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

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ClinicalTrials.gov Identifier: NCT04732468
Recruitment Status : Active, not recruiting
First Posted : February 1, 2021
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
ImmunityBio, Inc.

Tracking Information
First Submitted Date  ICMJE January 27, 2021
First Posted Date  ICMJE February 1, 2021
Last Update Posted Date July 20, 2021
Actual Study Start Date  ICMJE February 24, 2021
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2021)
  • Incidence of MAAEs and SAEs [ Time Frame: 1 week post final vaccine administration ]
    Incidence of medically-attended adverse events (MAAEs) and serious adverse events (SAEs) through 1 week post final vaccine administration
  • Incidence and severity of solicited local reactogenicity AEs [ Time Frame: 1 week post final vaccine administration ]
    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 post final vaccine administration ]
    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 post final vaccine administration ]
    Incidence and severity of unsolicited AEs through 1 week post final vaccine administration
  • Incidence of MAAEs and SAEs [ Time Frame: 30 days post final vaccine ]
    Incidence of MAAEs and SAEs through 30 days post final vaccine administration
  • Incidence of MAAEs and SAEs [ Time Frame: 6 months post final vaccine ]
    Incidence of MAAEs and SAEs through 6 months post final vaccine
  • Incidence and severity of unsolicited AEs [ Time Frame: 30 days post final vaccine administration ]
    Incidence and severity of unsolicited AEs through 30 days post final vaccine administration
  • Incidence of changes of laboratory safety examinations [ Time Frame: Day 387 ]
    Incidence of abnormal changes of laboratory safety examinations
  • Vital Sign - Temperature [ Time Frame: Day 387 ]
    Changes in vital signs from Grades 1-4: Temperature - measured in (°C) or (°F)
  • Vital Sign - Heart rate [ Time Frame: Day 387 ]
    Changes in vital signs from Grades 1-4: Heart rate - measured by how many heart beats per minute
  • Vital Sign - Blood Pressure [ Time Frame: Day 387 ]
    Changes in vital signs from Grades 1-4: Systolic/Diastolic - measured in mm Hg
  • Vital Sign - Respiratory Rate [ Time Frame: Day 387 ]
    Changes in vital signs from Grades 1-4: Respiratory Rate - measured in how many breaths per minute
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2021)
  • GMFR in IgG titer [ Time Frame: Day 387 ]
    Geometric mean fold rise (GMFR) in IgG titer
  • GMT of S-specific, RBD-specific, and N-specific antibodies [ Time Frame: Day 387 ]
    Geometric mean titer (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, in the absence of evidence of incident natural infection
  • GMT of neutralizing antibody [ Time Frame: Day 387 ]
    GMT in neutralizing antibody, in the absence of evidence of incident natural infection
  • 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 Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE COVID-19 Oral and Subcutaneous Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenovirus Platform in Healthy Volunteers in USA
Official Title  ICMJE 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
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 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 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 Covid19
Intervention  ICMJE
  • Biological: 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.
  • Drug: 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.
Study Arms  ICMJE
  • Experimental: Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for injection) and 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) will be administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).
    Interventions:
    • Biological: hAd5-S-Fusion+N-ETSD (Suspension for injection)
    • Drug: hAd5-SFusion+ N-ETSD (Oral capsule)
  • Experimental: Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for injection) and 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) will be administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).
    Interventions:
    • Biological: hAd5-S-Fusion+N-ETSD (Suspension for injection)
    • Drug: hAd5-SFusion+ N-ETSD (Oral capsule)
  • Experimental: Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral capsule)
    For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) will be administered on days 1 (prime) and on day 22 (boost).
    Intervention: Drug: hAd5-SFusion+ N-ETSD (Oral capsule)
  • Experimental: Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+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) will be administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost).
    Interventions:
    • Biological: hAd5-S-Fusion+N-ETSD (Suspension for injection)
    • Drug: hAd5-SFusion+ N-ETSD (Oral capsule)
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)
26
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2021)
65
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 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. Ability to swallow a capsule.
  6. Temperature < 38°C.
  7. Negative for SARS-CoV-2 (qPCR or LAMP test) and no known previous COVID-19 exposure or disease.
  8. 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. Current or former 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, authorized, or approved 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 NCT04732468
Other Study ID Numbers  ICMJE COVID-4.005
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
Responsible Party ImmunityBio, Inc.
Study Sponsor  ICMJE ImmunityBio, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ImmunityBio, Inc.
Verification Date January 2021

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