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

Phase 1
Completed
Conditions
COVID-19
Interventions
Biological: hAd5-S-Fusion+N-ETSD vaccine
Registration Number
NCT04591717
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
34
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.

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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Cohort 3a: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublinguallyhAd5-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 3c: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublinguallyhAd5-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 3b: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublinguallyhAd5-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 2: 1.0 mL of hAd5-S-Fusion+N-ETSD SChAd5-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 3d: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublinguallyhAd5-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
Cohort 1: 0.5 mL of hAd5-S-Fusion+N-ETSD SChAd5-S-Fusion+N-ETSD vaccine0.5 mL of hAd5-S-Fusion+N-ETSD SC (5 × 10e10 VP/dose) on days 1 and 22
Primary Outcome Measures
NameTimeMethod
Incidence and severity of solicited systemic reactogenicity AEs1 week

Incidence and severity of solicited systemic reactogenicity AEs through 1 week post final vaccine administration

Incidence of abnormal changes of laboratory safety examinations30 days

Incidence of abnormal changes of laboratory safety examinations

Vital Signs - Fever30 days

Changes in vital signs from Grades 1-4:

- Fever - measured in (°C) or (°F)

Vital Signs - Hypertension30 Days

Changes in vital signs from Grades 1-4:

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

GMT of S-specific, RBD-specific, and N-specific antibodies against 2019 novel coronavirusDay 387

GMT of S-specific, RBD-specific, and N-specific antibodies against 2019 novel coronavirus tested by ELISA in serum

GMFR in neutralizing antibodyDay 387

GMFR in neutralizing antibody

Incidence of MAAEs and SAEs30 days to 6 months

Incidence of MAAEs and SAEs through 30 days and 6 months post final vaccine administration

Vital Signs - Tachycardia30 Days

Changes in vital signs from Grades 1-4:

- Tachycardia - measured in beats per minute

Vital Signs - Hypotension30 Days

Changes in vital signs from Grades 1-4:

- Hypotension (systolic) - measured in mm Hg

Vital Signs - Respiratory Rate30 Days

Changes in vital signs from Grades 1-4:

- Respiratory Rate - measured in how many breaths per minute

GMFR in IgG titerDay 387

GMFR in IgG titer

Vital Signs - Bradycardia30 Days

Changes in vital signs from Grades 1-4:

- Bradycardia - measured in how many beats per minute

CD8+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N proteinDay 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 proteinDay 387

CD4+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein measured by standard immune assay

Incidence and severity of solicited local reactogenicity AEs1 week

Incidence and severity of solicited local reactogenicity AEs through 1 week post final vaccine administration

Incidence and severity of unsolicited AEs30 days

Incidence and severity of unsolicited AEs through 30 days post final vaccine administration

Percentage of subjects who seroconvertedDay 387

Percentage of subjects who seroconverted (as defined as 4-fold change in antibody titer relative to baseline)

GMTDay 387

GMT of neutralizing antibody

Seroconversion rate of neutralizing antibodyDay 387

Seroconversion rate of neutralizing antibody (as defined as 4-fold change in antibody titer relative to baseline)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Hoag Memorial Hospital Presbyterian

🇺🇸

Newport Beach, California, United States

Chan Soon - Shiong Institute for Medicine

🇺🇸

El Segundo, California, United States

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