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COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral-COVID-19 in Normal Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04591717
Recruitment Status : Active, not recruiting
First Posted : October 19, 2020
Last Update Posted : March 29, 2022
Sponsor:
Information provided by (Responsible Party):
ImmunityBio, Inc.

Tracking Information
First Submitted Date  ICMJE October 13, 2020
First Posted Date  ICMJE October 19, 2020
Last Update Posted Date March 29, 2022
Actual Study Start Date  ICMJE October 19, 2020
Estimated Primary Completion Date November 19, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2020)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: October 15, 2020)
  • 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 [ Time Frame: Day 387 ]
    GMFR in neutralizing antibody
  • 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 [ Time Frame: Day 387 ]
    GMFR in IgG titer
  • 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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral-COVID-19 in Normal Healthy Volunteers
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE Biological: hAd5-S-Fusion+N-ETSD vaccine
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 Arms  ICMJE
  • 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
    Intervention: Biological: hAd5-S-Fusion+N-ETSD vaccine
  • 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
    Intervention: Biological: hAd5-S-Fusion+N-ETSD vaccine
  • 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
    Intervention: Biological: hAd5-S-Fusion+N-ETSD vaccine
  • 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
    Intervention: Biological: hAd5-S-Fusion+N-ETSD vaccine
  • 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
    Intervention: Biological: hAd5-S-Fusion+N-ETSD vaccine
  • 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
    Intervention: Biological: hAd5-S-Fusion+N-ETSD vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 19, 2021)
34
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2020)
35
Estimated Study Completion Date  ICMJE November 19, 2022
Estimated Primary Completion Date November 19, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy adults, age 18 - 55 years, inclusive, at time of enrollment.
  2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
  3. Agrees to the collection of biospecimens (eg, nasopharyngeal [NP] swabs) and venous blood per protocol.
  4. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
  5. Temperature < 38°C.
  6. Negative for SARS-CoV-2 (qPCR or LAMP test) and no known previous COVID-19 exposure or disease.
  7. 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:

  1. Allergy to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past.
  2. 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.
  3. Live in a nursing home or long-term care facility.
  4. Chronic lung disease including chronic obstructive pulmonary disease (COPD) or moderate to severe asthma.
  5. Pulmonary fibrosis.
  6. Active smoker.
  7. Bone marrow or organ transplantation.
  8. Obesity (defined as body mass index [BMI] of 30 kg/m2 or higher).
  9. Diabetes.
  10. Chronic kidney disease.
  11. Liver disease.
  12. Sickle cell disease.
  13. Thalassemia.
  14. Doctors, nurses, first responders, and other healthcare workers working in direct contact with COVID-19 patients.
  15. Any disease associated with acute fever, or any infection.
  16. Self-reported history of severe acute respiratory syndrome (SARS).
  17. History of hepatitis B or hepatitis C.
  18. HIV or other acquired or hereditary immunodeficiency.
  19. Serious cardiovascular diseases, such as heart failure, coronary artery disease, cardiomyopathies, arrhythmia, conduction block, myocardial infarction, pulmonary hypertension, severe hypertension without controllable drugs, etc.
  20. Cerebrovascular disease.
  21. Cystic fibrosis.
  22. Neurologic conditions, such as dementia.
  23. Hereditary or acquired angioneurotic edema.
  24. Urticaria in the last 12 months.
  25. No spleen or functional asplenia.
  26. Platelet disorder or other bleeding disorder that may cause injection contraindication.
  27. 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.)
  28. Prior administration of blood products in last 4 months.
  29. Prior administration of other research medicines in last 1 month.
  30. Received or plans to receive an attenuated vaccine within 1 month before or after each study vaccination.
  31. Received or plans to receive an inactivated vaccine within 14 days before or after each study vaccination.
  32. Current treatment with investigational agents for prophylaxis of COVID-19.
  33. Have a household contact that has been diagnosed with COVID-19.
  34. Current anti-tuberculosis prophylaxis or therapy.
  35. 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).
  36. According to the judgement of investigator, various medical, psychological, social or other conditions that could affect the subjects ability to sign informed consent.
  37. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04591717
Other Study ID Numbers  ICMJE QUILT-COVID-19-hAd5-Vaccine
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party ImmunityBio, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE ImmunityBio, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ImmunityBio, Inc.
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP