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...
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| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | ibuzatrelvir, Nirmatrelvir/ ritonavir, BNT162b2/RIV |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Molnupiravir |
| Invivyd, Inc. | IVVD | 2 | PHASE3 | VYD2311 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Tradipitant |
| Moderna, Inc. | MRNA | 2 | PHASE2 | mRNA-1283, mRNA-1273 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Traws Pharma, Inc. | TRAW | 1 | PHASE2 | Ratutrelvir |
| GeoVax Labs, Inc. | GOVX | 1 | PHASE2 | GEO-CM04S1 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE2 | Remdesivir |
hAd5-S-Fusion+N-ETSD vaccine is an investigational COVID-19 vaccine developed by ImmunityBio, Inc. It is designed to prevent infection with SARS-CoV-2, the virus that causes COVID-19. The vaccine uses a second-generation adenoviral platform and has been studied in Phase 1 clinical trials in healthy adult volunteers.
hAd5-S-Fusion+N-ETSD vaccine is being developed for the prevention of COVID-19, the disease caused by the SARS-CoV-2 virus. It is intended for use in healthy adults to induce an immune response against the virus. The vaccine is investigational and has not been approved for any indication.
The hAd5-S-Fusion+N-ETSD vaccine is being developed by ImmunityBio, Inc., a biopharmaceutical company. ImmunityBio trades on the Nasdaq stock exchange under the ticker symbol IBRX. The company is responsible for the research, development, and clinical testing of this vaccine candidate.
The hAd5-S-Fusion+N-ETSD vaccine is in Phase 1 clinical development. It has been evaluated in early-stage trials to assess safety and immune response in healthy volunteers. The vaccine is investigational and has not received approval from the FDA or any other regulatory agency.
The hAd5-S-Fusion+N-ETSD vaccine has been studied in two completed Phase 1 clinical trials: NCT04710303, conducted in South Africa with 41 healthy adult participants, and NCT04591717, conducted in the United States with 34 healthy adult volunteers. Both trials evaluated the vaccine in adults aged 18 years and older.