RQ3013 / RNACure Biopharma, Shanghai Jiao Tong University, Fudan University, Walvax - LARVOL DELTA

Development of a dissolving microneedle patch for transdermal delivery of SARS-CoV-2 mRNA vaccine with enhanced stability and immunogenicity. (PubMed, J Control Release) - "Notably, the DMP induced a comparable IgG response to IM (5 μg) at a substantially lower actual delivery dose (approximately 2 μg), without systemic toxicity or skin irritation. These findings demonstrate that this DMP represents an effective, stable, and patient-friendly strategy for mRNA vaccine delivery, combining enhanced immunogenicity with improved storage stability and simplified administration."

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

Efficacy, immunogenicity, and safety of heterologous boosting with a novel chimera Chinese mRNA (RQ3013) SARS-CoV-2 vaccine: A randomized, double-blind, active-controlled trial. (PubMed, Hum Vaccin Immunother) - "All SAEs were not related to the vaccination. These findings suggest that a chimeric mRNA vaccine design involving multiple antigenic epitopes provides broader protection across subvariants and variants of SARS-CoV-2 than the subunit vaccine ZF2001."

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

A Study to Investigate the Safety, Immunogenicity of Bivalent mRNA Vaccine RQ3027 and RQ3025 as a Booster Dose in Healthy Adults (clinicaltrials.gov) - P=N/A | N=376 | Completed | Sponsor: Affiliated Hospital of Yunnan University | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

Safety, immunogenicity, and efficacy of an mRNA COVID-19 vaccine (RQ3013) given as the fourth booster following three doses of inactivated vaccines: a double-blinded, randomised, controlled, phase 3b trial. (PubMed, EClinicalMedicine) - "The heterologous prime-boost regimen with RQ3013 elicited superior immune responses and demonstrated better protection against symptomatic SARS-CoV-2 infections compared with Ad5-nCoV or ZF2001, supporting the use of RQ3013 as a booster vaccination in adults. Yunnan Province Science and Technology Department (grant no.202302AA310047)."

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

A Study to Investigate the Safety, Immunogenicity of Bivalent mRNA Vaccine RQ3027 and RQ3025 as a Booster Dose in Healthy Adults (clinicaltrials.gov) - P=N/A | N=420 | Recruiting | Sponsor: Affiliated Hospital of Yunnan University | N=280 ➔ 420

Enrollment change • Infectious Disease • Novel Coronavirus Disease • IL4

A Study to Investigate the Safety, Immunogenicity of a Bivalent mRNA Vaccine RQ3025 as a Booster Dose in Healthy Adults (clinicaltrials.gov) - P=N/A | N=280 | Recruiting | Sponsor: Affiliated Hospital of Yunnan University

New trial • Infectious Disease • Novel Coronavirus Disease • IL4

A Phase 1a Trial to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 mRNA Chimera Vaccine Against COVID-19 (clinicaltrials.gov) - P1a | N=120 | Not yet recruiting | Sponsor: Walvax Biotechnology Co., Ltd. | Initiation date: Jun 2022 ➔ Dec 2022 | Trial primary completion date: Aug 2022 ➔ Feb 2023

Trial initiation date • Trial primary 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

A Phase 1a Trial to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 mRNA Chimera Vaccine Against COVID-19 (clinicaltrials.gov) - P1a | N=120 | Not yet recruiting | Sponsor: Walvax Biotechnology Co., Ltd. | Phase classification: P1 ➔ P1a

Phase classification • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Randomized, Blinded, Positive Control Phase Ⅰa Trial to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 mRNA Chimera Vaccine (RQ3013) in Healthy Adults Aged 18-59 Years (clinicaltrials.gov) - P1 | N=120 | Not yet recruiting | Sponsor: Walvax Biotechnology Co., Ltd.

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

A Phase 1b Trial to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 mRNA Chimera Vaccine Against COVID-19 (clinicaltrials.gov) - P1b | N=120 | Not yet recruiting | Sponsor: Walvax Biotechnology Co., Ltd.

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

Newly added product (World Health Organization) - Preclinical, Novel Coronavirus Disease

Pipeline update