Phase 1

[키워드] 95% CI adverse event All participants Alpha anti-RBD antibody assigned Asymptomatic Beta clinical clinical trial clinical trials Complete control group control groups convalescent convalescent individual convalescent individuals COVID-19 criteria Cuba defined delta variant Delta variants dimeric double-blind education elicited ELISA Endpoint enrolled Environment evaluate evaluated experimental group first stage geometric mean geometric mean titre geometric mean titres greater hematology ICTRP IgG antibodies immune response immunogenicity immunology increase in injected injection injection site Intervention intervention group Mild minor Moderate COVID-19 natural immunity Negative PCR neutralisation test neutralising antibody Occurrence Open-label Pain participant Participants PCR test per-protocol population Phase 1 Phase 2 Placebo placebo group placebo-controlled prevaccination Primary outcome Primary outcomes Public randomised Randomly Receptor binding domain recruited Registered registry reported Safety safety analysis safety population safety profile SARS-CoV-2 Science seamless secondary Secondary endpoints Serious Adverse Event Serious Adverse Events seroconversion rate sexual single dose stages study population technology the placebo group titre Trial two groups vaccination Vaccine vaccine immunogenicity Virus neutralisation Volunteer was done WHO-ICTRP
[DOI] 10.1016/S2213-2600(22)00100-X PMC 바로가기 [Article Type] Clinical Trial