Abstract
Background: This study examined the safety and immunogenicity of an inactivated SARS-CoV-2 vaccine.
Method: In a phase I randomized, double-blinded, placebo-controlled trial involving 192 healthy adults 18-59 years old, two injections of three doses (50 EU, 100 EU, 150 EU) of an inactivated SARS-CoV-2 vaccine or placebo were administered intramuscularly at a 2- or 4-week interval. The safety and immunogenicity of the vaccine were evaluated.
Results: Vaccination was completed in 191 subjects. Forty-four adverse reactions occurred within 28 days, most commonly mild pain and redness at the injection site or slight fatigue. At days 14 and 28, the seroconversion rates were 87.5% and 79.2% (50 EU), 100% and 95.8% (100 EU), and 95.8% and 87.5% (150 EU), respectively, with geometric mean titers (GMTs) of 18.1 and 10.6, 54.5 and 15.4, and 37.1 and 18.5, respectively, for the schedules with 2-week and 4-week intervals. Seroconversion was associated with synchronous upregulation of antibodies against the S protein, N protein and virion and a cytotoxic T lymphocyte (CTL) response. No cytokines and immune cells related to immunopathology were observed. Transcriptome analysis revealed the genetic diversity of immune responses induced by the vaccine.
Interpretation: In a population aged 18-59 years in this trial, this inactivated SARS-CoV-2 vaccine was safe and immunogenic.
Trial registration: CTR20200943 and NCT04412538 .
Keywords: Inactivated vaccine; Phase I; SARS-CoV-2.
【저자키워드】 SARS-CoV-2, Phase I, Inactivated vaccine, 【초록키워드】 SARS-CoV-2, immune response, Trial, fatigue, antibody, cytokine, immunopathology, SARS-CoV-2 vaccine, Randomized, placebo-controlled trial, N protein, Pain, Mild, Placebo, genetic diversity, synchronous, transcriptome analysis, CTL, inactivated, dose, Immune cell, Adverse reaction, phase, Safe, double-blinded, GMTs, injection, upregulation, immunogenic, seroconversion rate, virion, geometric mean titer, intervals, cytotoxic T lymphocyte, Administered, occurred, examined, healthy, evaluated, subjects, the S protein, the vaccine, intramuscularly, 【제목키워드】 SARS-CoV-2 vaccine, Randomized, Controlled trial, inactivated, double-blinded, Chinese,