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

Stopped early · Phase 1

Conditions studied: Covid19

In brief

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.

Key facts

Study ID

NCT04732468

Run by

ImmunityBio, Inc.

People needed

28

Starts

2021-02-24

Expected to finish

2023-01-09

Last updated by the study team

2024-10-15

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• Ability to swallow a capsule.
• 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.

You may not qualify if…

• 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.
• Current or former 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.

Where it is running

• Chan Soon - Shiong Institute for Medicine — El Segundo, California, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States

Full record on ClinicalTrials.gov

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