COVID-19Phase 1NCT04591717
COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral-COVID-19 in Normal Healthy Volunteers
A Phase 1 study testing hAd5-S-Fusion+N-ETSD vaccine in people with COVID-19, run by ImmunityBio, Inc. at 2 sites in United States.
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 of the hAd5-S-Fusion+N-ETSD vaccine and select a dose for future studies. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- hAd5-S-Fusion+N-ETSD vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Oct 2020to 18 Jan 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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.
- 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.
- Active smoker.
Show all 37Show fewer
- 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 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
About this study
Official title: Phase 1b Open-Label Study of the Safety, Reactogenicity, and Immunogenicity of Prophylactic Vaccination With 2nd Generation (E1/E2B/E3-Deleted) Adenoviral-COVID-19 in Normal Healthy Volunteers
This is a phase 1b, open-label study in adult healthy subjects. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of the hAd5-S-Fusion+N-ETSD vaccine and select a dose for future studies.
- Conditions
- COVID-19
- Being tested
- hAd5-S-Fusion+N-ETSD vaccine
- 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 vaccineBiological
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 group | Role | What they receive |
|---|---|---|
| Cohort 1: 0.5 mL of hAd5-S-Fusion+N-ETSD SC | Experimental | 0.5 mL of hAd5-S-Fusion+N-ETSD SC (5 × 10e10 VP/dose) on days 1 and 22 Receives: Biological: hAd5-S-Fusion+N-ETSD vaccine |
| Cohort 2: 1.0 mL of hAd5-S-Fusion+N-ETSD SC | Experimental | Cohort 2: 1.0 mL of hAd5-S-Fusion+N-ETSD SC (1 × 10e11 VP/dose) on days 1 and 22 Receives: Biological: hAd5-S-Fusion+N-ETSD vaccine |
| Cohort 3a: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually | Experimental | Cohort 3a: 1.0 mL of hAd5-S-Fusion+N-ETSD SC (1 × 10e11 VP/dose) and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on day 1; 1.0 mL of hAd5-S-Fusion+N-ETSD SC (1 × 10e11 VP/dose) and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on day 22 Receives: Biological: hAd5-S-Fusion+N-ETSD vaccine |
| Cohort 3b: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually | Experimental | Cohort 3b: 1.0 mL of hAd5-S-Fusion+N-ETSD SC (1 × 10e11 VP/dose) and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on day 1; no vaccine on day 22 Receives: Biological: hAd5-S-Fusion+N-ETSD vaccine |
| Cohort 3c: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually | Experimental | Cohort 3c: 1.0 mL of hAd5-S-Fusion+N-ETSD SC (1 × 10e11 VP/dose) and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on day 1; 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on day 22 Receives: Biological: hAd5-S-Fusion+N-ETSD vaccine |
| Cohort 3d: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually | Experimental | Cohort 3d: 1.0 mL of hAd5-S-Fusion+N-ETSD SC (1 × 10e11 VP/dose) and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on day 1; 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on days 15 and 29 Receives: Biological: hAd5-S-Fusion+N-ETSD vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of MAAEs and SAEs
Incidence of MAAEs and SAEs through 1 week post final vaccine administration
Measured: 1 week
Incidence and severity of solicited local reactogenicity AEs
Incidence and severity of solicited local reactogenicity AEs through 1 week post final vaccine administration
Measured: 1 week
Incidence and severity of solicited systemic reactogenicity AEs
Incidence and severity of solicited systemic reactogenicity AEs through 1 week post final vaccine administration
Measured: 1 week
Incidence and severity of unsolicited AEs
Incidence and severity of unsolicited AEs through 1 week post final vaccine administration
Measured: 1 week
Incidence of MAAEs and SAEs
Incidence of MAAEs and SAEs through 30 days and 6 months post final vaccine administration
Measured: 30 days to 6 months
Incidence and severity of unsolicited AEs
Incidence and severity of unsolicited AEs through 30 days post final vaccine administration
Measured: 30 days
Incidence of abnormal changes of laboratory safety examinations
Incidence of abnormal changes of laboratory safety examinations
Measured: 30 days
Vital Signs - Fever
Changes in vital signs from Grades 1-4:
- Fever - measured in (°C) or (°F)
Measured: 30 days
Vital Signs - Tachycardia
