A 2nd Generation E1/E2B/E3-Deleted Adenoviral COVID-19 Vaccine: The TCELL VACCINE TRIAL

NCT06022224 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: COVID-3.001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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)

  Up to 7 months (From day 1 to 6 months after last dose)

Study Arms (2)

hAd5-S-Fusion+N-ETSD

EXPERIMENTAL

Prime (SC, Day 1) + Boost (SC, Day 22) @ 1x10\^11 VP/dose

Biological: hAd5-S-Fusion+N-ETSD

Placebo

PLACEBO COMPARATOR

Prime (SC, Day 1) + Boost (SC, Day 22)

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

Interventions

hAd5-S-Fusion+N-ETSD BIOLOGICAL

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.

hAd5-S-Fusion+N-ETSD

Placebo (0.9% (w/v) saline) BIOLOGICAL

Clear and colorless liquid.

Placebo

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are eligible to be included in the study only if all of the following criteria apply:
• Age and Sex:
• 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:
• Participants who are willing and able to comply with all scheduled assessments, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
• 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.
• 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:
• 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.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Medical Conditions:
• 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.
• Phase 2 only: Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
• Receipt of medications intended to prevent COVID-19.
• Previous clinical or microbiological diagnosis of COVID-19.
• Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
• Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate subcutaneous injection.
• Women who are pregnant or breastfeeding.
• Prior/Concomitant Therapy:
• Previous vaccination with any coronavirus vaccine.
• 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.
• 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:

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (1)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

There is an insufficient number of subjects enrolled to evaluate the efficacy of the Investigational Product. Thus, only safety results are provided.

Results Point of Contact

• Title: Lennie Sender, Chief Operating Officer
• Organization: ImmunityBio

lennie.sender@immunitybio.com

855-797-9277

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 1, 2023
• Study Start: December 9, 2020
• Primary Completion: June 23, 2022
• Study Completion: July 19, 2023
• Last Updated: June 7, 2024
• Results First Posted: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)