This is a Phase 1/2a clinical trial to assess the safety and immunogenicity of AdCLD-CoV19 in healthy adults.
Part A is conducted as dose-escalation, single-center, open-label, a Phase 1 clinical trial. Part B is conducted as multi-center, open-label, a Phase 2a clinical trial. In Part A, we assess safety in all dose groups and set suitable two doses for Part B. In Part B, we assess immune responses against SARS-CoV-2 and set suitable dose for next phase of clinical trial. DSMB will evaluate safety during the whole study period.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
150
Replication-defective human adenovirus type 5/35 vector based vaccine expressing S protein of SARS-CoV-2.
Korea University Ansan Hospital
Ansan, Province, South Korea
The Catholic University of Korea, ST. Vincent's Hospital
Suwon, Province, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, State, South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, State, South Korea
Incidence of solicited adverse events(AEs)
Time frame: Through 7 days post-vaccination
Incidence of unsolicited AEs
Time frame: Through 28, 56 days post-vaccination
Incidence of serious adverse events(SAEs)
Time frame: Through 12 months post-vaccination
Incidence of adverse events of special interest(AESIs)
Time frame: Through 12 months post-vaccination
Seroconversion rate(SCR) of neutralization antibody using wild type SARS-CoV-2
Time frame: 4, 8 weeks post-vaccination
Geometric mean titer(GMT) of neutralization antibody using wild type SARS-CoV-2
Time frame: 4, 8 weeks post-vaccination
GMT of S protein specific antibody
Time frame: 2, 4, 8, 26, 52 weeks post-vaccination
Index of T cell response
Time frame: 2, 4, 26, 52 weeks post-vaccination
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Korea University Guro Hospital
Seoul, South Korea