S trimeric protein vaccine

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100 Translational Medicine associated with Recombinant novel coronavirus 2-valent (Alpha + Beta variants) S trimeric protein vaccine

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100 Patents (Medical) associated with Recombinant novel coronavirus 2-valent (Alpha + Beta variants) S trimeric protein vaccine

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7

Literatures (Medical) associated with Recombinant novel coronavirus 2-valent (Alpha + Beta variants) S trimeric protein vaccine

01 Oct 2023·eClinicalMedicine

Safety and immunogenicity of multivalent SARS-CoV-2 protein vaccines: a randomized phase 3 trial

Article

Author: Zhang, Miaomiao ; Alamadi, Ahmad ; Mahmoud, Sally A ; Hannawi, Suad ; Abuquta, Alaa ; Gao, Cuige ; Hassan, Aala ; Chen, Yuanxin ; Saifeldin, Linda ; Gai, Wenlin ; Xie, Liangzhi ; Yan, Lixin

BackgroundCOVID-19 vaccines that offer broad-spectrum protection are needed. We aimed to evaluate the safety and immunogenicity of multivalent vaccines, SCTV01E and SCTV01C, and compare them with an inactivated vaccine.MethodsIn the phase 3 trial (ClinicalTrials.gov: NCT05323461), adult participants previously vaccinated with Sinopharm's inactivated SARS-CoV-2 vaccine (BBBIP-CorV) were assigned to receive one booster dose of BBBIP-CorV, 20 μg SCTV01C, or 30 μg SCTV01E. The primary endpoint was to evaluate the geometric mean titers (GMT) of neutralizing antibody (nAb) against the Delta and Omicron BA.1 variants on day 28 after injection. Additional endpoints included GMTs of nAb against Delta (B.1.617.2) and Omicron BA.1 variants on day 180, GMTs against BA.5 on day 28, as well as solicited adverse events (AEs) within seven days, unsolicited AEs within 28 days, and serious AEs, AEs of special interest within 180 days after vaccination.FindingsBetween May 30, 2022 and October 28, 2022, a total of 1351 participants were randomized to BBBIP-CorV, SCTV01C, or SCTV01E in a 1:1:1 ratio, with immunogenicity assessments performed on the first 300 participants. For BBBIP-CorV, SCTV01C, and SCTV01E groups, the day 28 GMTs of neutralizing antibody against Omicron BA.1 were a 2.38-, 19.37-, and 28.06-fold increase from baseline; the GMTs against Omicron BA.5 were 2.07-, 15.89- and 21.11-fold increases; the GMTs against Delta variants were 1.97-, 12.76-, and 15.88-fold increases, respectively. The day 28 geometric mean ratio (GMR) of SCTV01C/BBIBP-CorV for Omicron BA.1 was 6.49 (95% CI: 4.75, 8.88), while the GMR of SCTV01E/BBIBP-CorV was 9.56 (95% CI: 6.85, 13.33). For the Delta variant, the day 28 GMR of SCTV01C/BBIBP-CorV was 6.26 (95% CI: 4.78, 8.19), and the day 28 GMR of SCTV01E/BBIBP-CorV was 7.26 (95% CI: 5.51, 9.56). On Day 180, the GMTs against Omicron BA.1 were 2.80-, 9.51-, and 15.56-fold increase from baseline, while those against Delta were 1.58-, 5.49-, and 6.63-fold for BBBIP-CorV, SCTV01C, and SCTV01E groups, respectively. Subgroup analyses showed that SCTV01C and SCTV01E induced uniformly high GMTs against both BA.1 and BA.5, demonstrating its superiority over BBIBP-CorV, regardless of baseline GMT levels. Safety and reactogenicity were similar among the three vaccines. Most AEs were Grade 1 or 2. There were 15 ≥Grade 3 AEs: 6 in the BBIBP-CorV group, 4 in the SCTV01C group and 5 in the SCTV01E group. No SAE was reported and one grade 1 AESI (Bell's palsy) was observed in SCTV01C group.InterpretationA booster dose of the tetravalent vaccine SCTV01E consistently induced high neutralizing antibody responses against Omicron BA.1, BA.5, and Delta variants, demonstrating superiority over inactivated vaccine. There is evidence to suggest that SCTV01E may have GMT superiority over bivalent vaccine SCTV01C against Delta, BA.1 and BA.5 variants.FundingThis study was sponsored by Sinocelltech Ltd., and funded by the Beijing Science and Technology Planning Project [Z221100007922012] and the National Key Research and Development Program of China [2022YFC0870600].

01 Feb 2023·Journal of Infection

Safety and immunogenicity of a bivalent SARS-CoV-2 recombinant protein vaccine, SCTV01C in unvaccinated adults: A randomized, double-blinded, placebo-controlled, phase I clinical trial

Letter

Author: Cui, Yimin ; Zhang, Tianzuo ; Fu, Yongpan ; Wang, Yanchao ; Han, Jun ; Shi, Rui ; Xu, Shuping ; Hu, Zhongyu ; Song, Qinqin ; Xie, Liangzhi ; Yang, Xinjie ; Wang, Guiqiang ; Zhao, Kexin ; He, Peng ; Li, Yanhua ; Du, Haijun

01 Feb 2023·Journal of Infection

Safety and immunogenicity of a bivalent SARS-CoV-2 protein booster vaccine, SCTV01C in adults previously vaccinated with inactivated vaccine: A randomized, double-blind, placebo-controlled phase 1/2 clinical trial

Letter

Author: Hannawi, Suad ; Abuquta, Alaa ; Alamadi, Ahmad ; Saf Eldin, Linda ; Mahmoud, Sally A ; Chen, Yuanxin ; Li, Jian ; Xie, Liangzhi

100 Deals associated with Recombinant novel coronavirus 2-valent (Alpha + Beta variants) S trimeric protein vaccine

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
COVID-19	CN	Sinocelltech Group Ltd.	04 Dec 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Discovery	-	Sinocelltech Group Ltd.	20 Mar 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05043311 (Pubmed) Manual	Phase 1/2	COVID-19	234	Placebo	hzedflblua(rxncjtjjvs) = eslcuazzpw fxmcdlepmb (hfhhmaflho ) View more	Positive	01 Jan 2023
				SCTV01C 20 μg	hzedflblua(rxncjtjjvs) = uifiqsbecy fxmcdlepmb (hfhhmaflho ) View more