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Study of the Safety of Prophylactic Vaccination With 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04591717
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
ImmunityBio, Inc.

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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: hAd5-S-Fusion+N-ETSD vaccine Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 19, 2020
Estimated Primary Completion Date : November 19, 2021
Estimated Study Completion Date : November 19, 2021

Arm Intervention/treatment
Experimental: Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 1010 VP per dose
(n = 10): hAd5-S-Fusion+N-ETSD at 5 × 1010 VP per dose
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.

Experimental: Cohort 2 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 1011 VP per dose
(n = 10): hAd5-S-Fusion+N-ETSD at 1 × 1011 VP per dose
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.

Experimental: Cohort 3 (n = 15): hAd5-S-Fusion+N-ETSD at 1 × 1011 VP per dose (or 5 × 1010 VP per dose)
(n = 15): hAd5-S-Fusion+N-ETSD at 1 × 1011 VP per dose (or 5 × 1010 VP per dose)
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.




Primary Outcome Measures :
  1. Incidence of MAAEs and SAEs [ Time Frame: 1 week ]
    Incidence of MAAEs and SAEs through 1 week post final vaccine administration

  2. 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

  3. 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

  4. Incidence and severity of unsolicited AEs [ Time Frame: 1 week ]
    Incidence and severity of unsolicited AEs through 1 week post final vaccine administration

  5. 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

  6. Incidence and severity of unsolicited AEs [ Time Frame: 30 days ]
    Incidence and severity of unsolicited AEs through 30 days post final vaccine administration

  7. Incidence of abnormal changes of laboratory safety examinations [ Time Frame: 30 days ]
    Incidence of abnormal changes of laboratory safety examinations

  8. Vital Signs - Fever [ Time Frame: 30 days ]

    Changes in vital signs from Grades 1-4:

    - Fever - measured in (°C) or (°F)


  9. Vital Signs - Tachycardia [ Time Frame: 30 Days ]

    Changes in vital signs from Grades 1-4:

    - Tachycardia - measured in beats per minute


  10. Vital Signs - Bradycardia [ Time Frame: 30 Days ]

    Changes in vital signs from Grades 1-4:

    - Bradycardia - measured in how many beats per minute


  11. Vital Signs - Hypertension [ Time Frame: 30 Days ]

    Changes in vital signs from Grades 1-4:

    - Hypertension (systolic/diastolic) - measured in mm Hg


  12. Vital Signs - Hypotension [ Time Frame: 30 Days ]

    Changes in vital signs from Grades 1-4:

    - Hypotension (systolic) - measured in mm Hg


  13. 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


  14. GMFR [ Time Frame: Day 387 ]
    GMFR in neutralizing antibody

  15. 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

  16. 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)

  17. GMFR [ Time Frame: Day 387 ]
    GMFR in IgG titer

  18. GMT [ Time Frame: Day 387 ]
    GMT of neutralizing antibody

  19. 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)

  20. 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

  21. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04591717


Contacts
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Contact: Lennie Sender 714-615-2350 Lennie.Sender@NantKwest.com

Locations
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United States, California
Hoag Memorial Hospital Presbyterian Recruiting
Newport Beach, California, United States, 92663
Contact: Deborah Fridman    949-764-4430    Deborah.fridman@hoag.org   
Sponsors and Collaborators
ImmunityBio, Inc.
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Responsible Party: ImmunityBio, Inc.
ClinicalTrials.gov Identifier: NCT04591717    
Other Study ID Numbers: QUILT-COVID-19-hAd5-Vaccine
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No