"SCTV01C" from_date:2012

Sustained immunogenicity of bivalent protein COVID-19 vaccine SCTV01C against antigen matched and mismatched variants. The development of bivalent or multivalent vaccines offers a promising strategy for combating SARS-CoV-2 mutations. In this phase 2 trial, conducted from 1 December 2021, to 25 July 2023, 392 unvaccinated adults aged ≥18 years were randomized to receive a primary series of two doses and a booster dose of SCTV01C, a bivalent protein SARS-CoV-2 vaccine. Geometric mean titers (GMTs) of neutralizing antibodies (nAb) against live Alpha, Beta, Delta, and Omicron showed 85.4-, 100.0-, 32.1-, and 9.8-fold increase from baseline on 28 days, and 49.4-, 55.3-, 5.7-fold increase against live Alpha, Beta, and Omicron on 90 days after primary series. At Day 28 and Day 90 following

Safety and immunogenicity of a bivalent SARS-CoV-2 protein booster vaccine, SCTV01C, in adults previously vaccinated with mRNA vaccine: a randomized, double-blind, placebo-controlled phase 1/2 clinical trial. Booster vaccination is an efficient way to address the waning protection of vaccines and immune escape of SARS-CoV-2 variants. We aimed to assess the safety and immunogenicity of SCTV01C , a novel bivalent protein vaccine as a booster for people who previously received two doses of mRNA vaccine. In this randomized, phase 1/2 trial, adults fully vaccinated with mRNA vaccines 3-24 month earlier were enrolled. Participants received SCTV01C at 20 μg, 40 μg or placebo. The primary endpoints were adverse reactions within 7 days and immunogenicity on Day 28 after vaccination. This trial

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.

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.

The Safety, Tolerability and Immunogenicity of COVID-19 Vaccine (SCTV01C) in Healthy, Unvaccinated Adults SCTV01C-02-1 is a randomized, double-blind, placebo controlled Phase Ⅰ/Ⅱ clinical trial of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant bivalent trimeric S protein vaccine manufactured by Sinocelltech, Ltd. The purpose of this study is to evaluate the safety , tolerability and immunogenicity of the experimental vaccine in healthy adults aged ≥ 18 Years previously unvaccinated. This study is a randomized, double-blind, multi-center, placebo-controlled phase Ⅰ/Ⅱ clinical trial in adults aged ≥ 18 years previously unvaccinated. The purpose of this study is to evaluate the safety , tolerability and immunogenicity of the experimental SARS-CoV-2 protein vaccine (SCTV01C

A Phase II Study of the Immunogenicity and Safety of SCTV01C 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. This is a randomized, double-blind, approved vaccine-controlled Phase II booster study to evaluate the immunogenicity and safety of SCTV01C compared with Comirnaty in participants aged ≥12 years and previously fully immunized with inactivated COVID-19 vaccine.

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 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. The study is a randomized, double-blind, and approved vaccine-controlled Phase II booster study. It will evaluate the immunogenicity and safety of one dose of SCTV01C or SCTV01E as booster compared with one dose of Sinopharm inactivated COVID-19 vaccine or one dose of Commirnaty as booster. The study will also evaluate the immunogenicity and safety of 2-dose vaccinations

A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C in Population Aged ≥18 Years and Previously Fully Vaccinated With COVID-19 Vaccine The objective of this study is to evaluate the immunogenicity and safety of SCTV01C in participants aged ≥18 years and previously fully immunized with either inactivated or mRNA COVID-19 vaccine or previously diagnosed with COVID-19 . The study is a randomized, double-blind, positive-controlled Phase II booster study. It will evaluate the immunogenicity and safety of SCTV01C compared with either Sinopharm inactivated COVID-19 vaccine or Comirnaty in participants aged ≥18 years and previously fully immunized with either inactivated or mRNA COVID-19 vaccine or previously diagnosed with COVID-19.

A Study to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E (Two Recombinant Protein COVID-19 Vaccines) in Population Aged ≥12 Years The objective of the study is to evaluate the immunogenicity and safety of SCTV01C or SCTV01E, comparing the immunogenicity data against Beta (B.1.351), Delta (B.1.617.2), Omicron (B.1.1.529) and other variants with Sinopharm inactivated COVID-19 vaccine or mRNA vaccine. The study is a randomized, double-blinded, active-controlled (Approved vaccine) Phase II clinical study. The study consists of 2 stages, Stage 1 and 2. In Stage 1, participants would randomly receive 2 doses of SCTV01C, SCTV01E, Sinopharm COVID-19 vaccine or mRNA vaccine on Day 0 and Day 28. Stage 1 is aimed to evaluate the immunogenicity and safety of SCTV01C or SCTV01E

The Safety and Immunogenicity of SCTV01C in Healthy Population Aged ≥18 Years Previously Vaccinated With Inactivated COVID-19 Vaccine. The objective of this study is to evaluate the safety, tolerability, and immunogenicity of SCTV01C in healthy population aged ≥18 years previously vaccinated with inactivated COVID-19 vaccine. This is a Phase I/II, multicenter, randomized, double-blinded trial designed to evaluate the safety, tolerability, and immunogenicity of SCTV01C in healthy population aged ≥18 years previously vaccinated with inactivated COVID-19 vaccine.

The Safety and Immunogenicity of SCTV01C in Healthy Population Aged ≥18 Years Previously Vaccinated With mRNA COVID-19 Vaccine. The objective of this study is to evaluate the safety, tolerability and immunogenicity of SCTV01C in healthy population aged ≥18 years previously vaccinated with mRNA COVID-19 vaccine. This is a Phase I/II/III, multicenter, randomized, double-blinded trial designed to evaluate the safety, tolerability and immunogenicity of SCTV01C in healthy population aged ≥18 years previously vaccinated with mRNA COVID-19 vaccine.

Safety and immunogenicity of a tetravalent and bivalent SARS-CoV-2 protein booster vaccine in men. The safety and immunogenicity of a protein-based tetravalent vaccine SCTV01E that contains spike protein ectodomain (S-ECD) of Alpha, Beta, Delta and Omicron BA.1 are assessed and compared with bivalent protein vaccine SCTV01C (Alpha and Beta variants) and monovalent mRNA vaccine (NCT05323461 males and 1 female, with a median age (range) of 27 (18-62) years, are assigned to receive one booster dose of BNT162b2, 20 µg SCTV01C or 30 µg SCTV01E and completed 4-week follow-up. All SCTV01E related adverse events (AEs) are mild or moderate and no Grade ≥3 AE, serious AE or new safety concerns are identified. Day 28 GMT of live virus neutralizing antibodies and seroresponse against Omicron BA.1

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

A Study to Evaluate the Immunogenicity and Safety of Two Recombinant Protein COVID-19 Vaccines in Population Aged ≥18 Years as Booster Vaccines 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