LVRNA009 / AIM Vaccine - LARVOL DELTA

Phase I study of a non-S2P SARS-CoV-2 mRNA vaccine LVRNA009 in Chinese adults. (PubMed, Vaccine) - P1 | "LVRNA009 has demonstrated promising results in safety and tolerability at all three dose levels among Chinese adults. LVRNA009 at three dose levels could rapidly induce strong humoral and cellular immune responses, including binding and neutralising antibody production and IFN- γ secretion, which showed good immunogenicity."

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

Clinical Trial of SARS-CoV-2 mRNA Vaccine in Chinese People (clinicaltrials.gov) - P2 | N=420 | Completed | Sponsor: AIM Vaccine Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Global Multi-center Clinical Study of SARS-CoV-2 mRNA Vaccine for the Prevention of COVID-19 (clinicaltrials.gov) - P3 | N=34000 | Recruiting | Sponsor: AIM Vaccine Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Aug 2023 ➔ Dec 2024

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

Clinical Trial of SARS-CoV-2 mRNA Vaccine(LVRNA009) as Heterologous Booster in Islamabad (clinicaltrials.gov) - P3 | N=1100 | Not yet recruiting | Sponsor: AIM Vaccine Co., Ltd. | Trial completion date: Jun 2024 ➔ Oct 2024 | Initiation date: Dec 2022 ➔ Apr 2023 | Trial primary completion date: Jun 2023 ➔ Oct 2023

Trial completion date • Trial initiation date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Global Multi-center Clinical Study of SARS-CoV-2 mRNA Vaccine for the Prevention of COVID-19 (clinicaltrials.gov) - P3 | N=34000 | Not yet recruiting | Sponsor: AIM Vaccine Co., Ltd.

New P3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Development of Bivalent mRNA Vaccines against SARS-CoV-2 Variants. (PubMed, Vaccines (Basel)) - "We previously developed an mRNA vaccine (LVRNA009) based on the S protein of the Wuhan-Hu-1 strain; the phases I and II clinical trials showed that LVRNA009 has a promising safety and immunogenicity profile...Finally, serum samples from mice immunized with Delta/BA.5 vaccine had high VNTs against all the tested pseudotyped SARS-CoV-2 strains including the Wuhan-Hu-1, Delta, and Omicron variants (p > 0.05). Therefore, a bivalent mRNA vaccine with Delta/BA.5 combination is promising to provide broad spectrum immunity against all VOCs."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Clinical Trial of SARS-CoV-2 mRNA Vaccine in Chinese People (clinicaltrials.gov) - P2 | N=420 | Active, not recruiting | Sponsor: AIM Vaccine Co., Ltd. | Trial completion date: Aug 2023 ➔ May 2023

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

Clinical Trial of SARS-CoV-2 mRNA Vaccine in China (clinicaltrials.gov) - P1 | N=144 | Active, not recruiting | Sponsor: AIM Vaccine Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2022 ➔ Oct 2023

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

Clinical Trial of SARS-CoV-2 mRNA Vaccine(LVRNA009) as Heterologous Booster in Islamabad (clinicaltrials.gov) - P3 | N=1100 | Not yet recruiting | Sponsor: AIM Vaccine Co., Ltd. | Trial completion date: Mar 2024 ➔ Jun 2024 | Initiation date: Sep 2022 ➔ Dec 2022 | Trial primary completion date: Mar 2023 ➔ Jun 2023

Trial completion date • Trial initiation date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Clinical Trial of SARS-CoV-2 mRNA Vaccine(LVRNA009) as Heterologous Booster in Islamabad (clinicaltrials.gov) - P3 | N=1100 | Not yet recruiting | Sponsor: AIM Vaccine Co., Ltd.

New P3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Clinical Trial of SARS-CoV-2 mRNA Vaccine in China (clinicaltrials.gov) - P1 | N=144 | Recruiting | Sponsor: AIM Vaccine Co., Ltd.

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

Phase Ⅱ Clinical Trial of SARS-CoV-2 mRNA Vaccine (clinicaltrials.gov) - P2 | N=420 | Active, not recruiting | Sponsor: AIM Vaccine Co., Ltd.

New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL13 • IL2 • IL4