This is a phase 1b, open-label study in adult healthy subjects. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity the combination of hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) and to select an optimal combination dose for future studies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
Chan Soon - Shiong Institute for Medicine
El Segundo, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Incidence of Solicited Local Reactogenicity AEs
Incidence of Solicited Local Treatment-Related Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
Time frame: 1 week post final vaccine administration
Incidence of Solicited Systemic Treatment-Related Reactogenicity AEs
Incidence of Solicited Systemic Treatment-Related Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
Time frame: 1 week post final vaccine administration
Incidence of Unsolicited AEs
Incidence of Unsolicited AEs Through 1 Week Post Final Vaccine Administration
Time frame: 1 week post final vaccine administration
Incidence of Unsolicited Treatment-Related AEs
Incidence of Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration
Time frame: 1 week post final vaccine administration
Incidence of Unsolicited AEs
Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
Time frame: 30 days post final vaccine
Incidence of Unsolicited Treatment-Related AEs
Incidence of Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration
Time frame: 30 Days Post Final
Incidence of MAAEs
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
Time frame: 6 Months post final vaccine administration
Incidence of Serious AEs
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Incidence of Serious Adverse Events Through 6 Months Post- Final Vaccine Administration
Time frame: 6 Months Post Final Vaccine