In this trial, a single-arm, open-label study design will be used to evaluate the safety and tolerability after vaccination with escalating doses of the investigational vaccine (Recombinant COVID-19 Vaccine (chimpanzee adenovirus vector) for Inhalation, RCVi) at low, medium, and high doses in healthy adults (previously primed with authorized vaccines).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
0.2mL/dose, Inhalation using a nebulizer
National University Hospital
Singapore, Singapore
Safety in terms of adverse events
Number of Participants with any local and systemic Adverse Events (AEs)
Time frame: within 30 minutes after vaccination
Safety in terms of solicited AEs
Number of Participants with solicited AEs
Time frame: within 7 days after vaccination
Safety in terms of unsolicited AEs
Number of Participants with unsolicited AEs
Time frame: within 28 days after vaccination
Safety in terms of laboratory-based AEs
Changes in laboratory test indicators of clinical significance after vaccination as compared with those before vaccination
Time frame: 4 days after vaccination
Safety in terms of SAEs
Number of Participants with SAEs
Time frame: within 6 months after vaccination
Safety in terms of MAAEs and AESIs
Incidence of all Medical Attended Adverse Events (MAAEs) requiring medical attention and Adverse Events of Special Interest (AESIs)
Time frame: within 6 months after vaccination
Immunogenicity in terms of Humoral immune response by ELISA
GMT of S protein specific antibody by ELISA
Time frame: 15, 29 days, 3 and 6 months after vaccination
Immunogencity in terms of Nab
GMT, seroconversion rate and GMFI of neutralizing antibody (NAb) response
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Time frame: 15, 29 days, 3 and 6 months after vaccination
Immunogencity in terms of Cellular immune response
Intracellular cytokine levels (ICS) in T lymphocytes
Time frame: 15 days after vaccination
Immunogencity in terms of Mucosal immune response
Anti-SARS-CoV-2 S protein mucosal IgA antibodies
Time frame: 15 days after vaccination