COVID-19Phase 2/3NCT06022224
A 2nd Generation E1/E2B/E3-Deleted Adenoviral COVID-19 Vaccine: The TCELL VACCINE TRIAL
A Phase 2/3 study testing hAd5-S-Fusion+N-ETSD in people with COVID-19, run by ImmunityBio, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- hAd5-S-Fusion+N-ETSD
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2020to 19 Jul 2023
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
- 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.
Who cannot join
- 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.
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- 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:
- Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation. Other Exclusions
- Investigator site staff or Sponsor employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
About this study
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
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
- Being tested
- hAd5-S-Fusion+N-ETSD, Placebo (0.9% (w/v) saline)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hAd5-S-Fusion+N-ETSDBiological
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.
Placebo (0.9% (w/v) saline)Biological
Clear and colorless liquid.
| Study group | Role | What they receive |
|---|---|---|
| hAd5-S-Fusion+N-ETSD | Experimental | Prime (SC, Day 1) + Boost (SC, Day 22) @ 1x10^11 VP/dose Receives: Biological: hAd5-S-Fusion+N-ETSD |
| Placebo | Placebo comparator | Prime (SC, Day 1) + Boost (SC, Day 22) Receives: Biological: Placebo (0.9% (w/v) saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 7 months (From day 1 to 6 months after last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start9 Dec 2020
- Primary completion23 Jun 2022
- Study completion19 Jul 2023
Why it stopped: There were no participants enrolled into Phase 3 portion of the study because the study was prematurely terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022224
- Sponsor's protocol ID
- COVID-3.001
- Status last verified
- Jun 2024
- First submitted
- 30 Aug 2023
- Last updated
- 7 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06022224
- Acronym / sponsor ID
- COVID-3.001
- Conditions
- COVID-19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There were no participants enrolled into Phase 3 portion of the study because the study was prematurely terminated.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 19 Jul 2023 (actual)
- First posted
- 1 Sep 2023 (actual)
- Results
- Posted 7 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| hAd5-S-Fusion+N-ETSD | Experimental | Biological: hAd5-S-Fusion+N-ETSDPrime (SC, Day 1) + Boost (SC, Day 22) @ 1x10^11 VP/dose |
| Placebo | Placebo comparator | Biological: Placebo (0.9% (w/v) saline)Prime (SC, Day 1) + Boost (SC, Day 22) |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects are eligible to be included in the study only if all of the following criteria apply:
- Male or female participants ≥16 years of age, at randomization.
- Participants who are willing and able to comply with all scheduled assessments, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hAd5-S-Fusion+N-ETSDClear 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 | hAd5-S-Fusion+N-ETSD |
| Placebo (0.9% (w/v) saline)Clear and colorless liquid. | Biological | Placebo |
Primary outcome
Number of Participants With Adverse Events
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing hAd5-S-Fusion+N-ETSD in people with COVID-19, run by ImmunityBio, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: Up to 7 months (From day 1 to 6 months after last dose)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.