tetano
Editor, Senior Moderator
Vaccine
. 2023 Nov 2:S0264-410X(23)01278-1.
doi: 10.1016/j.vaccine.2023.10.065. Online ahead of print. Phase I study of a non-S2P SARS-CoV-2 mRNA vaccine LVRNA009 in Chinese adults
Gui-Ling Chen[SUP] 1 [/SUP], Xu-Ya Yu[SUP] 2 [/SUP], Li-Ping Luo[SUP] 3 [/SUP], Fan Zhang[SUP] 2 [/SUP], Xia-Hong Dai[SUP] 4 [/SUP], Nan Li[SUP] 4 [/SUP], Zhen-Wei Shen[SUP] 5 [/SUP], Kai-Qi Wu[SUP] 4 [/SUP], Dan-Feng Lou[SUP] 4 [/SUP], Cong-Gao Peng[SUP] 4 [/SUP], Ting-Han Jin[SUP] 4 [/SUP], Yu-Mei Huang[SUP] 2 [/SUP], Xi Shao[SUP] 2 [/SUP], Qi Liu[SUP] 3 [/SUP], Qi Jiang[SUP] 4 [/SUP], Tong Guo[SUP] 4 [/SUP], Fang Cao[SUP] 2 [/SUP], Jing-Rui Zhu[SUP] 2 [/SUP], Xiao-Hong Wu[SUP] 6 [/SUP], Rong-Juan Pei[SUP] 7 [/SUP], Fei Deng[SUP] 7 [/SUP], Guo-Ping Jiang[SUP] 8 [/SUP], Yu-Hua Li[SUP] 9 [/SUP], Hai-Nv Gao[SUP] 10 [/SUP], Jian-Xing He[SUP] 11 [/SUP], Zhong-Chen[SUP] 12 [/SUP], Yu-Cai Peng[SUP] 13 [/SUP], Lan-Juan Li[SUP] 14 [/SUP]
Affiliations
Background: COVID-19 caused by SARS-CoV-2 is a great threat to public health. We present the safety and immunogenicity data from a phase I trial in China of an mRNA vaccine (LVRNA009).
Methods: In the single-centre, double-blind, placebo-controlled and dose-escalation study, 72 healthy unvaccinated adults aged 18-59 years were randomized (3:1) to receive LVRNA009 with one of three vaccine dosage (25, 50 and 100 μg) or placebo, to evaluate for the safety, tolerability and immunogenicity of LVRNA009.
Results: All these participants received two injections 28 days apart. No adverse events higher than grade 2 were reported during the study. A total of 30 participants (42 %) reported solicited adverse reactions during the first 14 days after vaccinations. Of the events reported, fever (n = 11, 15 %) was the most common systemic adverse reaction, and pain at the injection site (n = 17, 24 %) was the most frequent solicited local adverse reaction. Anti-S-protein IgG and neutralising antibodies were observed to have been induced 14 days after the first dose, significantly increased 7 days after the second dose, and remained at a high level 28 days after the second dose. Specific T-cell responses peaked 7 days and persisted 28 days after second vaccination.
Conclusion: 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.
Clinical trial registration number: Clinicaltrials.gov NCT05364047; Chictr.org.cn ChiCTR2100049349.
Keywords: Adverse reaction; Cellular immune; Coronavirus; Humoral immune; Immunogenicity; mRNA-based vaccine.
. 2023 Nov 2:S0264-410X(23)01278-1.
doi: 10.1016/j.vaccine.2023.10.065. Online ahead of print. Phase I study of a non-S2P SARS-CoV-2 mRNA vaccine LVRNA009 in Chinese adults
Gui-Ling Chen[SUP] 1 [/SUP], Xu-Ya Yu[SUP] 2 [/SUP], Li-Ping Luo[SUP] 3 [/SUP], Fan Zhang[SUP] 2 [/SUP], Xia-Hong Dai[SUP] 4 [/SUP], Nan Li[SUP] 4 [/SUP], Zhen-Wei Shen[SUP] 5 [/SUP], Kai-Qi Wu[SUP] 4 [/SUP], Dan-Feng Lou[SUP] 4 [/SUP], Cong-Gao Peng[SUP] 4 [/SUP], Ting-Han Jin[SUP] 4 [/SUP], Yu-Mei Huang[SUP] 2 [/SUP], Xi Shao[SUP] 2 [/SUP], Qi Liu[SUP] 3 [/SUP], Qi Jiang[SUP] 4 [/SUP], Tong Guo[SUP] 4 [/SUP], Fang Cao[SUP] 2 [/SUP], Jing-Rui Zhu[SUP] 2 [/SUP], Xiao-Hong Wu[SUP] 6 [/SUP], Rong-Juan Pei[SUP] 7 [/SUP], Fei Deng[SUP] 7 [/SUP], Guo-Ping Jiang[SUP] 8 [/SUP], Yu-Hua Li[SUP] 9 [/SUP], Hai-Nv Gao[SUP] 10 [/SUP], Jian-Xing He[SUP] 11 [/SUP], Zhong-Chen[SUP] 12 [/SUP], Yu-Cai Peng[SUP] 13 [/SUP], Lan-Juan Li[SUP] 14 [/SUP]
Affiliations
- PMID: 37925316
- DOI: 10.1016/j.vaccine.2023.10.065
Background: COVID-19 caused by SARS-CoV-2 is a great threat to public health. We present the safety and immunogenicity data from a phase I trial in China of an mRNA vaccine (LVRNA009).
Methods: In the single-centre, double-blind, placebo-controlled and dose-escalation study, 72 healthy unvaccinated adults aged 18-59 years were randomized (3:1) to receive LVRNA009 with one of three vaccine dosage (25, 50 and 100 μg) or placebo, to evaluate for the safety, tolerability and immunogenicity of LVRNA009.
Results: All these participants received two injections 28 days apart. No adverse events higher than grade 2 were reported during the study. A total of 30 participants (42 %) reported solicited adverse reactions during the first 14 days after vaccinations. Of the events reported, fever (n = 11, 15 %) was the most common systemic adverse reaction, and pain at the injection site (n = 17, 24 %) was the most frequent solicited local adverse reaction. Anti-S-protein IgG and neutralising antibodies were observed to have been induced 14 days after the first dose, significantly increased 7 days after the second dose, and remained at a high level 28 days after the second dose. Specific T-cell responses peaked 7 days and persisted 28 days after second vaccination.
Conclusion: 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.
Clinical trial registration number: Clinicaltrials.gov NCT05364047; Chictr.org.cn ChiCTR2100049349.
Keywords: Adverse reaction; Cellular immune; Coronavirus; Humoral immune; Immunogenicity; mRNA-based vaccine.