ZR-202-CoV / Walvax - LARVOL DELTA

Safety, reactogenicity, and immunogenicity of ZR-202-CoV and ZR-202a-CoV recombinant vaccines compared with Comirnaty®: a randomized, observer-blind, controlled, phase 1 study. (PubMed, Int J Infect Dis) - "Similar reactogenicity and immunogenicity profiles of ZR-202-CoV, ZR-202a-CoV and Comirnaty® support further clinical investigation in a wider population."

Journal • P1 data • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases

Safety, tolerability, and immunogenicity of a CpG/Alum adjuvanted SARS-CoV-2 recombinant protein vaccine (ZR202-CoV) in healthy adults: Preliminary report of a phase 1, randomized, double-blind, placebo-controlled, dose-escalation trial. (PubMed, Hum Vaccin Immunother) - "S-binding response (GMCs: 2708.7 ~ 4050.0 BAU/mL) and neutralizing activity by pseudovirus (GMCs: 363.1 ~ 627.0 IU/mL) and live virus SARS-CoV-2 (GMT: 101.7 ~ 175.0) peaked at 14 days after the second dose of ZR202-CoV. The magnitudes of immune responses compared favorably with COVID-19 vaccines with reported protective efficacy."

Clinical • Journal • P1 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Evaluation of Safety and Immunogenicity of the Recombinant ZR202-CoV and ZR202a-CoV Vaccines in Adults. (clinicaltrials.gov) - P1/2 | N=60 | Active, not recruiting | Sponsor: Shanghai Zerun Biotechnology Co.,Ltd | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2023 ➔ Aug 2023

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

Phase II Clinical Trial of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19 (clinicaltrials.gov) - P2 | N=528 | Active, not recruiting | Sponsor: Shanghai Zerun Biotechnology Co.,Ltd | N=1056 ➔ 528 | Trial completion date: Oct 2022 ➔ Nov 2023 | Trial primary completion date: Nov 2021 ➔ Apr 2022

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

Safety and Immunogenicity of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19 (clinicaltrials.gov) - P1/2 | N=84 | Active, not recruiting | Sponsor: Shanghai Zerun Biotechnology Co.,Ltd | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2023 ➔ Jun 2023 | Trial primary completion date: Sep 2022 ➔ May 2022

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

Phase I Clinical Trial of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19 (clinicaltrials.gov) - P1 | N=72 | Active, not recruiting | Sponsor: Shanghai Zerun Biotechnology Co.,Ltd | Recruiting ➔ Active, not recruiting | N=144 ➔ 72 | Trial completion date: Oct 2022 ➔ Jun 2023

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

Immunogenicity, durability, and safety of an mRNA and three platform-based COVID-19 vaccines as a third dose following two doses of CoronaVac in China: A randomised, double-blinded, placebo-controlled, phase 2 trial. (PubMed, EClinicalMedicine) - "More effective vaccine candidates against variants of concern as a booster dose are needed in people primed with two-dose inactivated COVID-19 vaccines...250 eligible volunteers, who had received a prime two-dose CoronaVac (3 to 5 weeks apart) vaccination 100-270 days before, were randomly assigned in a 1:1:1:1:1 ratio to receive a third dose of RQ3013 (30 μg mRNA per 0.15 mL), ChAdTS-S (5×10 viral particles per 0.5 mL), ZR202-CoV (25 μg prefusion-stabilized Spike ectodomain trimer per 0.5 mL), CoronaVac (3 μg inactivated CN02 strain of SARS-CoV-2 per 0.5 mL) or placebo (0.5 mL of 0.9% sodium chloride solution) via intramuscular injection into the upper arm at a single clinical site in Kunming, China...Although all study vaccines boosted neutralising antibodies with no safety concerns, RQ3013 showed much stronger cross-neutralisation and cellular responses, adding more effective vaccine candidates against the omicron variant. Yunnan Provincial Science and Technology..."

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

Phase II Clinical Trial of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19 (clinicaltrials.gov) - P2 | N=1056 | Active, not recruiting | Sponsor: Shanghai Zerun Biotechnology Co.,Ltd | Recruiting ➔ Active, not recruiting

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

Evaluation of Safety and Immunogenicity of the Recombinant ZR202-CoV and ZR202a-CoV Vaccines in Adults. (clinicaltrials.gov) - P1/2 | N=60 | Recruiting | Sponsor: Shanghai Zerun Biotechnology Co.,Ltd

New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19 (clinicaltrials.gov) - P1/2 | N=84 | Recruiting | Sponsor: Shanghai Zerun Biotechnology Co.,Ltd

New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases