This is a phase 1b, open-label study in adult healthy subjects. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of the hAd5-S-Fusion+N-ETSD vaccine and select a dose for future studies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
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 MAAEs and SAEs
Incidence of MAAEs and SAEs through 1 week post final vaccine administration
Time frame: 1 week
Incidence and severity of solicited local reactogenicity AEs
Incidence and severity of solicited local reactogenicity AEs through 1 week post final vaccine administration
Time frame: 1 week
Incidence and severity of solicited systemic reactogenicity AEs
Incidence and severity of solicited systemic reactogenicity AEs through 1 week post final vaccine administration
Time frame: 1 week
Incidence and severity of unsolicited AEs
Incidence and severity of unsolicited AEs through 1 week post final vaccine administration
Time frame: 1 week
Incidence of MAAEs and SAEs
Incidence of MAAEs and SAEs through 30 days and 6 months post final vaccine administration
Time frame: 30 days to 6 months
Incidence and severity of unsolicited AEs
Incidence and severity of unsolicited AEs through 30 days post final vaccine administration
Time frame: 30 days
Incidence of abnormal changes of laboratory safety examinations
Incidence of abnormal changes of laboratory safety examinations
Time frame: 30 days
Vital Signs - Fever
Changes in vital signs from Grades 1-4: \- Fever - measured in (°C) or (°F)
Time frame: 30 days
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Vital Signs - Tachycardia
Changes in vital signs from Grades 1-4: \- Tachycardia - measured in beats per minute
Time frame: 30 Days
Vital Signs - Bradycardia
Changes in vital signs from Grades 1-4: \- Bradycardia - measured in how many beats per minute
Time frame: 30 Days
Vital Signs - Hypertension
Changes in vital signs from Grades 1-4: \- Hypertension (systolic/diastolic) - measured in mm Hg
Time frame: 30 Days
Vital Signs - Hypotension
Changes in vital signs from Grades 1-4: \- Hypotension (systolic) - measured in mm Hg
Time frame: 30 Days
Vital Signs - Respiratory Rate
Changes in vital signs from Grades 1-4: \- Respiratory Rate - measured in how many breaths per minute
Time frame: 30 Days
GMFR in IgG titer
GMFR in IgG titer
Time frame: Day 387
GMT of S-specific, RBD-specific, and N-specific antibodies against 2019 novel coronavirus
GMT of S-specific, RBD-specific, and N-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Time frame: Day 387
Percentage of subjects who seroconverted
Percentage of subjects who seroconverted (as defined as 4-fold change in antibody titer relative to baseline)
Time frame: Day 387
GMFR in neutralizing antibody
GMFR in neutralizing antibody
Time frame: Day 387
GMT
GMT of neutralizing antibody
Time frame: Day 387
Seroconversion rate of neutralizing antibody
Seroconversion rate of neutralizing antibody (as defined as 4-fold change in antibody titer relative to baseline)
Time frame: Day 387
CD8+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein
CD8+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein measured by ELISPOT assay
Time frame: Day 387
CD4+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein
CD4+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein measured by standard immune assay
Time frame: Day 387