This is a clinical trial to evaluate the safety and immunogenicity of a recombinant adenovirus 5 vectored COVID-19 vaccine (Ad5-nCoV) with two doses and with different adminstration routes in healthy adults aged 18 years and older.
A total of 168 healthy adult volunteers will be vaccinated in this clinical trial according to open, partly randomized design from the healthy adults aged 18 years and older. The safety and immunogenicity of intramuscular vaccination and mucosal vaccination of two doses of Ad5-nCoV in different administration schedules will be evaluated.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
149
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Zhongnan Hospital
Wuhan, Hubei, China
Incidence of the AE in all groups
The occurrence of AE in all groups within 0-7 days after each vaccination;
Time frame: 0-7 days after each vaccination
Seroconversion rate of the IgG antibody against SARS-CoV-2
Seroconversion rate the IgG antibody against SARS-CoV-2 measured on Day 28 after last vaccination
Time frame: Day 28 after last vaccination
Geomean titers of the IgG antibody against SARS-CoV-2
Geomean titers of the IgG antibody against SARS-CoV-2 measured on Day 28 after last vaccination
Time frame: Day 28 after last vaccination
Seroconversion rate of the neutralizing antibody against SARS-CoV-2
Seroconversion rate of the neutralizing antibody against SARS-CoV-2 measured on Day 28 after last vaccination
Time frame: Day 28 after last vaccination
Geomean titers of the neutralizing antibody against SARS-CoV-2
Geomean titers of the neutralizing antibody against SARS-CoV-2 measured on Day 28 after last vaccination
Time frame: Day 28 after last vaccination
Incidence of the AE in all groups
The occurrence of AE in all groups within 0-30 minutes and 0-28 days after each vaccination.
Time frame: 0-30 minutes, 0-28 days after each vaccination
Incidence of Serious adverse events (SAE) in all groups
The occurrence of Serious adverse events (SAE) in all groups within 6 months after the final vaccination.
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Time frame: 6 months after the final vaccination
Geomean titers of the IgG antibody against SARS-CoV-2
Geomean titers of the IgG antibody against SARS-CoV-2 measured on Day 0, 14, 28 and 56 after first vaccination and on Day 14 and Day168 after last vaccination.
Time frame: Day 0, 14, 28 and 56 after first vaccination and Day 14 and Day168 after last vaccination.
Seroconversion rate of the IgG antibody against SARS-CoV-2
Seroconversion rate of the IgG antibody against SARS-CoV-2 measured on Day 0, 14, 28 and 56 after first vaccination and on Day 14 and Day168 after last vaccination.
Time frame: Day 0, 14, 28 and 56 after first vaccination and Day 14 and Day168 after last vaccination.
Geomean titers of the neutralizing antibody against SARS-CoV-2
Geomean titers of the neutralizing antibody against SARS-CoV-2 measured on Day 0, 14, 28 and 56 after first vaccination and on Day 14 and Day168 after last vaccination.
Time frame: Day 0, 14, 28 and 56 after first vaccination and Day 14 and Day168 after last vaccination.
Seroconversion rate of the neutralizing antibody against SARS-CoV-2
Seroconversion rate of the neutralizing antibody against SARS-CoV-2 measured on Day 0, Day14, Day 28 or Day 56 after first vaccination and on day 14, day 28 and day168 after last vaccination.
Time frame: Day 0, 14, 28 and 56 after first vaccination and on Day 14 and Day168 after last vaccination.
Cellular immune response by ELISpot
The positive rate of IFN-γ stimulated by S protein overlapping peptide library detected by ELISpot on Day 0 and Day 14 after each vaccination
Time frame: Day 0 and Day 14 after each vaccination
Geomean titers of neutralizing antibody response to Ad5-vector
Geomean titers of neutralizing antibody response to Ad5-vector on Day 0, 14 and 28 after each vaccination.
Time frame: Day 0, 14 and 28 after each vaccination.
Cellular immune response by ICS
The positive rate of the specific cytokines expressed by CD4+ and CD8+ T lymphocytes stimulated by S protein overlapping peptide library detected by intracellular cytokine staining on Day 0 and Day 14 after each vaccination
Time frame: Day 0 and Day 14 after each vaccination
Geomean titers of the IgA antibody against SARS-CoV-2
Geomean titers of the IgA antibody against SARS-CoV-2 on Day 0, 14 and 28 after each vaccination.
Time frame: Day 0, 14 and 28 after each vaccination