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

NCT04732468 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: COVID-4.005
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (8)

• Incidence of Solicited Local Reactogenicity AEs

  Incidence of Solicited Local Treatment-Related Reactogenicity Adverse Events Through 1 Week Post Final Vaccine

  1 week post final vaccine administration

• Incidence of Solicited Systemic Treatment-Related Reactogenicity AEs

  Incidence of Solicited Systemic Treatment-Related Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration

  1 week post final vaccine administration

• Incidence of Unsolicited AEs

  Incidence of Unsolicited AEs Through 1 Week Post Final Vaccine Administration

  1 week post final vaccine administration

• Incidence of Unsolicited Treatment-Related AEs

  Incidence of Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration

  1 week post final vaccine administration

• Incidence of Unsolicited AEs

  Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration

  30 days post final vaccine

• Incidence of Unsolicited Treatment-Related AEs

  Incidence of Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration

  30 Days Post Final

• Incidence of MAAEs

  Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration

  6 Months post final vaccine administration

• Incidence of Serious AEs

  Incidence of Serious Adverse Events Through 6 Months Post- Final Vaccine Administration

  6 Months Post Final Vaccine

Study Arms (4)

Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule)

EXPERIMENTAL

For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).

Biological: hAd5-S-Fusion+N-ETSD (Suspension for injection); Drug: hAd5-SFusion+ N-ETSD (Oral capsule)

Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule)

EXPERIMENTAL

For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).

Biological: hAd5-S-Fusion+N-ETSD (Suspension for injection); Drug: hAd5-SFusion+ N-ETSD (Oral capsule)

Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral capsule)

EXPERIMENTAL

For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost).

Drug: hAd5-SFusion+ N-ETSD (Oral capsule)

Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule)

EXPERIMENTAL

For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost).

Biological: hAd5-S-Fusion+N-ETSD (Suspension for injection); Drug: hAd5-SFusion+ N-ETSD (Oral capsule)

Interventions

hAd5-S-Fusion+N-ETSD (Suspension for injection) 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.

Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule); Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule); Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule)

hAd5-SFusion+ N-ETSD (Oral capsule) DRUG

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.

Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule); Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule); Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral capsule); Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (2)

Chan Soon - Shiong Institute for Medicine

El Segundo, California, 90245, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Suspensions; Injections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Limitations and Caveats

The study was terminated early due to low enrollment.

Results Point of Contact

• Title: Lennie Sender, Chief Operating Officer
• Organization: Immunitybio

lennie.sender@immunitybio.com

855-797-9277

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 1, 2021
• Study Start: February 24, 2021
• Primary Completion: July 11, 2022
• Study Completion: January 9, 2023
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)