- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04591717
COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral-COVID-19 in Normal Healthy Volunteers
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
El Segundo, California, United States, 90245
- Chan Soon - Shiong Institute for Medicine
-
Newport Beach, California, United States, 92663
- Hoag Memorial Hospital Presbyterian
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1: 0.5 mL of hAd5-S-Fusion+N-ETSD SC
0.5 mL of hAd5-S-Fusion+N-ETSD SC (5 × 10e10 VP/dose) on days 1 and 22
|
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.
|
Experimental: Cohort 2: 1.0 mL of hAd5-S-Fusion+N-ETSD SC
Cohort 2: 1.0 mL of hAd5-S-Fusion+N-ETSD SC (1 × 10e11 VP/dose) on days 1 and 22
|
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.
|
Experimental: Cohort 3a: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually
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
|
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.
|
Experimental: Cohort 3b: 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 (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
|
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.
|
Experimental: Cohort 3c: 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 (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
|
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.
|
Experimental: Cohort 3d: 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 (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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of MAAEs and SAEs
Time Frame: 1 week
|
Incidence of MAAEs and SAEs through 1 week post final vaccine administration
|
1 week
|
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
|
1 week
|
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
|
1 week
|
Incidence and severity of unsolicited AEs
Time Frame: 1 week
|
Incidence and severity of unsolicited AEs through 1 week post final vaccine administration
|
1 week
|
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
|
30 days to 6 months
|
Incidence and severity of unsolicited AEs
Time Frame: 30 days
|
Incidence and severity of unsolicited AEs through 30 days post final vaccine administration
|
30 days
|
Incidence of abnormal changes of laboratory safety examinations
Time Frame: 30 days
|
Incidence of abnormal changes of laboratory safety examinations
|
30 days
|
Vital Signs - Fever
Time Frame: 30 days
|
Changes in vital signs from Grades 1-4: - Fever - measured in (°C) or (°F) |
30 days
|
Vital Signs - Tachycardia
Time Frame: 30 Days
|
Changes in vital signs from Grades 1-4: - Tachycardia - measured in beats per minute |
30 Days
|
Vital Signs - Bradycardia
Time Frame: 30 Days
|
Changes in vital signs from Grades 1-4: - Bradycardia - measured in how many beats per minute |
30 Days
|
Vital Signs - Hypertension
Time Frame: 30 Days
|
Changes in vital signs from Grades 1-4: - Hypertension (systolic/diastolic) - measured in mm Hg |
30 Days
|
Vital Signs - Hypotension
Time Frame: 30 Days
|
Changes in vital signs from Grades 1-4: - Hypotension (systolic) - measured in mm Hg |
30 Days
|
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 |
30 Days
|
GMFR in IgG titer
Time Frame: Day 387
|
GMFR in IgG titer
|
Day 387
|
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
|
Day 387
|
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)
|
Day 387
|
GMFR in neutralizing antibody
Time Frame: Day 387
|
GMFR in neutralizing antibody
|
Day 387
|
GMT
Time Frame: Day 387
|
GMT of neutralizing antibody
|
Day 387
|
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)
|
Day 387
|
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
|
Day 387
|
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
|
Day 387
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QUILT-COVID-19-hAd5-Vaccine
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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