Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
hAd5-S-Fusion+N-ETSD vaccine · 2 trials · 2 indications
Number of Participants with MAAEs through 1 week post final vaccine administration
Number of Participants with solicited local reactogenicity AEs through 1 week post final vaccine administration
Number of Participants with solicited systemic reactogenicity AEs through 1 week post final vaccine administration
Number of Participants with unsolicited AEs through 1 week post final vaccine administration
Incidence of MAAEs and SAEs through 1 week post final vaccine administration
Incidence and severity of solicited local reactogenicity AEs through 1 week post final vaccine administration
Incidence and severity of solicited systemic reactogenicity AEs through 1 week post final vaccine administration
Incidence and severity of unsolicited AEs through 1 week post final vaccine administration
Changes in vital signs from Grades 1-4: \- Fever - measured in (°C) or (°F)
Changes in vital signs from Grades 1-4: \- Tachycardia - measured in beats per minute
Changes in vital signs from Grades 1-4: \- Bradycardia - measured in how many beats per minute
Changes in vital signs from Grades 1-4: \- Hypertension (systolic/diastolic) - measured in mm Hg
Changes in vital signs from Grades 1-4: \- Hypotension (systolic) - measured in mm Hg
Changes in vital signs from Grades 1-4: \- Respiratory Rate - measured in how many breaths per minute
GMT of S-specific, RBD-specific, and N-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Percentage of subjects who seroconverted (as defined as 4-fold change in antibody titer relative to baseline)
GMT of neutralizing antibody
Seroconversion rate of neutralizing antibody (as defined as 4-fold change in antibody titer relative to baseline)
CD8+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein measured by ELISPOT assay
CD4+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein measured by standard immune assay
| Arm | Type | Description |
|---|---|---|
| Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) per dose | EXPERIMENTAL | hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) per dose on Days 1 and 22 |
| Cohort 2 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose | EXPERIMENTAL | hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose on Days 1 and 22 |
| Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose | EXPERIMENTAL | hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose (or 5 × 10e10 VP per dose if safety concerns identified at higher dose) on Day 1 |
| Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP per dose | EXPERIMENTAL | hAd5-S-Fusion+N-ETSD at 2 × 10e10 VP per nostril (or 4 × 10e10 VP per dose) on Day 1 |
| 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 | EXPERIMENTAL | 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 |
| Name | Type | Description |
|---|---|---|
| hAd5-S-Fusion+N-ETSD vaccine | BIOLOGICAL | The hAd5-S-Fusion+N-ETSD vaccine is a hAd5 \[E1-, E2b-, E3-\] vector-based targeting vaccine encoding the SARS-CoV-2 S and N proteins. The hAd5-S-Fusion+N-ETSD vaccine is designed to induce both humoral and cellular responses even in individuals with pre-existing adenoviral immunity. |
Inclusion Criteria 1. Adults, age 18 - 50 years, inclusive, at time of first study vaccination. 2. Able to understand and provide a signed informed consent that fulfils the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines. 3. Agrees to the collection of bio...
The hAd5-S-Fusion+N-ETSD vaccine is an investigational vaccine being studied for the prevention of COVID-19. It is designed to generate an immune response against the SARS-CoV-2 virus, which causes COVID-19. The vaccine is currently in Phase 1 clinical trials and has not been approved by regulatory authorities.
The hAd5-S-Fusion+N-ETSD vaccine is being developed by ImmunityBio, Inc., a biopharmaceutical company. ImmunityBio is listed on the stock exchange under the ticker symbol IBRX. The company is conducting clinical trials to evaluate the safety and immunogenicity of this vaccine candidate.
The hAd5-S-Fusion+N-ETSD vaccine is in Phase 1 clinical development. It is an investigational vaccine and has not yet received regulatory approval. Two Phase 1 trials have been completed, one in the United States and one in South Africa, involving healthy adult volunteers.
The hAd5-S-Fusion+N-ETSD vaccine has been studied in two completed Phase 1 clinical trials. The first trial, NCT04591717, enrolled 34 healthy volunteers in the United States. The second trial, NCT04710303, enrolled 41 healthy adults in South Africa. Both trials evaluated the vaccine's safety and immune response in healthy individuals.
Yes, the hAd5-S-Fusion+N-ETSD vaccine is a COVID-19 vaccine candidate. It is designed to prevent COVID-19, the disease caused by the SARS-CoV-2 virus. The vaccine is being tested in healthy volunteers to assess its ability to generate an immune response against the virus.