Official Title
A Phase 2/3, Placebo-Controlled, Randomized, Observer-Blind Study To Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of a 2nd Generation E1/E2B/E3-Deleted Adenoviral COVID-19 Vaccine: The TCELL VACCINE TRIAL
Brief Summary

This is a phase 2/3, multicenter, randomized, placebo-controlled, observer-blind studyassessing the safety, tolerability, immunogenicity, and efficacy of prophylactichAd5-S-Fusion+N-ETSD against COVID-19. It is intended that a minimum of 25% of subjectswill be in the >55-year stratum. Safety, immunogenicity, and efficacy assessments will beconducted per the Schedule of Events (SoE) and subjects are expected to participate forup to a maximum of approximately 2 years.

Detailed Description

Not Provided

Terminated
COVID-19

Biological: 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.

Biological: Placebo (0.9% (w/v) saline)

Clear and colorless liquid.

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 16 Years ~ Maximum: 80 Years
Countries
United States
Locations

Hoag Memorial Hospital Presbyterian
Newport Beach 5376890, California 5332921, United States

Not Provided

ImmunityBio, Inc.
NCT Number
MeSH Terms
COVID-19
Sodium Chloride