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

NCT04591717 | Completed Phase 1 FDA Drug

• 1 other identifier: QUILT-COVID-19-hAd5-Vaccine
• Study Type: interventional
• Target: 34
• 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 of the hAd5-S-Fusion+N-ETSD vaccine and select a dose for future studies.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (21)

• Incidence of MAAEs and SAEs

  Incidence of MAAEs and SAEs through 1 week post final vaccine administration

  1 week

• Incidence and severity of solicited local reactogenicity AEs

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

  1 week

• Incidence and severity of solicited systemic reactogenicity AEs

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

  1 week

• Incidence and severity of unsolicited AEs

  Incidence and severity of unsolicited AEs through 1 week post final vaccine administration

  1 week

• Incidence of MAAEs and SAEs

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

  30 days to 6 months

• Incidence and severity of unsolicited AEs

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

  30 days

• Incidence of abnormal changes of laboratory safety examinations

  Incidence of abnormal changes of laboratory safety examinations

  30 days

• Vital Signs - Fever

  Changes in vital signs from Grades 1-4: \- Fever - measured in (°C) or (°F)

  30 days

• Vital Signs - Tachycardia

  Changes in vital signs from Grades 1-4: \- Tachycardia - measured in beats per minute

  30 Days

• Vital Signs - Bradycardia

  Changes in vital signs from Grades 1-4: \- Bradycardia - measured in how many beats per minute

  30 Days

• Vital Signs - Hypertension

  Changes in vital signs from Grades 1-4: \- Hypertension (systolic/diastolic) - measured in mm Hg

  30 Days

• Vital Signs - Hypotension

  Changes in vital signs from Grades 1-4: \- Hypotension (systolic) - measured in mm Hg

  30 Days

• Vital Signs - Respiratory Rate

  Changes in vital signs from Grades 1-4: \- Respiratory Rate - measured in how many breaths per minute

  30 Days

• GMFR in IgG titer

  GMFR in IgG titer

  Day 387

• GMT of S-specific, RBD-specific, and N-specific antibodies against 2019 novel coronavirus

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

  Day 387

• Percentage of subjects who seroconverted

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

  Day 387

• GMFR in neutralizing antibody

  GMFR in neutralizing antibody

  Day 387

• GMT

  GMT of neutralizing antibody

  Day 387

• Seroconversion rate of neutralizing antibody

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

  Day 387

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

  CD8+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein measured by ELISPOT assay

  Day 387

• CD4+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein

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

  Day 387

Study Arms (6)

Cohort 1: 0.5 mL of hAd5-S-Fusion+N-ETSD SC

EXPERIMENTAL

0.5 mL of hAd5-S-Fusion+N-ETSD SC (5 × 10e10 VP/dose) on days 1 and 22

Biological: hAd5-S-Fusion+N-ETSD vaccine

Cohort 2: 1.0 mL of hAd5-S-Fusion+N-ETSD SC

EXPERIMENTAL

Cohort 2: 1.0 mL of hAd5-S-Fusion+N-ETSD SC (1 × 10e11 VP/dose) on days 1 and 22

Biological: hAd5-S-Fusion+N-ETSD vaccine

Cohort 3a: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually

EXPERIMENTAL

Cohort 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

Biological: hAd5-S-Fusion+N-ETSD vaccine

Cohort 3b: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually

EXPERIMENTAL

Cohort 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

Biological: hAd5-S-Fusion+N-ETSD vaccine

Cohort 3c: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually

EXPERIMENTAL

Cohort 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

Biological: hAd5-S-Fusion+N-ETSD vaccine

Cohort 3d: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually

EXPERIMENTAL

Cohort 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

Biological: hAd5-S-Fusion+N-ETSD vaccine

Interventions

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.

Cohort 1: 0.5 mL of hAd5-S-Fusion+N-ETSD SC; Cohort 2: 1.0 mL of hAd5-S-Fusion+N-ETSD SC; Cohort 3a: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually; Cohort 3b: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually; Cohort 3c: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually; Cohort 3d: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually

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.
• 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.
• 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.

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

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

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: October 13, 2020
• First Posted: October 19, 2020
• Study Start: October 19, 2020
• Primary Completion: April 20, 2022
• Study Completion: January 18, 2023
• Last Updated: February 28, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)