Covid19Phase 1NCT04732468

COVID-19 Oral and Subcutaneous Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenovirus Platform in Healthy Volunteers in USA

A Phase 1 study testing hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule) in people with Covid19, run by ImmunityBio, Inc. at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a phase 1b, open-label study in adult healthy subjects. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity the combination of hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) and to select an optimal combination dose for future… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Covid19
What is being tested?: hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule)
Type of treatment: Vaccines, Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 2 sitesUnited States
Study dates: 24 Feb 2021to 9 Jan 2023
Phase: Phase 1
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 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adults, age 18 - 55 years, inclusive, at time of enrollment.
Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
Agrees to the collection of biospecimens (eg, nasopharyngeal [NP] swabs) and venous blood per protocol.
Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
Ability to swallow a capsule.
Temperature < 38°C.
Negative for SARS-CoV-2 (qPCR or LAMP test) and no known previous COVID-19 exposure or disease.
Agreement to practice effective contraception for female subjects of childbearing potential and non-sterile males. Female subjects of childbearing potential must agree to use effective contraception while on study until at least 1 month after the last dose of vaccine. Non-sterile male subjects must agree to use a condom while on study until at least 1 month after the last dose of vaccine. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), oral contraceptives, and abstinence.

Who cannot join

Allergy to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past.
Pregnant and nursing women. A negative serum or urine pregnancy test during screening and on the day of and prior to each dose must be documented before the vaccine is administered to a female subject of childbearing potential.
Live in a nursing home or long-term care facility.
Chronic lung disease including chronic obstructive pulmonary disease (COPD) or moderate to severe asthma.
Pulmonary fibrosis.
Current or former smoker.

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Bone marrow or organ transplantation.
Obesity (defined as body mass index [BMI] of 30 kg/m2 or higher).
Diabetes.
Chronic kidney disease.
Liver disease.
Sickle cell disease.
Thalassemia.
Doctors, nurses, first responders, and other healthcare workers working in direct contact with COVID-19 patients.
Any disease associated with acute fever, or any infection.
Self-reported history of severe acute respiratory syndrome (SARS).
History of hepatitis B or hepatitis C.
HIV or other acquired or hereditary immunodeficiency.
Serious cardiovascular diseases, such as heart failure, coronary artery disease, cardiomyopathies, arrhythmia, conduction block, myocardial infarction, pulmonary hypertension, severe hypertension without controllable drugs, etc.
Cerebrovascular disease.
Cystic fibrosis.
Neurologic conditions, such as dementia.
Hereditary or acquired angioneurotic edema.
Urticaria in the last 12 months.
No spleen or functional asplenia.
Platelet disorder or other bleeding disorder that may cause injection contraindication.
Chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness within 3 months before administration of study vaccine. (Including, but not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators. The use of low dose topical, ophthalmic, inhaled and intranasal steroid preparations will be permitted.)
Prior administration of blood products in last 4 months.
Prior administration of other research medicines in last 1 month.
Received or plans to receive an attenuated vaccine within 1 month before or after each study vaccination.
Received or plans to receive an inactivated vaccine within 14 days before or after each study vaccination.
Current treatment with investigational, authorized, or approved agents for prophylaxis of COVID-19.
Have a household contact that has been diagnosed with COVID-19.
Current anti-tuberculosis prophylaxis or therapy.
Currently receiving treatment for cancer or history of cancer in the last five years (except basal cell carcinoma of the skin and cervical carcinoma in situ).
According to the judgement of investigator, various medical, psychological, social or other conditions that could affect the subjects ability to sign informed consent.
Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Chan Soon - Shiong Institute for Medicine
El Segundo, California, 90245
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663

Other trials in United States

About this study

Official title: Phase 1b Open-Label Study of the Safety, Reactogenicity, and Immunogenicity of Subcutaneously and Orally Administered Prophylactic Vaccination With 2nd Generation (E1/E2B/E3-Deleted) Adenoviral COVID-19 in Normal Healthy Volunteers

Conditions: Covid19
Being tested: hAd5-S-Fusion+N-ETSD (Suspension for injection), hAd5-SFusion+ N-ETSD (Oral capsule)
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-ETSD (Suspension for injection)Biological
The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule)Drug
The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.

