COVID-19
Conditions
Brief summary
This is a phase 2/3, multicenter, randomized, placebo-controlled, observer-blind study assessing the safety, tolerability, immunogenicity, and efficacy of prophylactic hAd5-S-Fusion+N-ETSD against COVID-19. It is intended that a minimum of 25% of subjects will be in the \>55-year stratum. Safety, immunogenicity, and efficacy assessments will be conducted per the Schedule of Events (SoE) and subjects are expected to participate for up to a maximum of approximately 2 years.
Interventions
BIOLOGICALhAd5-S-Fusion+N-ETSD
Clear and colorless liquid. Each vaccine is supplied in a 2-mL vial containing 1.0 mL of extractable vaccine at a concentration of 1 × 10\^11 viral particles/mL.
BIOLOGICALPlacebo (0.9% (w/v) saline)
Clear and colorless liquid.
Sponsors
ImmunityBio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
The first 200 subjects randomized will comprise the phase 2 portion of the study. Enrollment may continue during this period and these subjects would be included in the phase 3 portion of the study.
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects are eligible to be included in the study only if all of the following criteria apply: Age and Sex: 1. Male or female participants ≥16 years of age, at randomization. • Refer to Appendix 2 for reproductive criteria for male and female participants. Type of Participant and Disease Characteristics: 2. Participants who are willing and able to comply with all scheduled assessments, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures. 3. Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. Specific criteria for Phase 3 participants with known stable infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) can be found in Appendix 3. 4. Participants who, in the judgment of the investigator, are at higher risk for SARS-CoV-2 infection and subsequent development of COVID-19 (including, but not limited to, use of mass transportation, relevant demographics, and frontline essential workers). Informed Consent: 5. Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply: Medical Conditions: 1. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 2. Phase 2 only: Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV). 3. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). 4. Receipt of medications intended to prevent COVID-19. 5. Previous clinical or microbiological diagnosis of COVID-19. 6. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. 7. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate subcutaneous injection. 8. Women who are pregnant or breastfeeding. Prior/Concomitant Therapy: 9. Previous vaccination with any coronavirus vaccine. 10. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (\<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. 11. Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study. Prior/Concurrent Clinical Study Experience: 12. Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation. Other Exclusions 13. Investigator site staff or Sponsor employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | Up to 7 months (From day 1 to 6 months after last dose) | To define the safety profile of prophylactic hAd5-SFusion+N-ETSD in the first 200 subjects randomized (Phase 2) |
Countries
United States
Participant flow
Pre-assignment details
Only the Phase 2 portion of the study enrolled participants. There were no participants enrolled into Phase 3 portion of the study because the study was prematurely terminated.
Participants by arm
| Arm | Count |
|---|---|
| hAd5-S-Fusion+N-ETSD Prime (SC, Day 1) + Boost (SC, Day 22) @ 1x10\^11 VP/dose
hAd5-S-Fusion+N-ETSD: Clear and colorless liquid. Each vaccine is supplied in a 2-mL vial containing 1.0 mL of extractable vaccine at a concentration of 1 × 10\^11 viral particles/mL. | 17 |
| Placebo Prime (SC, Day 1) + Boost (SC, Day 22)
Placebo (0.9% (w/v) saline): Clear and colorless liquid. | 18 |
| Total | 35 |
Baseline characteristics
| Characteristic | hAd5-S-Fusion+N-ETSD | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 55.3 years STANDARD_DEVIATION 8.43 | 51.0 years STANDARD_DEVIATION 18.12 | 53.1 years STANDARD_DEVIATION 14.23 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 17 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Healthy volunteers with no prior history of Covid | 17 Participants | 18 Participants | 35 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 16 Participants | 32 Participants |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Male | 7 Participants | 10 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 18 | 0 / 17 | 0 / 18 | 0 / 17 | 0 / 18 | 0 / 17 | 0 / 18 | 0 / 17 | 0 / 18 | 0 / 17 | 0 / 18 | 0 / 17 | 0 / 18 | 0 / 17 | 0 / 18 |
| other Total, other adverse events | 0 / 17 | 0 / 18 | 17 / 17 | 5 / 18 | 12 / 17 | 7 / 18 | 15 / 17 | 3 / 18 | 15 / 17 | 1 / 18 | 15 / 17 | 3 / 18 | 15 / 17 | 1 / 18 | 0 / 17 | 0 / 18 |
| serious Total, serious adverse events | 0 / 17 | 0 / 18 | 0 / 17 | 0 / 18 | 0 / 17 | 0 / 18 | 0 / 17 | 0 / 18 | 0 / 17 | 0 / 18 | 0 / 17 | 0 / 18 | 0 / 17 | 0 / 18 | 0 / 17 | 0 / 18 |
Outcome results
Primary
Number of Participants With Adverse Events
To define the safety profile of prophylactic hAd5-SFusion+N-ETSD in the first 200 subjects randomized (Phase 2)
Time frame: Up to 7 months (From day 1 to 6 months after last dose)
Population: Analysis population is all randomized subjects who received at least one dose of study intervention (safety analysis population)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 2 hAd5-S-Fusion+N-ETSD | Number of Participants With Adverse Events | 17 Participants |
| Phase 2 Placebo | Number of Participants With Adverse Events | 18 Participants |