SCTV01E / Sinocelltech - LARVOL DELTA

Baseline Anti-SARS-CoV-2 IgG and Protection from Symptomatic Infection: Post Hoc Analysis of the SCTV01E Phase 3 Randomized Trial. (PubMed, Vaccines (Basel)) - P3 | "Vaccinating the infected population was safe and did not compromise efficacy. Clinical Trial: NCT05308576."

Clinical • Journal • P3 data • Retrospective data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity of monovalent and multivalent subunit vaccines against SARS-CoV-2 variants in mice with divergent vaccination history. (PubMed, Microbiol Spectr) - "Furthermore, the XBB.1 monovalent vaccine and a tetravalent vaccine (SCTV01E-2) composed of pre-Omicron variant (Beta) and Omicron subvariants (BA.1, BQ.1.1, and XBB.1) showed comparable neutralizing potency against several Omicron sublineages (BA.1, BA.5, BQ.1.1, XBB.1, XBB.1.5, XBB.1.16, and EG.5) under divergent vaccination history, implicating that multivalent platforms could be explored as a flexible strategy if future strains diverge significantly from current variants.IMPORTANCEContinuous evolution of SARS-CoV-2 variants has raised the need to optimize immunization regimens and update vaccine compositions to protect against the newly emerging variants in the context of repeated vaccination. The significance of this research is briefly summarized as follows:1) Immunological biases toward earlier variants attenuated the potency of variant-based vaccines as a booster dose against subsequent variants, which can be mitigated by a second booster dose.2) In the context..."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Developmental and reproductive toxicity (DART) study of a novel SARS-CoV-2 tetravalent recombinant protein vaccine (SCTV01E) in rats. (PubMed, Reprod Toxicol) - "These results suggest a favorable safety profile for SCTV01E and its possible suitability for clinical trials in humans of reproductive potential. Furthermore, the efficient transplacental and lactational transfer of maternal antibodies observed in animal models suggests a potential protection: direct immunization of mothers may confer passive immunity to both fetuses in utero and neonates during breastfeeding."

Journal • Preclinical • Developmental Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity of the Tetravalent Recombinant COVID-19 Protein Vaccine SCTV01E in Children and Adolescents Aged 3 to 17 Years: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial. (PubMed, Vaccines (Basel)) - P3 | " SCTV01E was found to be safe and well tolerated in children and adolescents, generating a robust immune response against Omicron BA.5. This supports its potential use in younger populations."

Clinical • Journal • P2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and Safety of Omicron-Containing Multivalent COVID-19 Vaccines in Unvaccinated and Previously Vaccinated Adults. (PubMed, Vaccines (Basel)) - "Numerically identical ≥ grade 3 AEs [SCTV01E-1: 1.7% (2/121) and SCTV01E: 1.7% (2/119)] were reported. This trial demonstrates the effectiveness of updated multivalent vaccines with acceptable safety profiles."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Efficacy of the tetravalent protein COVID-19 vaccine, SCTV01E: a phase 3 double-blind, randomized, placebo-controlled trial. (PubMed, Nat Commun) - P3 | "Reactogenicity was generally mild and transient, with no reported vaccine-related SAE, adverse events of special interest (AESI), or deaths. The trial aligned with the shift from dominant variants BA.5 and BF.7 to XBB, suggesting SCTV01E as a potential vaccine alternative effective against present and future variants."

Clinical • Journal • P3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

SCTV01E-MRCT-1: A Study to Evaluate the Efficacy and Safety of SCTV01E (a COVID-19 Vaccine) in Population Aged ≥18 Years (clinicaltrials.gov) - P3 | N=10000 | Active, not recruiting | Sponsor: Sinocelltech Ltd. | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Oct 2024 ➔ Apr 2024 | Trial primary completion date: Oct 2023 ➔ May 2023

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity of Tetravalent Protein Vaccine SCTV01E-2 against SARS-CoV-2 EG.5 Subvaraint: A Phase 2 Trial. (PubMed, Vaccines (Basel)) - P2 | "No vaccine-related serious adverse events (SAEs), adverse events of special interest (AESIs), or deaths were reported. In summary, SCTV01E-2 elicited robust neutralizing responses against Omicron EG.5 and XBB.1 without raising safety concerns, highlighting its potential as a versatile COVID-19 vaccine against SARS-CoV-2 variants."

Journal • P2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E (Two Recombinant Protein COVID-19 Vaccines) in Population Aged ≥12 Years (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Sinocelltech Ltd. | N=480 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

SCTV01E: A PhaseⅡ Study to Evaluate the Safety & Immunogenicity of SARS-CoV-2 Alpha/Beta/Delta/Omicron Variants COVID-19 Vaccine (clinicaltrials.gov) - P2 | N=518 | Completed | Sponsor: Sinocelltech Ltd. | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Enhanced neutralization of SARS-CoV-2 variant BA.2.86 and XBB sub-lineages by a tetravalent COVID-19 vaccine booster. (PubMed, Cell Host Microbe) - "We evaluate the serum neutralization activities of participants who received COVID-19 inactivated vaccine (CoronaVac), those who received the recently approved tetravalent protein vaccine (SCTV01E), or those who had contracted a breakthrough infection with BA.5/BF.7/XBB virus. Cellular immunity assays also show that the SCTV01E booster elicits a higher frequency of virus-specific memory B cells. Our findings support the development of multivalent vaccines to combat future variants."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and immunogenicity of multivalent SARS-CoV-2 protein vaccines: a randomized phase 3 trial. (PubMed, EClinicalMedicine) - P3 | "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). There is evidence to suggest that SCTV01E may have GMT superiority over bivalent vaccine SCTV01C against Delta, BA.1 and BA.5 variants. This 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]."