Study groups in NCT04732468
Study group	Role	What they receive
Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule)	Experimental	For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost). Receives: Biological: hAd5-S-Fusion+N-ETSD (Suspension for injection); Drug: hAd5-SFusion+ N-ETSD (Oral capsule)
Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule)	Experimental	For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost). Receives: Biological: hAd5-S-Fusion+N-ETSD (Suspension for injection); Drug: hAd5-SFusion+ N-ETSD (Oral capsule)
Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral capsule)	Experimental	For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost). Receives: Drug: hAd5-SFusion+ N-ETSD (Oral capsule)
Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule)	Experimental	For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost). Receives: Biological: hAd5-S-Fusion+N-ETSD (Suspension for injection); Drug: hAd5-SFusion+ N-ETSD (Oral capsule)

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Solicited Local Reactogenicity AEs
Incidence of Solicited Local Treatment-Related Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
Measured: 1 week post final vaccine administration
Incidence of Solicited Systemic Treatment-Related Reactogenicity AEs
Incidence of Solicited Systemic Treatment-Related Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
Measured: 1 week post final vaccine administration
Incidence of Unsolicited AEs
Incidence of Unsolicited AEs Through 1 Week Post Final Vaccine Administration
Measured: 1 week post final vaccine administration
Incidence of Unsolicited Treatment-Related AEs
Incidence of Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration
Measured: 1 week post final vaccine administration
Incidence of Unsolicited AEs
Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
Measured: 30 days post final vaccine
Incidence of Unsolicited Treatment-Related AEs
Incidence of Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration
Measured: 30 Days Post Final
Incidence of MAAEs
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
Measured: 6 Months post final vaccine administration
Incidence of Serious AEs
Incidence of Serious Adverse Events Through 6 Months Post- Final Vaccine Administration
Measured: 6 Months Post Final Vaccine

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Feb 20219 Jan 2023

First posted1 Feb 2021
Study start24 Feb 2021
Primary completion11 Jul 2022
Study completion9 Jan 2023

Why it stopped: The study was terminated early due to low enrollment.

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 Covid19Studies 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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04732468
Sponsor's protocol ID: COVID-4.005
Status last verified: Sep 2024
First submitted: 27 Jan 2021
Last updated: 15 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Covid19 trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1b Open-Label Study of the Safety, Reactogenicity, and Immunogenicity of Subcutaneously and Orally Administered Prophylactic Vaccination With 2nd Generation (E1/E2B/E3-Deleted) Adenoviral COVID-19 in Normal Healthy Volunteers
ClinicalTrials.gov ID: NCT04732468
Acronym / sponsor ID: COVID-4.005
Conditions: Covid19
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated early due to low enrollment.
Enrolment: 28 participants (actual)
Lead sponsor: ImmunityBio, Inc.Industry (pharma, biotech, devices)
Study start: 24 Feb 2021 (actual)
Primary completion: 11 Jul 2022 (actual)
Study completion: 9 Jan 2023 (actual)
First posted: 1 Feb 2021 (actual)
Results: Posted 15 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule)	Experimental	Biological: hAd5-S-Fusion+N-ETSD (Suspension for injection), Drug: hAd5-SFusion+ N-ETSD (Oral capsule)For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).
Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule)	Experimental	Biological: hAd5-S-Fusion+N-ETSD (Suspension for injection), Drug: hAd5-SFusion+ N-ETSD (Oral capsule)For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).
Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral capsule)	Experimental	Drug: hAd5-SFusion+ N-ETSD (Oral capsule)For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost).
Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule)	Experimental	Biological: hAd5-S-Fusion+N-ETSD (Suspension for injection), Drug: hAd5-SFusion+ N-ETSD (Oral capsule)For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost).

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Healthy adults, age 18 - 55 years, inclusive, at time of enrollment.
Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
Agrees to the collection of biospecimens (eg, nasopharyngeal [NP] swabs) and venous blood per protocol.
Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
Ability to swallow a capsule.

Key exclusion criteria (37 listed)

Allergy to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past.
Pregnant and nursing women. A negative serum or urine pregnancy test during screening and on the day of and prior to each dose must be documented before the vaccine is administered to a female subject of childbearing potential.
Live in a nursing home or long-term care facility.
Chronic lung disease including chronic obstructive pulmonary disease (COPD) or moderate to severe asthma.
Pulmonary fibrosis.

