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Completed

NCT Number: NCT04591717

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chan Soon - Shiong Institute for Medicine, El Segundo, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hAd5-S-Fusion+N-ETSD vaccine

Biological

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 outcomes

  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 in IgG titer

    Time frame: Day 387

    GMFR in IgG titer

  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 in neutralizing antibody

    Time frame: Day 387

    GMFR in neutralizing antibody

  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

Sponsors and collaborators

Lead sponsor

ImmunityBio, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Oct 19, 2020
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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