Journal • P3 data • CNS Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and immunogenicity of a tetravalent and bivalent SARS-CoV-2 protein booster vaccine in men. (PubMed, Nat Commun) - P3 | "Day 28 GMT of live virus neutralizing antibodies and seroresponse against Omicron BA.1 and BA.5 with SCTV01E are significantly higher than those with SCTV01C and BNT162b2. These data indicate an overall neutralization superiority with tetravalent booster immunization in men."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate the Immunogenicity and Safety of A Recombinant Protein COVID-19 Vaccine as Booster Vaccines (clinicaltrials.gov) - P2 | N=600 | Not yet recruiting | Sponsor: Sinocelltech Ltd.

New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

SCTV01C-E-01-UAE-1: A Study to Evaluate the Immunogenicity and Safety of Two Recombinant Protein COVID-19 Vaccines in Population Aged ≥18 Years as Booster Vaccines (clinicaltrials.gov) - P3 | N=1800 | Active, not recruiting | Sponsor: Sinocelltech Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL4

A Phase III Clinical Trial to Evaluate the Efficacy and Safety of SCTV01E in Healthy People (clinicaltrials.gov) - P3 | N=6000 | Not yet recruiting | Sponsor: Sinocelltech Ltd.

New P3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

SCTV01E: A PhaseⅡ Study to Evaluate the Safety & Immunogenicity of SARS-CoV-2 Alpha/Beta/Delta/Omicron Variants COVID-19 Vaccine (clinicaltrials.gov) - P2 | N=750 | Recruiting | Sponsor: Sinocelltech Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A spike-trimer protein-based tetravalent COVID-19 vaccine elicits enhanced breadth of neutralization against SARS-CoV-2 Omicron subvariants and other variants. (PubMed, Sci China Life Sci) - P3 | "Together, our comprehensive immunogenicity evaluation results indicate that SCTV01E could become an important COVID-19 vaccine platform to combat surging infections caused by the highly immune evasive BA.4/5 variants. SCTV01E is currently being studied in a head-to-head immunogenicity comparison phase 3 clinical study with inactivated and mRNA vaccines (NCT05323461)."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

SCTV01E-MRCT-1: A Study to Evaluate the Efficacy and Safety of SCTV01E (a Recombinant Protein COVID-19 Vaccine) in Population Aged ≥18 Years (clinicaltrials.gov) - P3 | N=10000 | Not yet recruiting | Sponsor: Sinocelltech Ltd. | Trial completion date: Apr 2024 ➔ Oct 2024 | Initiation date: Apr 2022 ➔ Mar 2023 | Trial primary completion date: Oct 2022 ➔ Oct 2023

Trial completion date • Trial initiation date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

SCTV01E: A PhaseⅡ Study to Evaluate the Safety & Immunogenicity of SARS-CoV-2 Alpha/Beta/Delta/Omicron Variants COVID-19 Vaccine (clinicaltrials.gov) - P2 | N=750 | Not yet recruiting | Sponsor: Sinocelltech Ltd.

New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate the Immunogenicity and Safety of a Recombinant Protein COVID-19 Vaccine SCTV01E-1 in Population Aged Above 18 Years (clinicaltrials.gov) - P2 | N=400 | Not yet recruiting | Sponsor: Sinocelltech Ltd.

New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate the Immunogenicity and Safety of a Recombinant Protein COVID-19 Vaccine as a Booster Dose in Population Aged 12-17 Years (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: Sinocelltech Ltd.

New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL4

A Study to Evaluate the Immunogenicity and Safety of a Recombinant Protein COVID-19 Vaccine in Population Aged ≥18 Years (clinicaltrials.gov) - P2 | N=400 | Not yet recruiting | Sponsor: Sinocelltech Ltd.

New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL4

A Study to Evaluate the Immunogenicity and Safety of Two Recombinant Protein COVID-19 Vaccines in Population Aged ≥18 Years as Booster Vaccines (clinicaltrials.gov) - P3 | N=1800 | Not yet recruiting | Sponsor: Sinocelltech Ltd.

New P3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL4

A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E in Population Aged ≥12 Years Previously Fully Vaccinated With Inactivated COVID-19 Vaccine (clinicaltrials.gov) - P2 | N=400 | Not yet recruiting | Sponsor: Sinocelltech Ltd. | N=300 ➔ 400

Enrollment change • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL4