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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: 0.5 mL of hAd5-S-Fusion+N-ETSD SC | Experimental | 0.5 mL of hAd5-S-Fusion+N-ETSD SC (5 × 10e10 VP/dose) on days 1 and 22 |
|
| Cohort 2: 1.0 mL of hAd5-S-Fusion+N-ETSD SC | Experimental | Cohort 2: 1.0 mL of hAd5-S-Fusion+N-ETSD SC (1 × 10e11 VP/dose) on days 1 and 22 |
|
| Cohort 3a: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually | Experimental | Cohort 3a: 1.0 mL of hAd5-S-Fusion+N-ETSD SC (1 × 10e11 VP/dose) and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on day 1; 1.0 mL of hAd5-S-Fusion+N-ETSD SC (1 × 10e11 VP/dose) and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on day 22 |
|
| Cohort 3b: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually | Experimental | Cohort 3b: 1.0 mL of hAd5-S-Fusion+N-ETSD SC (1 × 10e11 VP/dose) and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on day 1; no vaccine on day 22 |
|
| Cohort 3c: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hAd5-S-Fusion+N-ETSD vaccine | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of MAAEs and SAEs | Incidence of MAAEs and SAEs through 1 week post final vaccine administration | 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 | 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 | 1 week |
| Incidence and severity of unsolicited AEs | Incidence and severity of unsolicited AEs through 1 week post final vaccine administration | 1 week |
| Incidence of MAAEs and SAEs | Incidence of MAAEs and SAEs through 30 days and 6 months post final vaccine administration | 30 days to 6 months |
| Incidence and severity of unsolicited AEs | Incidence and severity of unsolicited AEs through 30 days post final vaccine administration | 30 days |
| Incidence of abnormal changes of laboratory safety examinations | Incidence of abnormal changes of laboratory safety examinations | 30 days |
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Inclusion Criteria:
potential and non-sterile males. Female subjects of childbearing potential must agree to use effective contraception while on study until at least 1 month after the last dose of vaccine. Non-sterile male subjects must agree to use a condom while on study until at least 1 month after the last dose of vaccine. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), oral contraceptives, and abstinence.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chan Soon - Shiong Institute for Medicine | El Segundo | California | 90245 | United States | ||
| Hoag Memorial Hospital Presbyterian |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Cohort 3c: 1.0 mL of hAd5-S-Fusion+N-ETSD SC (1 × 10e11 VP/dose) and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on day 1; 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on day 22 |
|
| Cohort 3d: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually | Experimental | Cohort 3d: 1.0 mL of hAd5-S-Fusion+N-ETSD SC (1 × 10e11 VP/dose) and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on day 1; 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on days 15 and 29 |
|
| Vital Signs - Fever |
Changes in vital signs from Grades 1-4: - Fever - measured in (°C) or (°F) |
| 30 days |
| Vital Signs - Tachycardia | Changes in vital signs from Grades 1-4: - Tachycardia - measured in beats per minute | 30 Days |
| Vital Signs - Bradycardia | Changes in vital signs from Grades 1-4: - Bradycardia - measured in how many beats per minute | 30 Days |
| Vital Signs - Hypertension | Changes in vital signs from Grades 1-4: - Hypertension (systolic/diastolic) - measured in mm Hg | 30 Days |
| Vital Signs - Hypotension | Changes in vital signs from Grades 1-4: - Hypotension (systolic) - measured in mm Hg | 30 Days |
| Vital Signs - Respiratory Rate | Changes in vital signs from Grades 1-4: - Respiratory Rate - measured in how many breaths per minute | 30 Days |
| GMFR in IgG titer | GMFR in IgG titer | 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 | Day 387 |
| Percentage of subjects who seroconverted | Percentage of subjects who seroconverted (as defined as 4-fold change in antibody titer relative to baseline) | Day 387 |
| GMFR in neutralizing antibody | GMFR in neutralizing antibody | Day 387 |
| GMT | GMT of neutralizing antibody | Day 387 |
| Seroconversion rate of neutralizing antibody | Seroconversion rate of neutralizing antibody (as defined as 4-fold change in antibody titer relative to baseline) | 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 | 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 | Day 387 |
| Newport Beach |
| California |
| 92663 |
| United States |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |