To evaluate the safety and immunogenicity of the COVID-19 mRNA vaccine in people aged 18 years and older, 80 participants will be enrolled and divided into two groups: low- and high-dose groups. Each dose group will be divided into 2 age groups (20 people each):18 to 59 years old and ≥ 60 years old. Subjects will be randomized into vaccine group or placebo group in a ratio of 3:1. Subjects will receive 2 doses of either vaccine or placebo on Day 0 and Day 21, in which the low-dose group will received 0.3 ml of the study vaccine or placebo, and the high dose group will receive 0.5 ml of the study vaccine or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
43
2 doses of vaccine on Day 0 and Day 21
2 doses of placebo on Day 0 and Day 21
Beijing Friendship Hospital
Beijing, Beijing Municipality, China
Hebei Petro China Center Hospital
Langfang, Hebei, China
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, China
The incidence of adverse reactions (AR)
To evaluate the incidence of adverse reactions (AR) within 14 days of immunization in all subjects
Time frame: within 14 days of immunization
The incidence of adverse reactions (AR)
To evaluate the incidence of adverse reactions (AR) within 28 days of immunization in all subjects
Time frame: within 28 days of immunization
The incidence of SAE, MAE and AESI
To evaluation the incidence of SAE, MAE, and AESI within 12 months of full immunization in all subjects
Time frame: From vaccination to post of 12 months vaccination
The incidence of adverse reactions (AR)
To evaluate the incidence of adverse reactions (AR) within 60 minutes of each vaccination in all subjects
Time frame: Within 60 minutes of each vaccination
Changes in laboratory indicators
Changes in white blood cell count
Time frame: Day 4 and Day 7 post each vaccination
Changes in laboratory indicators
Changes in neutrophils
Time frame: Day 4 and Day 7 post each vaccination
Changes in laboratory indicators
Changes in lymphocyte count;
Time frame: Day 4 and Day 7 post each vaccination
Changes in laboratory indicators
Changes in platelet count;
Time frame: Day 4 and Day 7 post each vaccination
Immunogenicity of wild type neutralizing antibodies
Sero-conversation rate of anti-wild type neutralizing antibodies
Time frame: Before the 2nd dose, 14 days after the 2nd dose, and 28 days after the 2nd dose
Immunogenicity of wild type neutralizing antibodies
Geometric mean titer (GMT) of wild type neutralizing antibodies
Time frame: Before the 2nd dose, 14 days after the 2nd dose, and 28 days after the 2nd dose
Immunogenicity of wild type neutralizing antibodies
GMI of wild type neutralizing antibodies
Time frame: Before the 2nd dose, 14 days after the 2nd dose, and 28 days after the 2nd dose
Immunogenicity of anti-S-RBD Ig G antibodies
Sero-conversation rate of anti-S-RBD Ig G antibodies
Time frame: Before the 2nd dose, 14 days after the 2nd dose, and 28 days after the 2nd dose
Immunogenicity of anti-S-RBD Ig G antibodies
GMC of anti-S-RBD Ig G antibodies
Time frame: Before the 2nd dose, 14 days after the 2nd dose, and 28 days after the 2nd dose
Immunogenicity of anti-S-RBD Ig G antibodies
GMI of anti-S-RBD Ig G antibodies
Time frame: Before the 2nd dose, 14 days after the 2nd dose, and 28 days after the 2nd dose
Changes in vital signs
The incidence of outliers detected on vital signs
Time frame: Day 1 to 4 , Day 7 after the first dose, and the day of second dose, Day 4 after the second dose, and day 7 after the second dose
Immuno-persistency of wild type neutralizing antibodies
Sero-conversation rate of anti-wild type virus neutralizing antibodies
Time frame: Month 3,6 and 12 post second vaccination
Immuno-persistency of wild type neutralizing antibodies
GMT of wild type neutralizing antibodies
Time frame: Month 3,6 and 12 post second vaccination
Immuno-persistency of wild type neutralizing antibodies
GMI of wild type neutralizing antibodies
Time frame: Month 3,6 and 12 post second vaccination
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