Changes in vital signs from Grades 1-4:
- Tachycardia - measured in beats per minute
Measured: 30 Days
Vital Signs - Bradycardia
Changes in vital signs from Grades 1-4:
- Bradycardia - measured in how many beats per minute
Measured: 30 Days
Vital Signs - Hypertension
Changes in vital signs from Grades 1-4:
- Hypertension (systolic/diastolic) - measured in mm Hg
Measured: 30 Days
Vital Signs - Hypotension
Changes in vital signs from Grades 1-4:
- Hypotension (systolic) - measured in mm Hg
Measured: 30 Days
Vital Signs - Respiratory Rate
Changes in vital signs from Grades 1-4:
- Respiratory Rate - measured in how many breaths per minute
Measured: 30 Days
GMFR in IgG titer
GMFR in IgG titer
Measured: Day 387
GMT of S-specific, RBD-specific, and N-specific antibodies against 2019 novel coronavirus
GMT of S-specific, RBD-specific, and N-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Measured: Day 387
Percentage of subjects who seroconverted
Percentage of subjects who seroconverted (as defined as 4-fold change in antibody titer relative to baseline)
Measured: Day 387
GMFR in neutralizing antibody
GMFR in neutralizing antibody
Measured: Day 387
GMT
GMT of neutralizing antibody
Measured: Day 387
Seroconversion rate of neutralizing antibody
Seroconversion rate of neutralizing antibody (as defined as 4-fold change in antibody titer relative to baseline)
Measured: Day 387
CD8+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein
CD8+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein measured by ELISPOT assay
Measured: Day 387
CD4+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein
CD4+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein measured by standard immune assay
Measured: Day 387
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start19 Oct 2020
- Primary completion20 Apr 2022
- Study completion18 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 34 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
- NCT04591717
- Sponsor's protocol ID
- QUILT-COVID-19-hAd5-Vaccine
- Status last verified
- Mar 2022
- First submitted
- 13 Oct 2020
- Last updated
- 28 Feb 2023
- Results posted
- No
- 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 28 Feb 2023. 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 Prophylactic Vaccination With 2nd Generation (E1/E2B/E3-Deleted) Adenoviral-COVID-19 in Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04591717
- Acronym / sponsor ID
- QUILT-COVID-19-hAd5-Vaccine
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
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 1b, open-label study in adult healthy subjects. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of the hAd5-S-Fusion+N-ETSD vaccine and select a dose for future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: 0.5 mL of hAd5-S-Fusion+N-ETSD SC | Experimental | Biological: hAd5-S-Fusion+N-ETSD vaccine0.5 mL of hAd5-S-Fusion+N-ETSD SC (5 × 10e10 VP/dose) on days 1 and 22 |
| Cohort 2: 1.0 mL of hAd5-S-Fusion+N-ETSD SC | Experimental | Biological: hAd5-S-Fusion+N-ETSD vaccineCohort 2: 1.0 mL of hAd5-S-Fusion+N-ETSD SC (1 × 10e11 VP/dose) on days 1 and 22 |
| Cohort 3a: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually | Experimental | Biological: hAd5-S-Fusion+N-ETSD vaccineCohort 3a: 1.0 mL of hAd5-S-Fusion+N-ETSD SC (1 × 10e11 VP/dose) and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on day 1; 1.0 mL of hAd5-S-Fusion+N-ETSD SC (1 × 10e11 VP/dose) and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on day 22 |
| Cohort 3b: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually | Experimental | Biological: hAd5-S-Fusion+N-ETSD vaccineCohort 3b: 1.0 mL of hAd5-S-Fusion+N-ETSD SC (1 × 10e11 VP/dose) and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on day 1; no vaccine on day 22 |
| Cohort 3c: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually | Experimental | Biological: hAd5-S-Fusion+N-ETSD vaccineCohort 3c: 1.0 mL of hAd5-S-Fusion+N-ETSD SC (1 × 10e11 VP/dose) and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on day 1; 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on day 22 |
| Cohort 3d: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually | Experimental | Biological: hAd5-S-Fusion+N-ETSD vaccineCohort 3d: 1.0 mL of hAd5-S-Fusion+N-ETSD SC (1 × 10e11 VP/dose) and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on day 1; 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on days 15 and 29 |
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.
