Walvax and RNAcure Announce Safety, Immunogenicity and Efficacy Data from Phase 3b Clinical Study of RQ3013 (SARS-CoV-2 Variants mRNA Vaccine) Published in eClinicalMedicine
Data demonstrated better protection of RQ3013 against symptomatic SARS-CoV-2 infections compared with other licensed wild-type COVID-19 vaccines as a heterologous booster following three doses of inactivated vaccines with higher antibody levels and comparable safety profile, supporting the use of RQ3013 as a booster vaccination in adults, especially the elderly.
(September 26 2023, Kunming) Walvax Biotechnology Co., Ltd. (“Walvax”, 300142.SZ) and Shanghai RNACure Biopharma Co., Ltd. (RNACure) announced the publication of results from the phase 3b clinical study of its SARS-CoV-2 Variants mRNA Vaccine (RQ3013), demonstrating the well-performed safety, potent immunogenicity and promising efficacy as a heterologous booster in Chinese adults primed with three doses of inactivated vaccines. This study, registered on www.chictr.org.cn (ChiCTR2200065281), investigates safety performance, the neutralizing antibodies (nAbs) against circulating variants induced at Day 14 post the booster, relative vaccine efficacy (rVE) against symptomatic infections of any severity onset at least 7 days post the booster as compared to 2 wild-type COVID-19 vaccines licensed in China (adenoviral vectored vaccine Ad5-nCoV and protein subunit vaccine ZF2001) among healthy Chinese adults. The results were published in eClinicalMedicine, part of the Lancet Discovery Science, on September 20, 2023 (See full text on https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00408-X/fulltext). Key findings of the phase 3b clinical study are shown below:
- Comparable safety performance to other mRNA boosters: subjects who received RQ3013 as heterologous booster were less prone to reporting fatigue and myalgia compared to those receiving the other 2 comparator vaccines. Grade 3 events were few with comparable incidences across vaccines groups. Lower incidences of adverse reactions after a heterologous booster of RQ3013 were noted among participants aged 60 years and older, supporting the well-performed safety of RQ3013 in the elderly.
- Potent neutralizing antibody (nAb) responses: significant enhancement of humoral immune responses was noted following 3 different heterologous boosters, while RQ3013 exhibited superior immunogenicity compared to either Ad5-nCoV or ZF2001 (4.8-fold and 5.6-fold higher regarding nAb levels, respectively) as the 4th dose, among participants primed with 3 doses of inactivated vaccines.
- Promising efficacy against symptomatic infections: the relative vaccine efficacy (rVE) of RQ3013 against symptomatic infections as a heterologous booster ranged from 62.2% to 69.0% compared with the other 2 comparator vaccines, which are higher than the relative efficacy (compared with the inactivated vaccine) of other widely used mRNA boosters reported in literatures.
About the Phase 3b Clinical Study (RQ3013-005)
RQ3013-005, registered on Chinese Clinical Trial Registry at www.chictr.org.cn (ChiCTR2200065281), was designed as a double-blind, randomized, controlled, phase 3b clinical trial among healthy Chinese adults, and was conducted at Lancang County, Yunnan, China. Adults who had received three doses of inactivated COVID-19 vaccines at least 6 months prior were randomly allocated (3:1:1) to receive a heterologous booster of either RQ3013, Ad5-nCoV, or ZF2001. Adverse events collected within 28 days post the booster and serum geometric mean titers (GMTs) of neutralizing antibodies (nAbs) against Omicron BA.5 as measured by live-virus neutralization assay on Day 14 post the booster were assessed, and the relative vaccine efficacy (rVE) against the first episode of virologically confirmed symptomatic COVID-19 occurring at least 7 days post the booster was also demonstrated.
About RQ3013: SARS-CoV-2 variant mRNA vaccine (Chimeric S protein vaccine)
RQ3013 is an mRNA vaccine designed to contain pseudouridine-modified messenger RNAs encoding the spike protein harboring a combination of mutations responsible for immune evasion of SARS-CoV-2 variants of concern, which was administered intramuscularly 30 μg mRNA in 0.15 mL per dose.
Founded in 2001, Walvax Biotechnology Co., Ltd. (Walvax) is a leading vaccine producer, engaged in research and development, manufacturing and distribution of safe and efficacious quality vaccines. Headquartered in China’s southwestern city Kunming in Yunnan Province, Walvax went to IPO in 2010 (300142.SZ) and started business expansion from traditional vaccines to innovative vaccines. With the vision of dedicating to be the pride domestically and the pioneer globally in the vaccine industry, producing efficacious, quality, innovative and affordable products to protect people from the world’s deadliest diseases, Walvaxs purpose is to help everyone live a healthy life. For further information please visit https://en.walvax.com/about-us/our-company and follow us on Twitter at @WalvaxBiotech and LinkedIn.
Founded in 2019, Shanghai RNACure Biopharma Co., Ltd. (RNACure) is an innovative pharmaceutical enterprise focus on mRNA technology, in areas including Infectious disease vaccines, Cancer vaccines, Veterinary vaccines, Rare diseases vaccines etc. Headquartered in the Bay Valley Science Park, Shanghai. RNACure has developed a one-step mRNA drug development platform from early discovery of new targets to rapidly expanding pipelines. RNACure has strategically allianced with local universities, hospitals, research institutions and global pharmaceutical enterprises to speed up the development of innovative mRNA vaccines. With the vision of establishing an international advanced mRNA vaccine technology platform to achieved the technology research, development and industrialization of mRNA vaccines. For further information, please visit https://cn.rnacure.com/about-us