SYS6006 / CSPC Pharma - LARVOL DELTA

Safety and immunogenicity of a SARS-CoV-2 mRNA vaccine (SYS6006) in minks, cats, blue foxes, and raccoon dogs. (PubMed, Front Cell Infect Microbiol) - "SYS6006 was able to induce neutralizing antibodies against the SARS-CoV-2 wild-type, Delta, and Omicron BA.2 strain on day 7 after prime immunization, and two doses of immunization could enhance the neutralizing antibody responses and produce long-lasting potent antibodies for more than 8 months in minks and cats, blue foxes, and raccoon dogs, while all immunized animals had no abnormal clinical signs during immunization. These results provided here warrant further development of this safe and efficacious mRNA vaccine platform against animal COVID-19."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

The safety, immunogenicity, and efficacy of heterologous boosting with a SARS-CoV-2 mRNA vaccine (SYS6006) in Chinese participants aged 18 years or more: a randomized, open-label, active-controlled phase 3 trial. (PubMed, Emerg Microbes Infect) - "All COVID-19 cases were mild. SYS6006 heterologous boosting demonstrated good safety, superior immunogenicity and high efficacy against BA.5-associated COVID-19, and protected against XBB-associated COVID-19, particularly in the hybrid immune population.Trial registration: Chinese Clinical Trial Registry: ChiCTR2200066941."

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

Long-term immunogenicity and safety of heterologous boosting with a SARS-CoV-2 mRNA vaccine (SYS6006) in Chinese participants who had received two or three doses of inactivated vaccine. (PubMed, J Med Virol) - "ELISpot assay showed robust cellular immune response, which was not obviously affected by virus variation. In conclusion, SYS6006 heterologous boosting demonstrated long-term good safety and immunogenicity in participants who had received two or three doses of SARS-CoV-2 inactivated vaccine."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and immunogenicity of heterologous boosting with a bivalent SARS-CoV-2 mRNA vaccine (XBB.1.5/BQ.1) in Chinese participants aged 18 years or more: A randomised, double-blinded, active-controlled phase 1 trial. (PubMed, Vaccine) - "SYS6006.32 also induced robust pseudovirus Nab responses against XBB.1.16, XBB.2.3, and BA.2.86, with GMTs 3- to 6-fold higher than those induced by SYS6006. In conclusion, SYS6006.32 showed good safety profile and superior immunogenicity to the monovalent vaccine SYS6006."

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

Immunogenicity and safety of a SARS-CoV-2 mRNA vaccine (SYS6006) in healthy Chinese participants: A randomized, observer-blinded, placebo-controlled phase 2 clinical trial. (PubMed, Vaccine) - "No vaccination-associated serious AE was reported. In conclusion, two-dose vaccination with SYS6006 demonstrated good safety, tolerability and immunogenicity in immunologically naïve healthy participants aged 18 years or more."

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

Safety and immunogenicity of primary vaccination with a SARS-CoV-2 mRNA vaccine (SYS6006) in Chinese participants aged 18 years or more: Two randomized, observer-blinded, placebo-controlled and dose-escalation phase 1 clinical trials. (PubMed, Hum Vaccin Immunother) - "In conclusion, two-dose primary vaccination with SYS6006 demonstrated good safety and immunogenicity during a follow-up period of 51 days in immunologically naive population aged 18 years or more. (Trial registry: Chictr.org.cn ChiCTR2200059103 and ChiCTR2200059104)."

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

Effectiveness of a Second COVID-19 Vaccine Booster in Chinese Adults (clinicaltrials.gov) - P4 | N=10000 | Not yet recruiting | Sponsor: Jiangsu Province Centers for Disease Control and Prevention

New P4 trial • Infectious Disease • Novel Coronavirus Disease

A Study of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Older Adults. (clinicaltrials.gov) - P1 | N=40 | Active, not recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Enrolling by invitation ➔ Active, not recruiting | N=60 ➔ 40

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

A Study of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Participants Aged 18 Years or More (clinicaltrials.gov) - P2 | N=450 | Active, not recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Enrolling by invitation ➔ Active, not recruiting

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

A Study of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Adults Aged 18 -59 Years. (clinicaltrials.gov) - P1 | N=40 | Active, not recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Enrolling by invitation ➔ Active, not recruiting

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

A novel mRNA vaccine, SYS6006, against SARS-CoV-2. (PubMed, Front Immunol) - "SYS6006 vaccine could significantly reduce the viral RNA loads and prevent lung lesions in Delta variant infected hACE2 transgenic mice. Therefore, SYS6006 could provide significant immune protection against SARS-CoV-2."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Older Adults. (clinicaltrials.gov) - P1 | N=60 | Enrolling by invitation | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Recruiting ➔ Enrolling by invitation

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

A Study of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Adults Aged 18 -59 Years. (clinicaltrials.gov) - P1 | N=40 | Enrolling by invitation | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Recruiting ➔ Enrolling by invitation | N=60 ➔ 40

Enrollment change • Enrollment status • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Participants Aged 18 Years or More (clinicaltrials.gov) - P2 | N=450 | Enrolling by invitation | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Recruiting ➔ Enrolling by invitation

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

The Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (SYS6006) as Heterologous Booster in Participants Aged 18 Years and Older Vaccinated With Inactivated SARS-CoV-2 Vaccine (clinicaltrials.gov) - P=N/A | N=1000 | Recruiting | Sponsor: Zhongnan Hospital | Not yet recruiting ➔ Recruiting

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

The Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (SYS6006) as Heterologous Booster in Participants Aged 18 Years and Older Vaccinated With Inactivated SARS-CoV-2 Vaccine (clinicaltrials.gov) - P=N/A | N=1000 | Recruiting | Sponsor: Zhongnan Hospital

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

A Study of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Participants Aged 18 Years or More (clinicaltrials.gov) - P2 | N=600 | Recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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

A Study of COVID-19 mRNA Vaccine (SYS6006) in Chinese Healthy Adults Aged 18 -59 Years. (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

New P1 trial • Infectious Disease • Novel Coronavirus Disease

A Study of COVID-19 mRNA Vaccine (SYS6006) in Chinese Healthy Older Adults. (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

New P1 trial • Infectious Disease • Novel Coronavirus Disease