- Temperature < 38°C.
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 vaccineThe 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: 0.5 mL of hAd5-S-Fusion+N-ETSD SC, Cohort 2: 1.0 mL of hAd5-S-Fusion+N-ETSD SC, Cohort 3a: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually, Cohort 3b: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually, Cohort 3c: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually, Cohort 3d: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually |
Primary outcome
Incidence of MAAEs and SAEs
Time frame: 1 week
Incidence of MAAEs and SAEs through 1 week post final vaccine administration
Incidence and severity of solicited local reactogenicity AEs
Time frame: 1 week
Incidence and severity of solicited local reactogenicity AEs through 1 week post final vaccine administration
Incidence and severity of solicited systemic reactogenicity AEs
Time frame: 1 week
Incidence and severity of solicited systemic reactogenicity AEs through 1 week post final vaccine administration
Incidence and severity of unsolicited AEs
Time frame: 1 week
Incidence and severity of unsolicited AEs through 1 week post final vaccine administration
Incidence of MAAEs and SAEs
Time frame: 30 days to 6 months
Incidence of MAAEs and SAEs through 30 days and 6 months post final vaccine administration
Incidence and severity of unsolicited AEs
Time frame: 30 days
Incidence and severity of unsolicited AEs through 30 days post final vaccine administration
Incidence of abnormal changes of laboratory safety examinations
Time frame: 30 days
Incidence of abnormal changes of laboratory safety examinations
Vital Signs - Fever
Time frame: 30 days
Changes in vital signs from Grades 1-4: - Fever - measured in (°C) or (°F)
Vital Signs - Tachycardia
Time frame: 30 Days
Changes in vital signs from Grades 1-4: - Tachycardia - measured in beats per minute
Vital Signs - Bradycardia
Time frame: 30 Days
Changes in vital signs from Grades 1-4: - Bradycardia - measured in how many beats per minute
Vital Signs - Hypertension
Time frame: 30 Days
Changes in vital signs from Grades 1-4: - Hypertension (systolic/diastolic) - measured in mm Hg
Vital Signs - Hypotension
Time frame: 30 Days
Changes in vital signs from Grades 1-4: - Hypotension (systolic) - measured in mm Hg
Vital Signs - Respiratory Rate
Time frame: 30 Days
Changes in vital signs from Grades 1-4: - Respiratory Rate - measured in how many breaths per minute
GMFR in IgG titer
Time frame: Day 387
GMFR in IgG titer
GMT of S-specific, RBD-specific, and N-specific antibodies against 2019 novel coronavirus
Time frame: Day 387
GMT of S-specific, RBD-specific, and N-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Percentage of subjects who seroconverted
Time frame: Day 387
Percentage of subjects who seroconverted (as defined as 4-fold change in antibody titer relative to baseline)
GMFR in neutralizing antibody
Time frame: Day 387
GMFR in neutralizing antibody
GMT
Time frame: Day 387
GMT of neutralizing antibody
Seroconversion rate of neutralizing antibody
Time frame: Day 387
Seroconversion rate of neutralizing antibody (as defined as 4-fold change in antibody titer relative to baseline)
CD8+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein
Time frame: Day 387
CD8+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein measured by ELISPOT assay
CD4+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein
Time frame: Day 387
CD4+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein measured by standard immune assay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for COVID-19
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingPhase 4
A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Formulations
SARS-CoV-2
Not yet recruitingPhase 2
Study of VYD2311 for the Treatment of Adults With Long-COVID or Post-Vaccination Syndrome
Long COVID, COVID-19 (SARS-CoV-2 Infection)
Active, not recruiting
Motivational Interviewing Intervention for Families With Overweight and Obesity
Obesity & Overweight
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 vaccine in people with COVID-19, 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: finished, as of the sponsor's last update on 28 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 MAAEs and SAEs (time frame: 1 week). The study lists 21 primary outcomes in all. 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 28 Feb 2023.