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-ETSD (Suspension for injection)The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.	Biological	Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule), Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule), Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule)
hAd5-SFusion+ N-ETSD (Oral capsule)The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.	Drug	Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule), Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule), Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral capsule), Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule)

Primary outcome

Incidence of Solicited Local Reactogenicity AEs
Time frame: 1 week post final vaccine administration
Incidence of Solicited Local Treatment-Related Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
Incidence of Solicited Systemic Treatment-Related Reactogenicity AEs
Time frame: 1 week post final vaccine administration
Incidence of Solicited Systemic Treatment-Related Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
Incidence of Unsolicited AEs
Time frame: 1 week post final vaccine administration
Incidence of Unsolicited AEs Through 1 Week Post Final Vaccine Administration
Incidence of Unsolicited Treatment-Related AEs
Time frame: 1 week post final vaccine administration
Incidence of Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration
Incidence of Unsolicited AEs
Time frame: 30 days post final vaccine
Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
Incidence of Unsolicited Treatment-Related AEs
Time frame: 30 Days Post Final
Incidence of Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration
Incidence of MAAEs
Time frame: 6 Months post final vaccine administration
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
Incidence of Serious AEs
Time frame: 6 Months Post Final Vaccine
Incidence of Serious Adverse Events Through 6 Months Post- Final Vaccine Administration

Results and safety

Results posted to the registry on 15 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)	4	1
Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)	10	10
Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule)	10	10
Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule)	4	4

Primary outcome: Incidence of Solicited Local Reactogenicity AEs

Time frame: 1 week post final vaccine administration. Count of participants. Unit: Participants

Measure	Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) n = 4	Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) n = 10	Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule) n = 10	Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule) n = 4
Value	3	8	0	3

Population analysed: Analysis population is all subjects who received at least one dose of study intervention (safety analysis population)

Primary outcome: Incidence of Solicited Systemic Treatment-Related Reactogenicity AEs

Time frame: 1 week post final vaccine administration. Count of participants. Unit: Participants

Measure	Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) n = 4	Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) n = 10	Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule) n = 10	Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule) n = 4
Value	4	9	7	4

Population analysed: Analysis population is all subjects who received at least one dose of study intervention (safety analysis population)

Primary outcome: Incidence of Unsolicited AEs

Time frame: 1 week post final vaccine administration. Count of participants. Unit: Participants

Measure	Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) n = 4	Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) n = 10	Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule) n = 10	Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule) n = 4
Value	2	5	5	3

Primary outcome: Incidence of Unsolicited Treatment-Related AEs

Time frame: 1 week post final vaccine administration. Count of participants. Unit: Participants

Measure	Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) n = 4	Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) n = 10	Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule) n = 10	Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule) n = 4
Value	1	4	4	3

Adverse events

Time frame: Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1:Cohort 1	0 of 4 (0%)	3 of 4 (75%)	0 of 4
Group 1: Cohort 2	1 of 10 (10%)	8 of 10 (80%)	0 of 10
Group 1:Cohort 3	1 of 10 (10%)	0 of 10 (0%)	0 of 10
Group 1:Cohort 4	0 of 4 (0%)	3 of 4 (75%)	0 of 4
Group 2: Cohort 1	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Group 2: Cohort 2	0 of 10 (0%)	9 of 10 (90%)	0 of 10
Group 2: Cohort 3	0 of 10 (0%)	7 of 10 (70%)	0 of 10
Group 2: Cohort 4	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Group 3:Cohort 1	0 of 4 (0%)	2 of 4 (50%)	0 of 4
Group 3: Cohort 2	0 of 10 (0%)	5 of 10 (50%)	0 of 10
Group 3: Cohort 3	0 of 10 (0%)	5 of 10 (50%)	0 of 10
Group 3: Cohort 4	0 of 4 (0%)	3 of 4 (75%)	0 of 4
Group 4: Cohort 1	0 of 4 (0%)	1 of 4 (25%)	0 of 4
Group 4: Cohort 2	0 of 10 (0%)	4 of 10 (40%)	0 of 10
Group 4: Cohort 3	0 of 10 (0%)	4 of 10 (40%)	0 of 10
Group 4: Cohort 4	0 of 4 (0%)	3 of 4 (75%)	0 of 4
Group 5: Cohort 1	0 of 4 (0%)	2 of 4 (50%)	0 of 4
Group 5:Cohort 2	0 of 10 (0%)	5 of 10 (50%)

Limitations and caveats (from the sponsor): The study was terminated early due to low enrollment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 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.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule) in people with Covid19, run by ImmunityBio, Inc. at 2 sites 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 8 inclusion and 37 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 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 15 Oct 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?

Incidence of Solicited Local Reactogenicity AEs (time frame: 1 week post final vaccine administration). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04732468.

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 15 Oct 2024.