[Translation] A randomized, double-blind, placebo-controlled phase I clinical trial to evaluate the safety and immunogenicity of the respiratory syncytial virus IN006 bivalent mRNA vaccine (IN006) in healthy people aged 18 years and above
主要目的: 1)评价在18-59周岁健康受试者接种IN006的安全性和反应原性;2)评价在60周岁及以上健康受试者初次接种IN006的安全性和反应原性。
次要目的: 1)评价在18-59周岁健康受试者接种IN006的体液免疫应答及其持久性; 2)评价在18-59周岁健康受试者接种IN006的细胞免疫应答及其持久性; 3)评价在60周岁及以上健康受试者初次接种后12个月复种IN006的安全性和反应原性; 4)评价在60周岁及以上健康受试者初次接种IN006的体液免疫应答及其持久性; 5)评价在60周岁及以上健康受试者初次接种IN006的细胞免疫应答及其持久性。
[Translation] Primary objectives: 1) To evaluate the safety and reactogenicity of IN006 in healthy subjects aged 18-59 years; 2) To evaluate the safety and reactogenicity of IN006 in healthy subjects aged 60 years and above after initial vaccination.
Secondary objectives: 1) To evaluate the humoral immune response and its persistence after IN006 vaccination in healthy subjects aged 18-59 years; 2) To evaluate the cellular immune response and its persistence after IN006 vaccination in healthy subjects aged 18-59 years; 3) To evaluate the safety and reactogenicity of revaccination of IN006 12 months after initial vaccination in healthy subjects aged 60 years and above; 4) To evaluate the humoral immune response and its persistence after initial vaccination of IN006 in healthy subjects aged 60 years and above; 5) To evaluate the cellular immune response and its persistence after initial vaccination of IN006 in healthy subjects aged 60 years and above.